A Clinical Trial to Study the Safety and Efficacy of Bone Marrow Derived Autologous Cell for the Treatment of Stroke.

Study Overview
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Brief Summary
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This study is single, centre trial to study the safety and efficacy of Bone marrow derived autologous MNCS(100 million per dose)trial to be conducted for 36 months in stroke patients , the primary outcome measure will be the improvement in muscle power of Body and face

Detailed Description
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This study is single centre trial to study the safety and efficacy of Bone marrow derived autologous MNCS(100 million per dose)trial to be conducted for 36 months in stroke patients , the primary outcome measure will be the improvement in muscle power of Body and face

Official Title
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A Clinical Trial to Study the Safety and Efficacy of Bone Marrow Derived Autologous Cell for the Treatment of Stroke. It is Self Funded (Patients' Own Funding) Clinical Trial

Conditions
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Stroke,

Intervention / Treatment
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* Other: Intra thecal transplantation of Autologous Stem Cells


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient should suffer from stroke due to cerebral infarct or Haemorrhage or accelerated hypertension. willingness to undergo bone marrow derived autologous cell therapy. patient those provide fully Informed consent form for the study. Ability and willingness to regular visit to hospital and follow up during the protocol Procedure. Exclusion Criteria: Patients with pre - existing or Current systemic disease such as lung , liver ( exception; History of uncomplicated Hepatitis A),gastrointestinal, Cardiac , Immunodeficiency,(including HIV) Or laboratory Investigation that could cause a neurological defect.History of Life threating Allergic or immune- mediated reaction. Alcohol and drug abuse / dependence. Severe skin infection. Haemodynamically unstable. subject with primary and secondary diabetes , Insulin depenence,

Ages Eligible for Study
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Minimum Age: 18 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: Transfer of autologous MNC intrathecally<br>Intra thecal transplantation of autologous stem cells 100 Millions per dose in 3 divided doses at interval of 7days. | Other: Intra thecal transplantation of Autologous Stem Cells<br>* Intra thecal transplantation of Autologous Stem Cells<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in power of Body and facial Muscles | Improvement in power of Body and facial Muscles. | 6 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in Walking Ability | Improvement in Walking Ability in 6 month. | 6 months | 
| Improvement In Speech and cognition | - Improvement In Speech and cognition ,Time period-6 month | 6 Months | 
| Improvement in Vision in both eyes | Improvement in Vision in both eyes 6 month | 6 month |