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CompletedNCT02672163Updated Mar 5, 2020

Autologous Atrial Appendage Derived Cells in the Treatment of Heart Failure

An interventional study of CABG surgery and AADC therapy in Heart Failure, sponsored by Helsinki University Central Hospital. Completed at 1 site in Finland. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2020-03-05.

Sponsored by Helsinki University Central Hospital · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
36
Allocation
Non-randomized
Ages
18 Years to 75 Years
Sex
All
01

Study summary

This study aims to evaluate the safety and clinical feasibility of epicardially delivered autologous atrial appendage micrografts in the treatment of heart failure. The micrografts consisting atrial-derived cells and their extracellular matrix, are placed on an infarction scar during CABG surgery.

Read the detailed description

The atrial appendages are a tissue reservoir for cardiomyocyte stem and precursor cells. During coronary artery bypass graft (CABG) surgery part of the right atrial appendage can be excised upon insertion of the right atrial cannula of the heart-lung machine. This study aims to address the surgical feasibility and patient safety of epicardially delivered atrial appendage micrografts during CABG surgery.

Autologous cardiac cells are harvested from right atrial appendage during CABG of six patients. Micrografts consisting atrial appendage-derived cells (AADCs) and their extracellular matrix (ECM) of the atrial appendage are mechanically processed. The cells are placed on a tissue-engineered sheet with fibrin gel and tissue clue and further delivered epicardially on top of a infarction scar. Parameters including echocardiography reflecting cardiac insufficiency are studied pre- and post-operatively as well as at three and six months of the follow-up. Cardiac functional magnetic resonance imaging is performed preoperatively and at six-months follow-up. 20 patients will be recruited to serve as a control group. They are scheduled for elective CABG and are treated according to the normal hospital protocol, without the ECM sheet.

02

Conditions studied

  • Heart Failure

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Keywords

  • autologous micrografts
  • heart failure
  • coronary artery bypass surgery
  • cell therapy
  • atrial appendage
  • epicardial cell delivery
03

In context

Heart Failure

5,701 studies on the registry are indexed under Heart Failure; 1,220 are open to participants now.

This study's enrollment of 36 is below the median of 72 across 3,736 interventional studies indexed under Heart Failure.

Browse Heart Failure studies →

Lead sponsor

Helsinki University Central Hospital is the lead sponsor of 299 studies on the registry; 60 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Informed consent obtained
  • Left ventricular ejection fraction (LVEF) between ≤50% and ≥15%
  • New York Heart Association (NYHA) Class II-IV heart failure symptoms

Exclusion criteria

Exclusion Criteria:

  • Heart failure due to left ventricular outflow tract obstruction
  • History of life-threatening and possibly repeating ventricular arrhythmias or resuscitation, or an implantable cardioverter-defibrillator
  • Stroke or other disabling condition within 3 months before screening
  • Severe valve disease or scheduled valve surgery
  • Renal dysfunction (GFR \<84 ml/min/1.73m)
  • Other disease limiting life expectancy
  • Contraindications for coronary angiogram or MRI
  • Participation in some other clinical trial
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
36 participants (actual)

Study arms

  • Experimental
    AACD-Therapy group

    6 patients are recruited to the AADC-therapy group. Autologous atrial appendage derived cells (AADCs) are harvested from the appendage tissue removed during the venal cannulation of bypass. The cells and their extracellular matrix are placed with tissue clue to Cormatrix-sheet and further on top of the myocardium in the area of infarction scar. The procedure is done simultaneously with CABG surgery. The patients will be carefully monitored after the operations and cardiac MRI and echocardiogram will be performed previously to surgery as well as during the follow ups.

    Procedure: CABG surgery · Procedure: AADC therapy

  • Active comparator
    Control group

    20 patients are recruited to form the control group. They are patients scheduled for elective CABG surgery and they meet the same inclusion and exclusion criteria as the therapy group. There patients are followed as the hospital protocol with out any additional imagination or blood tests.

    Procedure: CABG surgery

Interventions

  • ProcedureCABG surgery

    Elective CABG surgery

  • ProcedureAADC therapy

    Atrial appendage derived cells are placed on the site of a infarct scar with matrix sheet

06

What researchers measure

Primary outcomes

  1. Safety; need for vasoactive medication

    For assessing haemodynamics during the operation and at the intensive care unit

    Time frame: 6 months

  2. Safety; cardiac index in l/min/m

    For assessing haemodynamics during the operation and at the intensive care unit

    Time frame: 6 months

  3. Safety; hemoglobin in g/l

    For assessing haemodynamics during the operation and at the intensive care unit

    Time frame: 6 months

  4. Safety; oxygen saturation in the pulmonary arterial blood (SvO2) in %

    For assessing haemodynamics during the operation and at the intensive care unit

    Time frame: 6 months

  5. Safety; serum potassium level in mmol/l

    For assessing haemodynamics during the operation and at the intensive care unit

    Time frame: 6 months

  6. Safety; blood glucose level in mmol/l

    For assessing haemodynamics during the operation and at the intensive care unit

    Time frame: 6 months

  7. Safety; Left ventricular ejection fraction (EF) in %

    For assessing cardiac function during and after the operation by echocardiogram

    Time frame: 6 months

  8. Safety; pericardial effusion in mm

    For assessing cardiac function after the operation by echocardiogram

    Time frame: 6 months

  9. Safety: telemetric monitoring of rhythm

    For assessing cardiac function after the operation

    Time frame: 6 months

  10. Feasibility: Success in completing the delivery of the cell sheet to the myocardium

    Measured in 0= success, 1= no success

    Time frame: 6 months

  11. Feasibility: Waiting time in minutes for the cell sheet

    Waiting time in minutes for the finished cell sheet to be placed on the myocardium after doing all the required anastomoses

    Time frame: 6 months

  12. Feasibility: Waiting time in minutes for the heart

    Waiting time in minutes for the the heart after doing all the anastomoses and before the cell sheet is finished

    Time frame: 6 months

  13. Feasibility: Closing the right atrial appendage

    Closing the right atrial appendage after removing the standardized tissue piece for preparing the cell sheet. According to the hospital protocol, appendage is closed with purse string suture. 0 = no additional suturing needed, 1 = additional suturing needed.

    Time frame: 6 months

Secondary outcomes

  1. Left ventricular wall thickness

    Measured by MRI

    Time frame: 6 months

  2. Change in the amount of myocardial scar tissue

    Measured by MRI

    Time frame: 6 months

  3. Change in left ventricular ejection fraction

    Measured by MRI

    Time frame: 6 months

  4. Plasma concentrations of N-terminal pro-B-type natriuretic peptide (NT-proBNP) levels

    Time frame: 6 months

  5. New York Heart Association class

    Time frame: 6 months

  6. Days in hospital

    Time frame: 1 month

  7. Changes in the quality of life.

    measured by questionnaire

    Time frame: 6 months

  8. Change in movement and diastolic function of left ventricular wall

    Measured by MRI

    Time frame: 6 months

  9. Local changes in systolic and diastolic function

    Measured by echocardiogram

    Time frame: 3 months

07

Study locations

1 site
  • Annu Nummi
    Helsinki, 00029, Finland
08

References and documents

Publications

  • Lehtinen M, Patila T, Vento A, Kankuri E, Suojaranta-Ylinen R, Poyhia R, Harjula A; Helsinki BMMC Collaboration. Prospective, randomized, double-blinded trial of bone marrow cell transplantation combined with coronary surgery - perioperative safety study. Interact Cardiovasc Thorac Surg. 2014 Dec;19(6):990-6. doi: 10.1093/icvts/ivu265. Epub 2014 Aug 20. PubMed 25142068 ↗
  • Lehtinen M, Schildt J, Ahonen A, Nikkinen P, Lauerma K, Sinisalo J, Kankuri E, Vento A, Patila T, Harjula A; Helsinki BMMC Collaboration. Combining FDG-PET and 99mTc-SPECT to predict functional outcome after coronary artery bypass surgery. Eur Heart J Cardiovasc Imaging. 2015 Sep;16(9):1023-30. doi: 10.1093/ehjci/jev032. Epub 2015 Mar 9. PubMed 25762563 ↗
  • Lehtinen M, Patila T, Kankuri E, Lauerma K, Sinisalo J, Laine M, Kupari M, Vento A, Harjula A; Helsinki BMMC Collaboration. Intramyocardial bone marrow mononuclear cell transplantation in ischemic heart failure: Long-term follow-up. J Heart Lung Transplant. 2015 Jul;34(7):899-905. doi: 10.1016/j.healun.2015.01.989. Epub 2015 Feb 7. PubMed 25797522 ↗
  • Lampinen M, Vento A, Laurikka J, Nystedt J, Mervaala E, Harjula A, Kankuri E. Rational Autologous Cell Sources For Therapy of Heart Failure - Vehicles and Targets For Gene and RNA Therapies. Curr Gene Ther. 2016;16(1):21-33. doi: 10.2174/1566523216666160104141809. PubMed 26725880 ↗
  • Nummi A, Mulari S, Stewart JA, Kivisto S, Teittinen K, Nieminen T, Lampinen M, Patila T, Sintonen H, Juvonen T, Kupari M, Suojaranta R, Kankuri E, Harjula A, Vento A; AADC consortium. Epicardial Transplantation of Autologous Cardiac Micrografts During Coronary Artery Bypass Surgery. Front Cardiovasc Med. 2021 Sep 14;8:726889. doi: 10.3389/fcvm.2021.726889. eCollection 2021. PubMed 34595223 ↗
  • Nummi A, Nieminen T, Patila T, Lampinen M, Lehtinen ML, Kivisto S, Holmstrom M, Wilkman E, Teittinen K, Laine M, Sinisalo J, Kupari M, Kankuri E, Juvonen T, Vento A, Suojaranta R, Harjula A; AADC consortium. Epicardial delivery of autologous atrial appendage micrografts during coronary artery bypass surgery-safety and feasibility study. Pilot Feasibility Stud. 2017 Dec 20;3:74. doi: 10.1186/s40814-017-0217-9. eCollection 2017. PubMed 29276625 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 5, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02672163
Lead sponsor
Helsinki University Central Hospital
Responsible party
Ari Harjula (Professor, Clinical research, Helsinki University Central Hospital) — Principal investigator
First posted
Feb 3, 2016
Start date
Feb 2016
Primary completion
Dec 2019
Completion
Dec 2019
Last update
Mar 5, 2020

Study contacts

Ari Harjula, Prof
study director · Heart and Lung Center, Helsinki University Hospital

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.

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