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Autologous Bone Marrow Transplant in Chronic Insulin Dependent Diabetic Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03562208
Recruitment Status : Recruiting
First Posted : June 19, 2018
Last Update Posted : June 19, 2018
Sponsor:
Information provided by (Responsible Party):
Global Cell Med

Tracking Information
First Submitted Date  ICMJE April 16, 2018
First Posted Date  ICMJE June 19, 2018
Last Update Posted Date June 19, 2018
Actual Study Start Date  ICMJE January 1, 2018
Estimated Primary Completion Date January 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 18, 2018)
C Peptide [ Time Frame: two years ]
C Peptide measurement
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: June 18, 2018)
  • Insulin Daly Dose [ Time Frame: Two years ]
  • A1C [ Time Frame: Two Years ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Autologous Bone Marrow Transplant in Chronic Insulin Dependent Diabetic Patients
Official Title  ICMJE Autologous Bone Marrow Transplant in Chronic Insulin Dependent Diabetic Patients Phase II Clinical Trial. Version: 1.3 - January 13, 2016
Brief Summary Diabetes, recently declared a pandemic by the World Health Organization, is a risk factor for increased mortality and morbidity. Its multi-functional complications, in the short and long term, are a serious problems for the global public health. Millions of patients, the world over, suffer Diabetes, a chronic and degenerative disease without treatments today. America, and particularly the Caribbean and Central America Region, is seriously affected despite the efforts of the Public Health Systems. Caribbean Region presented nearly twice the incidence and prevalence of type 1 and type 2 diabetes when compared with the rest of the Americas. Today stem cells are emerging as a valid alternative of treatment. In vitro experiments with adult stem cells demonstrated their ability to migrate and differentiate into cells of different lineages. The bone marrow stem cells are safe, effective and have a lot of scientific evidence that supports the carrying out of clinical research in phases II and III. Our protocol is an Autologous Bone Marrow Stem Cell Transplantation, without immune suppression or cell cultures. Our hypothesis is that the stem cells will act as immune modulators, angiogenic and in a regenerative way stimulating quiescent stem cells and improving the metabolic control by endogenous secretion of insulin.
Detailed Description Our clinical trial, authorized and controlled by the Government of Bahamas, offer safety data and effectiveness that encourage continued research. We will divide the patients into a treatment group and into a control group. We will control insulin daly dose, c peptide, A1C glycated hemoglobin and specific antibodies. Follow up two years.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description:

Group 1 (50 patients): Patients treated with total bone marrow, in the protocol as a group treatment will analyze type OPEN: The patient knows the treatment, as the investigator and sponsor. All patients continue to receive the standard treatment with insulin and other medicines prescribed by your doctor.

Group 2 (50 patients): Patient no treated, as a control group. All patients continue to receive the standard treatment with insulin and other medicines prescribed by your doctor.

Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Diabetes Mellitus Progression
  • Diabetes Complications
Intervention  ICMJE Biological: Adult Bone Marrow Stem Cells
Autologous Bone Marrow Stem Cells Transplant
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 18, 2018)
100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2020
Estimated Primary Completion Date January 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients diagnosed with chronic insulin dependent type 1 or 2 diabetes, with negative specific antibodies (Islets, GAD, E2) and low basal c peptide (Using C-peptide measurement (NV 0.9 mg / dl). Men and women, between 16 and 70 years old, derived voluntarily by their family doctors.

Exclusion Criteria:

-

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 16 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Alejandro D Mesples, MD 1 242 8213585 drmesples@stemcellbahamas.com
Contact: Mike Saire, LEED AP BD+C 407-616-9001 mike@sdds.biz
Listed Location Countries  ICMJE Bahamas
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03562208
Other Study ID Numbers  ICMJE 132016
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Global Cell Med
Study Sponsor  ICMJE Global Cell Med
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Desire Cox, MD National Stem Cell and Ethic Committee
PRS Account Global Cell Med
Verification Date June 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP