Clinical Trial: Safety and Efficacy of Bone Marrow MNC for the Treatment of Cerebral Palsy in Subjects Below 15 Years

Study Status: Active, not recruiting
Recruit Status: Unknown status
Study Type: Interventional

Official Title: Safety and Efficacy of Bone Marrow MNC for the Treatment of Cerebral Palsy in Subjects Below Years. It is Self Funded (Patients' Own Funding) Clinical Trial

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 patients ( below 15 years of age) with cerebral palsy in India. Primary outcome measures are improvement in walking ability and kinetic gait pattern.

Detailed 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
Sponsor: Chaitanya Hospital, Pune

Current Primary Outcome: Improvement in muscle rigidity using Ash worth scale and overall motor control using oxford scale. [ Time Frame: 6 months ]

- Improvement in muscle rigidity using Ash worth scale and overall motor control using oxford scale at Time point - 6 Months.


Original Primary Outcome: Same as current

Current Secondary Outcome: -Improvement in IQ by using Benit Kamat scale. [ Time Frame: 6 Months ]

-Improvement in IQ by using Benit Kamat scale. Improvement in social behaviour. Reduction in deformity.


Original Secondary Outcome: Same as current

Information By: Chaitanya Hospital, Pune

Dates:
Date Received: February 26, 2013
Date Started: March 2011
Date Completion: December 2015
Last Updated: September 16, 2014
Last Verified: September 2014