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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Ataxic Infantile Cerebral Palsy

Intervention / Treatment
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* Biological: stem cell (MNCs )


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: STEM CELL<br>Transfer of autologous stem cell [MNCs ]intrathecally | Biological: stem cell (MNCs )<br>* Intra thecal transplantation of autologous stem cell [MNCs ]Per dose at the interval<br>* Other names: Intra thecal autologous stem cell MNCs;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in muscle rigidity using Ash worth scale |  | 6 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in dysregulated phospholipid Metabolism |  | 6 months | 
| Improvement in walking ability and kinetic gait Pattern |  | 6 Months | 
| Improvement in overall motor control using oxford scale |  | 6 Months | 
| Improvement in orbitoFrontal-amygdala circuit and self-regulation of social -emotional behaviour |  | 6 month | 
| Improvement in motor-linked implicit learning |  | 6 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ataxic Infantile Cerebral Palsy stem cell therapy