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NCT03473301 · ClinicalTrials.gov registry record · Phase 1
A Study of UCB and MSCs in Children With CP: ACCeNT-CP
A Phase 1 study, sponsored by Joanne Kurtzberg, MD.
- Completed
- Registry status
- Phase 1
- Development phase
- 91
- Enrollment target
NCT03473301: Completed Phase 1 study, sponsored by Joanne Kurtzberg, MD.
NCT03473301 is a Phase 1 study that has completed, run by Joanne Kurtzberg, MD. The registered enrollment target is 91 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (52% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03473301, a Phase 1 study, has completed, sponsored by Joanne Kurtzberg, MD.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 91 participants
- Enrollment target
Study 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.
Primary Outcome
GMFM-66 is used to evaluate gross motor function in children with cerebral palsy and is scored using a propriety software program called the Gross Motor Ability Estimator that produces an interval level continuous score ranging from 0 to 100. Higher scores indicate better motor function. The primary endpoint in this study was computed from the GMFM-66 score in three steps: 1) The "observed" change in motor function from Baseline to Month 12 was calculated (positive values indicate improvement, n
Interventions
- BIOLOGICAL Infusion of allogeneic umbilical cord blood
- BIOLOGICAL Infusion of MSCs
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 91 participants |
| Start Date | 2018-04-10 |
| Est. Completion | 2021-05-31 |
| Phase | Phase 1 |
What the finished NCT03473301 record still lists
NCT03473301 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 91 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (52% higher).
The record links to 0 conditions, and to 2 interventions - of which Infusion of allogeneic umbilical cord blood is the first listed.
NCT03473301 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03473301 about?
NCT03473301 is a clinical study titled "A Study of UCB and MSCs in Children With CP: ACCeNT-CP". 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 st...
What is the current status of trial NCT03473301?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 91 participants. The study started on 2018-04-10. Estimated completion is 2021-05-31.
What interventions are being tested in trial NCT03473301?
The interventions under investigation include: Infusion of allogeneic umbilical cord blood (BIOLOGICAL), Infusion of MSCs (BIOLOGICAL).
Who is sponsoring clinical trial NCT03473301?
This trial is sponsored by Joanne Kurtzberg, MD, which has 15 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03473301's enrollment target sits among peer trials
91 626th of 2000 higher than 1,373 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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