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A Study of UCB and MSCs in Children With CP: ACCeNT-CP

NCT03473301 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 91

Last updated 2021-08-19

Study results available
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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.

Conditions

  • Cerebral Palsy

Interventions

BIOLOGICAL

Infusion of allogeneic umbilical cord blood

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

BIOLOGICAL

Infusion of MSCs

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

Sponsors & Collaborators

  • The Marcus Foundation

    collaborator OTHER

  • Joanne Kurtzberg, MD

    lead OTHER

Principal Investigators

  • Joanne Kurtzberg, MD · Duke University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
24 Months
Max Age
60 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-04-10
Primary Completion
2020-02-26
Completion
2021-05-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03473301 on ClinicalTrials.gov