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Could your Baby's cord blood improve cerebral palsy?

NCT ID NCT01147653

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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

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

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

More trials for these conditions

Other studies related to the condition(s) this trial covers.