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

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ClinicalTrials.gov Identifier: NCT01832441
Recruitment Status : Unknown
Verified September 2014 by Dr. Sachin Jamadar, Chaitanya Hospital, Pune.
Recruitment status was:  Recruiting
First Posted : April 16, 2013
Last Update Posted : September 17, 2014
Sponsor:
Information provided by (Responsible Party):
Dr. Sachin Jamadar, 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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus. Other: Intra thecal transplantation of autologous MNC Phase 1 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : September 2014
Estimated Primary Completion Date : September 2016
Estimated Study Completion Date : September 2016

Arm Intervention/treatment
Transfer of autologous MNC intrathecally
single arm Intra thecal transplantation of autologous MNC
Other: Intra thecal transplantation of autologous MNC
Intra thecal inj.of 100 millions MNC in 3 doses at 7 days interval




Primary Outcome Measures :
  1. Abolition or reduction of insulin by >50 percentage [ Time Frame: 6 months ]
    - Abolition or reduction of insulin by >50 percentage of ABMSCT by 6 month


Secondary Outcome Measures :
  1. Improvement in HbA1C levels [ Time Frame: 6 months ]
    Improvement in HbA1C levels as compared to baseline by the end of 6 months .



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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01832441


Contacts
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Contact: Sachin P Jamadar, D Ortho +918888788880 sac2751982@gmail.com
Contact: Smita S Bhoyar, B.A.M.S.PGCR 9372620569 drsmitabhoyar@rediff.com

Locations
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India
Chaitanya Hospital Recruiting
Pune, Maharashtra, India, 411009
Contact: Sachin S Jamadar, D ORTHO    +918888788880    sac2751982@gmail.com   
Principal Investigator: Anant E Bagul, MS         
Sponsors and Collaborators
Chaitanya Hospital, Pune
Investigators
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Principal Investigator: ANANT E BAGUL, M.S CHAITANYA HOSPITAL

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Responsible Party: Dr. Sachin Jamadar, CO-Investigator, Chaitanya Hospital, Pune
ClinicalTrials.gov Identifier: NCT01832441     History of Changes
Other Study ID Numbers: 00108
First Posted: April 16, 2013    Key Record Dates
Last Update Posted: September 17, 2014
Last Verified: September 2014

Keywords provided by Dr. Sachin Jamadar, Chaitanya Hospital, Pune:
Diabetes Mellitus stem cells [MNCS ]

Additional relevant MeSH terms:
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Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases