A clinical trial to study the safety and efficacy of Bone marrow derived Autologous cells for the treatment of cerebral palsy in subjects above 15 years.
- Conditions
- Health Condition 1: null- Cerebral Palsy above 15 years
- Registration Number
- CTRI/2011/091/000159
- Lead Sponsor
- Chaitanya Stem Cell Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 100
1. Should suffer from cerebral palsy due to prenatal and postnatal cause.
2. Willingness to undergoing Bone marrow derived autologous stem cell therapy
3. Ability to comprehend the explained protocol and thereafter give an informed consent as well as sign the required Informed Consent Form (ICF) for the study.
4. Ability and willingness to regularly visit the hospital / clinic for follow up during the follow up period / on prior agreed time points as per the protocol.
1. Patients with pre-existing or current systemic disease such as lung , liver (exception: history of uncomplicated hepatitis A) gastrointestinal , cardiac, immunodeficiency (including HIV) or any other condition determined by history or laboratory investigation that could cause a neurological defect (including syphilis, clinically relevant polyneuropathy) etc.
2. History of life threatening allergic or immune-mediated reaction.
3. Haemodynamically unstable subjects.
4. Subjects suffering from peripheral muscular dystrophy.
5. Severe skin infection and osteomyelitis/ or at the site of bone marrow aspiration potentially limiting the procedure.
6. Positive test results for Hepatitis A and Hepatitis B or C.
7. Alcohol and / or drug abuse/ dependence.
8. Subjects with primary or secondary diabetes, insulin dependence or with serum creatinine > 1.5 mg/dL.
9. Neurological disease caused by autoimmune or genetic cause
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 months
- Secondary Outcome Measures
Name Time Method Improvement in dysregulated phospholipid metabolism. - Improvement in orbito-frontal-amygdala circuit and self-regulation of social-emotional behavior.. - Improvement in motor-linked implicit learning. - Reduction in burden on familyTimepoint: 6 months