Trial record 4 of 16 for:    umbilical cord cerebral palsy

A Randomized Study of Autologous Umbilical Cord Blood Reinfusion in Children With Cerebral Palsy

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Roberson Foundation (funding)
Information provided by (Responsible Party):
Joanne Kurtzberg, MD, Duke University Medical Center
ClinicalTrials.gov Identifier:
NCT01147653
First received: June 17, 2010
Last updated: August 7, 2014
Last verified: August 2014

June 17, 2010
August 7, 2014
June 2010
January 2016   (final data collection date for primary outcome measure)
The primary measure of efficacy will be improvement of standardized measures of neurodevelopmental function. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01147653 on ClinicalTrials.gov Archive Site
  • A secondary objective is to determine effects on quality of life in these children. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • A secondary objective is to describe functional and morphologic changes on brain MRI in these children. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • A secondary objective is to ask whether there is a correlation between clinical response and RNA expression of neural, endotheial and inflammatory cytokines measured by RNA arrays in cord blood cells given to these patients. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
A Randomized Study of Autologous Umbilical Cord Blood Reinfusion in Children With Cerebral Palsy
Is Autologous Umbilical Cord Blood Reinfusion Beneficial in Children With Cerebral Palsy: A Randomized, Blinded, Placebo-Controlled, Crossover Study

The purpose of this study is to determine the efficacy of a single intravenous infusion of autologous umbilical cord blood (UCB) for the treatment of pediatric patients with spastic cerebral palsy.

Cerebral palsy results from in utero or perinatal injury to the developing brain, often through stroke, hypoxic insult or hemorrhage. Currently available treatments for patients with cerebral palsy are supportive, but not curative. Umbilical cord blood (UCB) has been shown to lessen the clinical and radiographic impact of hypoxic brain injury and stroke in animal models. UCB also engrafts and differentiates in brain, facilitating neural cell repair, in animal models and human patients with inborn errors of metabolism undergoing allogeneic, unrelated donor UCB transplantation. We hypothesize that, in the setting of brain injury, infusion of autologous UCB will facilitate neural cell repair resulting in improved function in pediatric patients with cerebral palsy.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Cerebral Palsy
  • CP
  • Spastic Cerebral Palsy
Biological: Autologous Umbilical Cord Blood or Placebo
All participants will be treated with autologous cord blood reinfusion, but the time course will vary between groups and participants will be blinded to the order in which they receive infusions. Patients will be randomized to receive their autologous umbilical cord blood cells first or placebo first. Subjects will receive both infusions but will be randomized and blinded by which they are receiving first and second.
  • Active Comparator: Autologous Umbilical Cord Blood Reinfusion
    All participants will be treated with autologous cord blood reinfusion, but the time course will vary between groups and participants will be blinded to the order in which they receive infusions.
    Intervention: Biological: Autologous Umbilical Cord Blood or Placebo
  • Placebo Comparator: Placebo
    All participants will be treated with autologous cord blood reinfusion, but the time course will vary between groups and participants will be blinded to the order in which they receive infusions.
    Intervention: Biological: Autologous Umbilical Cord Blood or Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
120
January 2016
January 2016   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Age ≥ 12 months and ≤ 6 years
  • Diagnosis: Spastic cerebral palsy with diplegia, hemiplegia, or quadraplegia.
  • Performance status: Gross Motor Function Classification Score levels II - IV as determined by the Gross Motor Function Measure-66 (see Appendix 1).
  • 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.
Both
12 Months to 6 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01147653
Pro00017801
No
Joanne Kurtzberg, MD, Duke University Medical Center
Joanne Kurtzberg, MD
Roberson Foundation (funding)
Principal Investigator: Joanne Kurtzberg, MD Duke University
Duke University
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP