Commercial Banking of Stem Cells From Cord Tissue, MenstrualBlood and few Other Biological Materials(Attn.editors: The following press release comes to youunder an arrangement with PRNewswire. PTI takes noeditorial responsibility for the same).
LifeCell's Views on ICMR's Recommendation to CurtailCommercial Banking of Stem Cells From Cord Tissue, MenstrualBlood and few Other Biological Materials CHENNAI, October 13, 2017/PRNewswire/ --Mr. Mayur Abhaya,CEO & Managing Director of LifeCell - India's largestumbilical cord stem cell bank differs in opinion from TheIndian Council of Medical Research (ICMR) in the guidelinerecommendation for preserving vital stem cells from cordtissue, menstrual blood and other biological sourcesconsidering many aspects.
(Logo:http://mma.prnewswire.com/media/542620/LifeCell_Logo.jpg )ICMR had made recommendations in its National guidelines tostem cell research, 2017, to suspend commercial banking ofstem cells derived from biological materials such as cordtissue, placenta, tooth extract and menstrual blood. In itsrecommendation, ICMR which functions under the health ministryhad stated that there is no scientific evidence tosubstantiate the clinical benefits of these stem cells.
Accordingly, the ICMR has issued guidelines stating thatcommercial banking of all other biological materials, otherthan UCB, is not permitted until further notification.
However, Mr. Mayur Abhaya, CEO & Managing Director ofLifeCell - India's largest umbilical cord stem cell bank, hasa different opinion based on the following reasons:Inconsistent Decision:A statement issued by the company says that the ICMR decisionseems to be inconsistent and seeks a rationale to thisguideline. Recently, Stempeutics Research (a group company ofManipal Education & Medical Group and a Joint Venture withCipla Group) had received approval to commercialise itsproduct 'Stempeucel' - a cultured adult allogeneic mesenchymalstem cells derived from bone marrow for treatment. The productwas approved for treating Critical Limb Ischemia due toBuerger's disease. Hence, this ban is inconsistent to thisapproval issued by DCGI.
Not as per the Global Practices:Preservation of cord tissue and other source of stem cellshave been prevalent across the globe considering its researchadvancements in medicine. Advanced economies like US andEurope have been encouraging support towardslicensing/registration of such banking practices. Eveninternationally acclaimed regulatory bodies such as USFDA,AABB have acknowledged and accredited cord tissue banking,whereas in India these guidelines throw a surprise, having theimpact of curtailing the future potential of stem celltreatments.
Right to Life:With many ongoing scientific research and clinical trialssubstantiating significant progress of cord tissue stem cells,it is not possible to ignore the unending possibilities thatthe 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 toeach person. Indeed, this right would form a part of the'right to life' guaranteed under the Constitution and requiresto be protected. Preserving cord tissue stem cells is a oncein a lifetime opportunity, which once lost by a person, cannotbe re-created subsequently. It is impossible to compensate aperson for this lost opportunity, hence it is recommended topreserve these at birth to gain access to treatments lateronce MSCs evolve into treatments in the near future.
Imprecise Target and Direction:In targeting the banking of the MSCs, the objective is clearlyto prevent misuse in the form of treatments using the MSCswithout proven clinical evidence. By targeting the banking ofthe MSCs, the ICMR is preventing access to the public of thebenefits at a future point of time when these could well bedeveloped as a proven therapy. If wrongful declaration by thebanking industry was the concern, guidelines could easily haveprescribed clear declarations by these banks of absence of ascientific body of research of the utility of these MSCs.
Banking is a mere storage, and not utilization. If utilisationwas a concern, restrictions on the release of the stored MSCscould easily have been prescribed, which has not even beenconsidered.
Mr. Mayur Abhaya, CEO & Managing Director, LifeCell said,"The decision to recommend a ban on banking of stem cells fromcord tissue, menstrual blood and other biological sources isvery unfortunate and totally overlooks the potentialcontribution of stem cells in research and development. Thoughtoday, applications of these are restricted, research andadvanced clinical trials across the globe on these productshave been demonstrating a significant progress. It is only amatter of time when these stem cells could become treatmentsolutions for many disorders that have very few other optionsfor treatment." Now, if the contention is that these cord tissue and otherMSC stem cells are going to be used for treatments today, ifthat 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 themtoday considering that it's once in a lifetime opportunity andwould stay protected when these stem cells turn into potentialtreatment opportunities. Rather it is imperative that theGovt. should impose a strict ban on usage of these MSC cellsfor treatments today and ensure compliance but not restrictpreservation for the future. I'm sure the DCGI would take afair view to provide the opportunity to preserve these stemcells for future use considering the advancing opportunitiesin research and clinical trials."About LifeCellLifeCell, established in 2004, is India's leading provider ofpreventive healthcare services for family wellness, such asstem cell banking and diagnostic testing, with facilities atChennai & Gurgaon with a network spanning over 200 cities inIndia and abroad. BabyCord, LifeCell's umbilical cord stemcell preservation services, is world's second largest withover 50,000 parents preserving their baby's stem cells with iteach year and over 2,70,000 parents already having trustedLifeCell.
With the recent launch of BabyCord Share, a community-based approach towards stem cell access is a global first andaims to provide families in India better future access to stemcells than even currently possible in advanced countries suchas the US. LifeCell's processing, storage and testingfacilities are the most accredited having receivedrecognitions from domestic and global bodies such as the AABB(formerly American Association of Blood Banks), College ofAmerican Pathologists, National Accreditation Board forLaboratories, World Health Organization, amongst many others,and is also US FDA registered.
BabyShield, LifeCell's preventive genetic screening anddiagnostic testing services, is India's market leader fornewborn screening services and recently forayed into prenatalscreening.
Visit us at: www.lifecell.inFor More details, please contactKrutika RajkumarSenior Manager, Corporate Communicationskrutika.r@lifecell.inMob: +91-9884493607Source: LifeCell International Private LimitedPRNewswireOSS.
This is unedited, unformatted feed from the Press Trust of India wire.