WO2014064439A1

WO2014064439A1 - A method and system for providing cell therapy

Info

Publication number: WO2014064439A1
Application number: PCT/GB2013/052758
Authority: WO
Inventors: Simon Davidson
Original assignee: Till Financial Limited
Priority date: 2012-10-22
Filing date: 2013-10-22
Publication date: 2014-05-01
Also published as: GB201218906D0

Abstract

The invention provides a method and system for providing cell therapy comprising:(a) obtaining from a depositor a body material and depositing the body material in a depository of such body material, (b) defining plural classes of insurance cover and specifying terms for each of the defined classes; (c) establishing an insurance policy stipulating that the depositor or a beneficiary of the depositor is indemnified for expenses incurred for a medical or cosmetic treatment requiring body material of the type deposited by the depositor, wherein the medical treatment utilizes either the deposited body material or substitute body material of the type deposited by the depositor, and (d) collecting a periodic premium for the insurance, wherein the premium is determined on the class of insurance.

Description

A Method and System for Providing Cell Therapy

The present invention relates to a method and system for providing cell therapy, in embodiments, to a method and system for providing insurance.

It is known that bone marrow transplantation is used in the treatment of a number of medical disorders including cancer, autoimmune diseases, blood disorders and metabolic disorders. Stem cells are important in such treatments. Stem cells are present in bone marrow. However, compatibility is a problem. To enable a successful treatment using stem cells, a compatible bone marrow donor is needed and yet, typically can only be found for 40-50% of all cases requiring bone marrow transplantation. Even if there is a suitable donor available, it can take weeks or longer to find the donor. In cases where the treatment is time-critical, say at some stages of cancer, this delay can be the difference between a patient surviving or not.

It is known that umbilical cord-blood also contains stem cells, and has been used as an alternative to bone marrow as a source of stem cells in the treatment of these disorders. Umbilical cord-blood can be collected from the umbilical cord of a newborn after severing of the cord from the newborn. Banks of umbilical cord-blood have been set up in several countries. An individual's cord-blood is collected at birth and preserved for long term storage using cryogenic methods and temperatures that are well known to the skilled person. The preserved blood is deposited in a cord-blood depository or bank (or unpreserved blood may be provided to bank which would undertake the preservation process). In any event, the result is that preserved cord blood is stored in a cord-blood bank for use later in the life of the infant if it becomes necessary.

Indeed, the blood is available for use by that person if he or she were

subsequently to develop a condition that would be treatable by implantation of stem cells derived from the cord-blood. A person whose cord-blood was deposited in a bank is thus secure in the knowledge that in the unlikely and unfortunate event of such cord blood becoming needed, it will be at hand. Such a person would not then be dependent upon finding a suitable donor, which as explained above, can sometimes lead to critical delays. Technically, it is known that due to the immaturity of cord-blood derived stem cells, a perfect tissue-typing (HLA) is often not required, in which case cord-blood may be used to treat a sibling of the cord donor. Cord-blood cells can also be grown or cultured ex- vivo if a larger number of cells than have been stored is needed. What is critical is the availability of at least some cord-blood cells so that the ex vivo culturing can begin. It should also be noted that cord-blood stem cells may be cultured ex-vivo in order to increase the number of stem cells available to the recipient.

Various insurance schemes have been disclosed and described. For example, inUS-A-2006/0190305 (Pelz), US-A-2009/0076860 (Pelz) and US-A-2011/0054950 (Pelz), there are described insurance policies for individuals that can be used to provide payments in the event that funding is needed to provide treatment using stem cells that have been preserved at birth.

Other examples of such methods are disclosed in US-A- 2003/0014285. This discloses a business method in which an insurance company pays the costs of depositing cord-blood in a cord-blood bank for a policy holder of the insurance company. The insurance company may offer this benefit, for example, in order to attract new policy holders. The cost of the deposition may be recouped from the premium of the insurance policy. US-A-2007/0050218 relates to a method of providing key-person, term life or critical illness insurance policies to provide life-saving and health enhancements in addition to the death benefits covered under existing policies. The content of all of these disclosures are hereby incorporated by reference.

Although these policies and inventions work, in some cases there are drawbacks. For example, their suitability for large groups is not ideal and they are not flexible to enable provision of protection to different people. According to a first aspect of the present invention, there is provided a method for providing insurance comprising: (a) obtaining from a depositor a body material and depositing the body material in a depository of such body material, (b) defining plural classes of insurance cover and specifying terms for each of the defined classes; (c) establishing an insurance policy stipulating that the depositor or a beneficiary of the depositor is indemnified for expenses incurred for a medical or cosmetic treatment requiring body material of the type deposited by the depositor, wherein the medical treatment utilizes either the deposited body material or substitute body material of the type deposited by the depositor, and (d) collecting a periodic premium for the insurance, wherein the premium is determined on the class of insurance.

A method is provided by which different classes of insurance may be provided to different users in dependence on need and other such factors. By providing such flexibility, a user is able to specify his needs and receive a more bespoke level of insurance.

In one example, at least two classes of insurance are provided and the amount of indemnity provided is dependent on the class. Thus flexibility is provided to both insurers and users and others in the insurance business to ensure that appropriate cover can be provided to all users.

Preferably, the two classes are provided as follows: (i) protection is provided for the new born only; and, (ii) protection is provided for the new born and up to a determined number of family members, e.g. siblings, of the new born;

Preferably, the classes are further divided in dependence on the premium paid and the amount provided by the insurer in the event of a claim. In one embodiment, the classes are defined in terms of the amount paid out as a lump sum to a claimant in the event of a claim.

In one example, in addition to lump sum payment to the insured for the primary claim, a further lump sum is paid to source alternative cells in the event that the stored cells are unavailable for any reason.

In one example, the amount of the further lump sum is different for different classes.

In one example, a further class is provided, defined as a bespoke class, in which the levels of payment and premiums are calculated based on a particular user's specified requirements. Thus complete flexibility is provided to both user and insurance provider.

In one example, a further payment is provided for the treatment of medical conditions not known of at the time the insurance is taken out. This is particularly innovative and useful feature of the present invention. For all policies thus far known to the skilled person, a set of medical conditions is laid out when the insurance policy is taken out and the policy will then pay out only in the event of one or more of those specified medical conditions arising. In contrast to this, the present method provides a means by which medical conditions that at the time of the policy being taken out are unknown, are also covered by a fixed lump sum payment. The amount of the further payment can be calculated at a level that might be expected to be sufficient to cover at least a significant proportion of the unknown cost, although clearly by the unknown nature of the cost, this will be an estimate. If less is needed to meet the cost of treatment for the unknown condition, then the further payment can still be made in full to a user.

In one example, the method further comprises indemnifying the depositor or beneficiary of the depositor for expenses incurred for a medical treatment utilizing the deposited body material. In one example, the deposited body material is selected from blood, umbilical cord blood, skin, foreskin, lymph, adult stem cells, fetal stem cells and sperm, tissue, organs, cadaveric material or indeed any appropriate biological material. In one example, the method further comprises storing in a database data indicative of the insurance policy.

In one example, the data indicative of an insurance policy provided to a depositor of body material in a depository of body material is selected from the policy holder's name, the date that the deposit was made, information relating to the deposited body material, a serial number or other identifier associated with the deposit, a location of the deposited body material in the depository.

According to a second aspect of the present invention, there is provided a system for providing insurance comprising a processor having a database of entries, the processor configured to input data indicative of an insurance policy comprising plural classes of insurance cover provided by an insurance provider to a depositor of body material in a depository of body material, the classes being determined in dependence on the premium paid, the system being further configured to store the data in an entry of the database, the insurance policy stipulating that the depositor or a beneficiary of the depositor is indemnified for expenses incurred for a medical or cosmetic treatment utilizing the deposited body material or substitute body material of the type deposited by the depositor, wherein the level . According to a third aspect of the present invention, there is provided a method for providing insurance comprising: (a) obtaining from a depositor a body material and depositing the body material in a depository of such body material; (b) specifying one or more medical or cosmetic treatments requiring body material of the type deposited by the depositor; (c) establishing an insurance policy stipulating that the depositor or a beneficiary of the depositor is indemnified for expenses incurred for one or more of the specified medical or cosmetic treatments, wherein the medical or cosmetic treatment utilizes either the deposited body material or substitute body material of the type deposited by the depositor, and (d) the insurance policy also stipulating that a further payment will be provided for treatment of one or more unspecified medical or cosmetic treatments.

According to a further aspect of the present invention, there is provided a method for providing cell therapy, the method comprising: (a) obtaining from a depositor a body material and depositing the body material in a depository of such body material;

(b) establishing an insurance policy stipulating that the depositor or a beneficiary of the depositor is indemnified, if there is an available medical or cosmetic treatment, for expenses incurred for the treatment requiring body material of the type deposited by the depositor, wherein the medical treatment utilizes either the deposited body material or substitute body material of the type deposited by the depositor; and (c) if there is no available medical or cosmetic treatment, providing critical illness cover to the depositor or beneficiary.

Embodiments of the present invention will now be described in detail with reference to the accompanying drawings, in which: Figure 1 is flow diagram showing some steps in an exemplary embodiment of the present invention; and,

Figure 2 is a schematic representation of a cord blood bank; and, Figure 3 is a flow diagram showing some steps in an exemplary embodiment of the present invention.

Figure 1 is flow diagram showing steps in an exemplary embodiment of the present invention. It will be appreciated that Figure is a modified version of Figure 1 of commonly assigned US-A-2006/0109035. In the following description, the invention is described in relation to the provision of cell therapy and insurance therefor to a depositor of umbilical cord-blood in a cord- blood depository. This is by way of example only, it being understood that the invention may be implemented for the provision of any body tissue or organ in a depository of such tissues or organs. Furthermore, although described in detail with reference to humans, it is equally applicable to animals and may well be used for family pets and the like. For example, it could be used for dogs, cats, horses and any other appropriate animal.

As used herein, the term "depositor" refers to an individual who has deposited a body tissue or organ in a depository of such tissues or organs, or a guardian or other party authorized to act on behalf of the individual.

FIG. 1 shows a flow chart for carrying out one embodiment of the method of the invention. In step 2, umbilical cord-blood of an individual is obtained and, in step 4, the obtained cord-blood is deposited in an umbilical cord-blood depository. Details relating to the depositor and the stored blood are entered into a database. Step 2 in this example, involves storage of cord blood, but in fact other materials can be used instead of cord- blood. In some examples, the material to be provided to the bank is one or more of blood, umbilical cord blood, skin, foreskin, lymph, adult stem cells, fetal stem cells, sperm, cells, bodily tissue, organs and cadaveric material. In one example, stem cells from a child's milk teeth can be used. Furthermore, although the individual is typically a human being, the method applies also to animals, in which case the costs of such treatments will be those of veterinary practitioners and the like.

After the blood has been deposited, in step 6, the depositor, is queried as to whether he wishes to acquire an insurance policy that indemnifies the depositor or a beneficiary for expenses incurred in the case that the donor or beneficiary requires medical or cosmetic treatment that utilizes the deposited blood. In step 8 it is determined whether the depositor wishes to purchase the insurance. If no, the process terminates as step 10. If a depositor does wish to acquire an insurance policy, it is determined what class of policy is desired. By providing different classes of insurance a greater degree of flexibility is provided both to the insurer and the depositor. In one example, at least two classes of insurance class are provided. The different classes can be based on any determinative factors, but in one example if a depositor is to be the only insured party then the insurance is at a first level. If the insurance is also to cover the siblings of the depositor then the insurance is at a second class.

Table 1 below shows an example of plural classes that may be used in the present

As can be seen for class 1 insurance the maximum levels of payout by the insurer for reimbursement and for sourcing of alternative cells is at the lowest possible level of x and y respectively. Clearly the values for x and y can be set on appropriate amounts at the time that the policy is created. In one non-limiting example, x is€3 Ok and y is€25k. The amounts paid out for the other classes are shown as multiples of x and y and again both the amounts and the multiples are exemplary only.

Class 1 there is no payout at all if another policy is held by the user and so a determination at the time of claim will need to be made if the user holds other insurance. If they do then no payment is made. If they do not then a payment will be made in the usual way. It will also be appreciated that any number of siblings can be written into the policy. In the example, up to 3 siblings are covered by the policy. What this means is that if any of up to 3 siblings requires treatment, then so long as the policy was taken out, they will be covered even if it is not their particular cord blood that is stored.

In contrast for the other classes shown, a payout of at least z is made irrespective of whether or not the user holds other insurance that pays out or not. In one example z is €25k.

Once it has been established at step 9 what class of insurance is desired, the process continues to step 12, in which an insurance policy is established for the depositor. The depositor is then instructed to pay a periodic premium for the insurance in dependence on the class selected. The precise amounts will be determined as would be known by the skilled person to enable coverage at the selected level. In step 16 it is determined whether the depositor has paid the premium. If no, the insurance is terminated (step 18) and the process ends at step 20. If at step 16 it is determined that the depositor did pay the premium, the process proceeds to step 22 where it is determined whether the depositor or a beneficiary designated by the depositor, requires medical or cosmetic treatment utilizing the stored cord-blood.

In a preferred embodiment, at step 17 it is identified if the required treatment was specified on the original policy. In some cases it will be covered as the policy is written to specify the most common or expected or well known ailments that might require stem cell treatment in due course. However, as science develops more conditions become known and indeed more treatments become available both for these new ones and for already known conditions. As will be explained, in one example, a further payment may be provided if a new treatment has become available that is not specified in the original policy.

If the determination as to requirement for treatment at step 22 is negative, it is determined in step 24 whether the policy has expired. If the policy has expired then the process terminates at step 27. If the policy has not expired, it is determined in step 25 whether the next periodic premium is due. If the next periodic premium is due, the process returns to step 14. If the next premium is not due, the process returns to step 22. If at step 22 it is determined that the depositor or beneficiary requires medical or cosmetic treatment utilizing the deposited cord-blood, then in step 23 it is determined whether the deposited cord-blood is suitable for the required treatment.

If yes, then in step 26 the required medical or cosmetic treatment is provided using the deposited cord-blood. If no, then in step 29 the required medical or cosmetic treatment is provided using substitute cord-blood. After the medical treatment has been provided in either step 26 or step 29, the depositor is indemnified for expenses relating to the provided treatment in accordance with the terms of the insurance policy (step 28). Furthermore if the additional feature described with reference to step 17 has been relied upon a further payment may be provided for the treatment of the condition not originally specified. The process terminates at step 30.

It will be appreciated that it will not be possible to know exactly how much treatment for an unknown condition will cost and so the further amount is determined to be at a level that is preferably likely to cover all the cost. Clearly though there may be some shortfall or some surplus.

In the example described above with reference to Figure 1 the features of:

(1) the further lump sum payment and

(2) the identification of class are shown as being part of the process. Although both features can be included in the same policy, both features need not necessarily be provided. In some cases only feature (1) is provided and in some examples only feature (2) is provided.

FIG. 2 shows a system 20 in accordance with one embodiment of this aspect of the invention. The system 20 includes a medical installation 22 where umbilical blood is collected, processed and stored. The medical installation may be a distributed installation, in which collection of the blood occurs at one location (e.g. a delivery room 24), processing the blood occurs at a second location (e.g. a laboratory 26), and storage of the blood is at a remotely located umbilical cord-blood depository 28. The system 20 further includes a first processor 30 having a memory comprising a databank of entries 32. Each entry 32 in the databank includes information relating to a deposit of cord-blood at the blood depository 28 when a cord-blood deposit is made at the cord-blood depository 28.

The information is input to the entry from a computer terminal (not shown in FIG. 2) located at the cord -blood depository that communicates with the processor 30 over a communication line 33 that may be a wired or wireless communication line. Details relating to the deposit include, for example, the depositor's name and other personal information, the date that the deposit was made, the volume of the deposit, any information relating to the blood such as the results of any immunological tests that were performed on the blood. The stored information may also include a serial number or other identifier associated with the deposit, as well as the location of the deposited blood in the blood depository.

The system 20 also includes a second processor 34. The second processor 34 is maintained by an insurance provider and includes a memory comprising a first databank of entries 36 and a second databank of entries 38. The first and second processors communicate with each other over a communication line 40. When a new entry 32 is made in the databank of the first processor, the first processor is configured to

communicate at least some of the data in the entry 32 to the second processor of the communication line 40. The second processor is configured to input the data and to store the input data into a new entry in the first database of the second processor. The second processor is further configured to alert the insurance company when a new entry has been made in the first database of the second processor, indicative of a new deposit at the cord-blood depository. This may be done, for example, by the second processor automatically sending an electronic message to a predetermined address informing the recipient of the message of the new cord-blood deposit at the cord-blood depository 28. It will be appreciated that any number of processors may be provided suitably configured to perform the specified tasks.

The message prompts the insurance provider to query the depositor of the deposit as to whether the depositor wishes to acquire from the insurance company an insurance policy that indemnifies the depositor for at least some of the expenses incurred in a medical or cosmetic treatment utilizing the umbilical cord-blood that was deposited by the depositor in the cord-blood depository. The depositor is asked to specify a class of insurance that is desired and the details of the classes are made available to the depositor. The classes may be as described above with reference to table 1.

If the depositor elects to acquire an insurance policy from the insurance company, details relating to the acquired policy are stored in a new entry 38 in the second database of the second processor. Each entry of the second database of the second processor thus contains data relating to an insurance policy sold by the insurance company to a depositor of umbilical cord-blood at the cord-blood depository, where the insurance policy indemnifies the depositor for expenses incurred for a medical or cosmetic treatment utilizing the deposited umbilical cord-blood.

Figure 3 is a flow diagram showing some steps in an exemplary embodiment of the present invention. In this example, at step 42 a trigger starts the process in that diagnosis is made of a condition named in the policy and for which cell therapy treatment is available and can be used. If the answer is yes, then the process proceeds to step 44 at which a determination is made as to whether or not existing or related costs are covered, e.g. by another policy held by the party. If the answer is no, at step 46, the Future Life policy described generally herein applies and appropriate cover is provided.

If, at step 44, it is determined that existing or related costs are covered, then the process proceeds to step 48 at which a determination is made as to whether all of the existing or related costs are covered. If they are, then Future Life Critical Illness cover applies at step 50, and if not, then wrap up cover is provided at step 52. This ensures that any gaps in other insurance that a patient or customer might have, are covered. It is preferred to include in the policy the requirement that for the wrap-up cover to apply a customer or patient must first have made a claim on their other insurance, e.g. medical insurance.

Table 2 below, shows an example of how the policy might be arranged to operate, such that it provides four levels of cover. These might be the same as or different from the classes of cover referred to above.

Cover Trigger Cover Provided Policy Cover

COVER 1 Diagnosis of condition named in Lump sum to be spent at €50,000

Policy [irrespective of available discretion of the responsible

Diagnosis cell-therapy) party [i.e. insured individual or

of condition legal guardian)

COVER 2 Clinician diagnoses condition and Reimbursement for any expense Up to

submits request for cells to be related to global search, requisite €40,000 / unit

Cord blood used for a procedure regulated testing, appropriate or total of search under the jurisdiction of the transportation costs, purchase €80,000 competent authority of that costs

country along with any other

local regulations -for a condition

named in Policy

COVER 3 Clinician diagnoses condition and Reimburse direct and indirect Balance of submits request for cells to be [e.g. wigs list) costs of medical €250,000

Clinical used for a procedure regulated treatment. Less 2 and 4 Cover under the jurisdiction of the

competent authority of that

country along with any other

local regulations -for a condition

named in the Policy.

COVER 4 Following the cell therapy Reimbursed home recovery Up to

[regulated under the support costs e.g. house deep €10,000 Home jurisdiction of the competent clean, wigs, diet, home help

Recovery authority of that country along

Support with any other local regulations

-for a condition named in the

Policy)

Table 2

Table 2 shows three covers 2 to 4, which correspond to the medical type insurance provided by the present policy and cover 1 corresponds to critical illness, which applies, say, if a cell therapy treatment is not available upon diagnosis of a condition named in the policy.

It is to be noted that it is preferred that the policy be held in the name of the bank, i.e. the core blood bank, and not directly in the name of an end user or patient. End users or patients are beneficiaries to receive payments and the like in the event of the policy being triggered and some or all of its conditions satisfied. In one preferred example, patients or customers of the bank are automatically included in the policy upon signing up to the bank and providing material to it, but they are able to opt out if desired.

Embodiments of the present invention have been described with particular reference to the examples illustrated. However, it will be appreciated that variations and modifications may be made to the examples described within the scope of the present invention.

Claims

1. A method for providing cell therapy, the method comprising:

(a) obtaining from a depositor a body material and depositing the body material in a depository of such body material,

(b) defining plural classes of insurance cover and specifying terms for each of the defined classes;

(c) establishing an insurance policy stipulating that the depositor or a beneficiary of the depositor is indemnified for expenses incurred for a medical or cosmetic treatment requiring body material of the type deposited by the depositor, wherein the medical treatment utilizes either the deposited body material or substitute body material of the type deposited by the depositor, and

(d) collecting a periodic premium for the insurance, wherein the premium is determined on the class of insurance.

2. A method according to claim 1, in which at least two classes of insurance are provided and in which the amount of indemnity provided is dependent on the class.

3. A method according to claim 2, in which the in which two classes are provided as follows:

(i) protection is provided for the new born only;

(ii) protection is provided for the new born and up to a determined number of family members or siblings of the new born;

4. A method according to claim 3, in which the classes are further divided in dependence on the premium paid and the amount provided by the insurer in the event of a claim.

5. A method according to any of claims 1 to 4, in which the classes are defined in terms of the amount paid out as a lump sum to a claimant in the event of a claim.

6. A method according to any of claims 1 to 5, in which in addition to lump sum payment to the insured for the primary claim, a further lump sum is paid to source alternative bodily material or cells in the event that the stored bodily material cells are unavailable for any reason.

7. A method according to any of claim 6, in which the amount of the further lump sum is different for different classes.

8. A method according to claim 3 or 4, in which a further class is provided, defined as a bespoke class in which the levels of payment and premiums are calculated based on a user's specified requirements.

9. A method according to any of claims 1 to 8, in which a further payment is provided for the treatment of medical claims not known of at the time the insurance is taken out.

10. A method according to any of claims 1 to 9, further comprising indemnifying the depositor or beneficiary of the depositor for expenses incurred for a medical treatment utilizing the deposited body material.

11. A method according to any of claims 1 to 10 wherein the deposited body material is selected from blood, umbilical cord blood, skin, foreskin, lymph, adult stem cells, fetal stem cells, sperm, cells, bodily tissue, organs and cadaveric material.

12. A method according to any of claims 1 to 11, further comprising storing in a database data indicative of the insurance policy.

13. A method according to claim 12, wherein the data indicative of an insurance policy provided to a depositor of body material in a depository of body material is selected from the policy holder's name, the date that the deposit was made, information relating to the deposited body material, a serial number or other identifier associated with the deposit, a location of the deposited body material in the depository.

14. A method according to claim 3, wherein the family members includes one or more of parents, grand-parents and siblings.

15. A system for providing cell therapy, the system comprising a processor having a database of entries, the processor configured to input data indicative of an insurance policy comprising plural classes of insurance cover provided by an insurance provider to a depositor of body material in a depository of body material, the classes being determined in dependence on the premium paid, the system being further configured to store the data in an entry of the database, the insurance policy stipulating that the depositor or a beneficiary of the depositor is indemnified for expenses incurred for a medical or cosmetic treatment utilizing the deposited body material or substitute body material of the type deposited by the depositor, wherein the level .

16. The system according to claim 15, wherein the data indicative of an insurance policy provided to a depositor of body material in a depository of body material is selected from the policy holder's name, the date that the deposit was made, information relating to the deposited body material, a serial number or other identifier associated with the deposit, a location of the deposited body material in the depository.

17. The system according to claim 15 or 16, wherein the processor is further configured to input information relating to a deposit of body material in the body material depository and to inform the insurance provider of the deposit.

18. A method for providing cell therapy, the method comprising:

(a) obtaining from a depositor a body material and depositing the body material in a depository of such body material;

(b) specifying one or more medical or cosmetic treatments requiring body material of the type deposited by the depositor; (c) establishing an insurance policy stipulating that the depositor or a beneficiary of the depositor is indemnified for expenses incurred for one or more of the specified medical or cosmetic treatments, wherein the medical or cosmetic treatment utilizes either the deposited body material or substitute body material of the type deposited by the depositor, and

(d) the insurance policy also stipulating that a further payment will be provided for treatment of one or more unspecified medical or cosmetic treatments.

19. A method for providing cell therapy, the method comprising:

(b) establishing an insurance policy stipulating that the depositor or a beneficiary of the depositor is indemnified, if there is an available medical or cosmetic treatment, for expenses incurred for the treatment requiring body material of the type deposited by the depositor, wherein the medical treatment utilizes either the deposited body material or substitute body material of the type deposited by the depositor; and

(c) if there is no available medical or cosmetic treatment, providing critical illness cover to the depositor or beneficiary.

20. A method for providing cell therapy, the method being substantially as shown in and/or described with reference to any of figures 1 to 3 of the accompanying drawings.

21. A system for providing cell therapy, the system being substantially as shown in and/or described with reference to any of figures 1 to 3 of the accompanying drawings.