A Phase II, Open-Label Safety and Tolerability Study of an Renal Autologous Cell Therapy (REACT) in Patients With Type 2 Diabetes and Chronic Kidney Disease (REGEN-003)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Prokidney
- 入组人数
- 10
- 试验地点
- 4
- 主要终点
- Procedure and/or Product Related Adverse Events
研究概览
简要总结
The purpose of the present study is to assess the safety and efficacy of up to 2 injections of REACT given 6 months (+4 weeks) apart (maximum).
详细描述
All subjects enrolled will receive REACT. Subjects will receive their first REACT injection as soon as the REACT product is manufactured and shipped to the clinical site. After 6 months (+4 weeks), a second injection will be given, as appropriate. Each subject's baseline rate of renal decline, based on adequate historical clinical data obtained 24 months prior to screening visit, will serve as a comparator for monitoring the rate of progression of renal insufficiency over time.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
盲法说明
Open label
入排标准
- 年龄范围
- 30 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The subject is male or female, 30 to 65 years of age on the date of informed consent.
- •The subject has an established diagnosis of T2DM.
- •The subject has an established diagnosis of diabetic nephropathy as the underlying cause of renal disease.
- •The subject has an established diagnosis of CKD not requiring renal dialysis, defined as having an eGFR between 14 and 20 mL/min/1.73m² inclusive at the Screening Visit and prior to REACT injection.
- •The subject has blood pressure less than 150/90 at the Screening Visit, prior to renal biopsy, and prior to REACT injection(s). Note BP should not be significantly below the previously recorded stable pressure.
- •A minimum of 3 measurements of eGFR or sCr should be obtained at least 3 months apart prior to the Screening Visit or within the previous 24 months to define the rate of progression of CKD. The subject should have adequate, historical clinical data to provide a reasonable estimate of the rate of progression of CKD. The Medical Monitor may be consulted to ensure there is sufficient data.
排除标准
- •The subject has a history of type 1 diabetes mellitus.
- •The subject has a history of renal transplantation.
- •The subject has a serum HbA1c level greater than 10% at the Screening Visit.
- •The subject has uncontrolled diabetes (defined as metabolically unstable by the Investigator).
- •The subject has hemoglobin levels less than 9 g/dL prior to each REACT injection.
研究组 & 干预措施
Renal Autologous Cell Therapy (REACT)
Renal Autologous Cell Therapy (REACT) Treatment - Patients will receive their first treatment of 2 injections of REACT as soon as REACT product is made available.
干预措施: Renal Autologous Cell Therapy (REACT) (Biological)
结局指标
主要结局
Procedure and/or Product Related Adverse Events
时间窗: Through 24 months following last REACT injection
Percentage of subjects with procedures and/or product related adverse events by System Organ Class and Preferred Term
次要结局
- Renal Specific Adverse Events(Through 24 months following last REACT injection)