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

Huntington Disease Clinical Trial

— BMACHC  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01834053
• Other study ID #: 00106
• Status: Recruiting
• Phase: Phase 1/Phase 2
• First received: April 11, 2013
• Last updated: September 16, 2014
• Start date: September 2014
• Est. completion date: June 2016

Study information

• Verified date: September 2014
• Source: Chaitanya Hospital, Pune
• Contact: Sachin P Jamadar, D Ortho
• Phone: +918888788880
• Email: sac2751982[@]gmail.com
• Is FDA regulated: No
• Health authority: India: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 35 Years to 44 Years

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Huntington Disease

Intervention

Biological:
• autologous Stem Cell
Intrathecal transplantation of autologous 100 millions Stem cells{MNCs } per dose'

Locations

Country	Name	City	State
India	Chaitanya Hospital	Pune	Maharashtra

Sponsors (1)

Lead Sponsor	Collaborator
Chaitanya Hospital, Pune

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement in Cognitive and psychiatric symptoms		6 Months	Yes
Secondary	Improvement in neuropsychiatric behaviour		6 Months	Yes
Secondary	Increase in life expectancy	Increase in life expectancy.Time period- 6 Months	6 Months	Yes
Secondary	Improvement in writhing motions or abnormal posturing	-Improvement in writhing motions or abnormal posturing	6 month	Yes
Secondary	Improvement in compulsive behaviour		6 month	Yes