Effects of umbilical cord derived stem cells injection in the treatment of children with cerebral palsy

Phase 2

Conditions: Spastic Cerebral Palsy.
Cerebral Palsy , Unspecified
G80.9

Registration Number: IRCT201706176907N13

Lead Sponsor: Tehran University of Medical Sciences

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Complete

Sex: All

Target Recruitment: 108

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
Severe liver dysfunction

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Motor development alteration with GMFM 66 score. Timepoint: Before intervention , 1 month after intervention , 3 months after intervention ,6 months after intervention , 12 months after intervention. Method of measurement: questionairre.;Change of motor function with GMFCS score. Timepoint: Before intervention , 1 month after intervention , 3 months after intervention ,6 months after intervention , 12 months after intervention. Method of measurement: questionairre.;Spasticity change of patients according to Ashworth scale. Timepoint: Before intervention , 1 month after intervention , 3 months after intervention ,6 months after intervention , 12 months after intervention. Method of measurement: questionairre.;Developmental status according to Stanford Binet test. Timepoint: Before intervention , 1 month after intervention , 3 months after intervention ,6 months after intervention , 12 months after intervention. Method of measurement: questionairre.

Secondary Outcome Measures

Name	Time	Method
Probable Change of brain lesions. Timepoint: Before intervention , 1 year after intervention. Method of measurement: Brain Magnetic Resonance Imaging (MRI) , Brain Magnetic Resonance Spectroscopy (MRS) , Brain Deep Tensor Imaging (DTI).;Fever. Timepoint: 24 hours after intervention , 48 hours after intervention , 72 hours after intervention. Method of measurement: Axillary thermometer.;Meningitis. Timepoint: First 3 days after intervention or any time after intervention. Method of measurement: Lumbar Puncture.;Hyper sensitivity reactions. Timepoint: First week after intervention. Method of measurement: Physical exam.