A clinical trial to study the safety and efficacy of Bone marrow derived Autologous cells for the treatment of cerebral palsy in subjects below 15 years.
Phase 2
- Conditions
- Health Condition 1: null- Cerebral Palsy below 15 years.
- Registration Number
- CTRI/2013/10/004098
- Lead Sponsor
- Arvind Bagul
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Not specified
- Target Recruitment
- 100
Inclusion Criteria
1. Subjects aged above 3 years and below 15 years with a diagnosis of Cerebral Palsy.
2. Regional nerve damage as shown by Magnetic Resonance Imaging (MRI)
3. Able to comprehend and give informed consent for the study and willing to come to the hospital for follow up visits as per the protocol requirements (patient or his legal guardian).
Exclusion Criteria
1. History of meningitis, meningoencephalitis, epilepsy or life ?threatening allergic or immune-mediated reaction
2. Hemodynamically unstable patients
3. History of or concurrent autoimmune disease or an acute episode of Guillain-barre syndrome
4. Peripheral muscular dystrophy
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Improvement in muscle rigidity using Ashworth scale. - Improvement in walking ability and kinetic gait pattern - Improvement in overall motor control using oxford scale. 3 monthsTimepoint: 6 weeks,3,6,9 months
- Secondary Outcome Measures
Name Time Method Improvement in IQ by using Benit Kamat scale - Improvement in social behavior - Reduction in irritability. - Reduction in deformityTimepoint: 3,6,9&12 months