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Autologous Bone Marrow Transplant in Chronic Insulin Dependent Diabetic Patients

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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

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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus Progression Diabetes Complications Biological: Adult Bone Marrow Stem Cells Phase 2 Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
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
Official Title: Autologous Bone Marrow Transplant in Chronic Insulin Dependent Diabetic Patients Phase II Clinical Trial. Version: 1.3 - January 13, 2016
Actual Study Start Date : January 1, 2018
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine



Intervention Details:
  • Biological: Adult Bone Marrow Stem Cells
    Autologous Bone Marrow Stem Cells Transplant


Primary Outcome Measures :
  1. C Peptide [ Time Frame: two years ]
    C Peptide measurement


Secondary Outcome Measures :
  1. Insulin Daly Dose [ Time Frame: Two years ]
  2. A1C [ Time Frame: Two Years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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:

-


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): NCT03562208


Contacts
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Contact: Alejandro D Mesples, MD 1 242 8213585 drmesples@stemcellbahamas.com
Contact: Mike Saire, LEED AP BD+C 407-616-9001 mike@sdds.biz

Locations
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Bahamas
Doctors Hospital Recruiting
Nassau, New Providence, Bahamas
Principal Investigator: Alejandro D Mesples, MD         
Principal Investigator: Sy C Pierre, MD         
Sponsors and Collaborators
Global Cell Med
Investigators
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Study Director: Desire Cox, MD National Stem Cell and Ethic Committee

Additional Information:
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Responsible Party: Global Cell Med
ClinicalTrials.gov Identifier: NCT03562208     History of Changes
Other Study ID Numbers: 132016
First Posted: June 19, 2018    Key Record Dates
Last Update Posted: June 19, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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
Keywords provided by Global Cell Med:
Diabetes Mellitus
Bone Marrow
Transplant
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Diabetes Complications
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs