Cerebral Palsy Clinical Trial
Official title:
Evaluation the Side Effects of Bone Marrow Derived CD133 Cells Transplantation in Cerebral Palsy Patients
Verified date | August 2010 |
Source | Royan Institute |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 12 |
Est. completion date | May 2012 |
Est. primary completion date | April 2012 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 4 Years to 12 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Iran, Islamic Republic of | Royan Institute | Tehran |
Lead Sponsor | Collaborator |
---|---|
Royan Institute |
Iran, Islamic Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | allergic reaction | evaluation the side effects of bone marrow derived CD133 transplantation in cerebral palsy patients | 1 month | |
Primary | local infection | infections in site of injection | 1 month | |
Primary | encephalitis | encephalitis due to cell transplantation | 1 month | |
Primary | meningitis | meningitis due to cell trnsplantation | 1 month | |
Primary | paralysis or sensory loss | paralysis or sensory loss below the level of the injection site | 6 months | |
Secondary | speech | evaluation the effect of bone marrow derived CD133 cells transplantation to improve speech ability in patients with cerebral palsy | 6 months | |
Secondary | motion | evaluation the effect of bone marrow derived CD133 transplantation to improve motion disability in patients with cerebral palsy | 6 months |
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