OLDSMAR, FL (January 8, 2013) – (OTC:CCEL) Cryo-Cell International
Chief Scientific Officer Linda L. Kelley
, PhD, expressed optimism that an effective treatment for cerebral palsy (CP) using cord blood stem cells may be on the horizon now that the first results of a Phase 2 study have been published. The paper by Dr. Min Young Kim and colleagues is the first to demonstrate efficacy using umbilical cord blood as therapy in a large, placebo-controlled, double-blind study in South Korea.
Cerebral palsy (CP) is a devastating disability acquired in early childhood which affects approximately 10,000 babies per year and results in lifelong motor and cognitive functional deficits. Dr. Kim’s team treated 96 children between the ages of 10 months and 10 years. Patients were divided into three groups:
- those treated with HLA-matched cord blood from unrelated donors along with the growth factor erythropoietin (EPO)
- those treated with placebo plus EPO, and
- those treated with placebo alone.
EPO was included in the study because of its previously demonstrated neural repair properties. In addition, all patients experienced an intensive one month in-patient rehabilitation program.
- The beneficial effects appeared in motor function and cognitive function.
- The degree of HLA matching correlated with outcomes; patients receiving closer matched units did better.
Dr. Kelley noted, “The study results are of profound importance and provide optimism for parents of thousands of children suffering with CP and for unborn children at risk of acquiring CP. Since there are few, if any, early warning signs predicting who will be affected by CP, these results should encourage all families to consider storing umbilical cord blood when the option is available to them.”
The study results seem to indicate that patients receiving autologous cord blood may have even better outcomes. Several clinical trials using autologous cord blood to treat cerebral palsy are on-going in the United States. Dr. Kelley commented, “Results from those studies should greatly extend our knowledge of the usefulness of cord blood for the treatment of a devastating condition for which there is currently no known treatment.”
Motor function and cognitive development changes were measured using an extensive group of well-established tests. The tests were performed at the initiation of the study and again at 1, 3 and 6 months. The data consistently revealed superior outcomes in the group that received cord blood compared to the other two groups. The differences were significant starting from 1 month or 3 months post-treatment and continued to 6 months post-treatment.
Some adverse events requiring hospitalization were noted; however, the incidence was the same regardless of the treatment group. Pneumonia and irritability were more frequent in the group that received cord blood than in the other two groups. Considering the overall frequency and severity of the adverse events, the authors concluded that the risks were not prohibitive to continued investigation of this new therapy for cerebral palsy.
HLA-matched allogeneic cord blood units were used in this study due to the unavailability of previously banked autologous cord blood. Complete information on the study is available here
About Cryo-Cell International
Cryo-Cell International, Inc. was founded in 1989. In 1992, it became the first private cord blood bank in the world to separate and store stem cells. Today, nearly 500,000 parents from 87 countries trust Cryo-Cell to preserve their family members’ stem cells. Cryo-Cell's mission is to provide clients with state-of-the-art stem cell cryopreservation services and support the advancement of regenerative medicine. Cryo-Cell operates in a facility that is compliant with Good Manufacturing Practice and Good Tissue Practice (cGMP/cGTP), and is ISO 9001:2008 certified and accredited by the American Association of Blood Banks. Cryo-Cell is a publicly traded company, OTC:QB Markets Group Symbol: CCEL. For more information, visit www.cryo-cell.com.