- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01763255
Multiple Transplantation of Bone Marrow Derived CD133 Cell in Cerebral Palsy
The Safety of Multiple Intrathecal Injection of Bone Marrow Derived CD133 Cells in Patients With Cerebral Palsy
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Locations
-
-
-
Tehran, Iran, Islamic Republic of
- Royan Institute
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: CD133 transplantation
The patients with cerebral palsy that underwent CD133 transplantation.
|
Intrathecal injection of Bone marrow derived CD133 cells
Other Names:
|
No Intervention: Control
The patients with cerebral palsy that underwent regular observation.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
motor dysfunction
Time Frame: 6months
|
Evaluation the motor dysfunction 6months after intrathecal injection.
|
6months
|
sensory dysfunction
Time Frame: 6months
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Evaluation the sensory dysfunction after intrathecal injection of CD133 cells.
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6months
|
unconsciousness
Time Frame: 48hours
|
Evaluation the rate of unconsciousness during 48hours after cell transplantation.
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48hours
|
fever
Time Frame: 48hours
|
Evaluation the symptom of infection like fever 48hours after cell transplantation.
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48hours
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
motor improvement
Time Frame: 6months
|
Measure the improvement of motor system by GMFM66.
|
6months
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Balance improvement
Time Frame: 6months
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Measure the balance improvement by BBS.
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6months
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Spasm
Time Frame: 6months
|
Evaluation the improvement of spasm after stem cell transplantation.
|
6months
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Nasser Aghdami, MD,PhD, Head of Royan department of degenerative medicine,Head of Royan celltherapy center
- Study Director: Ali Reza Zali, MD, Head of Neurosurgery research center of Shahid Beheshti University
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Royan-Nerve-003
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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