Phase 2 Study of Intravenous Administration of Allogeneic Mesenchymal Stem Cells in Patients With Type 1 Diabetes Mellitus.
Trial Snapshot
- Phase
- Phase 2
- Sponsor
- Universidad del Desarrollo
- Enrollment
- 10
- Locations
- 1
- Primary Endpoint
- Changes in insulin pancreatic reserve
Study Overview
Brief Summary
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.
Detailed 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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Changes in insulin pancreatic reserve
Time Frame: pre- and 1, 6, 24 months post-intervention
Levels of insulin secreted after the acute ingestion of a protein rich liquid diet
Secondary Outcomes
- Changes in insulin requirement(pre- and up to 24 months post-intervention)
Investigators
Paulette Conget
Dr
Universidad del Desarrollo