Abstract
Background: Recent extensive clinical evidence demonstrated that autologous adult stem cell therapy was safe and effective as a treatment strategy for type 1 diabetes. Our initial work was designed to examine the safety and efficacy of the implantation technique on 20 subjects with six months of evolution. This new report analyzes the results from three years follow up. Methods: With the authorization from the Ministry of Health of Argentina, 20 subjects with type 1 diabetes were treated with single autologous bone marrow cell transplantation into pancreatic blood flow through pancreatic artery catheterization immediately after bone marrow aspiration. The primary endpoint was defined as normalization of C-peptide and glycated hemoglobin (HbA1c) with insulin independence at 3 years posttreatment. Results: 15 subjects (75%) achieved clinical improvements. 7 subjects (33%) reached the primary endpoint, in which 4 subjets with decreased C-peptide levels required insulin administration again at 3 years post-treatment. Other 8 subjects (34%) showed partial function at 3 years post-treatment. There were no serious adverse events observed. No increases of islet cell antibody (ICA) and glutamic acid decarboxylase (GAD) antibody. Conclusion: This procedure may be a safe and effective treatment for chronic type 1 diabetes. The follow-up results showed a significant increase of the pancreatic secretion of C-peptide and a decrease in the daily dose of exogenous insulin. This effect partially disappears by the three years follow-up without an increase of the level of the ICA and GAD antibodies.
Highlights
In type 1 diabetes, significant destruction of b-cells occurs prior to diagnosis
The results demonstrated that the injection of bone marrow cells into the pancreatic microcirculation through catheterization is safe and easy to perform
The progressively decreased level of C-peptide in subjects with chronic type 1 diabetes is well known and the spontaneous remission has never been observed after current standard medical treatments
Summary
In type 1 diabetes, significant destruction of b-cells occurs prior to diagnosis. At the time of clinical onset, only 10% of normal b-cell mass remains [1]. Our initial work was designed to examine the safety and efficacy of the implantation technique on 20 subjects with six months of evolution This new report analyzes the results from three years follow up. 7 subjects (33%) reached the primary endpoint, in which 4 subjets with decreased C-peptide levels required insulin administration again at 3 years post-treatment. The follow-up results showed a significant increase of the pancreatic secretion of C-peptide and a decrease in the daily dose of exogenous insulin. This effect partially disappears by the three years follow-up without an increase of the level of the ICA and GAD antibodies
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