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

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

Status

UNKNOWN

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01832441

Acronym

BMACD

Enrollment

100

Registered

2013-04-16

Start date

2014-09-30

Completion date

2016-09-30

Last updated

2014-09-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus.

Keywords

Diabetes Mellitus stem cells [MNCS ]

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.

Interventions

OTHERIntra thecal transplantation of autologous MNC

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
Abolition or reduction of insulin by >50 percentage	6 months	\- Abolition or reduction of insulin by \>50 percentage of ABMSCT by 6 month

Secondary

Measure	Time frame	Description
Improvement in HbA1C levels	6 months	Improvement in HbA1C levels as compared to baseline by the end of 6 months .

Countries

India

Contacts

Primary ContactSachin P Jamadar, D Ortho

sac2751982@gmail.com+918888788880

Backup ContactSmita S Bhoyar, B.A.M.S.PGCR

drsmitabhoyar@rediff.com9372620569

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026