Overview

This trial is active, not recruiting.

Condition type 1 diabetes mellitus
Treatment mscs
Phase phase 2
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

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
type 1 diabetic patients receiving a single dose of allogeneic ex vivo expanded mesenchymal stem cells
mscs mesenchymal stem cells
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

Primary Outcomes

Measure
Changes in insulin pancreatic reserve
time frame: pre- and 1, 6, 24 months post-intervention

Secondary Outcomes

Measure
Changes in insulin requirement
time frame: pre- and up to 24 months post-intervention

Eligibility Criteria

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

Additional Information

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.
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Universidad del Desarrollo.