WO2019201863A1 - Procédé de suivi de la viabilité d'un greffon - Google Patents
Procédé de suivi de la viabilité d'un greffon Download PDFInfo
- Publication number
- WO2019201863A1 WO2019201863A1 PCT/EP2019/059685 EP2019059685W WO2019201863A1 WO 2019201863 A1 WO2019201863 A1 WO 2019201863A1 EP 2019059685 W EP2019059685 W EP 2019059685W WO 2019201863 A1 WO2019201863 A1 WO 2019201863A1
- Authority
- WO
- WIPO (PCT)
- Prior art keywords
- graft
- composition
- oxygen
- sealed container
- extracellular
- Prior art date
Links
Classifications
-
- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N27/00—Investigating or analysing materials by the use of electric, electrochemical, or magnetic means
- G01N27/26—Investigating or analysing materials by the use of electric, electrochemical, or magnetic means by investigating electrochemical variables; by using electrolysis or electrophoresis
- G01N27/403—Cells and electrode assemblies
- G01N27/406—Cells and probes with solid electrolytes
- G01N27/407—Cells and probes with solid electrolytes for investigating or analysing gases
- G01N27/409—Oxygen concentration cells
-
- A—HUMAN NECESSITIES
- A01—AGRICULTURE; FORESTRY; ANIMAL HUSBANDRY; HUNTING; TRAPPING; FISHING
- A01N—PRESERVATION OF BODIES OF HUMANS OR ANIMALS OR PLANTS OR PARTS THEREOF; BIOCIDES, e.g. AS DISINFECTANTS, AS PESTICIDES OR AS HERBICIDES; PEST REPELLANTS OR ATTRACTANTS; PLANT GROWTH REGULATORS
- A01N1/00—Preservation of bodies of humans or animals, or parts thereof
- A01N1/02—Preservation of living parts
- A01N1/0236—Mechanical aspects
- A01N1/0263—Non-refrigerated containers specially adapted for transporting or storing living parts whilst preserving, e.g. cool boxes, blood bags or "straws" for cryopreservation
-
- A—HUMAN NECESSITIES
- A01—AGRICULTURE; FORESTRY; ANIMAL HUSBANDRY; HUNTING; TRAPPING; FISHING
- A01N—PRESERVATION OF BODIES OF HUMANS OR ANIMALS OR PLANTS OR PARTS THEREOF; BIOCIDES, e.g. AS DISINFECTANTS, AS PESTICIDES OR AS HERBICIDES; PEST REPELLANTS OR ATTRACTANTS; PLANT GROWTH REGULATORS
- A01N1/00—Preservation of bodies of humans or animals, or parts thereof
- A01N1/02—Preservation of living parts
- A01N1/0205—Chemical aspects
- A01N1/021—Preservation or perfusion media, liquids, solids or gases used in the preservation of cells, tissue, organs or bodily fluids
- A01N1/0226—Physiologically active agents, i.e. substances affecting physiological processes of cells and tissue to be preserved, e.g. anti-oxidants or nutrients
-
- A—HUMAN NECESSITIES
- A01—AGRICULTURE; FORESTRY; ANIMAL HUSBANDRY; HUNTING; TRAPPING; FISHING
- A01N—PRESERVATION OF BODIES OF HUMANS OR ANIMALS OR PLANTS OR PARTS THEREOF; BIOCIDES, e.g. AS DISINFECTANTS, AS PESTICIDES OR AS HERBICIDES; PEST REPELLANTS OR ATTRACTANTS; PLANT GROWTH REGULATORS
- A01N1/00—Preservation of bodies of humans or animals, or parts thereof
- A01N1/02—Preservation of living parts
- A01N1/0236—Mechanical aspects
- A01N1/0263—Non-refrigerated containers specially adapted for transporting or storing living parts whilst preserving, e.g. cool boxes, blood bags or "straws" for cryopreservation
- A01N1/0273—Transport containers
-
- A—HUMAN NECESSITIES
- A01—AGRICULTURE; FORESTRY; ANIMAL HUSBANDRY; HUNTING; TRAPPING; FISHING
- A01N—PRESERVATION OF BODIES OF HUMANS OR ANIMALS OR PLANTS OR PARTS THEREOF; BIOCIDES, e.g. AS DISINFECTANTS, AS PESTICIDES OR AS HERBICIDES; PEST REPELLANTS OR ATTRACTANTS; PLANT GROWTH REGULATORS
- A01N1/00—Preservation of bodies of humans or animals, or parts thereof
- A01N1/02—Preservation of living parts
- A01N1/0278—Physical preservation processes
-
- A—HUMAN NECESSITIES
- A01—AGRICULTURE; FORESTRY; ANIMAL HUSBANDRY; HUNTING; TRAPPING; FISHING
- A01N—PRESERVATION OF BODIES OF HUMANS OR ANIMALS OR PLANTS OR PARTS THEREOF; BIOCIDES, e.g. AS DISINFECTANTS, AS PESTICIDES OR AS HERBICIDES; PEST REPELLANTS OR ATTRACTANTS; PLANT GROWTH REGULATORS
- A01N1/00—Preservation of bodies of humans or animals, or parts thereof
- A01N1/02—Preservation of living parts
- A01N1/0236—Mechanical aspects
- A01N1/0242—Apparatuses, i.e. devices used in the process of preservation of living parts, such as pumps, refrigeration devices or any other devices featuring moving parts and/or temperature controlling components
- A01N1/0247—Apparatuses, i.e. devices used in the process of preservation of living parts, such as pumps, refrigeration devices or any other devices featuring moving parts and/or temperature controlling components for perfusion, i.e. for circulating fluid through organs, blood vessels or other living parts
-
- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N2496/00—Reference solutions for assays of biological material
- G01N2496/70—Blood gas control solutios containing dissolved oxygen, bicarbonate and the like
Definitions
- the recipient is preferably a mammal.
- the recipient is a human, in particular waiting for a transplant, or a non-human mammal, for example a pig.
- the organ preservation solution is mixed with at least one oxygen carrier.
- the organ preservation solution comprises at least one oxygen carrier.
- Such an oxygen carrier is advantageously selected from reversibly oxygen-binding molecules.
- a transporter is chosen from Annelides extracellular hemoglobin, globins and globin protomers.
- the method according to the invention thus comprises a step a) of mixing an organ preservation solution with at least one oxygen carrier, preferably at least one molecule chosen from Annelides extracellular hemoglobin. , globins and protomers of globin, to obtain a composition, in a sealed container.
- the second category counting from 36 to 42 elements, groups polypeptide chains called "structure” or “linkers” having little or no active site but allowing the assembly of subunits called twelfths or protomers.
- Annelides extracellular hemoglobin and its globin protomers have intrinsic superoxide dismutase (SOD) activity, and therefore require no antioxidants to function, in contrast to the use of mammalian hemoglobin, for which the molecules Antioxidants are contained inside the red blood cell and are not related to hemoglobin.
- SOD superoxide dismutase
- Annelides extracellular hemoglobin, its globin protomers and / or globins do not require a cofactor to function, unlike mammalian hemoglobin, especially human hemoglobin.
- the extracellular hemoglobin of Annelides, its protomers of globin and / or its globins not having a blood typing, they make it possible to avoid any problem of immunological reaction.
- Hydroxyethyl starch 50 g / L
- IGL-1 ® having an osmolality of 320 mOsm / kg and a pH of 7.4, of the following formulation, for one liter in water:
- Soltran ® having an osmolality of 486 mOsm / kg and a pH of 7.1, and of the following formulation for one liter in water:
- NaOH preferably in an amount of between 20 and 125 mM
- the sealed container used in the process according to the invention, especially in step a), is any container suitable for the transport of graft.
- Such containers are known from the prior art.
- the container is as described in application FR2994163.
- the sealed container corresponds to the Biotainer 2.8L kit. It can be included in a carrying case, such as the one marketed under the name Vitalpack® EVO TM by E3 Cortex.
- the sealed container is a pot (or rigid primary packaging) - of sufficient size to contain the graft and the composition of step a) - closed by a lid provided with a handle.
- the cover comprises an opening, preferably circular, allowing the passage of the oxygen probe. This opening is waterproof: the edges of the opening are preferably coated with a seal and allow the attachment of the oxygen sensor.
- the introduction of the sealed container by a first access and its extraction by a second access preserves the sealed container, preventing it from being exposed to possible contamination of the first access that would have occurred during packaging operations.
- such a container is made by superposition of two sheets of flexible plastic material having free edges secured together.
- the container can be easily made to the dimensions of the contents (sealed container).
- the secured edges of the plastic sheets can be secured with peelable bonds. This then allows, by simple pulling, a corolla opening of the bag over its entire length and releases the contents without it being necessary to roll up the package around the sealed container.
- the sealing element comprises a peelable connection between two plastic surfaces.
- Step b) then comprises immersing the graft in this composition.
- the graft can be any organ that can be transplanted.
- the graft is a kidney, a heart, a pancreas, a lung, a liver or a whole heart-lungs.
- step c) of the process according to the invention preferably comprises the introduction of a single oxygen probe into the solution or composition obtained in a), or into the composition of step b).
- the oxygen sensor is preferably unique.
- the process according to the invention does not use two oxygen probes.
- the oxygen probe, or oximeter, used makes it possible to measure the concentration of molecular oxygen in the liquid mixture obtained in a) or b), thus to measure the quantity of dissolved oxygen present in the solution or composition of step a) or in the composition of step b). This measure avoids any invasive step in the graft.
- the oxygen sensor is a sensor for measuring dissolved oxygen by optical measurement, in particular by luminescence.
- it does not include a membrane or electrolyte.
- Such a probe is commercially available, especially under the reference Optod (Digisens range) by Ponsel.
- the graft is first added to the solution or composition of step a), and then the oxygen probe is introduced into the resulting mixture.
- the probe since the probe is in particular fixed on the lid of the sealed container, it can be introduced into the mixture at the same time as the step of fixing the lid on the sealed container, thus at the same time as step d).
- the method according to the invention comprises a step d) of closing the sealed container.
- steps c) and d) can be performed simultaneously or in any order.
- the probe in the case where the probe is fixed on the lid of the sealed container, it can be introduced into the mixture at the same time as the step of fixing the lid on the sealed container; in this case steps c) and d) are simultaneous.
- the graft can be transported in good conditions to its destination.
- the monitoring of the oxygenation of the graft is performed in real time.
- the transport can be carried out by any means (land or air transport), and requires no special condition. This is advantageous compared to the use of oxygen gas, which is present in specific containers (bottles in general) maintained at a given pressure, so less easy to transport (especially by air).
- Step e) of transport can be carried out by placing the sealed container in a suitable container.
- a suitable container is known from the prior art, and is suitable for graft transport.
- this container is a carrying case, for example as described in application EP1688124. It is more particularly a bag for the transport of a graft for a transplant involving at least one inner wall delimiting at least two compartments each having a working part, a first compartment being intended to receive one or more bottles and / or pots of biological samples from the donor (for example blood) protected by a block of flexible and elastic material while a second compartment contains an isothermal tank for receiving the sealed container according to the invention.
- the isothermal tank may comprise crushed ice or blocks of eutectic material.
- the graft can be preserved in dynamic perfusion.
- the process according to the invention may also comprise, after step d) and / or e), a step e ') of establishing a calibration curve representing the pO 2 of the composition obtained in a) in which the graft is immersed, optionally normalized with respect to graft weight, as a function of time.
- this calibration curve makes it possible to deduce, for a given graft, the optimal duration of oxygenation. For example, for a kidney, obtaining a calibration curve makes it possible to deduce the maximum duration of oxygenation, if a pO 2 of at least 50% is desired.
- the present invention also relates to a method for determining the viability of a graft, including the use of the calibration curve described above. This curve is obtained in particular according to the method described above.
- Such a method for determining the viability of a graft comprises in particular the following steps:
- step (i) providing an organ preservation solution in a sealed container.
- step (i) comprises mixing an organ preservation solution with at least one oxygen carrier selected from Annelides extracellular hemoglobin, its globins and globin protomers, in order to obtain a composition, in a sealed container;
- physiologically acceptable pO 2 value is meant a value that allows viability of the graft.
- the purpose of this study is to establish a link between the effects of extracellular hemoglobin Arenicola marina (M101) on the reduction of ischemia / reperfusion injury in static cold preservation and the mechanism of action of the molecule.
- M101 extracellular hemoglobin Arenicola marina
- sequential measurements are performed both at the functional level and at the cellular level.
- the spectral signature of M101 from 52h to 55h is characteristic of deoxyHb and shows that the molecule has transferred all its oxygen to the solution.
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- Life Sciences & Earth Sciences (AREA)
- Health & Medical Sciences (AREA)
- Engineering & Computer Science (AREA)
- General Health & Medical Sciences (AREA)
- Environmental Sciences (AREA)
- Zoology (AREA)
- Wood Science & Technology (AREA)
- Dentistry (AREA)
- Hematology (AREA)
- Mechanical Engineering (AREA)
- Chemical & Material Sciences (AREA)
- Biophysics (AREA)
- Physiology (AREA)
- Electrochemistry (AREA)
- Pathology (AREA)
- Immunology (AREA)
- General Physics & Mathematics (AREA)
- Biochemistry (AREA)
- Analytical Chemistry (AREA)
- Physics & Mathematics (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Molecular Biology (AREA)
- Agricultural Chemicals And Associated Chemicals (AREA)
Abstract
Description
Claims
Priority Applications (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
EP19717903.9A EP3780954A1 (fr) | 2018-04-17 | 2019-04-15 | Procédé de suivi de la viabilité d'un greffon |
BR112020021030-7A BR112020021030A2 (pt) | 2018-04-17 | 2019-04-15 | Método de monitoramento da oxigenação de um enxerto e método de determinação da viabilidade de um enxerto |
US17/047,945 US20210172900A1 (en) | 2018-04-17 | 2019-04-15 | Method for monitoring the viability of a graft |
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
FR1853340 | 2018-04-17 | ||
FR1853340A FR3080002B1 (fr) | 2018-04-17 | 2018-04-17 | Procede de suivi de la viabilite d'un greffon |
Publications (1)
Publication Number | Publication Date |
---|---|
WO2019201863A1 true WO2019201863A1 (fr) | 2019-10-24 |
Family
ID=62816766
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
PCT/EP2019/059685 WO2019201863A1 (fr) | 2018-04-17 | 2019-04-15 | Procédé de suivi de la viabilité d'un greffon |
Country Status (5)
Country | Link |
---|---|
US (1) | US20210172900A1 (fr) |
EP (1) | EP3780954A1 (fr) |
BR (1) | BR112020021030A2 (fr) |
FR (1) | FR3080002B1 (fr) |
WO (1) | WO2019201863A1 (fr) |
Cited By (1)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
WO2024023068A1 (fr) * | 2022-07-26 | 2024-02-01 | Hemarina | Utilisation d'une molécule d'annélide pour le traitement et/ou la prévention d'au moins une maladie associée à l'activation du complément |
Citations (5)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
EP1688124A1 (fr) | 2005-02-08 | 2006-08-09 | E3 Cortex | Sacoche pour le transport de greffons en vue de transplantations |
WO2010128159A1 (fr) * | 2009-05-07 | 2010-11-11 | Hemarina | Nouvelle hémoglobine et ses utilisations |
FR2975869A1 (fr) * | 2011-05-31 | 2012-12-07 | Hemarina | Composition de preservation d'organe et utilisations |
FR2994163A1 (fr) | 2012-07-31 | 2014-02-07 | E3 Cortex | Conteneur hermetique et procede d'emballage mettant en oeuvre un tel conteneur |
US20140045167A1 (en) * | 2012-08-10 | 2014-02-13 | Paragonix Technologies, Inc. | Methods for evaluating the suitability of an organ for transplant |
-
2018
- 2018-04-17 FR FR1853340A patent/FR3080002B1/fr active Active
-
2019
- 2019-04-15 US US17/047,945 patent/US20210172900A1/en active Pending
- 2019-04-15 EP EP19717903.9A patent/EP3780954A1/fr active Pending
- 2019-04-15 BR BR112020021030-7A patent/BR112020021030A2/pt unknown
- 2019-04-15 WO PCT/EP2019/059685 patent/WO2019201863A1/fr unknown
Patent Citations (5)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
EP1688124A1 (fr) | 2005-02-08 | 2006-08-09 | E3 Cortex | Sacoche pour le transport de greffons en vue de transplantations |
WO2010128159A1 (fr) * | 2009-05-07 | 2010-11-11 | Hemarina | Nouvelle hémoglobine et ses utilisations |
FR2975869A1 (fr) * | 2011-05-31 | 2012-12-07 | Hemarina | Composition de preservation d'organe et utilisations |
FR2994163A1 (fr) | 2012-07-31 | 2014-02-07 | E3 Cortex | Conteneur hermetique et procede d'emballage mettant en oeuvre un tel conteneur |
US20140045167A1 (en) * | 2012-08-10 | 2014-02-13 | Paragonix Technologies, Inc. | Methods for evaluating the suitability of an organ for transplant |
Non-Patent Citations (2)
Title |
---|
THUILLER ET AL.: "Supplementation With a New Therapeutic Oxygen Carrier Reduces Chronic Fibrosis and Organ Dysfunction in Kidney Static Preservation: A New 02 Therapeutic Molecule Improves Static Kidney Preservation", AM J TRANSPLANT., vol. 11, no. 9, 1 September 2011 (2011-09-01), pages 1845 - 60, XP055017389 * |
THUILLER ET AL.: "Supplementation With a New Therapeutic Oxygen Carrier Reduces Chronic Fibrosis and Organ Dysfunction in Kidney Static Preservation: A New 02 Therapeutic Molecule Improves Static Kidney Preservation", AM J TRANSPLANT., vol. 11, no. 9, September 2011 (2011-09-01), pages 1845 - 60 |
Cited By (1)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
WO2024023068A1 (fr) * | 2022-07-26 | 2024-02-01 | Hemarina | Utilisation d'une molécule d'annélide pour le traitement et/ou la prévention d'au moins une maladie associée à l'activation du complément |
Also Published As
Publication number | Publication date |
---|---|
EP3780954A1 (fr) | 2021-02-24 |
BR112020021030A2 (pt) | 2021-01-19 |
FR3080002B1 (fr) | 2020-11-20 |
US20210172900A1 (en) | 2021-06-10 |
FR3080002A1 (fr) | 2019-10-18 |
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