- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03562208
Autologous Bone Marrow Transplant in Chronic Insulin Dependent Diabetic Patients
June 18, 2018 updated by: Global Cell Med
Autologous Bone Marrow Transplant in Chronic Insulin Dependent Diabetic Patients Phase II Clinical Trial. Version: 1.3 - January 13, 2016
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.
Study Overview
Status
Unknown
Intervention / Treatment
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
Interventional
Enrollment (Anticipated)
100
Phase
- Phase 2
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Alejandro D Mesples, MD
- Phone Number: 1 242 8213585
- Email: drmesples@stemcellbahamas.com
Study Contact Backup
- Name: Mike Saire, LEED AP BD+C
- Phone Number: 407-616-9001
- Email: mike@sdds.biz
Study Locations
-
-
New Providence
-
Nassau, New Providence, Bahamas
- Recruiting
- Doctors Hospital
-
Principal Investigator:
- Alejandro D Mesples, MD
-
Principal Investigator:
- Sy C Pierre, MD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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:
-
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
C Peptide
Time Frame: two years
|
C Peptide measurement
|
two years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Insulin Daly Dose
Time Frame: Two years
|
Two years
|
A1C
Time Frame: Two Years
|
Two Years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Desire Cox, MD, National Stem Cell and Ethic Committee
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2018
Primary Completion (Anticipated)
January 1, 2020
Study Completion (Anticipated)
June 1, 2020
Study Registration Dates
First Submitted
April 16, 2018
First Submitted That Met QC Criteria
June 18, 2018
First Posted (Actual)
June 19, 2018
Study Record Updates
Last Update Posted (Actual)
June 19, 2018
Last Update Submitted That Met QC Criteria
June 18, 2018
Last Verified
June 1, 2018
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 132016
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
Drug and device information, study documents
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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