Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Mesoblast, Ltd.
Age
18–80
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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.
Clareo Health | Safety Study of Mesenchymal Precursor Cells in Type 2 Diabetes
