Autologous Bone Marrow Transplant in Chronic Insulin Dependent Diabetic Patients

Diabetes Complications Clinical Trial

Official title:

Autologous Bone Marrow Transplant in Chronic Insulin Dependent Diabetic Patients Phase II Clinical Trial. Version: 1.3 - January 13, 2016

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03562208
• Other study ID #: 132016
• Status: Recruiting
• Phase: Phase 2/Phase 3
• Start date: January 1, 2018
• Est. completion date: June 2020

Study information

• Verified date: June 2018
• Source: Global Cell Med
• Contact: Alejandro D Mesples, MD
• Phone: 1 242 8213585
• Email: drmesples[@]stemcellbahamas.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: June 2020
• Est. primary completion date: January 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

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:

Related Conditions & MeSH terms

• Diabetes Complications
• Diabetes Mellitus
• Diabetes Mellitus Progression
• Diabetes Mellitus, Type 1

Intervention

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

Locations

Country	Name	City	State
Bahamas	Doctors Hospital	Nassau	New Providence

Sponsors (1)

Lead Sponsor	Collaborator
Global Cell Med

Country where clinical trial is conducted

Bahamas, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	C Peptide	C Peptide measurement	two years
Secondary	Insulin Daly Dose		Two years
Secondary	A1C		Two Years

External Links

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