Clinical trial NCT03746938: First in Humans to Evaluate Collagen Patches With Stem Cells in Patients With Ischemic Left Ventricular Dysfunction
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
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Heart Failure With Reduced Ejection Fraction
Lead sponsor: Viscofan
Sponsor class: INDUSTRY
Collaborators: name: Ministerio de Ciencia e Innovación, Spain
First posted: 2018-11-20
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Composite safety endpoint formed by the major adverse cardiac and cerebrovascular events (MACCE) occurring on all visits during the first year after implantation.
timeFrame: During the first year after implantation
Secondary outcomes:
measure: Incidence of all-cause death
timeFrame: During the first year after implantation
measure: Incidence of cardiovascular death
timeFrame: During the first year after implantation
measure: Incidence of re-infarction
timeFrame: During the first year after implantation
measure: Incidence of need for revascularization
timeFrame: During the first year after implantation
measure: Incidence of hospitalization for heart failure
timeFrame: During the first year after implantation
measure: Incidence of sustained ventricular tachycardia
timeFrame: During the first year after implantation
measure: Incidence of ventricular fibrillation
timeFrame: During the first year after implantation
measure: Incidence of stroke
timeFrame: During the first year after implantation
measure: Incidence of surgical complications
timeFrame: During the first year after implantation
measure: Changes in the pericardial physiology
timeFrame: During the first year after implantation
measure: VT inducibility
timeFrame: During the first year after implantation
measure: Changes in DSA-HLA
timeFrame: During the first year after implantation
measure: Changes in proinflammatory cytokines
timeFrame: During the first year after implantation
measure: Changes in immunological cell types.
timeFrame: During the first year after implantation
measure: Changes in end-systolic volume
timeFrame: During the first year after implantation
measure: Changes in end-diastolic volume
timeFrame: During the first year after implantation
measure: Changes in left ventricular ejection fraction
timeFrame: During the first year after implantation
measure: Changes in sphericity index
timeFrame: During the first year after implantation
measure: Changes in segmental contraction score (normal / hypokinetic / akinetic / dyskinetic) in the 17 myocardial segments
timeFrame: During the first year after implantation
measure: Changes in systolic thickening by myocardial segments
timeFrame: During the first year after implantation
measure: Changes in the scar size expressed in grams
timeFrame: During the first year after implantation
measure: Changes in the viable myocardial mass expressed in grams
timeFrame: During the first year after implantation
measure: Changes in the scar size expressed in percentage of LV
timeFrame: During the first year after implantation
measure: Changes in the percentage of viable myocardium in LV
timeFrame: During the first year after implantation
measure: Changes in the functional class
timeFrame: During the first year after implantation
measure: Changes in the patient-perceived quality of life
timeFrame: During the first year after implantation
measure: Changes in the distance covered on the 6-minute walk test
timeFrame: During the first year after implantation
measure: Changes in the peak oxygen consumption on ergospirometry
timeFrame: During the first year after implantation
measure: Changes in the brain natriuretic peptide
timeFrame: During the first year after implantation
Other outcomes:
Locations:
city: Pamplona
country: Spain
facility: Clínica Universidad de Navarra
state: Navarra
city: Madrid
country: Spain
facility: Hospital General Universitario Gregorio Marañón
Study officials:
affiliation: Hospital General Universitario Gregorio Marañón
name: Francisco Jesús Fernández-Avilés Díaz
role: PRINCIPAL_INVESTIGATOR
References: