Safety Study of Mesenchymal Precursor Cells in Type 2 Diabetes
Status: | Completed |
---|---|
Conditions: | Diabetes |
Therapuetic Areas: | Endocrinology |
Healthy: | No |
Age Range: | 18 - 80 |
Updated: | 4/17/2018 |
Start Date: | April 2012 |
End Date: | October 2015 |
A Randomized, Placebo-Controlled Dose-Escalation Study to Assess the Safety and Tolerability of a Single Intravenous Infusion of Allogeneic Mesenchymal Precursor Cells (MPCs) in Patients With Type 2 Diabetes Sub-optimally Controlled on Metformin
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.
intravenous infusion of three doses of Mesenchymal Precursor Cells versus Placebo in subjects
with Type 2 Diabetes inadequately controlled on Metformin.
Key Inclusion Criteria:
- 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 Exclusion Criteria:
- 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.
We found this trial at
18
sites
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Compass Research LLC Compass Research is a clinical research company dedicated to testing new medications...
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Pennington Biomedical Research Center Unlike other medical research facilities where science occurs in separate labs...
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Cincinnati, Ohio 45219
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