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

Completed · Phase 1/Phase 2

Conditions studied: Cerebral Palsy

In brief

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.

Key facts

Study ID

NCT03473301

Run by

Joanne Kurtzberg, MD

People needed

91

Starts

2018-04-10

Expected to finish

2021-05-31

Last updated by the study team

2021-08-19

Who can join

Age: 2 and older, up to 5. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Duke University Medical Center — Durham, North Carolina, United States

Full record on ClinicalTrials.gov

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