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|NCT03473301 : A Study of UCB and MSCs in Children With CP: ACCeNT-CP|
|Phase||Phase 1/Phase 2|
|Ages||Min: 24 Months Max: 60 Months|
1. Age =24 months and =60 months adjusted age at the time of enrollment.
2. Diagnosis: Unilateral or bilateral hypertonic cerebral palsy secondary to in utero or
perinatal stroke/hemorrhage, hypoxic ischemic encephalopathy (including, but not
limited to, birth asphyxia), and/or periventricular leukomalacia.
3. Performance status: Gross Motor Function Classification Score levels I - IV
4. Review of brain imaging (obtained as standard of care prior to study entry) does not
suggest a genetic condition or brain malformation.
5. Legal authorized representative consent.
1. Available qualified autologous cord blood unit.
2. Hypotonic or ataxic cerebral palsy without spasticity.
3. Autism and autistic spectrum disorders.
5. Legally blind
6. Intractable seizures causing epileptic encephalopathy.
7. Evidence of a progressive neurologic disease.
8. Has an active, uncontrolled systemic infection or documentation of HIV+ status.
9. Known genetic disease or phenotypic evidence of a genetic disease on physical exam.
10. Concurrent genetic or acquired disease or comorbidity(ies) that could require a future
allogeneic stem cell transplant.
11. Requires ventilatory support, including home ventilator, CPAP, BiPAP, or supplemental
12. Impaired renal or liver function as determined by serum creatinine >1.5mg/dL and/or
total bilirubin >1.3mg/dL except in patients with known Gilbert's disease.
13. Possible immunosuppression, defined as WBC <3,000 cells/mL or absolute lymphocyte
count (ALC) <1500 with abnormal T-cell subsets.
14. Patient's medical condition does not permit safe travel.
15. Previously received any form of cellular therapy.
|Links||Permanent Link to THIS page: https://virtualtrials.com/nct/display1trial.cfm?nct=NCT03473301
| Link to official Clinicaltrials.gov listing