Could your Baby's cord blood improve cerebral palsy?
NCT ID NCT01147653
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested whether a single infusion of a child's own stored umbilical cord blood could improve motor skills in children with spastic cerebral palsy. Sixty-three children aged 1 to 6 years received either cord blood or a placebo, and their gross motor function was measured over a year. The goal was to see if this biological treatment could offer a safe way to ease the condition.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- autologous umbilical cord blood
- What this could lead to
- If it works, this could point toward a treatment that improves motor function in children with cerebral palsy.
- What could go wrong
- This is a small, early-phase trial with only 63 children. The results may not apply to all types of cerebral palsy, and the benefit may be modest or absent.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
63 people
The number who actually took part.
- Start date
-
Jun 2010
- Finished
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Mar 2016
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
12 months to 6 years
- Sex
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Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Age ≥ 12 months and ≤ 6 years * Diagnosis: Spastic cerebral palsy with diplegia, hemiplegia, or quadraplegia. * Performance status: Gross Motor Function (GMF) Classification Score levels II - IV or GMF Score leve I, age \>/= 2 years Spastic hemiplegia: GMF Score 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. An eligibility committee will meet to review the child's records and determine eligibility. Bilateral hypotonic CP (diplegia or quadriplegia): GMF Score II-IV and an abnormal brain MRI suggestive of an acquired etiology (versus a genetic etiology or brain malformation). * Autologous umbilical cord blood available at a private or public cord blood bank with a minimum total nucleated cell dose of ≥ 1 x 107 cells/kilogram. * Parental consent. Exclusion Criteria: * Athetoid cerebral palsy. * Autism and autistic spectrum disorders without motor disability. * Hypsarrhythmia. * Intractable seizures causing epileptic encephalopathy. * Evidence of a progressive neurologic disease. * Known HIV or uncontrolled bacterial, fungal, or viral infections. * Impaired renal or liver function as determined by serum creatinine \>1.5mg/dL and/or total bilirubin \>1.3mg/dL. * Head circumference \>3 standard deviations below the mean for age. * Known genetic disease or phenotypic evidence of a genetic disease on physical examination. * 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. * Patient's medical condition does not permit safe travel. * Previously received any form of cellular therapy. * Autologous umbilical cord blood unit has any of the following: 1. Total nuclear cell dose \< 1 x 107 cells/kilogram 2. Positive maternal infectious disease markers (except CMV) 3. Evidence of infectious contamination of the cord blood unit 4. Lack of a test sample to confirm identity 5. Evidence of a genetic disease * Unable to obtain parental consent.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Duke University Medical Center
Durham, North Carolina, 27705, United States
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Other studies related to the condition(s) this trial covers.
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