Autologous Bone Marrow Transplant in Chronic Insulin Dependent Diabetic Patients

NCT03562208 | Unknown Phase 2 DMC

• 1 other identifier: 132016
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus Progression; Diabetes Complications

Keywords

Diabetes Mellitus; Bone Marrow; Transplant

Outcome Measures

Primary Outcomes (1)

• C Peptide

  C Peptide measurement

  two years

Secondary Outcomes (2)

• Insulin Daly Dose

  Two years

• A1C

  Two Years

Interventions

Adult Bone Marrow Stem Cells BIOLOGICAL

Autologous Bone Marrow Stem Cells Transplant

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• Global Cell Med: lead

Study Sites (1)

Doctors Hospital

Nassau, New Providence District, The Bahamas

RECRUITING

Related Links

• Related Info

MeSH Terms

Conditions

Diabetes Complications; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Endocrine System Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Desire Cox, MD

  National Stem Cell and Ethic Committee

  STUDY DIRECTOR

Central Study Contacts

Alejandro D Mesples, MD

CONTACT

1 242 8213585; drmesples@stemcellbahamas.com

Mike Saire, LEED AP BD+C

CONTACT

407-616-9001; mike@sdds.biz

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: April 16, 2018
• First Posted: June 19, 2018
• Study Start: January 1, 2018
• Primary Completion: January 1, 2020
• Study Completion: June 1, 2020
• Last Updated: June 19, 2018

Record last verified: 2018-06

Locations

TH (1)