Study Safety and Efficacy of Bone Marrow Derived Autologous Cells for the Treatment of Diabetes Mellitus.

Phase 1

• Conditions: Diabetes Mellitus.
• Interventions: Other: Intra thecal transplantation of autologous MNC

• Registration Number: NCT01832441
• 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 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.

Study Timeline

• Study First Submitted: 2013-04-09
• Study First Submitted QC: 2013-04-12
• Study First Posted: 2013-04-16
• Status Verified: 2014-09
• Study Start: 2014-09
• Last Update Submitted: 2014-09-16
• Last Update Posted: 2014-09-17
• Primary Completion: 2016-09
• Study Completion: 2016-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Transfer of autologous MNC intrathecally	Intra thecal transplantation of autologous MNC	single arm Intra thecal transplantation of autologous MNC

Primary Outcome Measures

Name	Time	Method
Abolition or reduction of insulin by >50 percentage	6 months	- Abolition or reduction of insulin by \>50 percentage of ABMSCT by 6 month

Secondary Outcome Measures

Name	Time	Method
Improvement in HbA1C levels	6 months	Improvement in HbA1C levels as compared to baseline by the end of 6 months .

Trial Locations

Locations (1)

Chaitanya Hospital; 🇮🇳 Pune, Maharashtra, India