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

Primary Purpose

Heart Failure With Reduced Ejection Fraction

Status

Unknown status

Phase

Phase 1

Locations

Spain

Study Type

Interventional

Intervention

VB-C01

About this trial

This is an interventional treatment trial for Heart Failure With Reduced Ejection Fraction

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Clínica Universidad de Navarra
Hospital General Universitario Gregorio MarañónRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

VB-C01

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Incidence of all-cause death

Incidence of cardiovascular death

Incidence of re-infarction

Incidence of need for revascularization

Incidence of hospitalization for heart failure

Incidence of sustained ventricular tachycardia

Incidence of ventricular fibrillation

Incidence of stroke

Incidence of surgical complications

Changes in the pericardial physiology

Assessed by echocardiography or MRI

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.

Changes in DSA-HLA

Changes in proinflammatory cytokines

Changes in immunological cell types.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

Changes in the functional class

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

Changes in the patient-perceived quality of life

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

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

Changes in the peak oxygen consumption on ergospirometry

Changes in the brain natriuretic peptide

Full Information

NCT ID

NCT03746938

First Posted

November 13, 2018

Last Updated

November 15, 2018

Sponsor

Viscofan

Collaborators

Ministerio de Ciencia e Innovación, Spain

1. Study Identification

Unique Protocol Identification Number

NCT03746938

Brief Title

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

Acronym

CARDIOMESH

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.

Study Type

Interventional

2. Study Status

Record Verification Date

November 2018

Overall Recruitment Status

Unknown status

Study Start Date

November 13, 2018 (Anticipated)

Primary Completion Date

October 30, 2020 (Anticipated)

Study Completion Date

October 30, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Viscofan

Collaborators

Ministerio de Ciencia e Innovación, Spain

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Heart Failure With Reduced Ejection Fraction

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

VB-C01

Arm Type

Experimental

Arm Description

Intervention Type

Device

Intervention Name(s)

VB-C01

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Description

Time Frame