Clinical Trial Details
| Trial ID: | L6415 |
| Source ID: | NCT01576328 |
| Associated Drug: | Mesenchymal Precursor Cells (Mpcs) |
| Title: | Safety Study of Mesenchymal Precursor Cells in Type 2 Diabetes |
| Acronym: | |
| Status: | COMPLETED |
| Study Results: | NO |
| Results: | |
| Conditions: | Type 2 Diabetes |
| Interventions: | DRUG: Mesenchymal Precursor Cells (MPCs)|DRUG: Mesenchymal Precursor Cells (MPCs)|DRUG: Mesenchymal Precursor Cells (MPCs) |
| Outcome Measures: | Primary: Primary objective of the study is to assess the safety and tolerability of MPC therapy, Outcomes include the measurement of the following safety parameters: * Adverse events and serious adverse events(including hypoglycemia) * Vital signs (BP, HR, RR, O2 saturation) * Physical examinations * Results of clinical laboratory tests (hematology, biochemistry, and urinalysis, flow cytometry Class I and Class II PRA % with specificity, antibovine and antimurine antibody analysis) * Pulmonary function test * Electrocardiograms * Chest X-ray * Fundus oculi examination, 116 Weeks | |
| Sponsor/Collaborators: | Sponsor: Mesoblast, Ltd. |
| Gender: | ALL |
| Age: | ADULT, OLDER_ADULT |
| Phases: | PHASE1|PHASE2 |
| Enrollment: | 61 |
| Study Type: | INTERVENTIONAL |
| Study Designs: | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT |
| Start Date: | 2012-04 |
| Completion Date: | 2015-10 |
| Results First Posted: | |
| Last Update Posted: | 2020-06-02 |
| Locations: | SC Clinical Research, Garden Grove, California, 92844, United States|Diabetes Research Institute, Miami, Florida, 33136, United States|Compass Research, Orlando, Florida, 32806, United States|Pennington Biomedical Research Center, Baton Rouge, Louisiana, 70808, United States|Tulane University Medical Center, New Orleans, Louisiana, 70112, United States|Big Sky Clinical Research, Butte, Montana, 59701, United States|Desert Endocrinology Clinical Research Center-Henderson, Henderson, Nevada, 89052, United States|Alliance Against Diabetes/AAD Clinical Research, Las Vegas, Nevada, 89101, United States|Active Practices and Research, Newington, New Hampshire, 03801, United States|The Carl and Edyth Lindner Center for Research and Education at The Christ Hospital, Cincinnati, Ohio, 45219, United States|Providence Health Partners - Center for Clinical Reseach, Dayton, Ohio, 45439, United States|Dallas Diabetes and Endocrine Center, Dallas, Texas, 75230, United States|West Houston Clinical Research Services, Houston, Texas, 77055, United States|Paragon Research Center, San Antonio, Texas, 78205, United States|Wasatch Clinical Research, Salt Lake City, Utah, 84107, United States|National Clinical Research - Norfolk, Inc, Norfolk, Virginia, 23502, United States|National Clinical Research - Richmond, Inc., Richmond, Virginia, 23294, United States|Capital Clinical Research Center, Olympia, Washington, 98502, United States |
| URL: | https://clinicaltrials.gov/show/NCT01576328 |
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