Status:
COMPLETED
A Study of UCB and MSCs in Children With CP: ACCeNT-CP
Lead Sponsor:
Joanne Kurtzberg, MD
Collaborating Sponsors:
The Marcus Foundation
Conditions:
Cerebral Palsy
Eligibility:
All Genders
24-60 years
Phase:
PHASE1
PHASE2
Brief 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 tiss...
Detailed Description
This study is a phase I/II, prospective, randomized, open-label trial designed to determine the effect size of change in GMFM-66 score in subjects treated with hCT-MSC or allogeneic CB and assess the ...
Eligibility Criteria
Inclusion
- Age ≥24 months and ≤60 months adjusted age at the time of enrollment.
- Diagnosis: Unilateral or bilateral hypertonic cerebral palsy secondary to in utero or perinatal stroke/hemorrhage, hypoxic ischemic encephalopathy (including, but not limited to, birth asphyxia), and/or periventricular leukomalacia.
- Performance status: Gross Motor Function Classification Score levels I - IV
- Review of brain imaging (obtained as standard of care prior to study entry) does not suggest a genetic condition or brain malformation.
- Legal authorized representative consent.
Exclusion
- Available qualified autologous cord blood unit.
- Hypotonic or ataxic cerebral palsy without spasticity.
- Autism and autistic spectrum disorders.
- Hypsarrhythmia.
- Legally blind
- Intractable seizures causing epileptic encephalopathy.
- Evidence of a progressive neurologic disease.
- Has an active, uncontrolled systemic infection or documentation of HIV+ status.
- Known genetic disease or phenotypic evidence of a genetic disease on physical exam.
- Concurrent genetic or acquired disease or comorbidity(ies) that could require a future allogeneic stem cell transplant.
- Requires ventilatory support, including home ventilator, CPAP, BiPAP, or supplemental oxygen.
- Impaired renal or liver function as determined by serum creatinine \>1.5mg/dL and/or total bilirubin \>1.3mg/dL except in patients with known Gilbert's disease.
- Possible immunosuppression, defined as WBC \<3,000 cells/mL or absolute lymphocyte count (ALC) \<1500 with abnormal T-cell subsets.
- Patient's medical condition does not permit safe travel.
- Previously received any form of cellular therapy.
Key Trial Info
Start Date :
April 10 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 31 2021
Estimated Enrollment :
91 Patients enrolled
Trial Details
Trial ID
NCT03473301
Start Date
April 10 2018
End Date
May 31 2021
Last Update
August 19 2021
Active Locations (1)
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1
Duke University Medical Center
Durham, North Carolina, United States, 27705