Status:
UNKNOWN
Efficacy of Allogeneic Umbilical Cord Derived Hematopoietic and Mesenchymal Stem Cells in Cerebral Palsy
Lead Sponsor:
Tehran University of Medical Sciences
Collaborating Sponsors:
Hormozgan University of Medical Sciences
Conditions:
Cerebral Palsy, Spastic
Eligibility:
All Genders
4-14 years
Phase:
PHASE2
Brief Summary
Cerebral palsy(CP) consisted of a group of developmental disability in the field of motor function and is one of the major problems of pediatric neurology and at the present time there is no standard ...
Detailed Description
CP is characterized by aberrant control of movement or posture of a patient , appearing early in life , and not the result of a recognized progressive or degenerative brain disease . CP is an umbrella...
Eligibility Criteria
Inclusion
- 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 seizures
- Evidence of definite acquired abnormal imaging findings compatible with CP
- Informed consent is taken from their parents
- Exclusion criteria:
- Normal brain MRI
- Progressive neurologic disorders
- Congenital cortical malformations
- TORCH infections (Toxoplasmosis,Other,Rubella,Cytomegalovirus and Herpes 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) Malignancies
- Hemorrhagic diathesis
- Severe anemia ( Hemoglobin less than 8 g/dl )
- Ventilator dependent pulmonary diseases
- Renal insufficiency
- Severe liver dysfunction
Exclusion
Key Trial Info
Start Date :
July 23 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2019
Estimated Enrollment :
108 Patients enrolled
Trial Details
Trial ID
NCT03795974
Start Date
July 23 2017
End Date
December 1 2019
Last Update
January 8 2019
Active Locations (4)
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1
Tehran University of Medical Sciences , Growth and Development Research Center- Children's Medical Center
Tehran, Iran, 1419733151
2
Tehran University of Medical Sciences Chidren's Medical Center Radiology Department
Tehran, Iran, 1419733151
3
Tehran University of Medical Sciences, Department of Pediatric Neurology , Children's Medical Center
Tehran, Iran, 1419733151
4
ROYAN Stem Cell Technology Co
Tehran, Iran, 1665666311