EP2531975A2 - Système automatisé de sélection et de transmission de cellules biologiques allogéniques stockées à des fins de greffe, de thérapie et de recherche - Google Patents

Système automatisé de sélection et de transmission de cellules biologiques allogéniques stockées à des fins de greffe, de thérapie et de recherche

Info

Publication number
EP2531975A2
EP2531975A2 EP11705438A EP11705438A EP2531975A2 EP 2531975 A2 EP2531975 A2 EP 2531975A2 EP 11705438 A EP11705438 A EP 11705438A EP 11705438 A EP11705438 A EP 11705438A EP 2531975 A2 EP2531975 A2 EP 2531975A2
Authority
EP
European Patent Office
Prior art keywords
preparations
patient
preparation
hla
nsb
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Withdrawn
Application number
EP11705438A
Other languages
German (de)
English (en)
Inventor
Thomas Klein
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Cytolon AG
Original Assignee
Cytolon AG
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Cytolon AG filed Critical Cytolon AG
Priority to EP11705438A priority Critical patent/EP2531975A2/fr
Publication of EP2531975A2 publication Critical patent/EP2531975A2/fr
Withdrawn legal-status Critical Current

Links

Classifications

    • G—PHYSICS
    • G06—COMPUTING; CALCULATING OR COUNTING
    • G06Q—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR ADMINISTRATIVE, COMMERCIAL, FINANCIAL, MANAGERIAL OR SUPERVISORY PURPOSES; SYSTEMS OR METHODS SPECIALLY ADAPTED FOR ADMINISTRATIVE, COMMERCIAL, FINANCIAL, MANAGERIAL OR SUPERVISORY PURPOSES, NOT OTHERWISE PROVIDED FOR
    • G06Q10/00—Administration; Management
    • G—PHYSICS
    • G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H10/00—ICT specially adapted for the handling or processing of patient-related medical or healthcare data
    • G16H10/40—ICT specially adapted for the handling or processing of patient-related medical or healthcare data for data related to laboratory analysis, e.g. patient specimen analysis
    • G—PHYSICS
    • G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H10/00—ICT specially adapted for the handling or processing of patient-related medical or healthcare data
    • G16H10/60—ICT specially adapted for the handling or processing of patient-related medical or healthcare data for patient-specific data, e.g. for electronic patient records
    • G—PHYSICS
    • G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H20/00—ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance
    • G16H20/40—ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance relating to mechanical, radiation or invasive therapies, e.g. surgery, laser therapy, dialysis or acupuncture

Definitions

  • the invention relates to a system for the automatic, rapid and dynamic switching of biological cells for transplantation, therapy or research purposes between
  • the system is able to propose complete solutions for specific transplants for large patient registries online and automatically, taking into account prioritized repositories and providing medically and logistically advantageous solutions when ordering multiple specimens.
  • the system is capable of automatically selecting, integrating and coordinating service providers involved in the process, such as diagnostic service providers, logistics companies and processors of the required preparations.
  • Identifiers have appropriate NSB preparation for their patient.
  • the registered data refer to the so-called HLA match, to the number of cells present in the preparation and to other medical or biological data (for example blood group).
  • DCM Dilated cardiomyopathy
  • diabetes mellitus e.g., diabetes mellitus
  • Umbilical cord blood preparations a high cell count and a high / guaranteed product quality (including FDA etc. certification) is necessary and this in addition to simple and direct
  • SCBS total system
  • Umbilical cord blood which covers the entire life and production cycle (source material production, production, certified quality assurance and delivery).
  • the overall system meets FDA regulatory quality requirements and standards etc. such as: FACT, CGTP, AAB and from an existing (allogenic) umbilical cord blood supply, a preparation is selected which matches the patient tissue (matching).
  • the donor cells come from a certified source (umbilical cord blood bank), which records the relevant information (eg TNC, HLA loci, number CD34 + cells) per sample according to the quality standards.
  • the source material is processed so that only the relevant cells are processed further and the desired cells (eg CD34 + cells) are expanded ex vivo.
  • the stem cell products produced in this way are completed for use as a "patient treatment kit.” They contain a defined characteristic and can be used directly by the treating physician.
  • Ordered SCBS product matches at least 4/6 antigens or 3/6 alleles with 2 * 10 7 cells / kg in children ( ⁇ 12J) or patients ⁇ 50 kg body weight and 1 * 10 7 cells / kg body weight in all other patients
  • US 2002/0132343 A1 describes as a central element the ability to deliver the SCBS products directly To the transplant centers that have ordered the product, the SCBS products are packaged in special containers that are shipped by courier services, while maintaining quality standards The described SCBS system and methods do not address the issue of automated selection of appropriate products.
  • US 2002/0168639 A1 describes a profiled carrier on which on the one hand a sample tissue can be accommodated and on the other hand there is a microarray on which different comparative samples can be used for simultaneous analysis.
  • the responsiveness of the test tissue or microarray samples is stored in a database and set in relation to other information of the patient from which the test tissue originated (e.g., age, weight, sex, history of the disease).
  • the data bank system disclosed in US 2002/0168639 A1 is connected to an information management system (IMS) that can perform searches and correlations.
  • IMS information management system
  • GB 2407193 A describes a system for biological cell line experiments
  • the system consists of a unit that allows new experiments to be defined and run automatically, with the system being open to the modular registration and use of any experiment and device.
  • the second system component includes the automated analysis (image analysis) of the experiments - this is primarily based on the
  • Image evaluation of assays referenced i. the results of the assays (the experiments) are fed into and analyzed by the system.
  • Variable / extensible analysis techniques can be used.
  • the overall system autonomously controls the execution and analysis of several successive experiments.
  • the implementation process can be flexibly defined / adapted.
  • the results are in a database
  • GB 2407193 A shows that entire laboratory processes for experiments with cell lines
  • the GB . 2407193 A provides a framework for the automated data evaluation in the context of the process.
  • US 2004/0121369 A1 addresses the problem of automating the flexible use of a large number of devices and analytical methods in the context of complex biological laboratory experiments.
  • data for the evaluation to be sequentially transported through different software applications or to process the data in parallel is complex and requires individual human coordination (manual data formatting or time-consuming individual programming).
  • US 2004/0121369 A1 provides a flexible framework for the automation of laboratory experiments and their evaluation. The system enables flexible registration (connection) of
  • WO 02/077640 A2 discloses a system for efficiently processing and evaluating large amounts of data that arise in connection with the analysis of biomolecules with the aid of microarrays and likewise to optimize the analysis process. That revealed
  • lymphocytes are derived from peripheral blood from donors who mate with the patient at least in 4 loci.
  • Some tumors, viral infections and autoimmune diseases are to be treated by means of HLA matched allogeneic activated lymphocytes and no statements are made about the exact selection process.
  • DE 600 30 978 T2 discloses a method which makes it possible to quantitatively analyze several biological samples simultaneously by means of a sensor platform in a high-quality manner.
  • the chemical and physical properties of a sample to be analyzed are determined by the sensor platform and introduced into a signal evaluation.
  • the system can be used to determine the HLA values of samples.
  • Selection system that selects a suitable preparation and the coordinator or a requestor presents the result accordingly.
  • the prior art also does not describe, as with larger registers of patients automated comparison with the Inventory can be made, which is also updated automatically, but always refers to the manual search for a single patient.
  • the object of the invention was therefore to provide a system which does not have the disadvantages of the prior art and allows the automatic selection, further processing and distribution of one or more suitable preparations, in particular NSB preparations.
  • Computer, medical systems, memory devices and / or special processors communicate with each other and over a network consisting of the several
  • Processing units through which data is exchanged, are interconnected, wherein
  • the system includes the following steps:
  • the data of the NSB preparations are entered into the system via a mask, the system storing the data on a storage device accordingly and this data being readable via the processing units connected by the network.
  • a coordinator ie a person, for example, on behalf of a transplantation center for a recipient Searching for a suitable preparation, enters values or data of a recipient via a search mask, which must meet a suitable preparation, so that a "match" - a match, a hit - is present.
  • AML acute myeloid leukemia
  • DCM Diabetic Mellitus or Ischemic Stroke
  • Order processing and follow-up comprising the involvement of service providers comprising diagnostic service providers, logistics service providers or processors, whereby financial transactions are performed by the system, wherein
  • Factors including time and cost predictions, probability of success of the therapy, an HLA match, a patient weight, a number of nucleated cells (TNC), a number of hematopoietic cells (CD34 +) and a number of CD133 + cells ordered and
  • a coordinator at a transplant center who is looking for a suitable NSAID preparation for a recipient can use the system to access the preparations in an umbilical cord blood bank and quickly and easily match the recipient
  • AML acute myeloid leukemia
  • DCM dilated cardiomyopathy
  • diabetic mellitus ischemic stroke.
  • the priority or preference for a bank is a ranking of all banks by valuations of all customers of this bank, which can be carried out via the platform, in particular the system.
  • the user himself can give priority to banks by bringing the banks into a sequential order and thus generating a personal ranking. These orders can then be used in the search for a preparation.
  • a system describes a set of individual components that are related to each other and interact.
  • a system may include both programs and computer equipment (data processing equipment) as well as physical items such as shipping containers, NSB preparations.
  • processing units preferably describe input units via which data or information are input and are preferably stored in digital form.
  • the processing units preferably comprise computers, medical systems, memory devices and / or special processors suitable for input and storage.
  • the processing units may be present in a preferred embodiment separately and / or in various forms of hardware, software and / or firmware. So it may be beneficial if medical system, such as analysis devices, the automatically transferred data into the system and no manual input is required.
  • the teaching according to the invention is also a combination invention, in which the said elements interact to achieve overall technical success and a synergistic effect arises, which is reflected in the surprising properties of the system.
  • the inventive system compares the patient data of the managed
  • Patient register by means of a multi-level compatibility matrix and varying
  • the comparison is carried out fully automatically, wherein a physician can advantageously access the data online.
  • the physician can automatically be presented solution proposals, which single preparation (single-transplant) or which matching preparations (multi-transplant) come into question for a transplant.
  • the actual advantage of "ready to use" stored NSB preparations compared to the lengthy comparative search by coordinators can be fundamentally changed and substantially improved.
  • the system is suitable for all biological, biochemical or chemical substances, the time-critical mediation in transplants or other (medical)
  • the automated system is also used to select and impart chemical and biological therapeutic substances as well as the integration of molecular or genetic analyzes and diagnoses in the selection and definition of possible
  • the invention also relates to a system for switching and selecting biological, biochemical or chemical substances in one
  • a computer system a command given by a subject, the computer system comprising wired and / or wireless interconnected processing units, in particular computers, medical systems, memory devices and / or special processors through which data is exchanged, characterized by:
  • Diagnostic results and / or data of a DNA typing or initial or repeat treatment b) input of genetic, molecular or metabolic data of the at least one patient, NSB donor or an NSB recipient by another subject, wherein the genetic, molecular and / or metabolic analyzes are performed by a service provider or a research institution and this with the Computer system are connected via wired or wireless connections and wherein the genome, the proteome and / or the metabolome is characterized
  • the invention also relates to a machine-executed method for switching and selecting biological, biochemical or chemical substances on a computer system, a command given by a subject, wherein the
  • Computer system comprises wired and / or wireless connections interconnected processing units, in particular computers, medical systems, memory devices and / or special processors, which are exchanged data and the method is characterized by:
  • a treating physician is able to identify certain treatment corridors or to recognize exclusion criteria with regard to basically approved therapies and to point out the patient before the treatment.
  • the analyzes may be carried out by appropriate service providers, who may have access to the computer system and communicate with it via a network.
  • the data determined by the service providers be the first subject, i. H. preferably delivered to the doctor treated and this feeds them into the computer system.
  • the data includes RAW data that is compatible with, and preferably automatically populated with, the computer system.
  • the molecular, genetic and / or metabolic data may also be performed by a laboratory of the hospital where the patient is located.
  • the data after being entered into the computer system, is presented to the physician by imaging techniques.
  • This step-by-step approach to solutions through parallel or successive integration of diagnoses, analyzes or results and knowledge from scientific databases makes it possible for the first time to ensure complex processes for the personalization of therapy in the care of large numbers of patients.
  • Metabolic properties of a cell or tissue This includes:
  • Another aspect is the influence of the nutrient supply and the effect of active substances on the metabolism and the various functions of the cells, such as cell proliferation, differentiation and apoptosis.
  • the metabolic analysis analyzes the
  • Analytical methods are used in the metabolic analyzes, which in the context of the invention also as Metabolomics can be referred to, for example, GC / MS and LC / MS and NMR spectroscopy and ion mobility spectrometer used.
  • the proteome refers in particular to the entirety of all proteins in a living organism, a tissue, a cell or a cell compartment, under precisely defined conditions and at a specific time.
  • the proteome can preferably be analyzed by molecular analysis.
  • a distinction can be made between methods for the separation (chromatography, gel filtration, electrophoresis) of the individual protein species and those for the characterization and identification (mass spectroscopy, sequencing, staining) thereof.
  • the entirety of the hereditary information of a cell is referred to as the genome or hereditary material of a living being
  • DNA Deoxyribonucleic acid
  • the genome is preferably analyzed by genetic analysis (e.g., sequencing, DNA chips).
  • characteristic data of the samples NSAIDs or samples (e.g., blood, urine, faeces, cells, tissues, bone marrow) of the patient are inputted through processing units such as computers.
  • processing units such as computers.
  • the sample is automatically analyzed by one or more analyzers and examined values are automatically transferred to a processing unit.
  • laboratory streets which are a kind of series connection of different analysis devices, samples can be examined and characterized quickly and efficiently.
  • the analyzed values are automatically entered into the system or the computer system and are available so quickly.
  • the data that is, the values specific to a NSB preparation or a patient, are stored on a storage medium.
  • the storage medium or a data storage serves in the sense of the invention for the storage of
  • the storage medium is a mass storage device with preferably magnetic recording technology or semiconductor memory technology or a flash memory.
  • a mass memory referred to in the context of the invention, a storage medium, which stores a large amount of data or information preferably over a longer period.
  • a magnetic memory mass storage device may be used which writes binary data onto the surface of a rotating ferromagnetic disk.
  • Semiconductor memory are within the meaning of the invention data storage, which consist of a semiconductor, in which by means of
  • the data is stored in the form of binary electronic switching states in the integrated circuits. This enables permanent and secure storage of the data.
  • Further processors are within the meaning of the invention, service providers who perform a refining of the cell crude product, for example by so-called KITs or so-called bioreactors, to a better usable cell product.
  • KITs so-called KITs
  • bioreactors service providers who perform a refining of the cell crude product
  • a refinement describes a purification and / or treatment of cells or cell-containing solutions comprising blood with which, in particular, specific cell types can be isolated.
  • cells can be isolated that present certain surface markers, in particular glycoproteins on their surface.
  • the surface markers may comprise, for example, CD133, CD34, CD7, CD44 and / or CD24, where CD stands for "cluster of differentiation"
  • a KIT describes a set of parts that make up something
  • the KIT is preferably used to easily and quickly isolate and purify specific cell types, d. H. separate from other cells or components.
  • the KITs identify and purify stem cells that have at least one particular surface marker. After successful purification, the cells can be expanded, i. H. the cells may be preferred
  • Cell culture conditions are increased.
  • the processing is indispensable for the treatment of various diseases.
  • This complexity is further enhanced by the necessity of having the ever-renewing and expanding stock of stored preparations with a constantly renewing and expanding stock, e.g. on chronically ill patients and to give the attending physician the opportunity to initiate an order, delivery and possible further processing of one or more preparations, as soon as the system by comparing the inventory of preparations with the register of patients one or more solutions for the treatment of a recognizes individual patient.
  • the procedure is as follows: the attending physician registers the relevant patient with the necessary data, such as HLA type, weight or more
  • the depositing point of each preparation in addition to the features describing the preparation, can also mark a preparation by certain features, so that it can be e.g. only for the transplant
  • Indications are not automatically included in the search.
  • Other features can i.a. also prioritizations or classifications e.g. by price, effectiveness or
  • the system is capable of automatically and dynamically large To compare stored stock of cells or biological materials (including NSAIDs) with the requirements of registered patients, to identify solutions for the required therapy also as a combination of several stored preparations and, if appropriate, to trigger provisional reservations automatically.
  • patient and specimen information e.g., HLA scores or weight and cell count
  • information processing systems e.g., HLA scores or weight and cell count
  • the correspondence is essentially based on the fact that data of the NSB preparations with those of a recipient or
  • the system compares e.g. the HLA values of the NSB preparation with those of the recipient. If there is one or more matches, the corresponding preparation will be weighted to the number of
  • the information about the available umbilical cord blood preparations are advantageously made available and updated decentralized by the blood banks.
  • the information about the available NSBP inventory for example, converges in a repository (database) and is made available there for search.
  • the search parameters which are used in the weighting and automated selection can be stored centrally for the treating physicians and hospitals.
  • the preset search parameter sets can be called up and, if necessary, modified by an expert (expert mode).
  • the search for suitable NSBP advantageously takes place automatically, but can also be carried out or checked step by step by a specialist.
  • the system supports the processes via an automated workflow, that is, a workflow that runs in a predefined sequence of activities in an organization.
  • the workflow always informs about the upcoming orders and the work status of individual orders, which improves the quality of the results and makes the processes themselves more efficient and faster.
  • the system is able to collect the medically and pharmacologically necessary information.
  • the system can automate statistics on the processing speed and speed of blood banks, as well
  • the coordinator receives a clear presentation of the settlement and can use this, if necessary, improve work processes or order processing, as it receives useful evaluations on, for example, the blood bank.
  • AML acute myeloid leukemia
  • Cardiomyopathy diabetic mellitus or ischemic stroke. That is, the system compares the data of the NSB preparations with those of the patients, whereby the NSB preparations and the patients with in particular identical parameters and data sets are stored by the system on a storage medium.
  • patients and NSAIDs can be analyzed by molecular diagnostic analysis, generating genetic, molecular and / or metabolic data. The system can thus compare the data of the NSB preparations with those of the patients and
  • Logistic service providers and processors who carry out a purification of the cell raw product, in particular by KITs, to a better usable cell product are automatically connected to the system via a network, this includes the automated selection of service providers and their coordination by the system.
  • NSB preparations that are stored worldwide in various NSB banks or withdrawal centers are recorded with an advantageously uniform data set (Unit Report) as a parameter. That is, it is preferred that the NSB preparations be detected and stored in the system with at least one of the following parameters:
  • NBP umbilical cord blood preparation
  • Invention describes a parameter a characteristic, that is a characterizing
  • this operational information includes attributes of patients, clinics, physicians, donors, blood banks, NSAIDs (laboratory values, physical and informational properties), order and settlement information and controlling information including search / exclusion criteria, thresholds and weighting factors.
  • parameters are recorded which are for
  • Labeling of the preparations can be used.
  • the advantageous combination of the parameters is not described in the prior art and allows a clear assignment and detection of a preparation.
  • a database within the meaning of the invention, an NSBP database can be created, in which the parameters are stored.
  • the input of the parameters can, for example, be made decentralized by the NSB bank, whereby the database of the system can be maintained or updated by the latter.
  • the database of the system can be maintained or updated by the latter.
  • the status of the bank with regard to international certifications eg Fact - "Foundation for the Accreditation of Cellular Therapy" is saved, thereby ensuring It is also possible to register a contact person at the respective bank with contact details, for example a doctor or a coordinator who is responsible for maintaining the database at the bank is.
  • a system-uniform identification number is preferably assigned, which allows an unambiguous assignment. Besides, so the search for drugs from the NSB-Bank, both comprehensive. In addition will be
  • the system automatically collects settlement reliability information for each NSB bank and takes it into account during the search. Furthermore, data for the medical history of the Mother, child and family are included in the database according to a medical history sheet of the Maternity Hospital. This advantageously makes it possible to evaluate the preparations with regard to certain diseases, for example hereditary diseases.
  • the ethnicity of the mother, the father, and / or the child is beneficial as information because certain genetic variations may be associated with the ethnic background, and thus possibly one
  • the record of each specimen contains information on whether the specimen was frozen in segments (if so, how many) and fragments (if any, how many) and DNA samples (if any, how many). Fragments, segments and samples are used to determine the specimen later with regard to a specific
  • the system informs how many of the segments, fragments and DNA samples are still present at the request, or what other tests such as e.g. Confirmatory Typing (HR) or high-resolution HLA typing (CA) or colony assays (CA) have already been performed or were the results of this test.
  • HR Confirmatory Typing
  • CA high-resolution HLA typing
  • CA colony assays
  • the status of a preparation is recorded, i. if and since when the drug may be reserved by a clinic.
  • the database comprising the data or parameters may also be referred to as a data warehouse, i. a central data collection whose contents are data
  • MultiCord later double or multiple transplantation
  • the database contains the patient registers, ie the data of all patients managed by the individual transplant centers or clinics with the patient-related data (eg HLA type) and the therapy-related data (eg indication or frequency of therapy), which are also included in the dynamic comparison so that, when placing a new preparation or registering a new patient, a direct automated check is made as to whether a preparation can be used for a specific patient individually or in combination with other preparations for transplantation or therapy
  • the first order criterion for a multi-cord alignment between the registered preparations is the HLA match. At least four out of six HLA characteristics are preferred
  • an order describes a defined sequence of elements.
  • the order of the elements may be related to their properties, for example the parameters or attributes (eg NSB preparations).
  • the order criteria describe how the order is made (for example, stringing all NSB preparations according to their TNC size from the largest to the smallest preparation).
  • Filter criteria are applied, that is, for example, only preparations for a
  • Search are taken into account, which have a defined TNC size. It is particularly advantageous that with larger amounts of data these orders can be used as an index in order, for example, to perform efficient searches (also as a combination across multiple criteria).
  • the second order criterion is the blood groups equality or compatibility.
  • Equipments with blood groups Equality are again at the top, those with tolerability follow and blood groups which exclude lead to the unfit suitability as MultiCord with regard to certain other preparations.
  • Another important classification criterion is the priority assigned by the user on the basis of his experience with which certain deposits are preferred.
  • the deposits of the already selected preparations are taken into account by the system, so that further preparations from the same or logistically located if possible
  • Deposits are preferred.
  • the order criteria can also be applied analogously for a single-cord transplantation, in which case the data of one or more preparations are compared with those of a recipient.
  • the requesting clinic carries out a patient search, wherein the
  • a patient can be clearly characterized, advantageously comparing the data of a patient with stored data of a preparation in an NSB bank.
  • the patient and the preparation are characterized by the same criteria, whereby a direct comparison is possible.
  • Compatibility matrix are compared in several stages and different order criteria.
  • the compatibility matrix allows a direct and simple comparison of the
  • the treating physician is presented with a plurality of results, that is to say preparations which would be optimal for a patient. Furthermore, preparations for single-cords or multi-cords with regard to the
  • the criterion of indication and therapy suggestion of the treating physician the diagnosis, analysis and indication of the disease in which the patient suffers, for example, acute myeloid leukemia (AML), dilated cardiomyopathy (DCM), diabetes mellitus or ischemic stroke and for the the treating physician suggests a particular treatment (therapy).
  • the proposed therapy includes, among other things, a determination of the product to be used (for example umbilical cord blood preparation as finished medicinal product), the time, duration and duration of the treatment as well as the number, dosage and administration of the product (s) and possible measures in the event of a relapse.
  • the criterion of urgency is defined according to defined
  • the classification table can be determined by a coordinator and is oriented to the medical urgency with which the patient needs the preparation
  • the parameters which are important for a particular patient, for example, and which are consequently important for the search for a suitable preparation can be predefined before the search by the attending physician or the clinic, whereby an efficient and automated search processing is possible.
  • the information about the treating clinic not only for the
  • Quality assurance of the process is logged, but collected as necessary information in advance, without which the search process can not begin. Furthermore, the preferred embodiment automatically collects per-clinic statistics on the number and type of transplantation, thereby simplifying the evaluation of a clinic for its suitability for transplantation. This makes it particularly easy to exclude clinics that have little to no experience with transplants.
  • the order of the potential umbilical cord preparations is determined as follows:
  • the standard orders of preparations in a shortlist are based on the following criteria:
  • Order 1 rank first by match level, then by ordinal number, then by cell number
  • CDXX + p re p number of cells comprising particular surface marker of the group "Cluster of differentiation” comprising CD34 and / or CD133.
  • the preferred embodiment is also a combination in which said elements interact to achieve overall technical success, thereby producing a synergistic effect which results in a surprisingly efficient and rapid search for adequate preparations.
  • the ordering criteria within the meaning of the invention may also be referred to as search criteria.
  • the search can be carried out automatically, whereby the search can proceed much faster and no errors occur by persons involved in the search.
  • the search for a suitable preparation is divided into several stages.
  • the first stage is the "Basic Search.”
  • a so-called “long list” that is, a long list that advantageously includes all products in order of precedence that are in at least four out of six HLA typifications, will appear and comply with do not exclude blood group affiliation, ie
  • the result is a match level corresponding to the HLA matches between preparation and patient.
  • the clinic can also import preparations from NSB banks that are not registered in the "Basic Search".
  • the next level is the “Advanced Search”, whereby advantageously a two-part “Short List”, that is a short list, can be used.
  • the list advantageously includes possible single grafts (SingleCord View). These are preparations that correlate with the order criteria HLA-Match, patient weight and number of so-called nucleated cells (TNC) as well as number of hematopoietic cells (CD34 +), CD133 + cells and others
  • Cell types can be considered as a single graft.
  • the correlation is based on the following Key Figures: In an HLA match of six out of six, for example, the patient needs at least 3.0 x 10 7 TNC per kg of body weight of the patient; ie the patient has one
  • Body weight of, for example 55 kg the preparation could have a total of at least 1.65 x 10 9 nucleated cells.
  • the same patient requires at least 4.0 x 10 7 TNC per kg of body weight, according to which the preparation might have at least 2.2 x 10 9 TNC at a patient weight of 55 kg.
  • the preparation could have, for example, at least 5.0 ⁇ 10 7 TNC / kg, ie a total of 2.75 ⁇ 10 9 TNC.
  • ranking lists of the identified preparations can advantageously be prepared according to, for example, two selectable criteria: 1) highest HLA match and subsequently highest relative cell number or 2) highest relative cell number and subsequently highest HLA match. If the determined preparations have the same positioning, the further ranking of the preparations is optionally determined by the height of the cell number of CD34 + , CD133 + or other cell types.
  • the most suitable umbilical cord blood preparation from a given supply of NSB preparations can be identified and prepared for shipment.
  • the selection process of the preparation is automated. So it is possible to standardize the time-consuming manual selection procedure and to
  • Ranking of the NSB Bank in particular through evaluations of all clients of this bank, through personal prioritization of the user and / or ranking of the NSB Bank based on the first selected product in a multi-drug search based on logistically advantageous criteria.
  • the classification criteria or selection criteria or exclusion criteria may also be referred to as parameters within the meaning of the invention.
  • preparations with a CD34 + cell count higher than 10% of the TNC cell number are advantageously weighted differently.
  • Products containing less than 75% of CD34 + cells in the CA (Colony Assay) are excluded to guarantee a high number of hematopoietic stem cells.
  • Other criteria, such as blood group identity, ethnic identity and gender, may further limit the choice of drug.
  • old preparations can be excluded, whereby advantageously only those products are used for transplantation, which have not exceeded a defined age, whereby a surprisingly high quality is ensured.
  • the accreditation standard and ranking of the NSB Bank can also be used for selection.
  • banks can be excluded, for example, have little experience with the storage or transplantation of umbilical cord blood.
  • selection criteria can be defined that make the search for a suitable preparation easier and also can simplify the selection of a preparation.
  • This information can also be used on the reliability and delivery speed of the NSB, which are automatically collected by the system.
  • These additional criteria can be awarded once within the framework of the clinic policy or re-prioritized in each individual case. The prioritization decides the
  • the preferred embodiment be used to mediate double or multiple transplants (multicord). This makes it possible, depending on the required number of cells to perform a double or multiple transplantation. In other words, if the patient requires more cells than can be provided by a suitable preparation, another suitable preparation can be searched automatically.
  • MLp 1P2 Compatibility of 2 preparations with each other:
  • ML P1P2 ⁇ - 4 HLA prep and HLA preparation in Avon 6 values and blood group compatibility Exposure is not taken into account: otherwise
  • the preferred embodiment offers a second part of the "short list" of the MultiCord View with preparations which are matched to one another, that is to say, are mutually compatible.
  • the (sub-) preparation should be regarded as advantageous (as the "first"), indicating that the higher CD34 +, CD133 + or comparable further cell number, depending on the indication for which the search is made Cells that
  • Surface markers ie surface molecules of the Cluster of Differentiation group, which are specific for stem cells in particular, appear on the short list for each SingleCord and MultiCord and have a preliminary cost budget of a preparation according to standard values according to the status of the preparations calculated, as well as the probable delivery time as well as the probability of success of the treatment.
  • the search results can advantageously be displayed in a "compare view” with up to four specimens, which can be compared in a clear way with the patient data.
  • the "compare view” compares all data of the unit report with the data of the patient
  • the final stage of the selection process are the proposed solutions, which are advantageously presented to a treating physician in a clear manner.
  • the proposals advantageously comprise individual preparations and / or multi-cord preparations. It is the doctor's final decision as to whether and for which SingleCord or MultiCord he chooses.
  • this folder can be constructed as follows:
  • Sheet 1 can be a worksheet or a slip on which the one or more preparations in addition to the
  • Patient data will be shown and on the necessary further steps that can be processed until transplantation. These are above all the requirement of HR typing, DNA samples, CAs, but also direct contact with the NSB bank concerned, reservations up to the binding order, transport logistics, integration of processors and invoicing up to handover to the clinic administration ,
  • Sheet 2 of the proposed solution may contain the complete unit report (s).
  • Sheet 3 of the proposed solution can be used to document the decision; It summarizes the decision-making criteria of the doctor, determines the final budget and is signed by the doctor. On this sheet, the doctor can refer to other suggested solutions, which are used alternatively, if the desired solution can not or can not be implemented due to events.
  • Sheet 4 can provide a clear presentation in terms of the preparation, the timing and the transplantation in general, which is the doctor for the patient interview or the patient for information available.
  • the sheets from the suggested solution are available to the clinic for further processing, such as billing and follow-up of transplantation, such as
  • the patient's medical history is available to the NSB or NSB banks concerned at any given time
  • a cell preparation suitable for allogeneic transplantation is selected.
  • the transplanted tissue is not from the recipient but from a donor of the same biological species.
  • successful allografting requires as complete a match as possible with the recipient's tissue required.
  • the search for a suitable, that is appropriate preparation can be carried out easily, quickly and advantageously automatically based on the predefined parameters, which surprisingly the risk of
  • the automatic and complete selection for single-cord or multi-cord transplants takes place.
  • the treating physician and / or the coordinator appropriate preparations are proposed, which match based on the parameters to each other and generate no rejection reactions.
  • the preparations suitable for each other and for the patient are correspondingly displayed so as to considerably simplify and accelerate the selection.
  • the attending physician can accordingly be presented with both options and can judge for himself whether a multicord or single-cord transplantation should take place. Surprisingly, errors can be avoided by automatic selection and single-cord and / or multi-cord transplants can be presented to the attending physician.
  • the presentation takes place in a clear manner, whereby the selection of the preparations by the doctor is simplified:
  • search criteria be adapted to the entered criteria and / or parameters.
  • the extensibility of the data scheme of NSBP and patient is advantageous in order to be able to adjust further search criteria to the state of the art.
  • a matrix is used for the representation of the results obtained via the search criteria and the results are displayed visually.
  • the preferred embodiment offers a visual orientation about the best search results according to the currently selected search parameters.
  • the search results are arranged and visualized in a matrix.
  • the matrix can be dynamically resorted according to the different criteria.
  • the fit accuracy based on the preset search criteria is displayed in color.
  • the matrix may be referred to as a heat map, in which data of a parameter are listed as colors in a two-dimensional representation.
  • statistics on the expected costs and the time to be used are used.
  • statistics can be used for the search for a suitable preparation for the classification criteria determination.
  • preparations can be assessed faster and arranged accordingly.
  • a cost and time-reducing search is possible.
  • the coordinator and the doctor can advantageously focus on the suitability of the various well-defined and documented proposed solutions. It is preferred that the coordination between clinic, diagnostic and logistics service providers, processors, transplantation center and doctor treating done by the preferred embodiment. This ensures that there is reliable communication between the clinic, ie if necessary the attending physician, the transplant center and all other parties involved.
  • the search parameters and the results are clearly presented, which makes the selection considerably easier.
  • the parameters according to which the search is based are variable and can be adapted to the patient and / or the desired product. This is a major step forward from the current situation where coordinators are forced to evaluate possible transplants at a very early stage and according to different criteria. This leads today to unsatisfactory results and is very time and
  • one or more matching preparations can be searched and ordered in a short time.
  • a medical clinic for cardiology has a registry of well-qualified patients suffering from DCM (Dilated Cardiomyopathy).
  • DCM dilated Cardiomyopathy
  • Cardiomyopathies describe diseases of the heart muscle.
  • the left ventricle ventricle
  • all others are first
  • Heart cavities significantly expanded the heart can be compared to a large, flaccid sack.
  • the wall thicknesses are usually not or only slightly thickened (hypertrophied).
  • causes for DCM may have expired
  • DCM Heart muscle inflammation and chronic alcohol abuse.
  • a secondary form is the "ischemic DCM" due to coronary artery disease or the end-stage of a high-pressure heart DCM is a common cause of heart transplantation if the patient's condition with medication, coronary intervention, or cardiac resynchronization therapy (CRT) is not sufficiently improved The diagnosis is made after clinical suspicion with the typical
  • Symptoms were confirmed by imaging techniques (echocardiography, MRI, MSCT) and histologic (myocardial biopsy).
  • imaging techniques echocardiography, MRI, MSCT
  • histologic myocardial biopsy
  • Stem cells in the heart and in the affected tissue can be done recently by the so-called NOGA system.
  • NOGA system or NOGA mapping Using the NOGA system or NOGA mapping, a damaged heart muscle area can be measured by careful electromagnetic mapping of all the heart chambers. Based on this data, a 3-dimensional model of the mapped areas is calculated. Because of the won
  • Measurement signals are then followed by the targeted and selective injection, in particular of stem cells, into the marginal area of the affected heart area via a special, fine NOGA injection needle.
  • injections may be made into multiple points or areas of the heart.
  • a catheter system can be used that allows a catheter to be inserted through the inguinal artery into the left ventricle of the heart.
  • the cardiologist can either take tissue of the affected area for further analysis (biopsy) or he can inject stem cells directly into the affected tissue by means of an extendable needle.
  • biopsy biopsy
  • This state-of-the-art process allows for the first time, "large" cells in sufficient quantity directly into the To place affected tissues without loss by intravenous administration or to clog the arterial system of the heart inaccurate placement.
  • Umbilical cord blood to identify those preparations that are suitable for the individual patient and timely inform the attending physician, if there are enough preparations or cells for his patient.
  • the system automatically ensures that the preparations belonging to a proposed and selected solution are ordered from the various NSB banks, sent to the service provider for further processing at the same time, which selects the CD133 + or other cells and according to the doctor's prescription the drug is sent to the clinic for treatment on time.
  • the system coordinates transplantation of, for example, stem cells between clinics and NSB banks in a very short time. Significantly improved coordination saves time, which can be life-saving for a DCM patient.
  • the system is in this context able to NSB preparations, z. B. only for the restitution of hematopoiesis are stored from the cardio-
  • the system allows all data related to the chronically ill DCM patients to be stored and regularly adjusted for recurrent therapy requirements against the ever-changing stock of Nabeschnur Wegparaten in the system and the to inform the attending physician automatically according to his specifications about new therapy options, so that he can trigger another order at any time if necessary.
  • the same procedure can be used in all patients with heart failure
  • a cardiac surgeon e.g. be operated on during an open heart bypass operation. This eliminates the need to use a NOGA system.
  • the order and search may include the following steps:
  • the patient's doctor makes a written request for finding a suitable one
  • NBS preparation Umbilical cord blood preparation
  • Stem cell transplantation indication thus excluding an unauthorized search for an NSAID and thus blocking it for other searches.
  • the patient is assigned to a doctor and a clinic in the system.
  • a patient file advantageously a digital patient file is created.
  • patient data can be entered in a template with, for example, the following parameters:
  • HLA values A * 2301, 6801
  • the templates or parameters are variable and can advantageously be easily extended by further information.
  • HLA values of patient and NSB preparation are advantageously consistent in 4 out of 6 parameters.
  • search coordinator performing the search can also use preset search profiles.
  • the program After entering the patient data in the system and determining the search parameters, the program carries out the matching, that is, the characteristic properties of a preparation are compared with those of the patient.
  • the parameters of the search profile are applied as filters. From the inventory of all reported NSB preparations, a match list for the patient H.K. is advantageously generated based on the compatibility, that is, the agreement of the parameters.
  • NSB preparation with sufficient cell concentration can be used as the sole stem cell source for transplantation
  • a multi-graft search can be performed.
  • the match list is the basis for this further search. It can be sorted according to the individual specifications of the search coordinator. In this case, you can search again for a NSB preparation. This should advantageously be in 4 out of 6 HLA values, both matching the patient and matching the first NSB preparation. For this new matchlists are generated.
  • Solution report / reservation The various possible solutions are evaluated by the search coordinator. The final selection can be presented to the attending physician in the form of a report. After a thorough examination, he decides on the selection of the individual NSB preparations.
  • the NSB preparation could be reserved for the patient, which is advantageously confirmed by the NSB Bank. Without reservation, there is no guaranteed availability of the graft. If a reservation is not possible, another NSAID can be selected. Here the search process starts again.
  • NSB preparations defined as a solution
  • a verification can be carried out. This includes, for example:
  • the search coordinator can create a high resolution typing at the NSB Bank in
  • This system of order placement and acknowledgment of receipt ensures that all necessary verifications of the selected NSB preparations are made very quickly and efficiently.
  • the duration of the order processing by the NSB banks is specified.
  • the defined solutions are advantageously classified according to the quality of the NSB preparations in first and second choice.
  • a backup solution is available so that at the time of transplantation, appropriate NSB preparations are available.
  • the NSB-Bank will be informed of this date as soon as possible so that appropriate preparations can be made. This includes above all the provision of a nitrogen container for the transport of the NSB preparations. The actual transport is organized by the NSB-Bank, because there is the information, when the graft is ready to pick up. If the NSB bank finds that transport is not possible, for example because the NSB preparation has been damaged, the backup solution can be used. 4.2. Upon receipt of the NSB preparation at the transplant center, the condition of the nitrogen container in which the preparation was transported and the NSB preparation is checked and confirmed by the NSB Bank, eg cold chain interruptions can have a dramatic effect on the viability of the cells of the NSB Preparations have.
  • the laboratory of the transplantation clinic can determine the HLA values, determine the number of cells after the thawing of the NSB preparation and check the vitality of the cells. After this initial check, the NSB preparation is available to the patient.
  • transplant takes place immediately after the inception control because the cells of the NSB preparation should be administered promptly.
  • the processes from 4.1 to 5. can be carried out for each individual NSB preparation. Especially with multi-graft requirements originating from different NSB banks, careful coordination of the order is necessary in order to ensure the simultaneous arrival of the
  • a survey may be made of the patient's initial clinical data (e.g., conditioning protocol, underlying disease, prior chemotherapy protocols).
  • cryopreserved NSB preparations over donor preparations (bone marrow, peripheral blood) is the immediate ready-to-use availability. This immediate availability can in practice only come through a system as described above.
  • a person's details can be recorded, such as name, address, and other contact info. It may, for example, be an NSB donor, whereby further data can be entered into the database here (including maternity clinic and anamnesis of the mother, father and / or child).
  • data of the NSB bank can be recorded and stored.
  • Advantageous data includes transaction quality and a specific bank ID.
  • the data of the NSB preparations advantageously include HLA type, TNC number, or virus status. Based on this information, a preparation can be accurately characterized, with additional information about the preparation being further tested (including "High Resolution HLA Typing").
  • the preparation is examined by the tests and the quality can be easily judged.
  • the data of the preparation are compared with the data of a transplant patient, that is, for example, the blood type and the urgency can be compared.
  • genome, proteome, transcriptome, epigenome and / or metabolome data of the recipient i. H. the patient or the NSB preparation.
  • the preparation may advantageously be reserved for the patient by the transplantation clinic. This can be done for example by a coordinator or a treating doctor of the clinic.
  • data from the clinic can be recorded and stored in a preferred database. This includes the data clinic ID or
  • Fig. 2 shows an exemplary representation of the process flow.
  • new NSAIDs can be detected in the NSB Bank and incorporated into the preferred system.
  • the newly detected preparations can be compared with the NSB preparations present in the system for compatibility.
  • this can be compared with the NSB preparations present in the system for compatibility.
  • the standard search profiles can be used for clinics and doctors, where
  • an individualization of the order and exclusion criteria for coordination preference may be possible.
  • the search for a suitable for a transplant patients NSB preparation can be further adapted case-specific. It can be done a so-called Basic Search, in which advantageously all of the patient compatible NSB preparations are searched according to the preset order and / or exclusion criteria (Long List). Furthermore, it may be advantageous to perform a so-called Advanced Search, which determines the possible single transplants (SingleCord) and / or multi-grafts (MultiCord). In addition, the required budget, the time required and the quality of the result per graft could advantageously be listed on the basis of the tests still to be performed. In this case, the preparations found can be compared in a comparison view (comparison view), whereby individual preparations can be compared with each other.
  • a comparison view comparative.
  • the solution thus generated can be included in the patient record of the transplant patient, comprising the transmittal slips, Unit Report,
  • the preparation can be ordered from the NSB Bank.
  • the preparations found by the search can be reserved for a patient or for a clinic, whereby backup preparations can advantageously be established if the selected preparations are not available.
  • additional verification including DNA samples, high resolution
  • the preparations can be ordered and delivered.
  • FIG. 3 shows an exemplary representation of the preferred system architecture.
  • the illustration shows a schematic structure of a preferred data processing system part.
  • the preferred embodiment of the system can be divided into 3 subsections central system, TC
  • NSB bank umbilical cord blood bank subsystem
  • the system can advantageously be used via the Internet and intranet, with the individual parts being able to communicate with one another and exchange data via wireless or wired connections. It is shown that NSB preparations can be supplied by donors and analyzed by an HLA laboratory. The data generated there will be
  • the preparations may advantageously be physically processed and stored by the NSB Bank, whereby the data obtained on the NSB preparation may advantageously be administered to the NSB Bank in a laboratory management system.
  • selected NSB preparations can be transferred to the central system as data records in a decentralized and incremental manner.
  • the umbilical cord blood bank offers the preferred system Advantageously, the ability to administer, inspect contacts of the transplant center (TZ) contact, administration of the rehearsed NSB preparations, comfortable processing of inquiries and workflow tracking, administration of the complete billing of NSB preparation supplies and services as well as the management of follow-up information , It may also be advantageous if the NSB-Bank submits the order for taking samples via the system to, for example, the clinic. Furthermore, it can be seen in FIG. 3 that a doctor can determine the HLA values of patients and
  • the coordinator can, for example, perform a system-based search and provides solutions and advantageously NSB preparations for
  • the patient data can be managed by the transplant center or clinic in its own management system.
  • follow-up information after transplantation can be forwarded to the central system.
  • the transplant center for example, the system can provide the ability to administer, view contacts of NSB Bank contact, search for NSB preparations, convenient commissioning and control of inquiries and workflow tracking, administration of the complete billing of NSB preparation supplies and services as well as the administration of follow-up information.
  • the central system can be
  • the user data and their settings can advantageously be stored centrally, so that these
  • the administration of the central component (comprising setting up new users, clinics, NSB banks) can be carried out for example by a service staff. Information uploaded by the NSB Bank can be found in the
  • the NSB data may be preceded (eg, by a data warehouse cube) by (for example, modularly interchangeable) ordering criteria to advantageously guarantee a fast, efficient search even with complex multiple transplants.
  • the matching component can advantageously be modularly different
  • processed billing information can be sent to a billing component.
  • the follow-up information can be managed centrally and transferred to an external central office, which can, for example, generate follow-up statistics and return them regularly.
  • FIG. 4 shows a high-level overview of the system.
  • the figure shows an abstracted high-level overview of the described system with a focus on matching support and the Process support for larger registries of patients with different indications.
  • umbilical cord blood banks can put their preparations into the system and manage them through the system.
  • the umbilical cord blood bank can also identify for which indications which preparations may be used.
  • Transplant centers or clinics can also set up and manage large patient registries in the system. For the individual patient, data such as e.g. for typing for indication.
  • the auto-matching component of the system is capable of responding to any change in the patient or drug registry and correspondingly performing an automatic match operation for a patient or an indication of preset search parameters such that a transplant center for a patient according to its indication always the best possible solutions are indicated by the system.
  • the matching component can take into account both medical and logistical aspects, e.g. prefer a second preparation from the same clinic.
  • the system's workflow management then enables the largely automated handling of complex processes between all parties involved, including the NSB Bank, a clinic, a transplant center and a service provider.
  • the system can advantageously extend or reduce the number of participants at any time.
  • a transplant center can first reserve preparations and, if necessary, e.g. have another typing test done by the umbilical cord blood bank. complex
  • Transplantation rate can be improved. Every year, many people die because they can not be quickly treated with a suitable transplant. Has a
  • Transplant Center opted for a solution containing, for example, 2 preparations, e.g.
  • an order process can also be started via workflow management.
  • the system allows the transplantation center to order a processor to prepare the preparations for treatment, as well as the involvement of one or more logistics service providers to deliver the preparations to the transplant center for further processing and after refining Send.
  • the refinement preferably comprises the isolation and purification of specific cells. It is particularly preferred here to isolate stem cells.
  • typical stem cell markers can be used which are exclusively presented on the cell surface of stem cells. The markers allow a clear identification of stem cells, whereby the markers can also be used for the purification of the cells.
  • the stem cells are isolated from a solution by flow cytometry or special KITs. Becoming through the treatment
  • a solution refers to umbilical cord blood.
  • the processor receives the preparations accordingly and performs, for example, an enrichment of CD133 + cells using a selection kit.
  • cells positive for the cell surface molecule CD133 are isolated and enriched, but it may also be preferred that additional markers, particularly stem cell markers comprising CD133, CD34, CD7, CD44 and / or CD24 for the
  • additional markers particularly stem cell markers comprising CD133, CD34, CD7, CD44 and / or CD24 for the
  • the finished product can then be delivered to the transplantation center by another logistics service provider.
  • Processing processors and logistics service providers can be integrated into the system directly via their own user interface and can offer and confirm appointments, so that the System is able to give the transplant center an exact delivery date to prepare the treatment accordingly.
  • the Transplant Center is always able to check the current status of the preparations in the process via the system.
  • workflow management offers the option of billing to all involved after completion of the treatment
  • Fig. 5 shows a preferred use of the system.
  • the automated system is also capable of selecting and mediating chemical and biological therapeutic substances as well as integrating molecular or genetic analyzes and diagnoses in the selection and definition of possible therapeutic approaches.
  • the system allows the treating physician to identify certain treatment corridors by entering and gradually supplementing patient data through genetic, molecular or metabolic analysis, or to identify exclusion criteria for approved therapies and to demonstrate to the patient prior to treatment.
  • the system can be supported by imaging techniques.
  • This step-by-step approach to solutions through parallel or successive integration of diagnoses, analyzes or results and knowledge from scientific databases the system is for the first time able to ensure complex processes for the personalization of therapy in the supply of large numbers of patients. For example, it is possible that the NSB's detected by the system
  • Preparations and / or patients 2 are analyzed by genetic, molecular and / or metabolic analyzes (molecular diagnostics), which are clearly displayed by the system to a viewer, for example a treated doctor. Based on the molecular diagnostic analysis, preparations or patients can be selected that are suitable for a particular therapy. This selection can be made via the NSB preparations 1 or 2 patients.
  • the donors of the NSB preparations can also be referred to as a patient, since patients, ie possibly sick persons, donors of NSB preparations may be. For example, if a patient or donor is suffering from leukemia, e.g. B.
  • AML or CML is ill, it could be identified by the system and the attending physician could suggest to this patient or other AML patients possible therapy with biological, chemical or biochemical substances.
  • These substances include, for. As small molecules, targeted small molecules and biological antibodies or peptides. These may be, for example, inhibitors of certain enzymes or signaling pathways whose
  • Mechanism of action is known or unknown. The physician no longer needs to analyze the data from the molecular diagnostic analysis, but the system provides an overview or summary of the results, indicating possible therapeutic routes or treatments by the system.

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Abstract

L'invention concerne un système pour transmettre de manière automatique, rapide et dynamique des cellules biologiques à des fins de greffe, de thérapie ou de recherche pour des registres de patients dans différentes indications entre des centres de prélèvement ou des banques (dépôts) et des cliniques, des centres de transplantation ou des établissements de recherche, des prestataires de service (diagnostic, traitement des préparations et logistique), et pour surveiller et faciliter les processus allant de la transmission des demandes, l'intégration des techniques et technologies de diagnostic, en passant par le traitement, jusqu'à la livraison et le règlement d'une préparation cellulaire appropriée à l'allogreffe ou d'autres préparations biologiques, en passant par l'utilisation des préparations transmises jusqu'au suivi des résultats chez le patient et à la mise à disposition de ces données à des fins statistiques et autres. Le système est en mesure, pour la première fois, d'effectuer en ligne et de manière automatique des propositions de solutions complètes de greffes spécifiques à des patients individuels dans divers registres de patients, de prendre en compte les dépôts auxquels la priorité a été accordée et d'établir des propositions de solutions avantageuses du point de vue médical et logistique lors de la commande de plusieurs préparations. De plus, le système est en mesure, pour la première fois, d'intégrer au processus et de coordonner, de façon automatisée, les prestataires de service engagés dans le processus, tels que les entreprises de logistique et les entreprises de traitement des préparations nécessaires, et, en tant qu'outil central (plateforme), ce système peut conduire tous les processus et toutes les transactions financières.
EP11705438A 2010-02-05 2011-02-07 Système automatisé de sélection et de transmission de cellules biologiques allogéniques stockées à des fins de greffe, de thérapie et de recherche Withdrawn EP2531975A2 (fr)

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PCT/EP2011/000615 WO2011095365A2 (fr) 2010-02-05 2011-02-07 Système automatisé de sélection et de transmission de cellules biologiques allogéniques stockées à des fins de greffe, de thérapie et de recherche

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