Assessment of the Safety of Allogeneic Umbilical Cord Blood Infusions in Children With Cerebral Palsy

Completed · Phase 1

Conditions studied: Cerebral Palsy

In brief

This study is a single site, phase I, prospective study of the safety of intravenous sibling cord blood infusion in 15 children ages 1-6 years with Cerebral Palsy (CP). All subjects will be treated with sibling cord blood cells. The first six will receive cord blood cells from an HLA-matched sibling. The following nine subjects will receive cord blood cells from an HLA-mismatched (≥3/6 match) or matched sibling. The duration of study participation will be six months from the time of the cord blood infusion.

Key facts

Study ID

NCT02599207

Run by

Joanne Kurtzberg, MD

People needed

15

Starts

2015-11-01

Expected to finish

2018-07-01

Last updated by the study team

2019-12-04

Who can join

Age: 1 and older, up to 6. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age ≥12 months and ≤ 6 years at the time of CB infusion.
• Diagnosis: Cerebral palsy with diplegia, hemiplegia, or quadriplegia.
• Performance status:
• Bilateral cerebral palsy (diplegia or quadraplegia):
• Gross Motor Function Classification Score levels II - IV, or Gross Motor Function Classification Score level I, age ≥ 2 years
• Hemiplegia: Gross Motor Function Classification Score levels II - IV or minimal functional capabilities in the affected upper extremity. A subject classified as GMFCS level I with significant upper extremity impairment will be eligible if the affected upper extremity is used as an assist only.
• Review of brain imaging (obtained as standard of care prior to study entry) does not suggest a genetic condition or brain malformation.
• Suitably matched sibling donor CB unit (see section 6.2 for matching details) available at a private or public cord blood bank with a minimum total nucleated cell dose of ≥ 2.5 x 107 cells/kilogram.
• Legal authorized representative consent.

You may not qualify if…

• Available qualified autologous cord blood unit
• Autism and autistic spectrum disorders without motor disability.
• Hypsarrhythmia.
• 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) below normal for age 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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