Study Safety and Efficacy of Bone Marrow Derived Autologous Cells for the Treatment of Diabetes Mellitus.
BMACD
1 other identifier
interventional
100
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1 diabetes-mellitus
Started Sep 2014
Typical duration for phase_1 diabetes-mellitus
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 9, 2013
CompletedFirst Posted
Study publicly available on registry
April 16, 2013
CompletedStudy Start
First participant enrolled
September 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2016
CompletedSeptember 17, 2014
September 1, 2014
2 years
April 9, 2013
September 16, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Abolition or reduction of insulin by >50 percentage
\- Abolition or reduction of insulin by \>50 percentage of ABMSCT by 6 month
6 months
Secondary Outcomes (1)
Improvement in HbA1C levels
6 months
Study Arms (1)
Transfer of autologous MNC intrathecally
OTHERsingle arm Intra thecal transplantation of autologous MNC
Interventions
Intra thecal inj.of 100 millions MNC in 3 doses at 7 days interval
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Chaitanya Hospital
Pune, Maharashtra, 411009, India
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
ANANT E BAGUL, M.S
CHAITANYA HOSPITAL
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- CO-Investigator
Study Record Dates
First Submitted
April 9, 2013
First Posted
April 16, 2013
Study Start
September 1, 2014
Primary Completion
September 1, 2016
Study Completion
September 1, 2016
Last Updated
September 17, 2014
Record last verified: 2014-09