Trial | NCT01832454  Report issue

Title

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

  • Phase

    Phase 2/Phase 3

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    100
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.
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
Study Started
Mar 31
2011
Primary Completion
Nov 30
2015
Anticipated
Study Completion
Dec 31
2015
Anticipated
Last Update
Sep 17
2014
Estimate

Other Intra thecal inj of autologous MNC

Intra thecal inj of autologous MNC

Intra thecal inj of autologous MNC Other

Intra thecal inj of autologous MNC

Criteria 

Inclusion Criteria:

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 Criteria:

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
No Results Posted