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Allogeneic Mesenchymal Human Stem Cells Infusion Therapy for Endothelial DySfunctiOn in Diabetic Subjects

2016-09-01 14:53:21 | BioPortfolio

Summary

This is a 10 subject trial to demonstrate the safety of allogeneic hMSCs administered via infusion therapy for diabetic subjects with endothelial dysfunction.

Description

Ten (10) diabetic subject with endothelial dysfunction will be scheduled to undergo a peripheral intravenous infusion after meeting all inclusion/exclusion criteria at baseline.

Five (5) subjects will be treated with 20 million (2 x 107) allogeneic hMSC's and five (5) subjects will be treated with 100 million (100 x 106) allogeneic hMSC's

Follow up: Subjects will be followed at 3, 7, 14 and 28 days post-infusion to complete all safety and efficacy assessments and at 6 months post-infusion to complete safety assessments.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Diabetes Mellitus

Intervention

20 million Allogeneic Mesenchymal Human Stem Cells, 100 million Allogeneic Mesenchymal Human Stem Cells

Location

University of Miami Miller School of Medicine
Miami
Florida
United States
33136

Status

Not yet recruiting

Source

University of Miami

Results (where available)

View Results

Links

Published on BioPortfolio: 2016-09-01T14:53:21-0400

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Medical and Biotech [MESH] Definitions

Bone-marrow-derived, non-hematopoietic cells that support HEMATOPOETIC STEM CELLS. They have also been isolated from other organs and tissues such as UMBILICAL CORD BLOOD, umbilical vein subendothelium, and WHARTON JELLY. These cells are considered to be a source of multipotent stem cells because they include subpopulations of mesenchymal stem cells.

Insects are a class, Insecta, of Arthropoda whose members are characterized by division into three parts: head, thorax, and abdomen. They are the dominant group of animals on earth, several hundred thousand different kinds having been described. They have lived on earth for about 350 million years, as compared with less than 2 million for man. While insects are often commercially valuable and useful as scavengers, many species are harmful, causing enormous losses in agriculture and storage. Three orders, HEMIPTERA; DIPTERA; and Siphonaptera; are of medical interest in that they cause disease in man and animal. (From Dorland, 27th ed; Borror et al., An Introduction to the Study of Insects, 4th ed, p1)

Transfer of MESENCHYMAL STEM CELLS between individuals within the same species (TRANSPLANTATION, HOMOLOGOUS) or transfer within the same individual (TRANSPLANTATION, AUTOLOGOUS).

An immune response with both cellular and humoral components, directed against an allogeneic transplant, whose tissue antigens are not compatible with those of the recipient.

The treatment of patients without the use of allogeneic BLOOD TRANSFUSIONS or blood products.

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