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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 September 2016 |
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Main ID: |
NCT02893306 |
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Date of registration:
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27/08/2016 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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MSC Administration for the Management of Type 1 Diabetic Patients
DMT1-MSC |
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Scientific title:
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Phase 2 Study of Intravenous Administration of Allogeneic Mesenchymal Stem Cells in Patients With Type 1 Diabetes Mellitus. |
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Date of first enrolment:
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March 2012 |
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Target sample size:
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10 |
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Recruitment status: |
Active, not recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT02893306 |
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Study type:
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Interventional |
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Study design:
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Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 2
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Countries of recruitment
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Chile
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Contacts
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Name:
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Paulette Conget, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Universidad del Desarrollo |
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Name:
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Claudio Mizon, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Clinica Alemana de Santiago |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Type 1 Diabetes Mellitus
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Intervention(s)
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Biological: MSCs
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Primary Outcome(s)
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Changes in insulin pancreatic reserve
[Time Frame: pre- and 1, 6, 24 months post-intervention]
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Secondary Outcome(s)
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Changes in insulin requirement
[Time Frame: pre- and up to 24 months post-intervention]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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