Treatment of Children With Cerebral Palsy With Autologous Umbilical Cord Blood, a Pilot Study
NCT ID: NCT04243408
Last Updated: 2021-01-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
72 participants
INTERVENTIONAL
2020-07-08
2024-12-31
Brief Summary
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The study population will consist of 72 children ages 2 months to 12 years with cerebral palsy. The population will be randomly assigned to 2 groups, 36 children in each group. The study group be treated by cord blood in the beginning of the study and the control group by placebo product. The study population will be stratified to reduce variance 3 groups by age: 2-12 months / 1-6 years / 6-12 years The study will consist of 4 stages Stage 1: initial assessment by physiotherapist and occupational therapist / treatment by cord blood or placebo / blood work before and after treatment Stage 2: at stage 1 + 3 months assessment by physiotherapist and occupational therapist Stage 3: at stage 1 + 6 months assessment by physiotherapist and occupational therapist / cross-over treatment by cord blood or placebo / blood work before and after treatment Stage 4: at stage 1 + 12 months assessment by physiotherapist and occupational therapist The primary outcome is improvement motor skills six months after treatment at stage 3
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
The study population will consist of 72 children ages 2 months to 12 years with cerebral palsy. The population will be randomly assigned to 2 groups, the study group be treated by cord blood in the beginning of the study and the control group by placebo product.
The study population will be stratified to reduce variance 3 groups by age: 2-12 months / 1-6 years / 6-12 years The study will consist of 4 stages Stage 1: initial assessment by physiotherapist and occupational therapist / treatment by cord blood or placebo / blood work before and after treatment Stage 2: at stage 1 + 3 months assessment by physiotherapist and occupational therapist Stage 3: at stage 1 + 6 months assessment by physiotherapist and occupational therapist
TREATMENT
QUADRUPLE
Study Groups
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group 1
Autologous umbilical cord blood transfusion
single dose of an autologous umbilical cord blood transfusion
group 2
placebo
The placebo product will consist of the standard ingredients of the acellular content of the UCB unit. It will consist of 20 ml Dextran (Plander 40.000 - 50g/500ml, solution for infusion) and 20 ml of human Albumin 5% (solution for infusion). The volume of placebo product will be 40 ml
Interventions
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Autologous umbilical cord blood transfusion
single dose of an autologous umbilical cord blood transfusion
placebo
The placebo product will consist of the standard ingredients of the acellular content of the UCB unit. It will consist of 20 ml Dextran (Plander 40.000 - 50g/500ml, solution for infusion) and 20 ml of human Albumin 5% (solution for infusion). The volume of placebo product will be 40 ml
Eligibility Criteria
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Inclusion Criteria
* Performance status for children older than 2 months and younger than 12 months including all the following (Gross Motor Function Classification Score is less indicative before 12 months):
* Abnormal General Movements (in infants 2-6 months)
* Abnormal Hammersmith Infant Neurological Examination
* Performance status for children older than 12 months
* Bilateral spastic cerebral palsy (diplegia or quadraplegia): Gross Motor Function Classification Score levels I - IV
* Spastic hemiplegia: Gross Motor Function Classification Score levels I - IV. 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.
* Bilateral hypotonic cerebral palsy (diplegia or quadraplegia): Gross Motor Function Classification Score levels I - IV.
* An abnormal brain MRI suggestive of an acquired etiology (and not genetic etiology or brain malformation).
* 4\. Autologous umbilical cord blood available at a private or public cord blood bank with a minimum total nucleated cell dose of ≥ 2 x 10e7 cells/kilogram.
* 5\. Parental consent.
Exclusion Criteria
* 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.
* Requires ventilatory support, including home ventilator
* Surgical procedure or botulinum toxin injection from 6 months prior to the study and during the time of the study
* 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:
* Total nuclear cell dose \< 2 x 10e7 cells/kilogram
* Positive maternal infectious disease markers (except CMV)
* Evidence of infectious contamination of the cord blood unit
* Lack of a test sample to confirm identity
* Evidence of a genetic disease
* Unable to obtain parental consent.
2 Months
12 Years
ALL
No
Sponsors
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Sheba Medical Center
OTHER_GOV
Responsible Party
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Dr. Omer Bar-Yosef
M.D.-Ph.D. Peadiatric Neurology and Child Development. Deputy Director The Edmond and Lily Safra Children's Hospital
Principal Investigators
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Omer Bar-Yosef, MD.PHD
Role: STUDY_DIRECTOR
Sheba Medical Center
Locations
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Chaim Seba Medical Center
Ramat Gan, , Israel
Countries
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Central Contacts
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Facility Contacts
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Omer Bar-Yosef
Role: primary
References
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Bax M, Goldstein M, Rosenbaum P, Leviton A, Paneth N, Dan B, Jacobsson B, Damiano D; Executive Committee for the Definition of Cerebral Palsy. Proposed definition and classification of cerebral palsy, April 2005. Dev Med Child Neurol. 2005 Aug;47(8):571-6. doi: 10.1017/s001216220500112x.
Colver A, Fairhurst C, Pharoah PO. Cerebral palsy. Lancet. 2014 Apr 5;383(9924):1240-9. doi: 10.1016/S0140-6736(13)61835-8. Epub 2013 Nov 20.
Clark SL, Hankins GD. Temporal and demographic trends in cerebral palsy--fact and fiction. Am J Obstet Gynecol. 2003 Mar;188(3):628-33. doi: 10.1067/mob.2003.204.
Other Identifiers
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SHEBA-18-5102-OBY-CTIL
Identifier Type: -
Identifier Source: org_study_id
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