Accordingly, commercial banking of all other biological materials are not permitted until further notification," it stated. The new guidelines also reiterated that stem cell use in patients is investigational at present, with the exception of hematopoietic stem cell reconstitution "for approved indications". Hematopoietic stem cells are stem cells that are usually derived from the bone marrow, peripheral blood or umbilical cord blood.
Any stem cell use in patients must only be done within the purview of an approved and monitored clinical trial "with the intent to advance science and medicine…" the guidelines stated. Accordingly, every use of stem cells in patients outside an approved clinical trial is "unethical and shall be considered malpractice," it added.
This differs for adults and children, with children being allowed HSCT for fewer types of cancers and more types of non-malignant diseases. The guidelines formulated taking into account several new scientific and technical advancements and perceived challenges in stem cell research also outlines areas of research that are prohibited. This includes research related to human germline gene therapy, where DNA is transferred to reproductive cells to correct disease-causing gene variants passed on to the next generation.
Stem cell research is also prohibited in areas like cloning and transplanting living cells, tissues or organs between different species. The government aims to prevent exploitation and commoditization of resources through the new guidelines. Read more on Stem cell. Follow us on. Download et app. Become a member. Government imposes restrictions on stem cell banking, therapy to curb "rampant" unethical practices. Mail This Article. To date, fewer than ten single case reports have been published of autologous transplants of stem cells using UCB from commercial UCB banks.
Numerous studies are available on the probability of autologous use. It should be remembered, however, that numerous clinical trials involving a variety of diseases are underway. This means that the scientific picture is in continual flux and that attitudes toward autologous storage may evolve quickly. As Webb observed, if further research endorses the efficacy of UCB in the treatment of cerebral palsy or in other areas of regenerative medicine, the stance of the scientific community regarding private UCB banks could change: they might become a useful complement to public biobanks, which are often hampered by financial straits and, at times, by excessively tight regulatory constraints.
Banking for autologous purposes may be considered if such storage is part of a program whose primary mission is the use of cord blood units for allogeneic stem cell transplantation. Notwithstanding this, private biobanks are expanding rapidly both in size ViaCord, which in stored only a few thousand UCB units, held over , units in and in number. It is estimated that in , approximately 1 million UCB units were stored in more than private UCB banks worldwide.
The high number of units stored in private banks is also linked to the fact that these facilities apply less stringent criteria for acceptability particularly regarding the number of cells and their viability, clonogenic capacity, and sometimes, sterility than do public banks, which are regulated by international quality standards.
There is consequently a risk that units stored in private banks may be of low quality or low yield. There are, nonetheless, many reasons why parents still choose to pay for private storage. Although in the case of public UCB banks all healthy neonates are potential donors, family-directed banking implies a more focused approach to identifying the few candidates to benefit from cord blood collection.
Although the total number of directed UCB units stored is unknown, it is small in comparison with those in either allogeneic public banks or autologous private banks. Private UCB banking for family use is mainly a spin-off from autologous banking. Occasionally a sibling may benefit from this form of banking.
In countries in which direct banking programs do exist, it is usual to establish official lists of recognized indications for which the transplantation of hematopoietic stem cells has been proven to be effective and for which the harvesting of directed UCB is appropriate.
Family-directed UCB transplantation has several advantages over unrelated UCB transplantations, including greater likelihood of survival, decreased graft-versus-host disease, and the opportunity to recollect bone marrow cells from the same donor in the event of relapse or rejection. It is therefore to be hoped that the numbers of family-directed UCB banks will increase.
Cord blood banking: the prospects and challenges of implementation in Nigeria - MedCrave online
Other types of blood banks also exist, 52 for example, hybrid private—public facilities, although they are not numerous. Some of these banks divide the UCB into two parts, one of which is stored privately for autologous or related use and the other of which is donated to the public network. The challenge facing these banks is to combine the known potential of public-sector allogeneic storage with the possible, albeit currently remote, applications of autologous storage in specific fields of regenerative medicine.
It is hoped that in the future, treatments may be found for tissues or organs damaged by degenerative diseases. One of the more interesting possibilities being studied 58 is the use of UCB stem cells for functional neuroregeneration in children with cerebral palsy. One hybrid private—public facility is Virgin Bank, established by Richard Branson. This scheme has aroused interest in several quarters. The former holds units for private use family-directed , whereas units held in the latter are available to the general public.
Some private banks store UCB for autologous use while simultaneously creating links with networks managed by universities and public institutions. The World Marrow Donor Association has published a paper on the subject. Some form of public—private partnership could bring financial support to the public biobank network, which is frequently underfunded, but the difficulty lies in identifying a suitable model.
Accredited public UCB banks are linked to national registries. In the United States, for example, the federal government enacted legislation in to support the National Cord Blood Inventory, which is a registry of publicly available UCB units. National registries are linked, in turn, to international registries, which permit identification of the most suitable sample for each patient requiring a transplant.
The international standards with which all biobanks linked to the registries must comply are necessary to guarantee not only that products meet international best-practice standards but also the efficiency of the administrative procedures needed to organize the registries and source UCB units for transplantation.
The search for UCB units is usually set in motion by either a hematologist or an oncologist through referral to a transplant center. The search usually initiates in a domestic registry network before being extended to international networks, as the acquisition of UCB units from a foreign country inevitably implies increased costs. UCB registries thus function as a hub linking donors, recipients, clinics, biobanks, and regulatory agencies. The size of each registry is naturally of crucial importance: the larger the number of units registered, the greater the probability of finding a clinically useful match between donor and recipient.
Various studies have estimated the number of banked UCB units required to meet the needs of a given population. To decide how many UCB units should be included in an inventory, the benefits in terms of the greater numbers of transplants and life-years gained must be weighed against the costs involved. Identifying the appropriate size of national inventories is thus crucial not only for clinical reasons to ensure a match between supply and demand but also for reasons of economic sustainability.
The authors concluded that a bank containing 50, units would be optimal for the United Kingdom and that larger banks would only marginally increase the chance of finding suitable units. Donated UCB units can also be used to obtain products that are at least potentially marketable. Units that are unsuitable for storage and transplantation can, in fact, potentially be used for research purposes 71 or for the preparation of blood-derived products, particularly platelet gel, 72 subject to the consent of the parents who donated the sample.
The chance to prevent this biological resource being wasted can thus be transformed into an opportunity to increase the value of the altruistic gesture of donation, 73 or even a source of gain. Platelet gel is a blood-derived product obtained by aggregating concentrated platelets with calcium and biological or pharmacological proaggregation factors and is applied topically. Thanks to its plasticity and ease of modeling at the site of application, this preparation promotes and accelerates the repair of both cutaneous and bone tissues.
It is used in maxillofacial surgery, orthopedics, and the treatment of torpid cutaneous ulcers. On account of its reparative properties, the potential uses of platelet gel have expanded steadily into different fields, including aesthetic surgery and medicine. Because UCB is donated for philanthropic purposes, the exploitation for profit of platelet gel or other products derived from UCB could raise concerns. This problem could be avoided if these blood-derived products were used within the same health care facilities in which the units were harvested and did not enter any kind of commercial network.
It would naturally be necessary to include appropriate information on the relevant informed consent forms and to give parents the option both to refuse consent to the use of cord blood for the preparation of blood-derived products and to place restrictions on its use, such as limiting the use of platelet gel for therapeutic, but not cosmetic, purposes. The costs for each unit of UCB released from international networks for transplantation purposes have been estimated by various authors.
The calculations used different settings and parameters eg, inventory size, numbers of biobanks, duration of storage, percentages of release, etc and considered the expenses incurred in the various phases eg, labor costs, reagents and diagnostics, disposables, depreciation and maintenance, laboratory tests, overheads. One of the earliest of these studies was published by Sirchia et al 75 and estimated the fees per UCB unit released for transplantation that would allow cost recovery after 10 years. The authors considered three possible models with varying numbers of UCB banks and inventory sizes and took five UCB units per 1 million population per year as the rate of use for transplantation.
This equates to an annual requirement of units for Italy which is approximately four times the actual figure normally reported. A more detailed study was performed by Bart, who compared unrelated donor UCB and adult stem cell procurement.
To do this, he multiplied the available products UCB units banked and registered adult donors by the average costs per product, together with the costs of provided products provided UCB versus bone marrow or peripheral blood stem cells multiplied by the cumulative total number. The data elaborated by Bart indicate a considerable difference between the costs for UCB and adult stem cells from bone marrow or peripheral blood , which is, among other factors, because the vast majority of stored UCB units are never used for transplants.
Taken together, these studies reveal the variability in fees that biobanks receive for the release of blood units to transplant centers. The costs rise further if we consider that in a growing number of cases, patients receive multiple transplants to increase the likelihood of therapeutic success.
The whole issue of costs should nonetheless be considered in a broad perspective: It should not be forgotten that engraftment with UCB takes longer 21—35 days than engraftment with cells taken from an adult donor 20 days , thereby implying possibly higher hospitalization costs. All of these considerations apply in the public system, which is often subsidized.
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In the United States, for instance, public UCB banking is financed through a combination of government grants, private donations, and the fees received for UCB units released for transplant purposes. The challenge is to reduce the costs of the whole process of UCB banking harvesting, processing, storage without compromising quality and safety levels.
Unfortunately, this is an extremely difficult goal to achieve. Although this article is concerned with the bioeconomic aspects of public UCB banking, it is worthwhile mentioning a few data regarding the costs involved in private UCB banking, where profit is the stated objective. This method tracks hypothetical groups of people and permits a comparison of the expected costs and health benefits of two strategies private UCB banking and no banking. The authors conclude that private UCB banking is not generally cost-effective, except for families with a child who has a very high probability of needing a stem cell transplant.
Size is a crucial factor for registries: The larger they are, and the more heterogeneous their inventories, the greater the probability of finding a clinically useful match between donor and recipient. Communitas expresses a relationship and a link of reciprocity, whereas immunitas denotes a resistance to reciprocity, a defense and a protection against what is external.
Another reason, in some regions, is associated with the presence of ethnic minorities. Most UCB banks were initially established to address the problem of a disproportionately high percentage of Caucasian populations in bone marrow registries. Several nations have included provisions to encourage the harvesting of UCB from key minorities in their cord blood collection procedures. The international dimension is decisive, among other things, in contributing to the biovalue of UCB because of the need for access to widely dispersed immunotypes.
A few figures on the release, destination, and use of UCB allows a comparison between imports and exports and reveals the irregularity in movements. In some nations, exports clearly outnumber imports. Many Southeast Asian countries, for example, are self-sufficient, probably because of the relative homogeneity of their populations. Nor are strong exporting countries necessarily self-sufficient. In the United Kingdom, for instance, exports outnumber imports, but import costs are higher. The fees charged for the release of UCB units for transplantation frequently exceed the actual outlay incurred by biobanks for storage and preservation.
The international dimension contributes to the economic value of UCB, as it enables biobanks to include indirect costs beyond those incurred in harvesting and storage in the charges applied when cord blood is released in the global marketplace. This is justified on the basis that these services should be able to offset their costs and receive some compensation for the economic risks and the financial burden incurred in the process of collecting and storing blood samples.
Although the system is based on donations and altruism, the transactions described here could be seen as a form of masked commerce. Purchasing, or offering to purchase, cells, tissues or organs for transplantation, or their sale by living persons or by the next of kin for deceased persons, should be banned. This does not, however, prevent the existence in several states that are signatories to these and other documents prohibiting trade of the human body or its parts, not only of regulations that allow the sale and purchase of cells and tissues, but also of official tariffs for such transactions.
Public-sector hospitals in these states may legally sell biological samples to industrial concerns. Umbilical cord blood transplantation: the first 25 years and beyond. N Engl J Med. Future of cord blood for oncology uses. Bone Marrow Transplant.
Can Routine Commercial Cord Blood Banking Be Scientifically and Ethically Justified?
Pediatric related and unrelated cord blood transplantation for malignant diseases. Clinical use of umbilical cord blood hematopoietic stem cells. Biol Blood Marrow Transplant. Future of cord blood for non-oncology uses. Prasad VK, Kurtzberg J. Because public banks do not charge storage fees, medical centers do not always have the funds required to establish and maintain them.
Private versus public CBBs
A recent large study by the journal Pediatrics concluded that almost all cord blood transplants come from public banks: . In the Pediatrics study, transplant specialists who collectively have performed thousands of stem cell transplants for childhood leukemia and other illnesses report that only 50 involved privately banked blood. Support for public cord-blood banking is widespread in the medical community.
Forty-one cases involved blood used to treat a family member, often a sibling; in 36 of those cases the need for a transplant was known before the cord blood was collected. Only nine cases involved giving cord blood back to the donor, a practice known as autologous transplantation and the chief selling point for private cord-blood banking. Private banking is typically costly to parents and not covered by insurance.
The ability to use the cord blood may also depend on the long-term commercial viability of the enterprise. Since the FDA considers cord blood stored at public banks to be "drugs", but doesn't consider cord blood stored at private banks for use by the donor to be drugs, private banks are held to a lower regulatory standard.
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Cord blood transplants require less stringent matching between the tissue types of the donor and patient, known as their human leukocyte antigen HLA types. Minority ethnic groups have difficulty finding a perfectly matched transplant donor. Studies have found that allogeneic transplants have a better outcome when the donor and patient are related. The policy of the Society of Obstetricians and Gynaecologists of Canada SOGC supports public cord blood banking similar to the collection and banking of other blood products, i. Private storage of one's own cord blood is unlawful in Italy and France, and it is also discouraged in some other European countries.
The American Society for Blood and Marrow Transplantation states that public donation of cord blood is encouraged where possible, the probability of using one's own cord blood is very small, and therefore storage of cord blood for personal use is not recommended, and family member banking collecting and storing cord blood for a family member is recommended when there is a sibling with a disease that may be treated successfully with an allogeneic transplant. As of , contracts of the largest cord blood banks do not explicitly state that the cord blood belongs to the donors and child with all the rights and privileges one would reasonably expect from ownership.
The ambiguity leaves open future uses not approved by the donors and child. At the majority of private cord blood banking facilities, the mother owns all rights to the cord blood that was banked, until the minor in which the cord blood was taken turns eighteen. At that time the minor has all rights to his or her own banked cord blood. Concerns have been raised that the current interest in cord blood could cause a perception that cord blood is "unused" by the birth process, thus decreasing the amount of blood which is infused into the child as part of the birth process.
With the demand for cord blood increasing, there is a possibility that the cord could be clamped prematurely to preserve even more "extra" cord blood. The American Academy of Pediatricians notes: "if cord clamping is done too soon after birth, the infant may be deprived of a placental blood transfusion, resulting in lower blood volume and increased risk for anemia.