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Safety and Efficacy of Arterial Delivery of Autologous Bone Marrow Cells in the Treatment of Insulin-Dependent Diabetes

2014-08-27 03:19:32 | BioPortfolio

Summary

Diabetes mellitus is a long-term multi-organ disease with severe implications that constitute a major health problem worldwide. Type 1 diabetes is an autoimmune disorder in which the body's own immune system attacks and destroys the cells that make insulin. Exogenous administration of insulin is the primary method of controlling type 1 diabetes by regulating blood glucose levels, but this treatment does not reverse nor prevent disease progression.

Our hypothesis is that when implanting stimulated total bone marrow by arterial injection directly into the pancreas, we will achieve functional recovery of insulin-producing cells. This study will include patients with chronic type 1 diabetes and absence of lesions in target organs. We will follow the evolution of patients receiving autologous total bone marrow implantation by selective catheterization and compare to a non-treatment control group. All subjects will continue to use insulin therapy as needed to maintain the best possible glucose control.

The objective is to achieve a significant increase in C-peptide levels indicating a regeneration of the beta islet cells with a decrease in exogenous insulin usage in at least 70% of the patients.

This study is a follow-up to our initial study in which 22 patients received autologous total bone marrow. The initial study was 100% safe but additional studies like the one described above are needed to show efficacy.

Study Design

Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Conditions

Type 1 Diabetes Mellitus

Intervention

autologous bone marrow implantation, Saline injection

Location

School of Medicine, University of Morón
Buenos Aires
Argentina
B1708JPD

Status

Not yet recruiting

Source

University of Moron

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:19:32-0400

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Medical and Biotech [MESH] Definitions

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Neoplasms located in the bone marrow. They are differentiated from neoplasms composed of bone marrow cells, such as MULTIPLE MYELOMA. Most bone marrow neoplasms are metastatic.

A type of osseous tissue which makes up the inner part of bone. It has a spongy, honeycomb-like structure with struts or trabecula and contains the BONE MARROW. It has higher rate of BONE REMODELING turnover than CORTICAL BONE.

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