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

Phase 1

• Conditions: Huntington Disease
• Interventions: Biological: autologous Stem Cell

• Registration Number: NCT01834053
• Lead Sponsor: Chaitanya Hospital, Pune

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.

Study Timeline

• Study First Submitted: 2013-04-11
• Study First Submitted QC: 2013-04-15
• Study First Posted: 2013-04-17
• Status Verified: 2014-09
• Study Start: 2014-09
• Last Update Submitted: 2014-09-16
• Last Update Posted: 2014-09-17
• Primary Completion: 2016-06
• Study Completion: 2016-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
STEM CELL	autologous Stem Cell	Transfer of autologous Stem cell( MNCs) intrathecally

Primary Outcome Measures

Name	Time	Method
Improvement in Cognitive and psychiatric symptoms	6 Months

Secondary Outcome Measures

Name	Time	Method
Improvement in writhing motions or abnormal posturing	6 month	-Improvement in writhing motions or abnormal posturing
Improvement in neuropsychiatric behaviour	6 Months
Increase in life expectancy	6 Months	Increase in life expectancy.Time period- 6 Months
Improvement in compulsive behaviour	6 month

Trial Locations

Locations (1)

Chaitanya Hospital; 🇮🇳 Pune, Maharashtra, India