Safety and Efficacy of Bone Marrow MNC for the Treatment of Cerebral Palsy in Subjects Below 15 Years (BMCP2)

Chaitanya Hospital, Pune

Status and phase: Unknown; Phase 3; Phase 2

Conditions: Cerebral Palsy

Treatments: Other: Intra thecal inj of autologous MNC

Study type: Interventional

Funder types: Other

Identifiers

NCT01832454

00160

Details and patient eligibility

About

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.

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

Enrollment: 100 estimated patients

Sex: All

Ages: 3 to 15 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

100 participants in 1 patient group

Intra thecal inj of autologous MNC

Other group

Description:

Intra thecal inj of autologous MNC

Treatment:

Other: Intra thecal inj of autologous MNC