Safety and Efficacy of Bone Marrow Derived MNCs for Treatment of Cells for the Treatment of Hunting Tons Chorea.

Study Overview
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Brief Summary
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This study is Single arm, Single Centre trial to check the Safety and Efficacy of Bone Marrow Derived Autologous mononuclear cell {MNC} (100 Million per dose).trial to be conducted for 36 months in patients with diabetes Mellitus in India,Primary outcome measure are Improvement in cognitive and Psychiatric Symptoms and Improvement in Jerky,random, and Uncontrollable Movements called Chorea.

Detailed Description
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This study is Single arm, Single Centre trial study the Safety and Efficacy of Bone Marrow Derived Autologous mononuclear cells (MNCs) ,to be conducted for 36 months in patients with diabetes Mellitus in India,Primary outcome measure are Improvement in cognitive and Psychiatric Symptoms and Improvement in Jerky,random, and Uncontrollable Movements called Chorea.

Official Title
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Safety and Efficacy of Bone Marrow Derived MNCs for the Treatment of Huntingtons Chorea. It is Self Funded (Patients' Own Funding) Clinical Trial

Conditions
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Huntington Disease

Intervention / Treatment
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* Biological: autologous Stem Cell


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient should suffer from Hunting tons Chorea, Hunting tons chorea commonly become noticeable between the ages of 35 -44 Willingness to undergo Bone Marrow derived Autologous cell Therapy. Ability to comprehend the explained protocol and thereafter give an informed consent as well as sign the required Informed Consent form(ICF) for the study. Ability and willingness to regular visit to hospital for protocol procedures and follow up Exclusion Criteria: Patient with History of Immunodeficiency HIV+,Hepatitis B virus ( HBV) and History of Life threatening allergic or immune -Mediated Reaction. the site of bone marrow aspiration potentially limiting Procedure. alcohol and drug abuse / dependence. Severe skin infection. Haemodynamically unstable. =subject with primary and secondary diabetes , Insulin dependence. Neurological disease caused by autoimmune or genetic cause. patients suffering from peripheral muscular dystrophy.

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 44 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: autologous Stem Cell<br>* Intrathecal transplantation of autologous 100 millions Stem cells{MNCs } per dose'<br>* Other names: Intrathecal transplantation of autologous MNCs;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in Cognitive and psychiatric symptoms |  | 6 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in neuropsychiatric behaviour |  | 6 Months | 
| Increase in life expectancy | Increase in life expectancy.Time period- 6 Months | 6 Months | 
| Improvement in writhing motions or abnormal posturing | -Improvement in writhing motions or abnormal posturing | 6 month | 
| Improvement in compulsive behaviour |  | 6 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Huntington Disease,stem cell therapy