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

Chaitanya Hospital, Pune

Status and phase

Unknown

Phase 2

Phase 1

Conditions

Huntington Disease

Treatments

Biological: autologous Stem Cell

Study type

Interventional

Funder types

Other

Identifiers

NCT01834053

00106

Details and patient eligibility

About

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.

Full 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.

Enrollment

50 estimated patients

Sex

All

Ages

35 to 44 years old

Volunteers

Accepts Healthy Volunteers

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.