Safety Study of Mesenchymal Precursor Cells in Type 2 Diabetes
- Registration Number
- NCT01576328
- Lead Sponsor
- Mesoblast, Ltd.
- Brief Summary
This study is being conducted to assess the overall safety and tolerability of a single intravenous infusion of three doses of Mesenchymal Precursor Cells versus Placebo in subjects with Type 2 Diabetes inadequately controlled on Metformin.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 61
- Male and female subjects who are ≥ 18 and ≤ 80 years old
- 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
Key
- Prior participation in any stem cell study
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Cohort 2 Mesenchymal Precursor Cells (MPCs) MPC dose 2 or Placebo Cohort 3 Mesenchymal Precursor Cells (MPCs) MPC dose 3 or Placebo Cohort 1 Mesenchymal Precursor Cells (MPCs) MPC dose 1 or Placebo
- Primary Outcome Measures
Name Time Method Primary objective of the study is to assess the safety and tolerability of MPC therapy 116 Weeks 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (18)
SC Clinical Research
🇺🇸Garden Grove, California, United States
Pennington Biomedical Research Center
🇺🇸Baton Rouge, Louisiana, United States
Big Sky Clinical Research
🇺🇸Butte, Montana, United States
Active Practices and Research
🇺🇸Newington, New Hampshire, United States
Dallas Diabetes and Endocrine Center
🇺🇸Dallas, Texas, United States
Providence Health Partners - Center for Clinical Reseach
🇺🇸Dayton, Ohio, United States
National Clinical Research - Norfolk, Inc
🇺🇸Norfolk, Virginia, United States
Capital Clinical Research Center
🇺🇸Olympia, Washington, United States
Desert Endocrinology Clinical Research Center-Henderson
🇺🇸Henderson, Nevada, United States
Diabetes Research Institute
🇺🇸Miami, Florida, United States
Compass Research
🇺🇸Orlando, Florida, United States
Tulane University Medical Center
🇺🇸New Orleans, Louisiana, United States
Alliance Against Diabetes/AAD Clinical Research
🇺🇸Las Vegas, Nevada, United States
The Carl and Edyth Lindner Center for Research and Education at The Christ Hospital
🇺🇸Cincinnati, Ohio, 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 - Richmond, Inc.
🇺🇸Richmond, Virginia, United States