Autologous Bone Marrow Transplant in Chronic Insulin Dependent Diabetic Patients

Sponsor

Global Cell Med (Industry)

Overall Status

Unknown status

CT.gov ID

NCT03562208

Collaborator

(none)

100

Enrollment

Location

Anticipated Duration (Months)

3.5

Patients Per Site Per Month

Study Details

Study Description

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.

Study Design

Study Type:

Interventional

Anticipated 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.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 :

Jan 1, 2018

Anticipated Primary Completion Date :

Jan 1, 2020

Anticipated Study Completion Date :

Jun 1, 2020

Outcome Measures

Primary Outcome Measures

C Peptide [two years]
C Peptide measurement

Secondary Outcome Measures

Insulin Daly Dose [Two years]
A1C [Two Years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

16 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.