IRCT201706176907N13
Completed
Phase 2
Evaluation of the efficacy of allogeneic umbilical cord derived hematopoietic and mesenchymal stem cells on developmental functions of spastic cerebral palsy patients between 4-14 years old in comparison with control group , A Clinical trial phase II
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Tehran University of Medical Sciences
- Enrollment
- 108
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Spastic cerebral palsy (Diparetic , Quadriparetic)
- •Ages between 4 \- 14 years
- •Gross motor function classification (GMFC) between 2 \-5
- •No seizure disorder or with controlled seizure
- •Evidence of definite acquired abnormal imaging findings compatible with Cerebral Palsy
- •Informed consent taken from their parents
Exclusion Criteria
- •Normal brain MRI
- •Progressive neurological diseases ( for example leukodystrophy or neurometabolic disorders)
- •Congenital Cortical malformations
- •Toxoplasmosis Others Rubella Cytomegalovirus Hepatitis (TORCH) infections
- •Other types of cerebral palsy including athetoid , atonic , ataxic , and mixed type
- •Acute intercurrent infections such as Hepatitis C Virus ( HCV), Hepatitis B Virus (HBV) ,Human Immunodeficiency Virus (HIV)
- •Hemorrhagic diathesis
- •Severe anemia ( Hemoglobin less than 8 )
- •Ventilator dependent pulmonary diseases
- •Renal insufficiency
Outcomes
Primary Outcomes
Not specified
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