CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 91 enrolled
Drug / intervention
Infusion of allogeneic umbilical cord blood +1 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03473301
NCT03473301Phase 2Completed

A Phase I/II Study of Allogeneic Umbilical Cord Blood and Umbilical Cord Tissue-Derived Mesenchymal Stromal Cell Infusions in Children With Cerebral Palsy

Joanne Kurtzberg, MD·interventional·Posted Mar 22, 2018·Updated Aug 19, 2021

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

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCerebral Palsy
CountriesUnited States

Timeline

Phase 2CompletedFinished
201820192020202120222023202420252026
First PostedMar 22, 2018
Enrollment StartApr 10, 2018
Primary CompletionFeb 26, 2020
Study CompletionMay 31, 2021
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 8.3 years ago

Interventions

Infusion of allogeneic umbilical cord bloodbiological

Subjects will receive a single infusion of allogeneic umbilical cord blood at the baseline visit.

Infusion of MSCsbiological

Subjects will receive 3 infusions of MSCs (baseline, 3 months and 6 months).