Type 1 Diabetes Mellitus Clinical Trial
Official title:
Phase 2 Study of Intravenous Administration of Allogeneic Mesenchymal Stem Cells in Patients With Type 1 Diabetes Mellitus.
The purpose of this study is to evaluate whether the administration of multipotent stromal cell also referred as to mesenchymal stem cells (MSCs), modified Type 1 Diabetes progression.
Aim: to evaluate whether a single intravenous administration of allogeneic bone
marrow-derived multipotent stromal cell also referred as to mesenchymal stem cells (MSCs),
modified endogenous insulin secretion capacity and exogenous insulin requirement in patients
with Type 1 Diabetes Mellitus.
Participants: 10, females or males, 18 years or older, diagnosed with Type 1 Diabetes
Mellitus at most 1 year before enrollment, under exogenous insulin treatment, with
pancreatic reserve of insulin.
Intervention: intravenous administration of a single dose (2-3 millions/Kg) of allogeneic
MSCs.
Follow up: before and 1, 6, 24 months after MSC administration.
;
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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