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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01834053
Other study ID # 00106
Secondary ID
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


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
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