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Stem Cell Therapy

Allogeneic Umbilical Cord Blood for Cerebral Palsy (ACCeNT-CP Trial)

Phase 1 & 2
Waitlist Available
Research Sponsored by Joanne Kurtzberg, MD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights

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.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Gross Motor Function Measure (GMFM-66) in Excess of Expected Change
Secondary outcome measures
Number of Adverse Events

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: Cord Tissue Mesenchymal Stromal CellsExperimental Treatment1 Intervention
Subjects will receive three intravenous infusions of 2x106/kg human umbilical cord tissue cells (hCT-MSC), manufactured from allogeneic umbilical cord donors
Group II: Allogeneic Umbilical Cord BloodExperimental Treatment1 Intervention
Subjects will receive a single intravenous infusion of a maximum of 10x107/kg allogeneic umbilical cord blood (CB) cells
Group III: Natural HistoryActive Control1 Intervention
Subjects will not receive any study product infusion until after the 12 month assessment. At the 12 month visit, they will receive an infusion of allogeneic umbilical cord blood cells so that all study participants will receive some type of cellular therapy.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Infusion of allogeneic umbilical cord blood
2018
Completed Phase 2
~100
Infusion of MSCs
2018
Completed Phase 2
~100

Find a Location

Who is running the clinical trial?

The Marcus FoundationOTHER
16 Previous Clinical Trials
1,445 Total Patients Enrolled
Joanne Kurtzberg, MDLead Sponsor
18 Previous Clinical Trials
625 Total Patients Enrolled
3 Trials studying Cerebral Palsy
78 Patients Enrolled for Cerebral Palsy
~13 spots leftby Jul 2025
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