The Indian Council of Medical Research (ICMR) had made recommendations in its National guidelines to stem cell research, 2017, to suspend commercial banking of stem cells derived from biological materials such as cord tissue, placenta, tooth extract and menstrual blood. In its recommendation, ICMR had stated that there is no scientific evidence to substantiate the clinical benefits of these stem cells.
The ICMR guidelines state that commercial banking of all other biological materials, other than UCB, is not permitted until further notification.
The 2017 guidelines, reiterate that any stem cell use in patients, other than that for hematopoietic stem cell reconstitution for approved indications, is investigational at present. Accordingly, 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, and not offering it as therapy. In accordance with this stringent definition, every use of stem cells in patients outside an approved clinical trial is unethical and shall be considered as malpractice.
The move has drawn strong reactions from the industry players. Mr. Mayur Abhaya, CEO and Managing Director of LifeCell has questioned the guideline and has presented a different opinion based on the following reasons:
- Inconsistent Decision:
A statement issued by the company says that the ICMR decision seems to be inconsistent and seeks a rationale to this guideline. Recently, Stempeutics Research (a group company of Manipal Education & Medical Group and a Joint Venture with Cipla Group) had received approval to commercialize its product ‘Stempeucel’ – a cultured adult allogeneic mesenchymal stem cells derived from bone marrow for treatment. The product was approved for treating Critical Limb Ischemia due to Buerger’s disease. Hence, this ban is inconsistent to this approval issued by DCGI.
- Not as per the Global Practices:
Preservation of cord tissue and other sources of stem cells have been prevalent across the globe considering its research advancements in medicine. Advanced economies like the US and Europe have been encouraging support towards licensing/registration of such banking practices. Even internationally acclaimed regulatory bodies such as USFDA, AABB have acknowledged and accredited cord tissue banking, whereas in India these guidelines throw a surprise, having the impact of curtailing the future potential of stem cell treatments.
- Right to Life:
With much ongoing scientific research and clinical trials substantiating significant progress of cord tissue stem cells, it is not possible to ignore the unending possibilities that the Mesenchymal Stem Cells (‘MSC’) can provide to individuals, particularly for medical treatment and ailments they suffer. The right to store these MSCs are of critical importance to each person. Indeed, this right would form a part of the ‘right to life’ guaranteed under the Constitution and requires to be protected. Preserving cord tissue stem cells is a once in a lifetime opportunity, which once lost by a person, cannot be re-created subsequently. It is impossible to compensate a person for this lost opportunity, hence it is recommended to preserve these at birth to gain access to treatments later once MSCs evolve into treatments in the near future.
- Imprecise Target and Direction:
In targeting the banking of the MSCs, the objective is clearly to prevent misuse in the form of treatments using the MSCs without proven clinical evidence. By targeting the banking of the MSCs, the ICMR is preventing access to the public of the benefits at a future point of time when these could well be developed as a proven therapy. If wrongful declaration by the banking industry was the concern, guidelines could easily have prescribed clear declarations by these banks of the absence of a scientific body of research of the utility of these MSCs. Banking is a mere storage and not utilization. If utilization was a concern, restrictions on the release of the stored MSCs could easily have been prescribed, which has not even been considered.
Mr. Mayur Abhaya, CEO & Managing Director, LifeCell said, “The decision to recommend a ban on banking of stem cells from cord tissue, menstrual blood, and other biological sources is very unfortunate and totally overlooks the potential contribution of stem cells in research and development. Though today, applications of these are restricted, research and advanced clinical trials across the globe on these products have been demonstrating a significant progress. It is only a matter of time when these stem cells could become treatment solutions for many disorders that have very few other options for treatment.”
Now, if the contention is that these cord tissue and other MSC stem cells are going to be used for treatments today if that is the concern of ICMR then the answer is a clear “No” since they have not been approved for therapies.
Mr. Mayur added, “However it is important to preserve them today considering that it’s once in a lifetime opportunity and would stay protected when these stem cells turn into potential treatment opportunities. Rather it is imperative that the Govt. should impose a strict ban on usage of these MSC cells for treatments today and ensure compliance but not restrict preservation for the future. I’m sure the DCGI would take a fair view to provide the opportunity to preserve these stem cells for future use considering the advancing opportunities in research and clinical trials.”