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| Name | Class |
|---|---|
| Clinica Alemana de Santiago | OTHER |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DMT1+MSCs | Experimental | type 1 diabetic patients receiving a single dose of allogeneic ex vivo expanded mesenchymal stem cells |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MSCs | Biological | 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in insulin requirement | Daily dose of self-administered insulin | pre- and up to 24 months post-intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients with grade 3 through grade 5 adverse events (CTCAE v3.0) | Review of patient clinical records | up to 24 months post-intervention |
| Number of patients with grade 3 through grade 5 adverse events (CTCAE v3.0) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Paulette Conget, PhD | Universidad del Desarrollo | Principal Investigator |
| Claudio Mizon, MD | Clinica Alemana de Santiago | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinica Alemana de Santiago | Santiago | Santiago Metropolitan | Chile |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22644660 | Background | 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. | |
| 21304603 |
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Data will be publish in a peer review journal
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| D007333 | Insulin Resistance |
| D018450 | Disease Progression |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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Regular communication with patient and his/her physician in order to be informed of eventual complications
| up to 24 months post-intervention |
| 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. |
| 18489988 | Background | 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. |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D006946 | Hyperinsulinism |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |