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Call to Action to Support the REGROW Act

Květen 2016
Kyle Cetrulo


The entire cord blood community has circled the date Saturday, June 11, 2016 with great anticipation. For it is on this morning, from 8:15 to 10:00 am at the Plenary Session of the 14th International Cord Blood Symposium titled “Regenerative Medicine Applications of UCB in the Clinic: Results of Current Clinical Trials”, chaired by Dr. Joanne Kurtzberg, that we will hear the results of clinical trials that have focused on treating young children with cerebral palsy and autism with umbilical cord blood. 

The promise of successful cord blood clinical trials for the treatment of cerebral palsy is an incredibly exciting idea to ponder, not only for the lives of the patients it will dramatically improve, but also for the impact that these trials will have for cord blood banks, both public and private. If successful, these clinical trials have the potential to completely revolutionize the entire cord blood banking industry.

For the past decade, the cord blood banking penetration rate has hovered at 2 to 3% in the United States. In the book “Perinatal Stem Cells, 2nd Edition”, published in 2013, I predicted in my chapter “Perinatal Stem Cells: An Industry Perspective” that the cord blood market will expand to 15-20%  if the cerebral palsy clinical trials are shown to be a safe and effective treatment for neonatal brain injuries.

I still believe that this market growth is possible, but another important factor is required in order for this to happen. There needs to be a regulatory paradigm shift that allows patients access to cellular therapies, including cellular therapies that use cord blood, to treat brain injuries such as cerebral palsy. Unfortunately, the current regulatory structure is not working and will not allow this access. 

“We have had the current FDA regulatory structure for cell therapy in place for 15 years, and in that 15 years not one stem cell therapy had been approved. The scoreboard is not lying, there’s zero on it. Not one therapy has been approved. There is an issue here that we can’t ignore.”
-- C. Randle Mills, President of the California Institute of Regenerative Medicine (CIRM).

I want to emphasize again where we stand from a regulatory perspective in terms of patients having access to cord blood treatments for brain injuries:  We are not even close to having this be a reality regardless of the outcome of the current clinical trials that will be presented on June 11th. Not even close. And in fact it might not even be possible to obtain approval for this therapy under the current regulatory structure, because there are not enough children diagnosed with cerebral palsy who banked their own cord blood to conduct a Phase 3 clinical trial. As we stand today, it will be very difficult for a private cord blood banking client to access treatment to use their own child’s banked cord blood to treat their child’s cerebral palsy in the United States - outside of future clinical trials - unless the regulatory structure changes. 

What is exciting and amazing and happening right now, is that we have a huge opportunity as a community right in front of us to make this change with the REGROW Act.

I strongly urge the cord blood banking community to rally behind a proposed bill currently in the US congress call the “Reliable and Effective Growth for Regenerative Health Options that Improve Wellness”, or the REGROW Act. The REGROW Act in my opinion could be the single most important change to the cellular therapy industry in the last 30 years, since bone marrow transplantation became a standard of care. It is that important. 

But please do not take my word for it. Listen to what Dr. Kurtzberg says: (minutes 10:00-12:40 of the video).

“And so we’re at a point where we either do a Phase 3 trial - but there aren’t enough kids to do a Phase 3 trial to be perfectly honest - or we abandon this when it’s helping. Or we figure out some other way, and this legislation is perfect for this kind of therapy, which we’ve shown is safe, we’ve shown is effective and doesn’t meet the specifications for going forward to Phase 3.”
-- Dr. Joanne Kurtzberg.

Please reach out to your local representatives and urge them to support the REGROW Act.  This website makes it incredibly easy to contact your representatives: www.CellTherapyNow.org.  Please also sign my Change.org petition.

Cord Blood Banks, please join in support of the REGROW Act.  Send broadcasts to your mailing list asking for their support of REGROW.  Put out a Press Release.  Do something.  Do anything.  But support the REGROW Act!

Kyle Cetrulo and his co-founders formed the Perinatal Stem Cell Society in 2013 in order to provide a platform for collaboration and the dissemination of knowledge and information about perinatal stem cells. The 3rd Annual Perinatal Stem Cell Society conference will be held Feb. 26 - March 1, 2017 in Aspen, CO. Kyle Cetrulo’s involvement with perinatal stem cells goes back to 1998, when he became Director of the International Cord Blood Society (ICBS). Mr. Cetrulo organized the 5th and 6th International Congresses for the ICBS in 2002 and 2004, at which representatives from 23 countries participated. He edited two editions of Perinatal Stem Cells (Wiley Press, 2010 and 2013) and was a guest editor of the Stem Cell Reviews journal 2006 special edition focused on Perinatal Stem Cells. Mr. Cetrulo also co-founded Auxocell Laboratories, Inc. (Auxocell) in 2008.