Authors' objectives:

This report aims to assess the evidence available on the use of pluripotential stem cells or pancreas islets for the treatment of patients diagnosed with diabetes mellitus.

Authors' results and conclusions: There are no international studies published which have assessed the effectiveness of treatment with pluripotential stem cells in humans as this technique is still at the initial stages of experimentation. There are several case series reports published on pancreas islet transplants, with few patients included and mid-term follow-up. These studies were conducted in patients between 18 and 65 years old, with more than five years of diagnosis of Type 1 Diabetes Mellitus, with episodes of severe asymptomatic hypoglycemia, severe metabolic lability and follow-up and insulin therapy optimized by a specialist. Besides, the results found show that mean insulin-independence was 15 months; only 10% continue in this condition after five years. However, patients progress with lower metabolic lability, thus requiring less than 50% of the insulin dose received before the transplant.

Authors' recommendations: The evidence found agrees that manipulation of pluripotential stem cells is at experimental stage, consequently, its implementation should be restricted to the field of research. As regards pancreas islet transplant, most clinical trials identified include few patients, with no control group or mid-term follow-up. The evidence gathered demonstrates the difficulty in obtaining donors and it is still not enough to assess the consequences of long-term immunosuppression, graft viability over a longer period, and potential need for further pancreas islet transplants and their consequences. For these reasons this technique could only be developed within the framework of controlled clinical trials.

Authors' methods: Overview

Project Status: Completed

URL for project: http://www.iecs.org.ar/iecs-visor-publicacion.php?cod_publicacion=512&familia=5&origen_publicacion=buscador

Year Published: 2006

English language abstract: An English language summary is available

Publication Type: Not Assigned

Country: Argentina

Organisation Name: Institute for Clinical Effectiveness and Health Policy

Contact Address: Dr. Emilio Ravignani 2024, Buenos Aires - Argentina, C1414 CABA

Contact Name: info@iecs.org.ar

Contact Email: info@iecs.org.ar

Copyright: Institute for Clinical Effectiveness and Health Policy (IECS)