Safety Study of Mesenchymal Precursor Cells in Type 2 Diabetes
NCT ID: NCT01576328
Last Updated: 2020-06-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1/PHASE2
61 participants
INTERVENTIONAL
2012-04-30
2015-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Cohort 1
MPC dose 1 or Placebo
Mesenchymal Precursor Cells (MPCs)
Single intravenous infusion of MPCs Dose 1
Cohort 2
MPC dose 2 or Placebo
Mesenchymal Precursor Cells (MPCs)
Single intravenous infusion of MPCs Dose 2
Cohort 3
MPC dose 3 or Placebo
Mesenchymal Precursor Cells (MPCs)
Single intravenous infusion of MPCs Dose 3
Interventions
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Mesenchymal Precursor Cells (MPCs)
Single intravenous infusion of MPCs Dose 1
Mesenchymal Precursor Cells (MPCs)
Single intravenous infusion of MPCs Dose 2
Mesenchymal Precursor Cells (MPCs)
Single intravenous infusion of MPCs Dose 3
Eligibility Criteria
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Inclusion Criteria
* Subjects diagnosed with type 2 diabetes at least one year prior to Screening and receiving a stable, therapeutic dose of metformin \> 1500 mg/day according to local prescribing information for at least 3 months prior to Screening or the highest tolerated dose \> 1000 mg/day documented in the subject's history
* HbA1c \> 7.0% and \< 10.5% at Screening
* C-peptide \> 0.8 ng/mL at Screening
* Body mass index (BMI) \> 22 and \< 45 kg/m2 at Screening
* Body weight \< 150 kg at Screening
Exclusion Criteria
* Women who are pregnant, intending to become pregnant during the study period or currently lactating
* History of active substance abuse (including alcohol) within the past 2 years. Current alcohol abuse is defined as daily consumption of \>3 alcoholic beverage. Current cigarette smoking \> 10 cigarettes per day
* Severe hypoglycemia (defined as requiring third party assistance) or repeated and/or frequent hypoglycemia episodes (\> 2 episodes/week) within one month prior to Screening
* Patients receiving treatment for type 2 diabetes with diet and exercise alone, insulin therapy within 6 months of Screening except if used transiently for \< 7 days for intercurrent illness or any other anti-diabetic medication except metformin within 3 months of Screening
* Any concurrent medical condition/disorder or clinically symptomatic cardiovascular, gastrointestinal (including pancreatitis), renal, hematological, pulmonary, acute or chronic infectious disease, active retinal disease, or other disorder which in the Investigator's opinion would interfere with the subject's ability to complete the trial, would require administration of treatment that could affect the interpretation of the safety and efficacy variables or would preclude safe involvement in the study.
18 Years
80 Years
ALL
No
Sponsors
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Mesoblast, Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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K Segal, PhD
Role: STUDY_DIRECTOR
Mesoblast, Ltd.
Locations
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SC Clinical Research
Garden Grove, California, United States
Diabetes Research Institute
Miami, Florida, United States
Compass Research
Orlando, Florida, United States
Pennington Biomedical Research Center
Baton Rouge, Louisiana, United States
Tulane University Medical Center
New Orleans, Louisiana, United States
Big Sky Clinical Research
Butte, Montana, United States
Desert Endocrinology Clinical Research Center-Henderson
Henderson, Nevada, United States
Alliance Against Diabetes/AAD Clinical Research
Las Vegas, Nevada, United States
Active Practices and Research
Newington, New Hampshire, United States
The Carl and Edyth Lindner Center for Research and Education at The Christ Hospital
Cincinnati, Ohio, United States
Providence Health Partners - Center for Clinical Reseach
Dayton, Ohio, United States
Dallas Diabetes and Endocrine Center
Dallas, Texas, United States
West Houston Clinical Research Services
Houston, Texas, United States
Paragon Research Center
San Antonio, Texas, United States
Wasatch Clinical Research
Salt Lake City, Utah, United States
National Clinical Research - Norfolk, Inc
Norfolk, Virginia, United States
National Clinical Research - Richmond, Inc.
Richmond, Virginia, United States
Capital Clinical Research Center
Olympia, Washington, United States
Countries
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References
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Skyler JS, Fonseca VA, Segal KR, Rosenstock J; MSB-DM003 Investigators. Allogeneic Mesenchymal Precursor Cells in Type 2 Diabetes: A Randomized, Placebo-Controlled, Dose-Escalation Safety and Tolerability Pilot Study. Diabetes Care. 2015 Sep;38(9):1742-9. doi: 10.2337/dc14-2830. Epub 2015 Jul 7.
Other Identifiers
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MSB-DM003
Identifier Type: -
Identifier Source: org_study_id
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