A Phase 2/3 interventional study of Adult Bone Marrow Stem Cells in Diabetes Mellitus Progression and Diabetes Complications, sponsored by Global Cell Med. Status unknown at 1 site in Bahamas. Open to participants aged 16 Years and older. Per ClinicalTrials.gov, last updated 2018-06-19.
Sponsored by Global Cell Med · Phase 2/3, Interventional, and Treatment
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.
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.
267 studies on the registry are indexed under Diabetes Complications; 54 are open to participants now.
This study's planned enrollment of 100 is above the median of 72 across 171 interventional studies indexed under Diabetes Complications.
Browse Diabetes Complications studies →This is the only study on the registry with Global Cell Med as lead sponsor.
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Exclusion Criteria:
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Autologous Bone Marrow Stem Cells Transplant
C Peptide
C Peptide measurement
Time frame: two years
Insulin Daly Dose
Time frame: Two years
A1C
Time frame: Two Years
Plan to share: Undecided
Started Jan 2018 (actual). Primary completion is estimated for Jan 2020, 24 months after the start.
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This study is status unknown, as verified in Jun 2018. You cannot join it, but the record below documents what was studied.
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