Safety and Efficacy of Bone Marrow Derived MNCs for the Treatment of Huntingtons Chorea. It is Self Funded (Patients' Own Funding) Clinical Trial
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Huntington Disease
- Sponsor
- Chaitanya Hospital, Pune
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Improvement in Cognitive and psychiatric symptoms
- Last Updated
- 11 years ago
Overview
Brief Summary
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
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.
Investigators
Dr. Sachin Jamadar
CO-Investigator
Chaitanya Hospital, Pune
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Improvement in Cognitive and psychiatric symptoms
Time Frame: 6 Months
Secondary Outcomes
- Improvement in writhing motions or abnormal posturing(6 month)
- Improvement in neuropsychiatric behaviour(6 Months)
- Increase in life expectancy(6 Months)
- Improvement in compulsive behaviour(6 month)