The Stem Cell Source : clinical trials

Cord Blood Banks are Not Stem Cell Clinics

PublicAffairs — Tue, 23 Feb 2010 19:55:00 GMT

A recent story filed by Agence France-Presse (AFP), a Paris-based news service, offered a very misleading perspective on the current state of cord blood banking as well as the legitimate medical use of cord blood stem cells.

In essence, the reporter failed to recognize the difference between overseas “stem cell clinics” offering “unproven cures” and accredited cord blood banks in the U.S. that are facilitating FDA-approved research using a child’s own cord blood stem cells for new medical uses.

The story focused on comments made by one stem cell researcher, Dr. Irving Weissman, at the annual meeting of the American Association for the Advancement of Science (AAAS). Dr. Weissman appropriately denounces the practices of non-accredited “stem cell clinics,” which are often based in foreign countries with poor medical regulations, that offer infusions of stem cells as definitive treatments for a wide range of conditions. Several medical bodies and institutions have raised concerns about the inability of these clinics to substantiate their medical claims as well as the risk they pose to patient safety.

This is very different from the scientifically-valid and regulatory-approved research occurring in countries like the U.S. where pioneering physicians are studying the use of a child’s own cord blood stem cells as treatments for type 1 diabetes(1) and cerebral palsy(2). In fact, just last week Medical College of Georgia announced a new FDA-approved clinical trial to evaluate the use of a child’s own cord blood stem cells to treat cerebral palsy. It’s important to know that participants in these clinical trials were eligible because they had access to their own, genetically-unique cord blood stem cells because their parents made the decision to privately bank them at birth.

The protocols for these clinical trials require participants to have access to their own cord blood stem cells because they provide a guaranteed biological tissue match, do not require preparatory therapies like chemotherapy, do not pose the immune complications of donor cell infusions, and eliminate the need for anti-rejection drugs which can create complications. In other words, using a child’s own cord blood stem cells allows researchers to explore the potential of these cells in a way that is safe for patients.

It’s also important to note, that cord blood stem cells have been used for more than two decades to treat nearly 80 conditions, including certain cancers, blood disorders and immune diseases. Furthermore, stem cell researchers and leading medical organizations recognize that cord blood stem cells have unique characteristics. In fact, the American College of Obstetricians and Gynecologists states that cord blood stem cells “offers several distinct advantages” over other sources of stem cells when used in treatments for these types of conditions(3).

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(1)Clincialtrials.gov. Umbilical Cord Blood Infusion to Treat Type 1 Diabetes. University of Florida. http://clinicaltrials.gov/ct2/show/NCT00305344?term=cord+blood+and+diabetes&rank=1. Accessed February 2010.
(2)Clinicaltrials.gov. Safety and Effectiveness of Cord Blood Stem Cell Infusion for the Treatment of Cerebral Palsy in Children. Medical College of Georgia. http://www.clinicaltrials.gov/ct2/show/NCT01072370?term=cerebral+palsy+and+cord+blood&rank=1. Accessed February 2010.
(3)ACOG Committee Opinion. Umbilical Cord Blood Banking. Obstetrics and Gynecology. 2008;111(2):475-477.

New Initiative Provides Safety Net to Infants Born At-Risk for Brain Injury While Helping To Advance Cord Blood Stem Cell Clinical Research

PublicAffairs — Mon, 22 Feb 2010 23:22:00 GMT

CBR is launching a new program in collaboration with a select group of leading U.S. medical institutions that will enable children born at risk for brain injuries to participate in new medical research using their own cord blood stem cells. The program, called Newborn Possibilities, will ensure that the cord blood of children born at-risk for developing cerebral palsy is preserved, so that if the child is later diagnosed with the condition, he or she may be eligible to receive a new treatment (being researched under approval from the FDA) using the child’s own cord blood stem cells.

The program is being jointly launched in Tucson by CBR, Tucson Medical Center and two prominent advocacy organizations based in Tucson, Save the Cord Foundation and Watching Over Mothers and Babies Foundation (WOMB). CBR plans to expand the program to other medical centers across the country in order to connect patients who may be at risk for neurological disabilities (and who have access to their cord blood stem cells) to FDA-approved clinical trials.

CBR will be providing cord blood banking collection and storage at no cost to the families who qualify, and the program is expected to enroll nearly 700 children in its first year. Because these children will have access to their own cord blood, they may be eligible for the first FDA-approved human clinical trial evaluating the safety and efficacy of using a child’s own newborn blood stem cells to treat cerebral palsy.

A recent report by the March of Dimes estimates that 1 out of every 10 pregnancies in the U.S. results in a premature birth. Infants who survive premature birth face a higher risk of developing neurological complications such as cerebral palsy.

In addition, nearly 1.4 million individuals suffer a traumatic brain injury each year. One of the highest risk groups are infants ages 0-4. To date, there has been no cure for treating brain injuries.

What’s on your mind?

PublicAffairs — Wed, 19 Aug 2009 17:35:00 GMT

As the Stem Cell Source blog closes in on its sixth month, we want to take the opportunity to see if we are writing about the issues that matter to you.

So what questions do you have? Do you want to know more about public policy, advances in cord blood stem cell science, or the status of clinical trials? Do you want to hear from doctors, clients, or CBR staff?

Please email us and let us know what topics interest you. We will use your input as the basis for future blog posts. We can’t respond to individual inquiries, but we’ll do our best to address on our blog the answers to our readers’ most common questions.