Autologous Bone Marrow Transplant in Chronic Insulin Dependent Diabetic Patients

Phase 2

• Conditions: Diabetes Complications; Diabetes Mellitus Progression

• Registration Number: NCT03562208
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2018-01-01
• Study First Submitted: 2018-04-16
• Status Verified: 2018-06
• Study First Submitted QC: 2018-06-18
• Last Update Submitted: 2018-06-18
• Study First Posted: 2018-06-19
• Last Update Posted: 2018-06-19
• Primary Completion: 2020-01
• Study Completion: 2020-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
C Peptide	two years	C Peptide measurement

Secondary Outcome Measures

Name	Time	Method
A1C	Two Years
Insulin Daly Dose	Two years

Trial Locations

Locations (1)

Doctors Hospital; 🇧🇸 Nassau, New Providence, Bahamas