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

Heart Failure With Reduced Ejection Fraction Clinical Trial

— 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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03746938
• Other study ID #: CARDIOMESH
• Status: Recruiting
• Phase: Phase 1
• 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
• 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.

Related Conditions & MeSH terms

• Heart Failure
• Heart Failure With Reduced Ejection Fraction
• Ventricular Dysfunction
• Ventricular Dysfunction, Left

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