MSC Administration for the Management of Type 1 Diabetic Patients

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.

Inclusion Criteria:

• differential diagnosis of Type 1 Diabetes
• diagnosed performed at most 1 year before enrollment
• pancreatic reserve of insulin higher than 0.8 nmol/L/h
• good general health status
• informed consent of patient
• consent of treating physician
• proved psychiatric competence to be enrolled in a clinical study

Exclusion Criteria:

• pregnancy
• significant comorbidities
• HIV, HBV, HCV, HTLV-1, HLTV-2 or VDRL positive