First FDA-approved stem cell trial in pediatric cerebral palsy

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This is very exciting news – First FDA-approved stem cell trial in pediatric cerebral palsy.

Medical College of Georgia researchers are conducting the first FDA-approved clinical trial to determine whether an infusion of stem cells from umbilical cord blood can improve the quality of life for children with cerebral palsy.

While no controlled clinical trials have been conducted to date, previous studies have shown marked improvement in children with cerebral palsy about three months after an initial infusion of cord blood.

“Evidence up to this point has been purely anecdotal,” Dr. Carroll said. “While a variety of cord blood stem cell therapies have been used successfully for more than 20 years, this study is breaking new ground in advancing therapies for brain injury — a condition for which there is currently no cure.”

Here’s the protocol for the study:

Children will begin the study with a neurological exam by MCG pediatric neurologists Elizabeth Sekul and Nicole Brockway. Then, half of the study participants will receive an infusion of their own cord blood while the other half receive a placebo. Three months later, the children will be evaluated without physicians knowing which group received the stem cell infusion. Afterward, children who didn’t get the cord blood initially will receive an infusion. Children will return three and six months later for evaluation.

While this is exciting news for those of us who represent families with children having special needs, including children with cerebral palsy, I cannot even imagine what great news this is for the parents of such children.  Granted, this is perhaps just a first step BUT what a first step.  Here’s hoping it all goes extremely well.  We’ll try to stay up with this story.  Good luck to ALL involved in the project!

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5 Responses to “First FDA-approved stem cell trial in pediatric cerebral palsy”

  1. David Granovsky Says:

    Excellent news but let’s not forget the Duke University and Northwestern University clinical trials on pediatric cerebral palsy with umbilical cord derived stem cells that preceded this one: http://repairstemcell.wordpress.com/2010/02/12/first-fda-approved-stem-cell-trial-in-pediatric-cerebral-palsy/ plus, you can get treatments already (if you are willing to leave the country): http://repairstemcells.org/Treatment/Treatment-Request.aspx?d=Cerebral%20Palsy

  2. Brian Nash Says:

    Excellent comment. I had seen references to this earlier research but did not have the depth of information you provided. Thanks for your informative comment. Hopefully others will pick up on it as well.

  3. Announcement: Newborn Possibilities Program underway in AZ – stem cell research related to cerebral palsy « Medical Malpractice and Catastrophic Injury Litigation | Eye Opener: The Nash & Associates Blog Says:

    […] those of you who follow our blog postings and/or the recent news concerning stem cell research relating to cerebral palsy are aware, the Food […]

  4. Cerebral Palsy Verdict: $23.3 Million – Minnesota – birth injury – delay in performing C-Section « Medical Malpractice and Catastrophic Injury Litigation | Eye Opener: The Nash & Associates Blog Says:

    […] research studies are underway and new therapies are being developed for infants with cerebral palsy.  Nevertheless, […]

  5. Cerebral Palsy: Cord Blood Stem Cell Research and Treatment in Clinical Trials – Update « Medical Malpractice and Catastrophic Injury Litigation | Eye Opener: The Nash & Associates Blog Says:

    […] have reported previously on various topics involving cord blood and stem cell research as they relate to a number […]

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