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
|Condition or disease||Intervention/treatment||Phase|
|Type 1 Diabetes Mellitus||Biological: MSCs||Phase 2|
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 (Clinical Trial)|
|Actual Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
type 1 diabetic patients receiving a single dose of allogeneic ex vivo expanded mesenchymal stem cells
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
- 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
- Changes in insulin requirement [ Time Frame: pre- and up to 24 months post-intervention ]Daily dose of self-administered insulin
- 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
- 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
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
|Clinica Alemana de Santiago|
|Santiago, Region Metropolitana, Chile|
|Principal Investigator:||Paulette Conget, PhD||Universidad del Desarrollo|
|Principal Investigator:||Claudio Mizon, MD||Clinica Alemana de Santiago|