LifeCell - India’s largest umbilical cord stem cell bank has challenged the Indian Council of Medical Research (ICMR) recommendations 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 which functions under the health ministry had stated that there is no scientific evidence to substantiate the clinical benefits of these stem cells. Accordingly, the ICMR has issued guidelines stating that commercial banking of all other biological materials, other than UCB, is not permitted until further notification.

Mayur Abhaya, chief executive officer & managing director of LifeCell - India’s largest umbilical cord stem cell bank questioned the hurried decision of ICMR in this guideline recommendations for preserving vital stem cells from cord tissue, menstrual blood and other biological material without considering many aspects. He commented that the decision does not carry a rationale for many reasons which he elaborated.

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 commercialise 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.

Preservation of cord tissue and other source of stem cells have been prevalent across the globe considering its research advancements in medicine. Advanced economies like 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.

With many 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 for individuals, particularly for medical treatment for ailments that they may 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 recreated subsequently. Who would be able 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.

In targeting the banking of the MSCs, the ICMR has lost perspective of the objective sought to be achieved.  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 proved therapy.  If wrongful declaration by the banking industry was the concern, guidelines could easily have prescribed clear declarations by these banks of absence of a scientific body of research of the utility of these MSCs.  Banking is a mere storage, and not utilization.  If utilisation was a concern, restrictions on the release of the stored MSCs could easily have been prescribed, which has not even been considered.

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.

Mayur added, “However it is important to preserve them today considering that it is a 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”.