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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03746938
Other study ID # CARDIOMESH
Secondary ID
Status Recruiting
Phase Phase 1
First received
Last updated
Start date November 13, 2018
Est. completion date October 30, 2020

Study information

Verified date November 2018
Source Viscofan
Contact Ana Casado Plasencia
Phone +34 683 375 694
Email casadoa@viscofan.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 10
Est. completion date October 30, 2020
Est. primary completion date October 30, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Spain Hospital General Universitario Gregorio Marañón Madrid
Spain Clínica Universidad de Navarra Pamplona Navarra

Sponsors (2)

Lead Sponsor Collaborator
Viscofan Ministerio de Ciencia e Innovación, Spain

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. During the first year after implantation
Secondary Incidence of all-cause death During the first year after implantation
Secondary Incidence of cardiovascular death During the first year after implantation
Secondary Incidence of re-infarction During the first year after implantation
Secondary Incidence of need for revascularization During the first year after implantation
Secondary Incidence of hospitalization for heart failure During the first year after implantation
Secondary Incidence of sustained ventricular tachycardia During the first year after implantation
Secondary Incidence of ventricular fibrillation During the first year after implantation
Secondary Incidence of stroke During the first year after implantation
Secondary Incidence of surgical complications During the first year after implantation
Secondary Changes in the pericardial physiology Assessed by echocardiography or MRI During the first year after implantation
Secondary 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. During the first year after implantation
Secondary Changes in DSA-HLA During the first year after implantation
Secondary Changes in proinflammatory cytokines During the first year after implantation
Secondary Changes in immunological cell types. During the first year after implantation
Secondary 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. During the first year after implantation
Secondary 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. During the first year after implantation
Secondary 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. During the first year after implantation
Secondary 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. During the first year after implantation
Secondary 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. During the first year after implantation
Secondary 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. During the first year after implantation
Secondary 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. During the first year after implantation
Secondary 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. During the first year after implantation
Secondary 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. During the first year after implantation
Secondary 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. During the first year after implantation
Secondary Changes in the functional class According to the New York Heart Association (NYHA) for dyspnea During the first year after implantation
Secondary Changes in the patient-perceived quality of life According to the Minnesota Living with Heart Failure Questionnaire (MLHFQ) During the first year after implantation
Secondary Changes in the distance covered on the 6-minute walk test During the first year after implantation
Secondary Changes in the peak oxygen consumption on ergospirometry During the first year after implantation
Secondary Changes in the brain natriuretic peptide During the first year after implantation
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