NCT02893306

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.

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Universidad del Desarrollo · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Type 1 Diabetes Mellitus

Interventions

Type	Name	Description
BIOLOGICAL	MSCs	origin: bone marrow of healthy donor; manipulation: ex vivo expanded; via: intravenous; vehicle: 5% human recombinant albumin in physiological serum; dose: 2-3 millions/Kg; dosage: single

Timeline

• Start date: 2012-03-01
• Primary completion: 2017-03-01
• Completion: 2017-03-01
• First posted: 2016-09-08
• Last updated: 2016-09-08

Locations

1 site across 1 country: Chile