Side Effects of Bone Marrow Derived CD133 Transplantation in Cerebral Palsy

Phase 1

Completed

• Conditions: Cerebral Palsy
• Interventions: Biological: CD133 stem cell injection

• Registration Number: NCT01404663
• 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 bone marrow stem cell transplantation in patients with cerebral palsy.

Detailed Description

Our study evaluate the side effects of bone marrow derived CD133 cells transplantation in 4-12years old patients with cerebral palsy.first all the patients undergone a comprehensive evaluation(physical exam, serology tests,EEG,MRI,GMFM66).

After bone marrow aspiration,autologous stem cells prepare for each patient. In operation room ,the cells are transplanted by intrathecal injection. all the patients would be under observed to notice acute side effects and 3,6,9 and 12 months after injection they will be followed and evaluate by comprehensive tests.

Study Timeline

• Status Verified: 2010-08
• Study First Submitted: 2011-07-26
• Study First Submitted QC: 2011-07-27
• Study First Posted: 2011-07-28
• Study Start: 2011-10
• Primary Completion: 2012-04
• Study Completion: 2012-05
• Last Update Submitted: 2018-03-06
• Last Update Posted: 2018-03-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

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

Exclusion Criteria

1. Children who have a diagnosis of "mixed" types of CP (i.e. athetosis) or other movement disorders (i.e. ataxia)
2. 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.
3. Children who have a metallic or electrical implants

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
stem cell recipients	CD133 stem cell injection	The 4-12 years old patients with cerebral palsy who undergone bone marrow derived CD133 transplantation

Primary Outcome Measures

Name	Time	Method
allergic reaction	1 month	evaluation the side effects of bone marrow derived CD133 transplantation in cerebral palsy patients
local infection	1 month	infections in site of injection
encephalitis	1 month	encephalitis due to cell transplantation
meningitis	1 month	meningitis due to cell trnsplantation
paralysis or sensory loss	6 months	paralysis or sensory loss below the level of the injection site

Secondary Outcome Measures

Name	Time	Method
speech	6 months	evaluation the effect of bone marrow derived CD133 cells transplantation to improve speech ability in patients with cerebral palsy
motion	6 months	evaluation the effect of bone marrow derived CD133 transplantation to improve motion disability in patients with cerebral palsy

Trial Locations

Locations (1)

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