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

November 15, 2018 updated by: Viscofan

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
10

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Spain
      • Madrid, Spain, 28007
    • Navarra
      • Pamplona, Navarra, Spain, 31008
        • Not yet recruiting
        • Clinica Universidad de Navarra
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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%).

Exclusion Criteria:

  • 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.
  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: VB-C01
Surgical 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.
Device: VB-C01
Surgical implant of VB-C01 (Collagen membrane seeded with allogeneic stem cells isolated from adipose tissue, ADSC).

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
MACCE include: all-cause death, cardiovascular death, re-infarction, need for revascularization, hospitalization for heart failure, sustained ventricular tachycardia, ventricular fibrillation, or stroke.
During the first year after implantation

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Incidence of all-cause death
Time Frame: During the first year after implantation
During the first year after implantation
Incidence of cardiovascular death
Time Frame: During the first year after implantation
During the first year after implantation
Incidence of re-infarction
Time Frame: During the first year after implantation
During the first year after implantation
Incidence of need for revascularization
Time Frame: During the first year after implantation
During the first year after implantation
Incidence of hospitalization for heart failure
Time Frame: During the first year after implantation
During the first year after implantation
Incidence of sustained ventricular tachycardia
Time Frame: During the first year after implantation
During the first year after implantation
Incidence of ventricular fibrillation
Time Frame: During the first year after implantation
During the first year after implantation
Incidence of stroke
Time Frame: During the first year after implantation
During the first year after implantation
Incidence of surgical complications
Time Frame: During the first year after implantation
During the first year after implantation
Changes in the pericardial physiology
Time Frame: During the first year after implantation
Assessed by echocardiography or MRI
During the first year after implantation
VT inducibility
Time Frame: During the first year after implantation
Heterogeneous tissue on MRI as well as the presence of late potentials on the electrophysiological study scheduled at 1 year of follow-up.
During the first year after implantation
Changes in DSA-HLA
Time Frame: During the first year after implantation
During the first year after implantation
Changes in proinflammatory cytokines
Time Frame: During the first year after implantation
During the first year after implantation
Changes in immunological cell types.
Time Frame: During the first year after implantation
During the first year after implantation
Changes in end-systolic volume
Time Frame: During the first year after implantation
Measured by echocardiography comparing the baseline study of each patient with the studies performed in that same patient during the follow-up.
During the first year after implantation
Changes in end-diastolic volume
Time Frame: During the first year after implantation
Measured by echocardiography comparing the baseline study of each patient with the studies performed in that same patient during the follow-up.
During the first year after implantation
Changes in left ventricular ejection fraction
Time Frame: During the first year after implantation
Measured by echocardiography comparing the baseline study of each patient with the studies performed in that same patient during the follow-up.
During the first year after implantation
Changes in sphericity index
Time Frame: During the first year after implantation
Measured by echocardiography comparing the baseline study of each patient with the studies performed in that same patient during the follow-up.
During the first year after implantation
Changes in segmental contraction score (normal / hypokinetic / akinetic / dyskinetic) in the 17 myocardial segments
Time Frame: During the first year after implantation
Measured by echocardiography comparing the baseline study of each patient with the studies performed in that same patient during the follow-up.
During the first year after implantation
Changes in systolic thickening by myocardial segments
Time Frame: During the first year after implantation
Measured by echocardiography comparing the baseline study of each patient with the studies performed in that same patient during the follow-up.
During the first year after implantation
Changes in the scar size expressed in grams
Time Frame: During the first year after implantation
Measured by MRI comparing the baseline study of each patient with the studies performed in that same patient during the follow-up.
During the first year after implantation
Changes in the viable myocardial mass expressed in grams
Time Frame: During the first year after implantation
Measured by MRI comparing the baseline study of each patient with the studies performed in that same patient during the follow-up.
During the first year after implantation
Changes in the scar size expressed in percentage of LV
Time Frame: During the first year after implantation
Measured by MRI comparing the baseline study of each patient with the studies performed in that same patient during the follow-up.
During the first year after implantation
Changes in the percentage of viable myocardium in LV
Time Frame: During the first year after implantation
Measured by MRI comparing the baseline study of each patient with the studies performed in that same patient during the follow-up.
During the first year after implantation
Changes in the functional class
Time Frame: During the first year after implantation
According to the New York Heart Association (NYHA) for dyspnea
During the first year after implantation
Changes in the patient-perceived quality of life
Time Frame: During the first year after implantation
According to the Minnesota Living with Heart Failure Questionnaire (MLHFQ)
During the first year after implantation
Changes in the distance covered on the 6-minute walk test
Time Frame: During the first year after implantation
During the first year after implantation
Changes in the peak oxygen consumption on ergospirometry
Time Frame: During the first year after implantation
During the first year after implantation
Changes in the brain natriuretic peptide
Time Frame: During the first year after implantation
During the first year after implantation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Viscofan

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Ministerio de Ciencia e Innovacion, Spain

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Francisco Jesús Fernández-Avilés Díaz, Hospital General Universitario Gregorio Maranon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 13, 2018

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 30, 2020

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 30, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 13, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 15, 2018

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 20, 2018

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 20, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 15, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CARDIOMESH

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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