Safety and Efficacy of Bone Marrow MNC for the Treatment of Cerebral Palsy in Subjects Below 15 Years
NCT01832454 · Status: UNKNOWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 100
Last updated 2014-09-17
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 patients ( below 15 years of age) with cerebral palsy in India. Primary outcome measures are improvement in walking ability and kinetic gait pattern.
Conditions
- Cerebral Palsy
Interventions
- OTHER
-
Intra thecal inj of autologous MNC
Intra thecal inj of autologous MNC
Sponsors & Collaborators
-
Chaitanya Hospital, Pune
lead OTHER
Principal Investigators
-
Anant E Bagul, M.S. · chaitanya stem cell centre
Study Design
- Allocation
- NA
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 3 Years
- Max Age
- 15 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2011-03-31
- Primary Completion
- 2015-11-30
- Completion
- 2015-12-31
Countries
- India
Study Locations
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