Trial | NCT02893306  Report issue

Title

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.

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Unknown status

  • Intervention/Treatment

    MSCs

  • Study Participants

    10
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.
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 Started
Mar 31
2012
Primary Completion
Mar 31
2017
Anticipated
Study Completion
Mar 31
2017
Anticipated
Last Update
Sep 08
2016
Estimate

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

  • Other names: mesenchymal stem cells

DMT1+MSCs Experimental

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

Criteria 

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
No Results Posted