MSC Administration for the Management of Type 1 Diabetic Patients

Phase 2

• Conditions: Type 1 Diabetes Mellitus
• Interventions: Biological: MSCs

• Registration Number: NCT02893306
• Lead Sponsor: Universidad del Desarrollo

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 Timeline

• Study Start: 2012-03
• Study First Submitted: 2016-08-27
• Status Verified: 2016-09
• Study First Submitted QC: 2016-09-01
• Last Update Submitted: 2016-09-01
• Study First Posted: 2016-09-08
• Last Update Posted: 2016-09-08
• Primary Completion: 2017-03
• Study Completion: 2017-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
DMT1+MSCs	MSCs	type 1 diabetic patients receiving a single dose of allogeneic ex vivo expanded mesenchymal stem cells

Primary Outcome Measures

Name	Time	Method
Changes in insulin pancreatic reserve	pre- and 1, 6, 24 months post-intervention	Levels of insulin secreted after the acute ingestion of a protein rich liquid diet

Secondary Outcome Measures

Name	Time	Method
Changes in insulin requirement	pre- and up to 24 months post-intervention	Daily dose of self-administered insulin

Trial Locations

Locations (1)

Clinica Alemana de Santiago; 🇨🇱 Santiago, Region Metropolitana, Chile