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

Viscofan10 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Heart Failure With Reduced Ejection Fraction

Interventions

VB-C01DEVICE

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Locations (2)

Clínica Universidad de Navarra

Pamplona, Navarre, Spain

NOT_YET_RECRUITING

Hospital General Universitario Gregorio Marañón

Madrid, Spain

RECRUITING

Outcomes

Primary Outcomes

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.

Time frame: During the first year after implantation

Secondary Outcomes

Incidence of all-cause death

Time frame: During the first year after implantation

Incidence of cardiovascular death

Time frame: During the first year after implantation

Incidence of re-infarction

Time frame: During the first year after implantation

Incidence of need for revascularization

Time frame: During the first year after implantation

Incidence of hospitalization for heart failure

Time frame: During the first year after implantation

Incidence of sustained ventricular tachycardia

Time frame: During the first year after implantation

Incidence of ventricular fibrillation

Time frame: During the first year after implantation

Incidence of stroke

Time frame: During the first year after implantation

Incidence of surgical complications

Central Contacts

Ana Casado Plasencia

CONTACT

+34 683 375 694 casadoa@viscofan.com

Blanca Jáuregui

CONTACT

+34 620 853 544 JaureguiB@viscofan.com

Data from ClinicalTrials.gov

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Time frame: During the first year after implantation

Changes in the pericardial physiology

Assessed by echocardiography or MRI

Time frame: During the first year after implantation

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.

Time frame: During the first year after implantation

Changes in DSA-HLA

Time frame: During the first year after implantation

Changes in proinflammatory cytokines

Time frame: During the first year after implantation

Changes in immunological cell types.

Time frame: During the first year after implantation

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.

Time frame: During the first year after implantation

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.

Time frame: During the first year after implantation

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.

Time frame: During the first year after implantation

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.

Time frame: During the first year after implantation

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.

Time frame: During the first year after implantation

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.

Time frame: During the first year after implantation

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.

Time frame: During the first year after implantation

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.

Time frame: During the first year after implantation

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.

Time frame: During the first year after implantation

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.

Time frame: During the first year after implantation

Changes in the functional class

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

Time frame: During the first year after implantation

Changes in the patient-perceived quality of life

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

Time frame: 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

Changes in the peak oxygen consumption on ergospirometry

Time frame: During the first year after implantation

Changes in the brain natriuretic peptide

Time frame: During the first year after implantation