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
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 61
- 试验地点
- 18
- 主要终点
- Primary objective of the study is to assess the safety and tolerability of MPC therapy
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
Cohort 1
MPC dose 1 or Placebo
干预措施: Mesenchymal Precursor Cells (MPCs) (Drug)
Cohort 2
MPC dose 2 or Placebo
干预措施: Mesenchymal Precursor Cells (MPCs) (Drug)
Cohort 3
MPC dose 3 or Placebo
干预措施: Mesenchymal Precursor Cells (MPCs) (Drug)
结局指标
主要结局
Primary objective of the study is to assess the safety and tolerability of MPC therapy
时间窗: 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
次要结局
未报告次要终点