Safety and Efficacy of Bone Marrow Derived Autologous Cells Treatment of Cerebral Palsy in Subjects Above 15 Years

Safety and Efficacy of Bone Marrow Derived Autologous Cells for the Treatment of Cerebral Palsy in Subjects Above Years (BMACCP) .It is Self Funded (Patients' Own Funding) Clinical Trial

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 size 100 patients should be treated (above 15 years of age) with cerebral palsy in India. Primary outcome measures are improvement in walking ability and kinetic gait pattern.

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 per dose)study enrolment duration 36 months sample size 100 patients should be treated (above 15 years of age) with cerebral palsy, in India. Primary outcome measures are improvement in walking ability and kinetic gait pattern as per as various clinical scales and also changes in the brain.

Inclusion Criteria:

• 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 Criteria:

• 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