Safety and Effectiveness of Cord Blood Stem Cell Infusion for the Treatment of Cerebral Palsy in Children
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01072370|
Recruitment Status : Withdrawn
First Posted : February 22, 2010
Last Update Posted : October 7, 2022
- Study Details
- Tabular View
- No Results Posted
- How to Read a Study Record
|Condition or disease||Intervention/treatment||Phase|
|Cerebral Palsy||Biological: Cord Blood Infusion Biological: Intravenous Sham||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Placebo-Controlled, Observer-Blinded, Crossover Study to Evaluate the Safety and Effectiveness of a Single, Autologous, Cord Blood Stem Cell Infusion for the Treatment of Cerebral Palsy in Children|
|Study Start Date :||January 2010|
|Actual Primary Completion Date :||February 28, 2019|
|Actual Study Completion Date :||February 28, 2019|
|Active Comparator: Treatment Group 1||
Biological: Cord Blood Infusion
red-cell depleted, mononuclear cell enriched cord blood unit prepared for infusion
Other Name: Stem cell infusion
|Sham Comparator: Treatment Group 2||
Biological: Intravenous Sham
intravenous infusion of 5% dextrose, ¼ normal saline solution
Other Name: Placebo
- Confirm the safety of autologous cord blood infusion in children with cerebral palsy by repeated follow-up over one year with clinical and laboratory evaluations. [ Time Frame: 1 year ]
- Confirm the efficacy of autologous cord blood infusion in children with cerebral palsy using patient questionnaire and standardized Gross Motor Function Measure evaluation. [ Time Frame: 3-4 months ]
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||1 Year to 12 Years (Child)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- Must be more than 1 year of age and less than 12 years of age at the time of screening for inclusion in the study.
- Clinical evidence of a non-progressive motor disability due to brain dysfunction. The subjects will not have the ability to sit independently by one year of age or the ability to walk by 18 months of age.
- Have stored umbilical cord blood with Cord Blood Registry (CBR) that meets all selection and testing criteria.
- Willing to comply with all study procedures.
- The nucleated cells available in the cord blood sample stored at CBR must exceed 1 X 107 cells per kg body weight. (Note: Because cord blood collection has been in process for about 16 years but widely for far less than that period, the age of most subjects likely will be considerably less than 12 years of age. Due to the amount due of cord blood available for most subjects, the body weight of subjects usually will not exceed 25 kg).
- The patients must be seizure-free or seizures adequately controlled. If there is a suspicion of seizures and EEG should be done prior to inclusion.
- Have complicating medical issues that would interfere with blood drawing, such as venous access so limited that success is unlikely
- Presence of obstructive hydrocephalus.
- Presence of progressive neurological disease.
- Presence of significant defect of brain development, such as schizencephaly or agenesis of corpus callosum
- Presence of known chromosomal anomaly
- Presence of major congenital anomaly
- Severe intrauterine growth restriction (birth weight less than 1800 grams)
- Cord blood viability <60%
- Positive infectious disease markers from mother's blood or cord blood at the time of collection.
- Evidence of illness on planned infusion date (such as but not limited to fever >38.5, vomiting, diarrhea, wheezing, or crackles)
- Use of immunosuppressive drugs
- Evidence of known genetic disorder
- Impaired hepatic or renal function
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01072370
|United States, Georgia|
|Augusta, Georgia, United States, 30912|
|Study Chair:||James E Carroll, M.D.||Augusta University|
|Responsible Party:||James E. Carroll, Professor and Chief, Child Neurology, Augusta University|
|Other Study ID Numbers:||
|First Posted:||February 22, 2010 Key Record Dates|
|Last Update Posted:||October 7, 2022|
|Last Verified:||October 2022|
Umbilical Cord Blood
Autologous Blood Transfusion
Nervous System Diseases
Brain Damage, Chronic
Central Nervous System Diseases