The U.S. Food & Drug Administration (FDA) will regulate a new clinical trial that will involve stem cell treatment for young children with cerebral palsy (CP).
On its ClinicalTrials.gov Web site, the National Institutes for Health (NIH) said the study’s purpose is “to compare the safety and effectiveness of two types of stem cells (either banked cord blood or bone marrow) in children between the ages of 2 to 10 years with CP.”
Cord Blood Registry (CBR), an umbilical cord blood bank located in San Bruno, Calif., announced that it will be a collaborator on the study. In all, 30 children — 15 with cord blood in storage and 15 without — are being sought to participate. The children in the cord blood portion of the study must already have their cord blood currently banked with CBR.
In each group, five of the children will be randomized to a placebo control group, NIH said in its announcement. The identities of those children will be kept a secret till the 12-month follow-up visit. At that time, the parents of children in the placebo groups will be informed, and parents can elect to enroll their children in the bone marrow harvest stem cell treatment or the umbilical cord blood stem cell treatment.
Study visits — one baseline/treatment visit and three follow-up visits — will be held at University of Texas Health Medical School and Children’s Memorial Hermann Hospital, both in Houston.
In January, the study had met its quota of 15 children for the bone marrow portion of the program, NIH announced.
