Status:
UNKNOWN
Study Safety and Efficacy of Bone Marrow Derived Autologous Cells for the Treatment of Diabetes Mellitus.
Lead Sponsor:
Chaitanya Hospital, Pune
Conditions:
Diabetes Mellitus.
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
PHASE2
Brief Summary
This study is Single arm, Single Centre trial to check the Safety and Efficacy of Bone Marrow Derived Autologous mono nuclear cells (100 Million per dose).trial to be conducted for 36 months in patien...
Detailed Description
his study is Single arm, Single Centre trial to check the Safety and Efficacy of Bone Marrow Derived Autologous mono nuclear cells (100 Million per dose).trial to be conducted for 36 months in patient...
Eligibility Criteria
Inclusion
- Patient should suffer from Diabetes Mellitus.
- 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
- Patient with History of Immunodeficiency HIV+,Hepatitis B ,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. Patients with History of Hypertension and Hypersensitive.
Key Trial Info
Start Date :
September 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2016
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT01832441
Start Date
September 1 2014
End Date
September 1 2016
Last Update
September 17 2014
Active Locations (1)
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1
Chaitanya Hospital
Pune, Maharashtra, India, 411009