Wednesday, 13 February 2013

MSG announces the first FDA approved stem cell trial for Cerebral Palsy

The Medical College of Georgia (MSG) announced yesterday, the first FDA-approved, placebo controlled human stem cell clinical trial for Cerebral Palsy (CB). Purpose of the trial is to test the safety and efficacy of autologous stem cells, taken from umbilical cord blood, as a potential treatment for the condition.

According to the announcement, a total of 40 children, between the ages 2 and 12 will participate, whose parents had previously stored their umbilical cord blood at the Cord Blood Registry. Principal investigator of the study will be Dr. James Carroll, chief of pediatric neurology in MCG School of Medicine.

Umbilical cord blood is rich in multipotent stem cells, which can differentiate into many different types of somatic cells. Carroll says that their preclinical studies have shown that stem cells infusions can reverse CB brain damages by creating new cells that replace the damaged ones, adding that due to their autologous nature there is little, if any, risk of rejection and other complications.

This is because the recipient acts as the donor as well, and as a result the "donored" cells carry the same genetic material. Carroll also said that there is anecdotal evidence in the published literature indicating that stem cell infusions from cord blood result in a significant improvement in CB patients

The cerebrum (red) is the main brain area affected by Cerebral Palsy

The children will first receive a neurological exam by paediatric neurologists Nicole Brockway and Elizabeth Sekul and will be divided into two groups. Half of the children will receive the real deal, whereas the rest will receive placebo treatment (control group). After three months, all children will be evaluated by physicians, who will all be unaware of the group each child belongs to. 

If no adverse effects are reported, the placebo group will  receive the stem cell therapy as well. The children will  be followed up for a period of six months during which they will be examined  for any motor and neurological improvements.

Eligible for enrolment will be patients that "have been unable to sit independently by 12 months or unable to walk by 18 month". Additionally, they must be seizure-free or have seizures that are adequately controlled. For consistency reasons, the stem cells used will be taken from only one stem cell bank, the Cord Blood Registry in Tucson.

"For the purposes of this study, we're not looking at stem cells as a possible cure; rather whether stem cells can help change the course of these types of brain injuries in children" Dr. Carroll said.

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