Status:
UNKNOWN
Safety and Efficacy of Bone Marrow Derived Autologous Cells Treatment of Cerebral Palsy in Subjects Above 15 Years
Lead Sponsor:
Chaitanya Hospital, Pune
Conditions:
Ataxic Infantile Cerebral Palsy
Eligibility:
All Genders
15-70 years
Phase:
PHASE1
PHASE2
Brief Summary
This Study is Single arm, Single Centre trial to study the safety and efficacy of bone marrow derived autologous mononuclear cells (100 millions per dose)study enrollment duration 36 months sample siz...
Detailed Description
Cerebral Palsy is commonest cause of Disability in India and south East Asia. This Study is devised to quantify the safety and efficacy of bone marrow derived autologous mononuclear cells(100 millions...
Eligibility Criteria
Inclusion
- Subject aged above 15 years with a diagnosis of Cerebral Palsy. Regional Nerve damage as shown by Magnetic Resonance Imaging(MRI)
- Patient suffer from cerebral palsy due to prenatal and postnatal cause,
- Willing to undergoing Bone Marrow derived autologous stem cell therapy.
- Able to Comprehend and give written informed consent form for the study
- willing to come to the hospital for follow up visits as per the protocol requirements
Exclusion
- History of meningitis,meningoencephalitis , epilepsy or life threatening allergic or immune -mediated reaction
- Hemodynamically unstable patients
- history of or concurrent autoimmune disease or acute episode if Guillain- barre syndrome
- peripheral Muscular dystrophy
Key Trial Info
Start Date :
March 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2016
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT01834664
Start Date
March 1 2013
End Date
June 1 2016
Last Update
September 17 2014
Active Locations (1)
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1
Chaitanya Hospital
Pune, Maharashtra, India, 411009