Study Safety and Efficacy of Bone Marrow Derived Autologous Cells for the Treatment of Diabetes Mellitus. It is Self Funded (Patients' Own Funding) Clinical Trial

Chaitanya Hospital, Pune1 site in 1 country100 target enrollmentSeptember 2014

ConditionsDiabetes Mellitus.

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Diabetes Mellitus.
Sponsor: Chaitanya Hospital, Pune
Enrollment: 100
Locations: 1
Primary Endpoint: Abolition or reduction of insulin by >50 percentage
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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 patients with diabetes Mellitus in India,Primary outcome measure are abolition or reduction of insulin by>50 percentage by the end of 6 months of ABMSCT-Any reduction in requirement of Insulin dosage and Improvement in HbA1C Level.

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 patients with diabetes Mellitus in India,Primary outcome measure are abolition or reduction of insulin by\>50 percentage by the end of 6 months of ABMSCT-Any reduction in requirement of Insulin dosage and Improvement in HbA1C Level.

Registry

clinicaltrials.gov

Start Date

September 2014

End Date

September 2016

Last Updated

11 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Chaitanya Hospital, Pune

Responsible Party

Principal Investigator

Dr. Sachin Jamadar

CO-Investigator

Chaitanya Hospital, Pune

Eligibility Criteria

Inclusion Criteria

•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 Criteria

•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.