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

Chaitanya Hospital, Pune

Status and phase: Unknown; Phase 2; Phase 1

Conditions: Ataxic Infantile Cerebral Palsy

Treatments: Biological: stem cell (MNCs )

Study type: Interventional

Funder types: Other

Identifiers

NCT01834664

00109

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 15 to 70 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

STEM CELL

Other group

Description:

Transfer of autologous stem cell \[MNCs \]intrathecally

Treatment:

Biological: stem cell (MNCs )