MSC Administration for the Management of Type 1 Diabetic Patients

Study Overview
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Brief Summary
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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
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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.

Official Title
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Phase 2 Study of Intravenous Administration of Allogeneic Mesenchymal Stem Cells in Patients With Type 1 Diabetes Mellitus.

Conditions
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Type 1 Diabetes Mellitus

Intervention / Treatment
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* Biological: MSCs


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DMT1+MSCs<br>type 1 diabetic patients receiving a single dose of allogeneic ex vivo expanded mesenchymal stem cells | Biological: MSCs<br>* 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<br>* Other names: mesenchymal stem cells;|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in insulin requirement | Daily dose of self-administered insulin | pre- and up to 24 months post-intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Type1 Diabetes Mellitus, Multipotent stromal cell, Mesenchymal stem cell, Insulin, Pancreatic reserve, Disease progression