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This is a 10 subject trial to demonstrate the safety of allogeneic hMSCs administered via infusion therapy for diabetic subjects with endothelial dysfunction.
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.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
20 million Allogeneic Mesenchymal Human Stem Cells, 100 million Allogeneic Mesenchymal Human Stem Cells
University of Miami Miller School of Medicine
Not yet recruiting
University of Miami
Published on BioPortfolio: 2016-09-01T14:53:21-0400
This study will assess the safety and efficacy of systemic (IV) administration of escalating doses of allogeneic MSCs in modulating immune cell phenotypes and suppressing aortic inflammati...
The study is a phase I/II trial where allogeneic human mesenchymal stem cells (hMSCs) are injected intracfect into the lumbar facet joints. Forty (40) subjects are scheduled to undergo inj...
This study will evaluate the safety and efficacy of mesenchymal stem cells in patients with cirrhosis of liver. Stem cells will be injected into the hepatic artery. Improvement in various ...
Eighty (80) subjects with Alcohol Use Disorder and Comorbid Major Depression, fulfilling all inclusion/exclusion criteria's will be randomly assigned to receive allogeneic human Mesenchyma...
This is a prospective, multicenter, double-blind, placebo controlled interventional study to evaluate the safety and efficacy of allogeneic mesenchymal stem cells (MSCs) in 20 patients wit...
The superficial digital flexor tendon (SDFT) is a structure frequently affected by injuries in high-performance athletic horses, and there are limited therapeutic options. Regenerative medicine has ev...
CD134 (OX40), which is a cellular receptor for human herpesvirus-6B (HHV-6B) and expresses on activated T cells, may play a key role for HHV-6B replication after allogeneic hematopoietic stem cell tra...
Adenovirus (ADV) reactivation can cause significant morbidity and mortality in children after allogeneic stem cell transplantation. Antiviral drugs can control viremia, but viral clearance requires re...
The mesenchymal stem cells (MSCs) of peripheral blood (PB) have been recognized as a promising source for allogeneic cell therapy. The objective of the present study was to isolate and characterize MS...
T - and natural killer (NK) cell neoplasms are a heterogeneous group of rare diseases with often inferior outcome. Only few studies exist, clarifying the role of allogeneic transplantation in differen...
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.
Diabetes is a lifelong condition that causes a person's blood sugar level to become too high. The two main types of diabetes are: type 1 diabetes type 2 diabetes In the UK, diabetes affects approximately 2.9 million people. There are a...
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