At a glance
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Autologous Cell Therapies for Cerebral Palsy-Chronic (ACT for CP)
In Brief
A Phase 2 clinical trial evaluating umbilical cord blood (hUCB) cells, Saline Infusion (Placebo), and 1 other intervention for Cerebral Palsy. Completed, enrolled 20 participants across 1 site.
Detailed Summary
The purpose of this study 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. 15 children with banked cord blood at CBR and 15 children without banked cord blood will be enrolled into the study. The study involves one baseline/treatment visit and 3 follow-up visits at 6 months, 12 months, and 2 years. Five children in each group will be randomized to a placebo control group at the baseline/treatment visit. Parents will not be told if their child received stem cells or a placebo until the 12 month follow-up visit. At that time parents may elect to have their child receive the stem cell treatment; either bone marrow harvest or umbilical cord blood if banked with CBR. All study visits will be conducted at the UTHealth Medical School and Children's Memorial Hermann Hospital in Houston, Texas. As of 1/21/2014 we have met our enrollment limit for children without banked cord blood undergoing bone marrow harvest for stem cells.
Study Details
Timeline
Interventions
Autologous umbilical cord blood banked with the Cord Blood Registry.
A total of 10 children (5 from each cohort) will be randomized to a placebo infusion at the baseline visit and then have the opportunity to cross-over to stem cell treatment at the 1yr. visit.
Autologous stem cells from bone marrow harvest.