Safety and Effectiveness of Banked Cord Blood or Bone Marrow Stem Cells in Children With Cerebral Palsy (CP).
Status:
Completed
Trial end date:
2018-02-21
Target enrollment:
Participant gender:
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.
Phase:
Phase 2
Details
Lead Sponsor:
The University of Texas Health Science Center, Houston
Collaborators:
Cord Blood Registry (CBR) Let's Cure CP Foundation Mission Connect, a program of TIRR Foundation