Status:
UNKNOWN
Sequential Treatment of Extra-Corporeal Shock Wave Combined With aUtologous Bone marRow Mesenchymal Stem Cells on Patients With ischEmic Heart Disease : the S-CURE Study
Lead Sponsor:
Shanghai 10th People's Hospital
Conditions:
Ischemic Heart Disease
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
PHASE2
Brief Summary
This study is designed to evaluate the efficacy, safety and tolerability of autologous bone marrow derived mesenchymal stem cells compared to placebo (sham operation) when administered via percutaneou...
Eligibility Criteria
Inclusion
- Males and non-pregnant, non-lactating females;
- Chronic ischemic heart failure, previous anterior myocardial infarction \> 3months;
- Viable myocardium is detected by D-SPECT;
- LVEF \< 50% measured by echocardiography or NYHA II-IV;
- No planed reasonable revascularization procedures;
- At least 30 days standard medical therapy for heart failure before screening;
- Worsening heart failure within 6 months or have a NT-proBNP ≥1000 pg/mL or BNP ≥200 pg/mL within 30 days of screening (including screening); or have a 6-minute walk test (6MWT) distance of ≤425 meters at screening;
- Written informed consent.
Exclusion
- Ventricular thrombus;
- Myocardial infarction, TIA or stroke \< 3 months;
- CRT/CRT-D implantation, heart transplantation, cardiomyoplasty, left ventricular reduction surgery, heart failure-related device interventions, or cardiac shunt implantation;
- Active infection or fever;
- Chronic inflammatory disease;
- HIV infection or active hepatitis;
- Hemoglobin A1c (HbA1c) ≥ 9% at screening;
- Body mass index (BMI) ≥ 40 kg/m2 at screening;
- Chronic kidney disease (CKD) requiring dialysis (Stage 5) or estimated creatinine clearance \< 30 mL/min/1.73㎡ at screening;
- Allergies to any equine, porcine, or bovine products;
- Abnormal laboratory values at screening：Platelets \< 50,000 μL;Hemoglobin \< 9.0 g/dL; Aspartate aminotransferase/alanine aminotransferase (AST/ALT) \> 3 times the upper limit of normal (ULN);
- Pregnancy;
- Mental retardation;
- Participation in other clinical study \< 1 month.
Key Trial Info
Start Date :
April 3 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2022
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT03397095
Start Date
April 3 2018
End Date
April 1 2022
Last Update
August 28 2019
Active Locations (1)
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1
Shanghai Tenth People's Hospital, Tongji University
Shanghai, Shanghai Municipality, China, 200072