NCT03092284

Brief Summary

The present aim is to perform at clinical double-blind placebo-controlled Cardiology Stem Cell Centre - Adipose Stem Cells (CSCC\_ASC) study in heart failure patients to investigate the regenerative capacity of the CSCC\_ASC treatment.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
81

participants targeted

Target at P50-P75 for phase_2 heart-failure

Timeline
Completed

Started Sep 2015

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

July 20, 2015

Completed
1 month until next milestone

Study Start

First participant enrolled

September 1, 2015

Completed
1.6 years until next milestone

First Posted

Study publicly available on registry

March 27, 2017

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2021

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2022

Completed
Last Updated

September 6, 2022

Status Verified

September 1, 2022

Enrollment Period

5.8 years

First QC Date

July 20, 2015

Last Update Submit

September 2, 2022

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (1)

  • change in left ventricle end-systolic volume (LVESV) from base line to 6 months follow-up measured by echocardiography and computerized tomography

    change in left ventricle end-systolic volume (LVESV) from base line to 6 months follow-up measured by echocardiography and computerized tomography

    6 months

Secondary Outcomes (8)

  • Incidence of Treatment-Emergent Adverse Events

    12 months

  • Efficacy left ventricle

    6 months

  • Efficacy clinical function assessed by change in Kansas City Cardiomyopathy Questionnaire (KCCQ) from baseline to 6 months follow-up

    6 months

  • Efficacy clinical function assessed by change in Seattle Angina Questionnaire and 6 min walking test from baseline to 6 months follow-up

    6 months

  • Efficacy clinical function assessed by change in 6 min walking test from baseline to 6 months follow-up

    6 months

  • +3 more secondary outcomes

Study Arms (2)

Cardiology Stem Cell Centre Adipose Stem Cell (CSCC_ASC)

ACTIVE COMPARATOR

Allogeneic adipose derived stromal cells

Biological: Cardiology Stem Cell Centre Adipose Stem Cell (CSCC_ASC)

Placebo

PLACEBO COMPARATOR

Saline

Biological: Placebo

Interventions

Cardiology Stem Cell Centre Adipose Stem Cell (CSCC_ASC)BIOLOGICAL

Direct intramyocardial injection of CSCC\_ASC

Cardiology Stem Cell Centre Adipose Stem Cell (CSCC_ASC)
PlaceboBIOLOGICAL

Saline

Placebo

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%
  • Plasma NT-pro-BNP \> 300 pg/ml (\> 35 pmol/L) in sinus rhythm and plasma NT-pro-BNP \> 422 pg/ml (\> 450 pmol/L) in patients with atrial fibrillation
  • 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

You may not qualify if:

  • Heart Failure (NYHA I or IV)
  • Other revascularisation treatment within four months of treatment
  • Moderate to severe aortic stenosis (valve area \< 1.3 mm2) or valvular disease with option for surgery.
  • 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)
  • Anticoagulation treatment that cannot be paused during cell injections
  • Patients with reduced immune response
  • Pregnant women
  • Other experimental treatment within four weeks of baseline tests
  • Participation in another intervention trial

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cardiac Catheterization Laboratory 2014, The Heart Centre, University Hospital, Rigshospitalet

Copenhagen Ø, 2100, Denmark

Location

Related Publications (1)

  • Qayyum AA, Mouridsen M, Nilsson B, Gustafsson I, Schou M, Nielsen OW, Hove JD, Mathiasen AB, Jorgensen E, Helqvist S, Joshi FR, Johansen EM, Follin B, Juhl M, Hojgaard LD, Haack-Sorensen M, Ekblond A, Kastrup J. Danish phase II trial using adipose tissue derived mesenchymal stromal cells for patients with ischaemic heart failure. ESC Heart Fail. 2023 Apr;10(2):1170-1183. doi: 10.1002/ehf2.14281. Epub 2023 Jan 13.

    PMID: 36638837DERIVED

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Jens Kastrup, Professor MD

    Rigshospitalet, Denmark

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor Chief Physician

Study Record Dates

First Submitted

July 20, 2015

First Posted

March 27, 2017

Study Start

September 1, 2015

Primary Completion

July 1, 2021

Study Completion

July 1, 2022

Last Updated

September 6, 2022

Record last verified: 2022-09

Data Sharing

IPD Sharing
Will share

Data can be share for scientific collaboration

Locations

DK(1)