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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 (S-CURE)

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ClinicalTrials.gov Identifier: NCT03397095
Recruitment Status : Recruiting
First Posted : January 11, 2018
Last Update Posted : August 13, 2018
Sponsor:
Information provided by (Responsible Party):
Ya-Wei Xu, Shanghai 10th People's Hospital

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 percutaneous coronary infusion to patients with ischemic heart disease, who are screened by D-SPECT and have pretreated with 3-month cardiac shock wave therapy.

Condition or disease Intervention/treatment Phase
Ischemic Heart Disease Combination Product: CSWT+BMMSCs Device: CSWT+Sham operation Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: S-CURE study has a two-stage design. Stage 1 is an open-labled, lead-in study. 20 participants will be enrolled in this stage. It is conducted to assess the feasibility and safety of the study procedures as well as the bioactivity of the products. Stage 2 is an randomized, placebo controlled study, 100 participants will be enrolled in this stage.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Sequential Treatment of Extra-Corporeal Shock Wave Combined With aUtologous Bone marRow Mesenchymal Stem Cells in Patients With ischEmic Heart Disease : the S-CURE Study
Actual Study Start Date : April 3, 2018
Estimated Primary Completion Date : June 1, 2019
Estimated Study Completion Date : April 1, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: CSWT+BMMSCs
Patients in CSWT+BMMSCs group will receive a 3-month cardiac shock wave therapy and then a total of 1 million/kg BMMSCs will be infused using the stop-flow technique through an over-the-wire balloon catheter positioned in a coronary artery or bypass graft supplying the targeting viable myocardium.
Combination Product: CSWT+BMMSCs
All participants will screened by D-SPECT to assess the myocardium viability. If the viable myocardium is detected, Patients will be randomized to receive cardiac shock wave therapy with an equipment (Modulith SLC; Storz Medical, Switzerland) followed the recommended protocol developed by Tohoku University of Japan and the protocol developed by the University of Essen, Germany. An over-the-wire catheter will be positioned in the target coronary artery and the cells resuspended in saline will be injected intracoronary.

Sham Comparator: CSWT+Sham operation
Placebo group will receive a 3-month CSWT and a sham procedure.
Device: CSWT+Sham operation
Patients randomized to this group will receive a routine cardiac shock wave therapy and coronary angiography. No cells will be administered via the coronary artery.




Primary Outcome Measures :
  1. Change from baseline to 6 months follow-up in LVEF. [ Time Frame: 6 months ]
    The primary outcome will evaluate the change in left ventricular function as measured by echocardiography and D-SPECT for left ventricular ejection fraction (LVEF).

  2. Change from baseline to 6 months follow-up in infarct size. [ Time Frame: 6 months ]
    The primary outcome will evaluate the change in infarct size as measured by D-SPECT.


Secondary Outcome Measures :
  1. Change from baseline to 6 months follow-up in exercise distance increment [ Time Frame: 6 months ]
    A secondary objective will be the changes from baseline to 6 months post-treatment in the distance walked as measured by the 6-minute walk test.

  2. Change from baseline to 6 months follow-up in quality of life measured by MLHFQ [ Time Frame: 6 months ]
    A secondary objective will be the change in quality of life in patients treated with bone marrow derived mesenchymal stem cells compared to placebo using the Minnesota Living with Heart Failure Questionnaire (MLHFQ).

  3. Change from baseline to 6 months follow-up in NYHA Classification. [ Time Frame: 6 months ]
    A secondary objective will be the change from baseline to Month 6 in NYHA Classification in patients treated with BMMSCs compared to placebo.

  4. Percent of patients with adverse events. [ Time Frame: 6 months ]
    A secondary objective will be the overall safety and tolerability of BMMSCs versus placebo in patients with ICM from time of cell-infusion through 6 months post-treatment follow-up by the percentage of patients with adverse events.

  5. Change from baseline to 6 months follow-up in exercise time increment. [ Time Frame: 6 months ]
    A secondary objective will be the changes from baseline to 6 months post-treatment in the exercise time as measured by the cardiopulmonary exercise test.

  6. Change from baseline to 6 months follow-up in quality of life measured by KCCQ [ Time Frame: 6 months ]
    A secondary objective will be the change in quality of life in patients treated with bone marrow derived mesenchymal stem cells compared to placebo using the Kansas City Cardiomyopathy Questionnaire (KCCQ).


Other Outcome Measures:
  1. Percent of patients with major adverse cardiac events (MACE) [ Time Frame: 6 months ]
    A secondary objective will be the overall safety and tolerability of BMMSCs versus placebo in patients with ICM by the percentage of patients who experience MACE events. MACE events include: unstable angina requiring hospitalization, myocardial infarction, stroke, worsening heart failure requiring hospitalization, VAD implantation, heart transplant, resuscitated sudden death, and cardiovascular death.

  2. Average number of clinical events over 12 months post-treatment [ Time Frame: 12 months ]
    A secondary outcome will assess the efficacy of BMMSc compared to placebo on the average number of events per patient over 12 months post-treatment in each treatment arm (total number events in each arm/total number of patients in each arm). The events include: all-cause deaths, cardiovascular hospitalizations, and unplanned outpatient or emergency department visits to treat acute decompensated heart failure. The clinical events used in this endpoint will be adjudicated by an independent clinical endpoint committee who are blinded to treatment.



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Males and non-pregnant, non-lactating females;
  2. Chronic ischemic heart failure, previous anterior myocardial infarction > 3months;
  3. Viable myocardium is detected by D-SPECT;
  4. LVEF < 50% measured by echocardiography or NYHA II-IV;
  5. No planed reasonable revascularization procedures;
  6. At least 30 days standard medical therapy for heart failure before screening;
  7. 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;
  8. Written informed consent.

Exclusion Criteria:

  1. Ventricular thrombus;
  2. Myocardial infarction, TIA or stroke < 3 months;
  3. CRT/CRT-D implantation, heart transplantation, cardiomyoplasty, left ventricular reduction surgery, heart failure-related device interventions, or cardiac shunt implantation;
  4. Active infection or fever;
  5. Chronic inflammatory disease;
  6. HIV infection or active hepatitis;
  7. Hemoglobin A1c (HbA1c) ≥ 9% at screening;
  8. Body mass index (BMI) ≥ 40 kg/m2 at screening;
  9. Chronic kidney disease (CKD) requiring dialysis (Stage 5) or estimated creatinine clearance < 30 mL/min/1.73㎡ at screening;
  10. Allergies to any equine, porcine, or bovine products;
  11. 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);
  12. Pregnancy;
  13. Mental retardation;
  14. Participation in other clinical study < 1 month.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03397095


Contacts
Contact: Yuxi Sun +86 15216718171 zhggsmlsyx@163.com
Contact: Dachun Xu, MD,PhD +86 18917684045 xdc77@aliyun.com

Locations
China, Shanghai
Shanghai Tenth People's Hospital, Tongji University Recruiting
Shanghai, Shanghai, China, 200072
Contact: Dachun Xu, MD,PhD    +86 18917684045    xdc77@aliyun.com   
Contact: Yawei Xu, MD,PhD    +86 13916698181    xuyawei@tongji.edu.cn   
Sponsors and Collaborators
Shanghai 10th People's Hospital
Investigators
Principal Investigator: Yawei Xu, MD,PhD Shanghai 10th People's Hospital

Publications:

Responsible Party: Ya-Wei Xu, Professor, Shanghai 10th People's Hospital
ClinicalTrials.gov Identifier: NCT03397095     History of Changes
Other Study ID Numbers: S-CURE
First Posted: January 11, 2018    Key Record Dates
Last Update Posted: August 13, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Ya-Wei Xu, Shanghai 10th People's Hospital:
stem cells, ischemic heart disease.

Additional relevant MeSH terms:
Ischemia
Heart Diseases
Myocardial Ischemia
Coronary Artery Disease
Pathologic Processes
Cardiovascular Diseases
Vascular Diseases
Coronary Disease
Arteriosclerosis
Arterial Occlusive Diseases