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Clinical Trial Details

Trial ID: L3122
Source ID: NCT00690066
Associated Drug: Prochymal®
Title: PROCHYMAL® (Human Adult Stem Cells) for the Treatment of Recently Diagnosed Type 1 Diabetes Mellitus (T1DM)
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Type 1 Diabetes Mellitus|Type 1 Diabetes|Diabetes Mellitus, Insulin-Dependent|Juvenile Diabetes
Interventions: DRUG: PROCHYMAL®|DRUG: Placebo
Outcome Measures: Primary: C-peptide area under the concentration curve (AUC) response (MMTT), 1 year | Secondary: Peak C-peptide response (MMTT), 2 years|Basal C-peptide response, 2 years|Total daily insulin dose (units/kg), 2 years|Glycosylated hemoglobin (HbA1c) levels, 2 years|Number of severe and documented hypoglycemic events, 2 years|Changes in levels of glutamic acid decarboxylase (GAD) or islet antigen 2 (IA-2) autoantibodies, 2 years
Sponsor/Collaborators: Sponsor: Mesoblast, Inc. | Collaborators: Juvenile Diabetes Research Foundation
Gender: ALL
Age: CHILD, ADULT
Phases: PHASE2
Enrollment: 63
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2008-06-11
Completion Date: 2011-12-19
Results First Posted:
Last Update Posted: 2021-12-23
Locations: University of Alabama, Division of Endocrinology & Metabolism, Birmingham, Alabama, 35294, United States|Scripps Whittier Diabetes Institute, La Jolla, California, 92037, United States|Stanford University, Stanford, California, 94305, United States|University of Florida, Gainesville, Florida, 32610, United States|Diabetes Research Institute, Miami, Florida, 33136, United States|University of Kentucky, Lexington, Kentucky, 40502, United States|University of Minnesota, Minneapolis, Minnesota, 55455, United States|Desert Endocrinology CRC, Henderson, Nevada, 89052, United States|Nevada Alliance Against Diabetes, Las Vegas, Nevada, 89101, United States|University of North Carolina Diabetes Care Center, Chapel Hill, North Carolina, 27599, United States|American Health Research, Inc., Charlotte, North Carolina, 28207, United States|The Lindner Clinical Trial Center, Cincinnati, Ohio, 45219, United States|Providence Health Partners - Center for Clinical Research, Dayton, Ohio, 45439, United States|Cumberland Valley Endocrinology, Carlisle, Pennsylvania, 17015, United States|AM Diabetes & Endocrinology Center, Bartlett, Tennessee, 38133, United States|The University of Texas Southwestern Medical Center, Dallas, Texas, 75390, United States|Optimum Clinical Research, Inc., Salt Lake City, Utah, 84102, United States|The Strelitz Diabetes Center, Eastern VA Medical School, Norfolk, Virginia, 23510, United States|University of Wisconsin Health- West Clinic, Madison, Wisconsin, 53717, United States|Clinical and Transitional Science Institute, Milwaukee, Wisconsin, 53226, United States
URL: https://clinicaltrials.gov/show/NCT00690066

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress