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


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
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

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

Secondary Outcomes

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.