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Heart Failure With Reduced Ejection FractionPhase 1CARDIOMESHNCT03746938

First in Humans to Evaluate Collagen Patches With Stem Cells in Patients With Ischemic Left Ventricular Dysfunction

A Phase 1 study testing VB-C01 in people with Heart Failure With Reduced Ejection Fraction, run by Viscofan at 2 sites in Spain.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

It´s a first open-label trial in humans to evaluate the safety and efficacy of epicardial delivery of collagen patches with adipose-derived stem cells in patients with ischemic heart disease and left ventricular dysfunction that remain symptomatic despite optimal medical treatment. Read more about this study

Who is it for?
Ages 18 to 80 years
What is being tested?
VB-C01
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
2 sitesSpain
Study dates
13 Nov 2018to 30 Oct 2020
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Men and women aged ≥18 years and ≤80 years.
  • LVEF ≤35% as assessed by echocardiography, confirmed by MRI if there are no contraindications for this procedure.
  • History of revascularised or nonrevascularisable coronary artery disease as the cause of ventricular dysfunction.
  • NYHA functional class III for dyspnea under optimal medical treatment.
  • Ability to perform the exercise test with respiratory gas consumption. MVO2 should be ≥ 10 and ≤ 18 ml/kg/min in the exercise test.
  • Ability to perform a 6-minute walk test > 100 m and ≤ 400 m.
  • Haemodynamic stability (blood pressure > 100/40 mmHg, heart rate < 110 bpm and oxygen saturation at rest in room air > 95%).

Who cannot join

  • Participation in another clinical trial within 30 days prior to inclusion.
  • Prior treatment with cell or gene therapy.
  • Diagnosis of acute myocardial infarction with 3 months prior to inclusion.
  • Significant coronary artery disease eligible for revascularization.
  • Significant valvular disease eligible for surgery.
  • Presence of uncontrolled ventricular arrhythmias (VR or VF) at the time of implant surgery.
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  • Women who are pregnant or breastfeeding.
  • Mental disease or psychological condition that impedes the subject from understanding the nature of the protocol and granting his/her consent.
  • Advanced dementia according to the Barthel index.
  • Active systemic infection.
  • History of primary or acquired immunodeficiency or on immunosuppressive therapy (within 3 months prior to inclusion or if the need for immunotherapy is foreseeable at any time during the study follow-up).
  • Tumour disease, except that eradicated at least 5 years prior to inclusion in the study and without receiving chest radiotherapy. Completely eradicated nonmelanoma skin tumours (at any time) not requiring chest chemotherapy or radiotherapy) are permitted.
  • History of autoimmune disease.
  • Stroke within 12 months prior to inclusion.
  • Respiratory compromise or need for home oxygen therapy.
  • Life expectancy of less than 1 year for any reason.

Trial locations and contacts

2 sites in 1 country.

Ana Casado Plasencia contact

+34 683 375 694

casadoa@viscofan.com

Blanca Jáuregui contact

+34 620 853 544

JaureguiB@viscofan.com

Spain2 sites, 2 recruiting

  • Hospital General Universitario Gregorio Marañón

    Madrid, 28007

    Javier Bermejo Thomas, 915868290, javier.bermejo@salud.madrid.org

    Recruiting

  • Clínica Universidad de Navarra

    Pamplona, Navarre, 31008

    Laura Ribillaga, larribillaga@unav.es

    Not yet recruiting

Other trials in Spain

About this study

Official title: First Open-label Trial in Humans to Evaluate the Safety and Efficacy of Epicardial Delivery of Collagen Patches With Adipose-derived Stem Cells in Patients With Ischemic Heart Disease and Left Ventricular Dysfunction.

It´s a first open-label trial in humans to evaluate the safety and efficacy of epicardial delivery of collagen patches with adipose-derived stem cells in patients with ischemic heart disease and left ventricular dysfunction that remain symptomatic despite optimal medical treatment.

Being tested
VB-C01

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • VB-C01Device

    Surgical implant of VB-C01 (Collagen membrane seeded with allogeneic stem cells isolated from adipose tissue, ADSC).

Study groups in NCT03746938
Study groupRoleWhat they receive
VB-C01ExperimentalSurgical technique: Via left lateral thoracotomy, the heart is lifted and supported on two deep pericardial points with 4-0 or 5-0 Prolene double arrmed suture. Each suture is passed through the reinforced frame of the collagen membrane containing the stem cells (VB-C01) and then tied, while the upper part of the patch is held with forceps. After securing the lower part of the pericardial layer, the heart is allowed to slowly recover its position with the pericardial cavity while the collagen membrane is mobilized to cover all of the target area. If necessary, some sutures can be used to fix the patch VB-C01 to the epicardial surface of the heart. Each suture is likewise passed through the reinforced frame of the membrane.
Receives: Device: VB-C01

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Composite safety endpoint formed by the major adverse cardiac and cerebrovascular events (MACCE) occurring on all visits during the first year after implantation.

    MACCE include: all-cause death, cardiovascular death, re-infarction, need for revascularization, hospitalization for heart failure, sustained ventricular tachycardia, ventricular fibrillation, or stroke.

    Measured: During the first year after implantation

Secondary outcomes (29)

  1. Incidence of all-cause death

    Measured: During the first year after implantation

  2. Incidence of cardiovascular death

    Measured: During the first year after implantation

  3. Incidence of re-infarction

    Measured: During the first year after implantation

  4. Incidence of need for revascularization

    Measured: During the first year after implantation

  5. Incidence of hospitalization for heart failure

    Measured: During the first year after implantation

  6. Incidence of sustained ventricular tachycardia

    Measured: During the first year after implantation

  7. Incidence of ventricular fibrillation

    Measured: During the first year after implantation

  8. Incidence of stroke

    Measured: During the first year after implantation

  9. Incidence of surgical complications

    Measured: During the first year after implantation

  10. Changes in the pericardial physiology

    Assessed by echocardiography or MRI

    Measured: During the first year after implantation

  11. VT inducibility

    Heterogeneous tissue on MRI as well as the presence of late potentials on the electrophysiological study scheduled at 1 year of follow-up.

    Measured: During the first year after implantation

  12. Changes in DSA-HLA

    Measured: During the first year after implantation

  13. Changes in proinflammatory cytokines

    Measured: During the first year after implantation

  14. Changes in immunological cell types.

    Measured: During the first year after implantation

  15. Changes in end-systolic volume

    Measured by echocardiography comparing the baseline study of each patient with the studies performed in that same patient during the follow-up.

    Measured: During the first year after implantation

  16. Changes in end-diastolic volume

    Measured by echocardiography comparing the baseline study of each patient with the studies performed in that same patient during the follow-up.

    Measured: During the first year after implantation

  17. Changes in left ventricular ejection fraction

    Measured by echocardiography comparing the baseline study of each patient with the studies performed in that same patient during the follow-up.

    Measured: During the first year after implantation

  18. Changes in sphericity index

    Measured by echocardiography comparing the baseline study of each patient with the studies performed in that same patient during the follow-up.

    Measured: During the first year after implantation

  19. Changes in segmental contraction score (normal / hypokinetic / akinetic / dyskinetic) in the 17 myocardial segments

    Measured by echocardiography comparing the baseline study of each patient with the studies performed in that same patient during the follow-up.

    Measured: During the first year after implantation

  20. Changes in systolic thickening by myocardial segments

    Measured by echocardiography comparing the baseline study of each patient with the studies performed in that same patient during the follow-up.

    Measured: During the first year after implantation

  21. Changes in the scar size expressed in grams

    Measured by MRI comparing the baseline study of each patient with the studies performed in that same patient during the follow-up.

    Measured: During the first year after implantation

  22. Changes in the viable myocardial mass expressed in grams

    Measured by MRI comparing the baseline study of each patient with the studies performed in that same patient during the follow-up.

    Measured: During the first year after implantation

  23. Changes in the scar size expressed in percentage of LV

    Measured by MRI comparing the baseline study of each patient with the studies performed in that same patient during the follow-up.

    Measured: During the first year after implantation

  24. Changes in the percentage of viable myocardium in LV

    Measured by MRI comparing the baseline study of each patient with the studies performed in that same patient during the follow-up.

    Measured: During the first year after implantation

  25. Changes in the functional class

    According to the New York Heart Association (NYHA) for dyspnea

    Measured: During the first year after implantation

  26. Changes in the patient-perceived quality of life

    According to the Minnesota Living with Heart Failure Questionnaire (MLHFQ)

    Measured: During the first year after implantation

  27. Changes in the distance covered on the 6-minute walk test

    Measured: During the first year after implantation

  28. Changes in the peak oxygen consumption on ergospirometry

    Measured: During the first year after implantation

  29. Changes in the brain natriuretic peptide

    Measured: During the first year after implantation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Nov 2018
  2. Study start13 Nov 2018 (estimated)
  3. Primary completion30 Oct 2020 (estimated)
  4. Study completion30 Oct 2020 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
10 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03746938
Sponsor's protocol ID
CARDIOMESH
Acronym
CARDIOMESH
Status last verified
Nov 2018
First submitted
13 Nov 2018
Last updated
20 Nov 2018
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing VB-C01 in people with Heart Failure With Reduced Ejection Fraction, run by Viscofan at 2 sites in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 20 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Ana Casado Plasencia (+34 683 375 694, casadoa@viscofan.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Composite safety endpoint formed by the major adverse cardiac and cerebrovascular events (MACCE) occurring on all visits during the first year after implantation. (time frame: During the first year after implantation). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03746938.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2018.

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