Multiple Transplantation of Bone Marrow Derived CD133 Cell in Cerebral Palsy

Phase 1

Completed

• Conditions: Cerebral Palsy

• Registration Number: NCT01763255
• Lead Sponsor: Royan Institute

Brief Summary

Cerebral palsy (CP) is condition, sometimes thought of as a group of disorders that can involve brain and nervous system functions such as movement, learning, hearing, seeing, and thinking.Cerebral palsy is caused by injuries or abnormalities of the brain. Most of these problems occur as the baby grows in the womb, but they can happen at any time during the first 2 years of life, while the baby's brain is still developing.Bone marrow derived stem cells are known as a effective therapy.

In this study the investigators evaluate the side effect of multiple intrathecal injection of bone marrow stem cell in patients with cerebral palsy.

Detailed Description

In this study,we evaluate the safety of multiple transplantation of bone marrow derived stem cells.the children(4-12years)with definite diagnose of cerebral palsy enroll to the study.first of all all the physical exam,laboratory test,EEG and MRI is done.after hospital admission,the patient underwent bone marrow transplantation.In laboratory,the cells are separated and prepared for injection.after 24hours the neurosurgeon inject the cells(intrathecal).the patient would be under observed for 48hours.If no allergic reaction or abnormal neurological symptoms accrued,patients can be discharged and would be followed up 1,3 and 6months after injection.at the end of the 6months,the patients would receive second injection as same as the previous process.then they are followed at 1,3 immediate local and systemic side effect(fever,respiratory distress,erythema,rash,increase of heart rate or blood pressure)and neurological symptoms:motor dysfunction,sensory dysfunction,sphincter dysfunction,nausea,vomiting,head ache.EEG,MRI,GMFM66

Study Timeline

• Status Verified: 2011-01
• Study Start: 2012-04
• Study First Submitted: 2012-12-25
• Study First Submitted QC: 2013-01-05
• Study First Posted: 2013-01-08
• Primary Completion: 2014-04
• Study Completion: 2014-04
• Last Update Submitted: 2014-04-24
• Last Update Posted: 2014-04-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 8

Inclusion Criteria

• diagnosis of spastic quadriplegic CP Children must be between the ages of 4 and 12 years Children must be cleared by an orthopedic surgeon for risk of hip subluxation or dislocation and cannot have significant scoliosis (curvature > 40 degrees) Children must be seizure-free or seizure controlled

Exclusion Criteria

• Children who have a diagnosis of "mixed" types of CP (i.e. athetosis) or other movement disorders (i.e. ataxia) Children who have had a selective dorsal rhizotomy, are presently are receiving intrathecal Baclofen, or have changed their spasticity medications in the past 6 months.

Children who have a metallic or electrical implants

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
motor dysfunction	6months	Evaluation the motor dysfunction 6months after intrathecal injection.
sensory dysfunction	6months	Evaluation the sensory dysfunction after intrathecal injection of CD133 cells.
unconsciousness	48hours	Evaluation the rate of unconsciousness during 48hours after cell transplantation.
fever	48hours	Evaluation the symptom of infection like fever 48hours after cell transplantation.

Secondary Outcome Measures

Name	Time	Method
motor improvement	6months	Measure the improvement of motor system by GMFM66.
Balance improvement	6months	Measure the balance improvement by BBS.
Spasm	6months	Evaluation the improvement of spasm after stem cell transplantation.

Trial Locations

Locations (1)

Royan Institute; 🇮🇷 Tehran, Iran, Islamic Republic of