MSC Administration for the Management of Type 1 Diabetic Patients (DMT1-MSC)

Universidad del Desarrollo

Status and phase: Unknown; Phase 2

Conditions: Type 1 Diabetes Mellitus

Treatments: Biological: MSCs

Study type: Interventional

Funder types: Other

Identifiers

NCT02893306

DMT1-MSC

Details and patient eligibility

About

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.

Full 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.

Enrollment: 10 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

DMT1+MSCs

Experimental group

Description:

type 1 diabetic patients receiving a single dose of allogeneic ex vivo expanded mesenchymal stem cells

Treatment:

Biological: MSCs