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Stem Cell Therapy in IschEmic Non-treatable Cardiac Disease (SCIENCE)

This study is currently recruiting participants.
Verified March 2017 by JKastrup, Rigshospitalet, Denmark
Sponsor:
ClinicalTrials.gov Identifier:
NCT02673164
First Posted: February 3, 2016
Last Update Posted: March 21, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
European Union
Information provided by (Responsible Party):
JKastrup, Rigshospitalet, Denmark
  Purpose
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.

Condition Intervention Phase
Heart Failure Biological: CSCC_ASC Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Stem Cell Therapy in IschEmic Non-treatable Cardiac Disease - SCIENCE A European Multi-Centre Trial

Resource links provided by NLM:


Further study details as provided by JKastrup, Rigshospitalet, Denmark:

Primary Outcome Measures:
  • left ventricle end-systolic volume (LVESV) [ Time Frame: 6 months ]
    The primary endpoint is change in left ventricle end-systolic volume (LVESV) from baseline to 6 months follow-up measured by ECHO, MR and CT between CSCC_ASC and placebo treated


Secondary Outcome Measures:
  • Safety [ Time Frame: 6 months ]
    Incidence and severity of serious adverse events and suspected unrelated serious adverse events 12 months follow-up


Estimated Enrollment: 138
Actual Study Start Date: January 2017
Estimated Study Completion Date: April 2020
Estimated Primary Completion Date: April 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: CSCC_ASC
Cardiology Stem Cell Centre_adipose derived stem cells (CSCC_ASC)
Biological: CSCC_ASC
The stem cells will be injected directly into the myocardium using the NOGA XP system (BDS, US)
Other Name: Cardiology Stem Cell Centre_adipose derived stem cells
Placebo Comparator: Placebo
Saline
Biological: CSCC_ASC
The stem cells will be injected directly into the myocardium using the NOGA XP system (BDS, US)
Other Name: Cardiology Stem Cell Centre_adipose derived stem cells

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).

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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): NCT02673164


Contacts
Contact: Jens Kastrup, Professor MD +4535452819 jens.kastrup@regionh.dk

Locations
Denmark
2014 Department of Cardiology, The Heart Centre, University Hospital Rigshospitalet Recruiting
Copenhagen, Denmark, 2100
Contact: Jens Kastrup, MD DMSc    +4535452817    jens.kastrup@regionh.dk   
Principal Investigator: Jens Kastrup, MD DMSc         
Sponsors and Collaborators
JKastrup
European Union
Investigators
Principal Investigator: Jens Kastrup, Professor MD Rigshospitalet, Denmark
  More Information

Responsible Party: JKastrup, MD Professor, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT02673164     History of Changes
Other Study ID Numbers: SCIENCE
First Submitted: February 1, 2016
First Posted: February 3, 2016
Last Update Posted: March 21, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Data can be shared for Scientific collaboration

Keywords provided by JKastrup, Rigshospitalet, Denmark:
Heart failure
stem cell
adipose derived stem cell
Stem cell therapy
ischemic heart disease

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases