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This study is a phase II, prospective, double blind, placebo-controlled study of the efficacy of autologous umbilical cord blood infusion.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| group 1 | Experimental |
| |
| group 2 | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Autologous umbilical cord blood transfusion | Other | single dose of an autologous umbilical cord blood transfusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| Motor developmental improvement | Gross Motor Function Measurement - 66 (GMFM-66). All score are normalized with mean 100 and STD of 15. High score is better than low score . | 6 months |
| Motor developmental improvement | Peabody developmental motor scales-second edition (PDMS-2). All score are normalized with mean 100 and STD 10. High score is better | 6 months |
| Functional assessment | Pediatric Evaluation of Disability Evaluation . Score 0-100 higher score better functionality Pediatric Evaluation of Disability Inventory-Computer Adaptive Test (PEDI-CAT) | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Functional assessment | Adaptive Behavior Assessment System, Third Edition (ABAS-3). All score are normalized with mean 100 and STD of 10. High score is better than low score . | 6 months |
| Functional assessment |
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Inclusion Criteria:
Age ≥ 2 month and ≤ 12 years.
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):
Performance status for children older than 12 months
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:
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.
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.
Lack of a test sample to confirm identity
Evidence of a genetic disease
Unable to obtain parental consent.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Omer Bar-Yosef, MD.PHD | Contact | 972-35302895 | Omer.BarYosef@sheba.health.gov.il |
| Name | Affiliation | Role |
|---|---|---|
| Omer Bar-Yosef, MD.PHD | Sheba Medical Center | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chaim Seba Medical Center | Recruiting | Ramat Gan | Israel |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16108461 | Background | 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. | |
| 24268104 | Background |
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data set of the baseline of the children, the quantity of cord blood transfusion they received and the clinical followup information.
within 2 years from the end of data collection
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| ID | Term |
|---|---|
| D002547 | Cerebral Palsy |
| ID | Term |
|---|---|
| D001925 | Brain Damage, Chronic |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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This study is a phase II, prospective, double blind, placebo-control study of the efficacy of autologous umbilical cord blood infusion.
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
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The randomization will be done by external source and the assignment will disclosed to cord bank bank only. They will produce either a cord blood or placebo unit which will be completely covered. Each unit will have its own index number that will be documented by the research coordinator. Neither the researcher or the family will know the nature of the unit.
| placebo | Other | 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 |
|
Vineland Adaptive Behavior Scales-Second Edition (VINELAND-II). All score are normalized with mean 100 and STD of 15. High score is better than low score .
| 6 months |
| 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. |
| 12634632 | Background | 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. |