Status:
UNKNOWN
Safety and Efficacy of Bone Marrow MNC for the Treatment of Cerebral Palsy in Subjects Below 15 Years
Lead Sponsor:
Chaitanya Hospital, Pune
Conditions:
Cerebral Palsy
Eligibility:
All Genders
3-15 years
Phase:
PHASE2
PHASE3
Brief Summary
This Study is Single arm, Single Centre trail to check the safety and efficacy of bone marrow derived autologous mononuclear cells(100 millions per dose )trial to be conducted for 36 months in 100 pat...
Detailed Description
This Study is Single arm, Single Centre trail to check the safety and efficacy of bone marrow derived autologous mononuclear cells(100 millions per dose )trial to be conducted for 36 months in 100 pat...
Eligibility Criteria
Inclusion
- Subject aged above 3 years and below 15 years with a diagnosis of Cerebral Palsy.
- Regional Nerve damage as shown by Magnetic Resonance Imaging(MRI)
- 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,meningoencephalits,epilepsy or life threatening allergic or immune -mediated reaction 2
- Hemodynamically unstable patients
- history of or concurrent autoimmune disease or acute episode if Guillain- barre syndrome
- peripheral Muscular dystropy
Key Trial Info
Start Date :
March 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2015
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT01832454
Start Date
March 1 2011
End Date
December 1 2015
Last Update
September 17 2014
Active Locations (1)
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1
Chaitnany Hospital
Pune, Maharashtra, India, 411009