MSC Administration for the Management of Type 1 Diabetic Patients
NCT ID: NCT02893306
Last Updated: 2016-09-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
10 participants
INTERVENTIONAL
2012-03-31
2017-03-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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DMT1+MSCs
type 1 diabetic patients receiving a single dose of allogeneic ex vivo expanded mesenchymal stem cells
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
Interventions
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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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* significant comorbidities
* HIV, HBV, HCV, HTLV-1, HLTV-2 or VDRL positive
18 Years
ALL
No
Sponsors
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Clinica Alemana de Santiago
OTHER
Universidad del Desarrollo
OTHER
Responsible Party
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Paulette Conget
Dr
Principal Investigators
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Paulette Conget, PhD
Role: PRINCIPAL_INVESTIGATOR
Universidad del Desarrollo
Claudio Mizon, MD
Role: PRINCIPAL_INVESTIGATOR
Clinica Alemana de Santiago
Locations
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Clinica Alemana de Santiago
Santiago, Santiago Metropolitan, Chile
Countries
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References
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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.
Other Identifiers
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DMT1-MSC
Identifier Type: -
Identifier Source: org_study_id
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