CTRI/2020/02/023109尚未招募1 期
A prospective, open label, two arm, phase I clinical study to evaluate the safety and efficacy of R-HSC-010 in patients with chronic kidney disease
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Incidence of adverse events occurring during the study
研究概览
简要总结
This is a prospective, open label, two arm, phase I clinical study to evaluate the safety and efficacy of R-HSC-010 in patients with chronic kidney disease. The primary purpose of this study is to check if the UCMSC (Stem Cells) are effective and Safe at given doses in patients with CKD. Study hypothesis is that stem cells will decrease the severity of CKD from stage III to stage II or Stage I.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Must be able to give voluntary written informed consent
- •Age 18 to 65 years
- •BMI between 18-30 kg/m2
- •Patients with stage III chronic kidney disease
- •Subjects with moderate to severe albuminuria ≥30 mg/g (≥3 mg/mmol)
- •Proteinuria >1 gm/day
- •Subjects should have LVEF > 45% as confirmed by 2D –ECHO
- •Patient should be afebrile 24 hours prior to procedure
- •Serum glutamic oxaloacetic transaminase (SGOT), serum glutamic pyruvic transaminase (SGPT) and total bilirubin <2 times upper limit of normal (ULN)
- •Females of childbearing potential must have negative serum pregnancy test at screening and agree to use adequate contraception throughout the study period.
排除标准
- •Patients with Acute Renal Failure
- •Severe co-morbidities like cardiac insufficiency, congestive cardiac failure, malignancy, infection, sepsis and bed sores or any other condition which will contraindicate the use of study treatment or procedures
- •Chronic kidney disease due to autoimmune etiology, connective tissue disease, amyloidosis and storage disorders
- •Haemoglobin less than 9 gm/dl
- •Uncontrolled Diabetes mellitus with HbA1C ≥ 8.0%
- •Patients with HIV, HBsAg and HCV test positive
- •Known bleeding or coagulation disorder
- •Known hematologic disease
- •Evidence of active malignancy within one year prior to IP administration
- •Severe skin infection or osteomyelitis
- •Pregnant or breast feeding, or planning to become pregnant during study period
- •Presence of ongoing local or systemic infection
- •Subjects judged by the investigator to be at significant risk of failing to comply with the requirements of the protocol
- •Treatment with an investigational product within 1 year prior to trial entry
- •Uncontrolled hypertension (systolic blood pressure >140 mmHg and diastolic blood pressure > 90 mmHg)
- •Participation in any other clinical trial over the past 1 year.
结局指标
主要结局
Incidence of adverse events occurring during the study
时间窗: Day 0, 1 Month, 3 Month, 6 Month, 9 month and 12 Month
次要结局
- Decrease in chronic kidney disease stage (from stage III to II or I) as per KDIGO guidelines at all post-therapy study visits(Day 0, 1 Month, 3 Month, 6 Month, 9 month and 12 Month)
研究者
研究点 (1)
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