MSC Administration for the Management of Type 1 Diabetic Patients (DMT1-MSC)
September 1, 2016 updated by: Paulette Conget, Universidad del Desarrollo
Phase 2 Study of Intravenous Administration of Allogeneic Mesenchymal Stem Cells in Patients With Type 1 Diabetes Mellitus.
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.
Study Overview
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 Type
Interventional
Enrollment (Actual)
10
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Region Metropolitana
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Santiago, Region Metropolitana, Chile
- Clinica Alemana de Santiago
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: DMT1+MSCs
type 1 diabetic patients receiving a single dose of allogeneic ex vivo expanded mesenchymal stem cells
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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:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Changes in insulin pancreatic reserve
Time Frame: pre- and 1, 6, 24 months post-intervention
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Levels of insulin secreted after the acute ingestion of a protein rich liquid diet
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pre- and 1, 6, 24 months post-intervention
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Changes in insulin requirement
Time Frame: pre- and up to 24 months post-intervention
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Daily dose of self-administered insulin
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pre- and up to 24 months post-intervention
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Number of patients with grade 3 through grade 5 adverse events (CTCAE v3.0)
Time Frame: up to 24 months post-intervention
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Review of patient clinical records
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up to 24 months post-intervention
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Number of patients with grade 3 through grade 5 adverse events (CTCAE v3.0)
Time Frame: up to 24 months post-intervention
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Regular communication with patient and his/her physician in order to be informed of eventual complications
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up to 24 months post-intervention
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Paulette Conget, PhD, Universidad del Desarrollo
- Principal Investigator: Claudio Mizon, MD, Clinica Alemana de Santiago
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Ezquer F, Ezquer M, Contador D, Ricca M, Simon V, Conget P. The antidiabetic effect of mesenchymal stem cells is unrelated to their transdifferentiation potential but to their capability to restore Th1/Th2 balance and to modify the pancreatic microenvironment. Stem Cells. 2012 Aug;30(8):1664-74. doi: 10.1002/stem.1132.
- Ezquer F, Ezquer M, Simon V, Conget P. The antidiabetic effect of MSCs is not impaired by insulin prophylaxis and is not improved by a second dose of cells. PLoS One. 2011 Jan 27;6(1):e16566. doi: 10.1371/journal.pone.0016566.
- Ezquer FE, Ezquer ME, Parrau DB, Carpio D, Yanez AJ, Conget PA. Systemic administration of multipotent mesenchymal stromal cells reverts hyperglycemia and prevents nephropathy in type 1 diabetic mice. Biol Blood Marrow Transplant. 2008 Jun;14(6):631-40. doi: 10.1016/j.bbmt.2008.01.006. Epub 2008 Apr 14.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2012
Primary Completion (Anticipated)
March 1, 2017
Study Completion (Anticipated)
March 1, 2017
Study Registration Dates
First Submitted
August 27, 2016
First Submitted That Met QC Criteria
September 1, 2016
First Posted (Estimate)
September 8, 2016
Study Record Updates
Last Update Posted (Estimate)
September 8, 2016
Last Update Submitted That Met QC Criteria
September 1, 2016
Last Verified
September 1, 2016
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- DMT1-MSC
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Yes
IPD Plan Description
Data will be publish in a peer review journal
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.