IRCT20110628006907N18
Not Yet Recruiting
Phase 2
A Triple blinded, Parallel Randomized clinical trial Phase II&III of 3 Times Intrathecal Injections of an Umbilical Cord-Derived Mesenchymal Stromal Cell Product WhartoCell” in Children with Cerebral Palsy
ROYAN stem cell technology Co0 sites150 target enrollmentTBD
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Spastic Cerebral Palsy.
- Sponsor
- ROYAN stem cell technology Co
- Enrollment
- 150
- Status
- Not Yet Recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Spastic cerebral palsy (Dip, Quadri, Hemiparetic ) Ages between 2 \- 14 years Gross motor function classification (GMFC) 2 \-4 No seizure disorder or with controlled seizure Acquired brain MRI finding compatible with CP Informed consent of parents
Exclusion Criteria
- •Normal brain MRI Progressive neurological diseases Congenital brain cortical malformations TORCH infections( Toxoplasmosis, Others, Rubella Cytomegalovirus Hepatitis C ) Other types of cerebral palsy (athetoid , atonic , ataxic , mixed ) Acute infections (Human Immunodeficiency Virus , Hepatitis C Virus ) Hemorrhagic diathesis Severe anemia ( Hemoglobin less than 8 ) Ventilator dependent pulmonary diseases Severe renal dysfunction Severe liver dysfunction
Outcomes
Primary Outcomes
Not specified
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