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

Study Overview
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Brief Summary
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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.

Detailed Description
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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

Official Title
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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

Conditions
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Cerebral Palsy

Intervention / Treatment
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* Other: Intra thecal inj of autologous MNC


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 15 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

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Intra thecal inj of autologous MNC<br>Intra thecal inj of autologous MNC | Other: Intra thecal inj of autologous MNC<br>* Intra thecal inj of autologous MNC<br>|

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 and overall motor control using oxford scale. | - Improvement in muscle rigidity using Ash worth scale and overall motor control using oxford scale at Time point - 6 Months. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| -Improvement in IQ by using Benit Kamat scale. | -Improvement in IQ by using Benit Kamat scale. Improvement in social behaviour. Reduction in deformity. | 6 Months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cerebral palsy stem cells [MNCS]