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

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.

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.