Stem Cell Therapy in IschEmic Non-treatable Cardiac Disease

NCT ID: NCT02673164

Last Updated: 2021-01-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 133 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-01-31
• Study Completion Date: 2020-12-31

Brief Summary

The aim of the SCIENCE study is, in an international multicentre double-blind placebo-controlled study, to investigate efficacy of direct intra-myocardial injection of 100 mio. allogeneic Cardiology Stem Cell Centre_adipose derived stem cells (CSCC_ASCs) in patients with reduced left ventricular Ejection Fraction (EF) (≤45%) and heart failure.

Detailed Description

The aim of the SCIENCE study is, in an international multicentre double-blind placebo-controlled study, to investigate efficacy of direct intra-myocardial injection of 100 mio. allogeneic Cardiology Stem Cell Centre_adipose derived stem cells (CSCC_ASCs) in patients with reduced left ventricular EF (≤45%) and heart failure.

The primary objective is to investigate the regenerative capacity of direct intra-myocardial injection of 100 mio. allogeneic CSCC_ASCs in patients with reduced left ventricular EF (≤45%) and heart failure in a double-blind placebo-controlled design.

A total of 138 patients with will be enrolled in the study and treated in a 2:1 randomization with either CSCC_ASC or placebo (saline).

Conditions

Heart Failure

Study Design

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

Study Groups

CSCC_ASC

Cardiology Stem Cell Centre\_adipose derived stem cells (CSCC\_ASC)

Group Type: ACTIVE_COMPARATOR

CSCC_ASC

Intervention Type: BIOLOGICAL

The stem cells will be injected directly into the myocardium using the NOGA XP system (BDS, US)

Placebo

Saline

Group Type: PLACEBO_COMPARATOR

CSCC_ASC

Intervention Type: BIOLOGICAL

The stem cells will be injected directly into the myocardium using the NOGA XP system (BDS, US)

Interventions

CSCC_ASC

The stem cells will be injected directly into the myocardium using the NOGA XP system (BDS, US)

Intervention Type: BIOLOGICAL

Other Intervention Names

Cardiology Stem Cell Centre_adipose derived stem cells

Eligibility Criteria

Inclusion Criteria

1. 30 to 80 years of age

2. Signed informed consent

3. Chronic stable ischemic heart disease

4. Symptomatic heart failure New York Heart Association (NYHA) class II-III

5. EF ≤ 45% on echocardiography, Computerized Tomography (CT) or Magnetic Resonances Imaging (MRI) scan

6. Plasma NT-pro-BNP > 300 pg/ml (> 35 pmol/L)

7. Maximal tolerable heart failure medication

8. Heart failure medication unchanged two months prior to inclusion. Changes in diuretics accepted.

9. No option for percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG)

10. Patients who have had PCI or CABG within six months of inclusion must have a new coronary angiography less than one month before inclusion or at least four months after the intervention to rule out early restenosis

11. Patients cannot be included until three months after implantation of a cardiac resynchronisation therapy device (CRTD) and until 1 month after an ICD unit

Exclusion Criteria

1. Heart Failure (NYHA class I or IV)

2. Acute coronary syndrome with acute reversible elevation of CKMB or troponins, stroke or transitory cerebral ischemia within six weeks of inclusion. Constant elevated troponin due to renal failure, heart failure etc. do not exclude the patient.

3. Other revascularisation treatment within four months of treatment

4. If clinically indicated the patient should have a coronary angiography before inclusion

5. Moderate to severe aortic stenosis (valve area < 1.3 cm2) or valvular disease with option for surgery or interventional therapy.

6. Aortic valve replacement with an artificial heart valve. However, a trans-septal treatment approach can be considered in these patients.

7. If the patient is expected to be candidate for MitraClip therapy of mitral regurgitation in the 12 months follow-up period.

8. Diminished functional capacity for other reasons such as: obstructive pulmonary disease (COPD) with forced expiratory volume (FEV) <1 L/min, moderate to severe claudication or morbid obesity

9. Clinical significant anaemia (haemoglobin < 6 mmol/L), leukopenia (leucocytes < 2 109/L), leucocytosis (leucocytes > 14 109/L) or thrombocytopenia (thrombocytes < 50 109/L)

10. Reduced kidney function (estimated Glomerular Filtration Rate (eGFR) < 30 ml/min)

11. Left ventricular thrombus

12. Anticoagulation treatment that cannot be paused during cell injections. Patients can continue with platelet inhibitor treatment

13. Patients with reduced immune response or known anti-HLA (human leukocyte antigen) antibodies

14. History with malignant disease within five years of inclusion or suspected malignity - except treated skin cancer other than melanoma

15. Pregnant women

16. Other experimental treatment within four weeks of baseline tests

17. Participation in another intervention trial

18. Life expectancy less than one year

19. Known hypersensitivity to Dimethyl sulfoxide (DMSO), penicillin and streptomycin

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

European Union

OTHER

Sponsor Role: collaborator

JKastrup

OTHER

Sponsor Role: lead

Responsible Party

JKastrup

MD Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Jens Kastrup, Professor MD

Role: PRINCIPAL_INVESTIGATOR

Rigshospitalet, Denmark

Locations

2014 Department of Cardiology, The Heart Centre, University Hospital Rigshospitalet

Copenhagen, , Denmark

Countries

Denmark

Other Identifiers

SCIENCE

Identifier Type: -

Identifier Source: org_study_id