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

NCT ID: NCT03397095

Last Updated: 2019-08-28

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-04-03
• Study Completion Date: 2022-04-01

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.

Conditions

Ischemic Heart Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: EXPERIMENTAL

CSWT+BMMSCs

Intervention Type: COMBINATION_PRODUCT

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.

CSWT+Sham operation

Placebo group will receive a 3-month CSWT and a sham procedure.

Group Type: SHAM_COMPARATOR

CSWT+Sham operation

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: COMBINATION_PRODUCT

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.

Intervention Type: DEVICE

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai 10th People's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Ya-Wei Xu

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yawei Xu, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

Shanghai 10th People's Hospital

Locations

Shanghai Tenth People's Hospital, Tongji University

Shanghai, Shanghai Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Yuxi Sun

Role: CONTACT

zhggsmlsyx@163.com

+86 15216718171

Dachun Xu, MD,PhD

Role: CONTACT

xdc77@aliyun.com

+86 18917684045

Facility Contacts

Dachun Xu, MD,PhD

Role: primary

xdc77@aliyun.com

+86 18917684045

Yawei Xu, MD,PhD

Role: backup

xuyawei@tongji.edu.cn

+86 13916698181

References

Schachinger V, Erbs S, Elsasser A, Haberbosch W, Hambrecht R, Holschermann H, Yu J, Corti R, Mathey DG, Hamm CW, Suselbeck T, Assmus B, Tonn T, Dimmeler S, Zeiher AM; REPAIR-AMI Investigators. Intracoronary bone marrow-derived progenitor cells in acute myocardial infarction. N Engl J Med. 2006 Sep 21;355(12):1210-21. doi: 10.1056/NEJMoa060186.

Reference Type: BACKGROUND

PMID: 16990384 (View on PubMed)

Assmus B, Walter DH, Seeger FH, Leistner DM, Steiner J, Ziegler I, Lutz A, Khaled W, Klotsche J, Tonn T, Dimmeler S, Zeiher AM. Effect of shock wave-facilitated intracoronary cell therapy on LVEF in patients with chronic heart failure: the CELLWAVE randomized clinical trial. JAMA. 2013 Apr 17;309(15):1622-31. doi: 10.1001/jama.2013.3527.

Reference Type: BACKGROUND

PMID: 23592107 (View on PubMed)

Patel AN, Henry TD, Quyyumi AA, Schaer GL, Anderson RD, Toma C, East C, Remmers AE, Goodrich J, Desai AS, Recker D, DeMaria A; ixCELL-DCM Investigators. Ixmyelocel-T for patients with ischaemic heart failure: a prospective randomised double-blind trial. Lancet. 2016 Jun 11;387(10036):2412-21. doi: 10.1016/S0140-6736(16)30137-4. Epub 2016 Apr 5.

Reference Type: BACKGROUND

PMID: 27059887 (View on PubMed)

Bonow RO, Maurer G, Lee KL, Holly TA, Binkley PF, Desvigne-Nickens P, Drozdz J, Farsky PS, Feldman AM, Doenst T, Michler RE, Berman DS, Nicolau JC, Pellikka PA, Wrobel K, Alotti N, Asch FM, Favaloro LE, She L, Velazquez EJ, Jones RH, Panza JA; STICH Trial Investigators. Myocardial viability and survival in ischemic left ventricular dysfunction. N Engl J Med. 2011 Apr 28;364(17):1617-25. doi: 10.1056/NEJMoa1100358. Epub 2011 Apr 4.

Reference Type: BACKGROUND

PMID: 21463153 (View on PubMed)

Other Identifiers

S-CURE

Identifier Type: -

Identifier Source: org_study_id