MSC Administration for the Management of Type 1 Diabetic Patients
This trial is active, not recruiting.
|Condition||type 1 diabetes mellitus|
|Sponsor||Universidad del Desarrollo|
|Collaborator||Clinica Alemana de Santiago|
|Start date||March 2012|
|End date||March 2017|
|Trial size||10 participants|
|Trial identifier||NCT02893306, DMT1-MSC|
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.
|Endpoint classification||efficacy study|
|Intervention model||single group assignment|
Changes in insulin pancreatic reserve
time frame: pre- and 1, 6, 24 months post-intervention
Changes in insulin requirement
time frame: pre- and up to 24 months post-intervention
Male or female participants at least 18 years old.
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
|Official title||Phase 2 Study of Intravenous Administration of Allogeneic Mesenchymal Stem Cells in Patients With Type 1 Diabetes Mellitus.|
|Principal investigator||Paulette Conget, PhD|
|Description||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.|
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