At a glance
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A Phase I/II Study of Allogeneic Umbilical Cord Blood and Umbilical Cord Tissue-Derived Mesenchymal Stromal Cell Infusions in Children With Cerebral Palsy
In Brief
A Phase 2 clinical trial evaluating Infusion of allogeneic umbilical cord blood and Infusion of MSCs for Cerebral Palsy. Completed, enrolled 91 participants across 1 site.
Detailed Summary
The main purpose of this study is to estimate change in motor function 12 months after treatment with a single dose of allogeneic umbilical cord blood (AlloCB) or repeated doses of umbilical cord tissue-derived mesenchymal stromal cells (hCT-MSC) in children with cerebral palsy. In addition, this study will contribute much needed data to the clinical trials community on the natural history of the motor function in CP over short-term (less than 1 year) time periods relevant to the conduct of clinical trials and assess the safety of AlloCB and hCT-MSC infusion in children with cerebral palsy.
Study Details
Timeline
Interventions
Subjects will receive a single infusion of allogeneic umbilical cord blood at the baseline visit.
Subjects will receive 3 infusions of MSCs (baseline, 3 months and 6 months).