NCT02673164

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
133

participants targeted

Target at P50-P75 for phase_2 heart-failure

Timeline
Completed

Started Jan 2017

Longer than P75 for phase_2 heart-failure

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 1, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 3, 2016

Completed
11 months until next milestone

Study Start

First participant enrolled

January 1, 2017

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

January 19, 2021

Status Verified

January 1, 2021

Enrollment Period

3.9 years

First QC Date

February 1, 2016

Last Update Submit

January 15, 2021

Conditions

Heart Failure

Keywords

Heart failurestem celladipose derived stem cellStem cell therapyischemic heart disease

Outcome Measures

Primary Outcomes (1)

  • left ventricle end-systolic volume (LVESV)

    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

    6 months

Secondary Outcomes (1)

  • Safety - Serious adverse events

    6 months

Study Arms (2)

CSCC_ASC

ACTIVE COMPARATOR

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

Biological: CSCC_ASC

Placebo

PLACEBO COMPARATOR

Saline

Biological: CSCC_ASC

Interventions

CSCC_ASCBIOLOGICAL

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

Also known as: Cardiology Stem Cell Centre_adipose derived stem cells
CSCC_ASCPlacebo

Eligibility Criteria

Age30 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • to 80 years of age
  • Signed informed consent
  • Chronic stable ischemic heart disease
  • Symptomatic heart failure New York Heart Association (NYHA) class II-III
  • EF ≤ 45% on echocardiography, Computerized Tomography (CT) or Magnetic Resonances Imaging (MRI) scan
  • Plasma NT-pro-BNP \> 300 pg/ml (\> 35 pmol/L)
  • Maximal tolerable heart failure medication
  • No option for percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG)
  • Patients cannot be included until three months after implantation of a cardiac resynchronisation therapy device (CRTD) and until 1 month after an ICD unit

You may not qualify if:

  • Heart Failure (NYHA class I or IV)
  • Other revascularisation treatment within four months of treatment
  • Moderate to severe aortic stenosis (valve area \< 1.3 cm2) or valvular disease with option for surgery or interventional therapy.
  • Aortic valve replacement with an artificial heart valve. However, a trans-septal treatment approach can be considered in these patients.
  • If the patient is expected to be candidate for MitraClip therapy of mitral regurgitation in the 12 months follow-up period.
  • 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
  • Clinical significant anaemia (haemoglobin \< 6 mmol/L), leukopenia (leucocytes \< 2 109/L), leucocytosis (leucocytes \> 14 109/L) or thrombocytopenia (thrombocytes \< 50 109/L)
  • Reduced kidney function (estimated Glomerular Filtration Rate (eGFR) \< 30 ml/min)
  • Left ventricular thrombus
  • Anticoagulation treatment that cannot be paused during cell injections. Patients can continue with platelet inhibitor treatment
  • Patients with reduced immune response or known anti-HLA (human leukocyte antigen) antibodies
  • Pregnant women
  • Other experimental treatment within four weeks of baseline tests
  • Participation in another intervention trial
  • Life expectancy less than one year
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Copenhagen, 2100, Denmark

Location

MeSH Terms

Conditions

Heart FailureMyocardial Ischemia

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesVascular Diseases

Study Officials

  • Jens Kastrup, Professor MD

    Rigshospitalet, Denmark

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MD Professor

Study Record Dates

First Submitted

February 1, 2016

First Posted

February 3, 2016

Study Start

January 1, 2017

Primary Completion

December 1, 2020

Study Completion

December 1, 2020

Last Updated

January 19, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will share

Data can be shared for Scientific collaboration

Locations

DK(1)