as seen in BioInsights
In News by Sarah Freeston
The efficacy of autologous stem cell therapy for children who have been diagnosed as having a prenatal or perinatal stroke is being tested in an FDA-regulated clinical trial, it has been announced. The hope is that the stem cells will help to repair to damage caused by the stroke and ease the often debilitating symptoms.
The launch news came from Cord Blood Registry® (CBR®), the world’s largest newborn stem cell company. The Phase I trial, which is the first to assess a newborn stem cell therapy for pediatric stroke, will be conducted at Florida’s Hospital for Children. If the first trial demonstrates effectiveness, a further Phase II trial will assess safety and will further refine the treatment in more selected patients.
Stroke constitutes one of the leading causes of death in children, and occurs in approximately one in 3500 live births, according to the American Stroke Association. The risk of stroke peaks just before and immediately after birth and the risk remains highest during the first year of life. Survivors of pediatric stroke can suffer from seizures, muscle spasticity, and more severe consequences, such as hemiparesis or cerebral palsy. The need for new, effective treatments was summarized by James Baumgartner, Pediatric Neurosurgeon and principal investigator of the trial, “There is a critical need for the development of new treatments as the incidence and prevalence of pediatric stroke have increased over time. By supporting this and other trials and investing in the types of regenerative medicine research that hold significant potential to meet the future needs of families, CBR is helping advance newborn stem cell research and therapies.”
The team is currently enrolling ten children into the trial who are aged between 6 weeks and 6 years, who experienced a stroke either in utero or just after birth. The subjects need to have a CBR-processed cord blood unit that was collected at birth. Following baseline neurologic assessment to assess the impact of the stroke, the children will receive a single autologous stem cell infusion and follow-up assessments at six and twelve months.
“Our Cerebral Palsy Family Network (CPFN) has been following stem cell research and the impact it can have on children born with cerebral palsy whether it is by in utero stroke or other brain damage. Because of our extensive reach within the CP community, our families have been asked and have participated in NIH studies including the funding of research projects. These clinical trials are critical to making a better life for children with neurological deficits,” commented Janice Godwin, Executive Director of the CPFN.
If successful, preliminary results should be available as early as 2018.
Source: Groundbreaking clinical trial to assess the use of newborn stem cells in the treatment of pediatric stroke; Cord Blood Registry Original Press Article
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