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

NCT ID: NCT01832441

Last Updated: 2014-09-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-30

Study Completion Date

2016-09-30

Brief Summary

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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

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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.

Conditions

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Diabetes Mellitus.

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Transfer of autologous MNC intrathecally

single arm Intra thecal transplantation of autologous MNC

Group Type OTHER

Intra thecal transplantation of autologous MNC

Intervention Type OTHER

Intra thecal inj.of 100 millions MNC in 3 doses at 7 days interval

Interventions

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Intra thecal transplantation of autologous MNC

Intra thecal inj.of 100 millions MNC in 3 doses at 7 days interval

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Chaitanya Hospital, Pune

OTHER

Sponsor Role lead

Responsible Party

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Dr. Sachin Jamadar

CO-Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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ANANT E BAGUL, M.S

Role: PRINCIPAL_INVESTIGATOR

CHAITANYA HOSPITAL

Locations

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Chaitanya Hospital

Pune, Maharashtra, India

Site Status RECRUITING

Countries

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India

Central Contacts

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Sachin P Jamadar, D Ortho

Role: CONTACT

+918888788880

Smita S Bhoyar, B.A.M.S.PGCR

Role: CONTACT

9372620569

Facility Contacts

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Sachin S Jamadar, D ORTHO

Role: primary

+918888788880

Other Identifiers

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00108

Identifier Type: -

Identifier Source: org_study_id

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