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

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ClinicalTrials.gov Identifier: NCT02893306
Recruitment Status : Unknown
Verified September 2016 by Paulette Conget, Universidad del Desarrollo.
Recruitment status was:  Active, not recruiting
First Posted : September 8, 2016
Last Update Posted : September 8, 2016
Sponsor:
Collaborator:
Clinica Alemana de Santiago
Information provided by (Responsible Party):
Paulette Conget, 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.

Condition or disease Intervention/treatment Phase
Type 1 Diabetes Mellitus Biological: MSCs Phase 2

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 2 Study of Intravenous Administration of Allogeneic Mesenchymal Stem Cells in Patients With Type 1 Diabetes Mellitus.
Study Start Date : March 2012
Estimated Primary Completion Date : March 2017
Estimated Study Completion Date : March 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

Arm Intervention/treatment
Experimental: DMT1+MSCs
type 1 diabetic patients receiving a single dose of allogeneic ex vivo expanded mesenchymal stem cells
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 Name: mesenchymal stem cells




Primary Outcome Measures :
  1. Changes in insulin pancreatic reserve [ Time Frame: 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 :
  1. Changes in insulin requirement [ Time Frame: pre- and up to 24 months post-intervention ]
    Daily dose of self-administered insulin


Other Outcome Measures:
  1. Number of patients with grade 3 through grade 5 adverse events (CTCAE v3.0) [ Time Frame: up to 24 months post-intervention ]
    Review of patient clinical records

  2. Number of patients with grade 3 through grade 5 adverse events (CTCAE v3.0) [ Time Frame: up to 24 months post-intervention ]
    Regular communication with patient and his/her physician in order to be informed of eventual complications



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02893306


Locations
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Chile
Clinica Alemana de Santiago
Santiago, Region Metropolitana, Chile
Sponsors and Collaborators
Universidad del Desarrollo
Clinica Alemana de Santiago
Investigators
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Principal Investigator: Paulette Conget, PhD Universidad del Desarrollo
Principal Investigator: Claudio Mizon, MD Clinica Alemana de Santiago

Publications:
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Responsible Party: Paulette Conget, Dr, Universidad del Desarrollo
ClinicalTrials.gov Identifier: NCT02893306     History of Changes
Other Study ID Numbers: DMT1-MSC
First Posted: September 8, 2016    Key Record Dates
Last Update Posted: September 8, 2016
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Data will be publish in a peer review journal
Keywords provided by Paulette Conget, Universidad del Desarrollo:
Type1 Diabetes Mellitus
Multipotent stromal cell
Mesenchymal stem cell
Insulin
Pancreatic reserve
Disease progression
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases