Efficacy of Allogeneic Umbilical Cord Derived Hematopoietic and Mesenchymal Stem Cells in Cerebral Palsy

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 curative medical or surgical treatment for it .Stem cell therapy is one of a new and hopeful therapeutic methods of therapy for CP .This double blind study designed for the evaluation of safety and therapeutic effects of intrathecal hematopoietic and mesenchymal stem cells derived from allogenic umbilical cord in change and probable improvement of developmental functions of spastic CP participants between 4-14 years old and comparing with control group of CP participants without cell therapy . 108 cases recruited and randomly divided to 3 groups of 36 cases : hematopoietic stem cells derived from allogenic umbilical cord , Mesenchymal cells derived from allogenic umbilical cord and control group without injection and appearance simulating lumbar puncture without awareness of the patients and evaluators . Developmental functions and spasticity evaluated before intervention and will be done 1 , 3 , 6 and 12 months after injection . During this period neuro rehabilitation will be continued . Brain neuroimaging were done at the recruitment time and will be repeated after 12 months .

Conditions

• Cerebral Palsy, Spastic

Interventions

BIOLOGICAL

MNC

Hematopoietic stem cells derived from allogenic umbilical cord

BIOLOGICAL

MSC

Mesenchymal cells derived from allogenic umbilical cord

PROCEDURE

Control

control group without injection and appearance simulating lumbar puncture without awareness of the patients and evaluators , but rehabilitation continued .

Sponsors & Collaborators

• Hormozgan University of Medical Sciences

  collaborator OTHER

• Tehran University of Medical Sciences

  lead OTHER

Principal Investigators

• Mahmoudreza Ashrafi, MD · Tehran University of Medical Sciences, Children's Medical Center

• Amirali Hamidieh, MD · Tehran University of Medical Sciences , Children's Medical Center

• Hadi Montazerlotfelahi, MD · Alborz University of Medical Sciences

• Anahita Majma, MD · Tehran University of Medical Sciences Children's Medical Center

• Masood Ghahvechi akbari, MD · Tehran University of Medical Sciences ,Children's Medical Center

• Ali Reza Moaeidi, MD · Hormozgan University of Medical Sciences

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

4 Years

Max Age

14 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-07-23

Primary Completion

2019-10-31

Completion

2019-12-31

Countries

• Iran

Study Locations