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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    Page 1 of 1 (4 locations)

    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