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

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ClinicalTrials.gov Identifier: NCT03746938
Recruitment Status : Recruiting
First Posted : November 20, 2018
Last Update Posted : November 20, 2018
Sponsor:
Collaborator:
Ministerio de Ciencia e Innovación, Spain
Information provided by (Responsible Party):
Viscofan

Tracking Information
First Submitted Date  ICMJE November 13, 2018
First Posted Date  ICMJE November 20, 2018
Last Update Posted Date November 20, 2018
Estimated Study Start Date  ICMJE November 13, 2018
Estimated Primary Completion Date October 30, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 15, 2018)
Composite safety endpoint formed by the major adverse cardiac and cerebrovascular events (MACCE) occurring on all visits during the first year after implantation. [ Time Frame: 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: November 15, 2018)
  • 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 [ Time Frame: During the first year after implantation ]
  • Changes in the pericardial physiology [ Time Frame: During the first year after implantation ]
    Assessed by echocardiography or MRI
  • VT inducibility [ Time Frame: During the first year after implantation ]
    Heterogeneous tissue on MRI as well as the presence of late potentials on the electrophysiological study scheduled at 1 year of follow-up.
  • 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 [ Time Frame: During the first year after implantation ]
    Measured by echocardiography comparing the baseline study of each patient with the studies performed in that same patient during the follow-up.
  • Changes in end-diastolic volume [ Time Frame: During the first year after implantation ]
    Measured by echocardiography comparing the baseline study of each patient with the studies performed in that same patient during the follow-up.
  • Changes in left ventricular ejection fraction [ Time Frame: During the first year after implantation ]
    Measured by echocardiography comparing the baseline study of each patient with the studies performed in that same patient during the follow-up.
  • Changes in sphericity index [ Time Frame: During the first year after implantation ]
    Measured by echocardiography comparing the baseline study of each patient with the studies performed in that same patient during the follow-up.
  • Changes in segmental contraction score (normal / hypokinetic / akinetic / dyskinetic) in the 17 myocardial segments [ Time Frame: During the first year after implantation ]
    Measured by echocardiography comparing the baseline study of each patient with the studies performed in that same patient during the follow-up.
  • Changes in systolic thickening by myocardial segments [ Time Frame: During the first year after implantation ]
    Measured by echocardiography comparing the baseline study of each patient with the studies performed in that same patient during the follow-up.
  • Changes in the scar size expressed in grams [ Time Frame: During the first year after implantation ]
    Measured by MRI comparing the baseline study of each patient with the studies performed in that same patient during the follow-up.
  • Changes in the viable myocardial mass expressed in grams [ Time Frame: During the first year after implantation ]
    Measured by MRI comparing the baseline study of each patient with the studies performed in that same patient during the follow-up.
  • Changes in the scar size expressed in percentage of LV [ Time Frame: During the first year after implantation ]
    Measured by MRI comparing the baseline study of each patient with the studies performed in that same patient during the follow-up.
  • Changes in the percentage of viable myocardium in LV [ Time Frame: During the first year after implantation ]
    Measured by MRI comparing the baseline study of each patient with the studies performed in that same patient during the follow-up.
  • Changes in the functional class [ Time Frame: During the first year after implantation ]
    According to the New York Heart Association (NYHA) for dyspnea
  • Changes in the patient-perceived quality of life [ Time Frame: During the first year after implantation ]
    According to the Minnesota Living with Heart Failure Questionnaire (MLHFQ)
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE First in Humans to Evaluate Collagen Patches With Stem Cells in Patients With Ischemic Left Ventricular Dysfunction
Official Title  ICMJE 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.
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Heart Failure With Reduced Ejection Fraction
Intervention  ICMJE Device: VB-C01
Surgical implant of VB-C01 (Collagen membrane seeded with allogeneic stem cells isolated from adipose tissue, ADSC).
Study Arms  ICMJE Experimental: VB-C01
Surgical technique: Via left lateral thoracotomy, the heart is lifted and supported on two deep pericardial points with 4-0 or 5-0 Prolene double arrmed suture. Each suture is passed through the reinforced frame of the collagen membrane containing the stem cells (VB-C01) and then tied, while the upper part of the patch is held with forceps. After securing the lower part of the pericardial layer, the heart is allowed to slowly recover its position with the pericardial cavity while the collagen membrane is mobilized to cover all of the target area. If necessary, some sutures can be used to fix the patch VB-C01 to the epicardial surface of the heart. Each suture is likewise passed through the reinforced frame of the membrane.
Intervention: Device: VB-C01
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 15, 2018)
10
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 30, 2020
Estimated Primary Completion Date October 30, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Ana Casado Plasencia +34 683 375 694 casadoa@viscofan.com
Contact: Blanca Jáuregui +34 620 853 544 JaureguiB@viscofan.com
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03746938
Other Study ID Numbers  ICMJE CARDIOMESH
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Viscofan
Study Sponsor  ICMJE Viscofan
Collaborators  ICMJE Ministerio de Ciencia e Innovación, Spain
Investigators  ICMJE
Principal Investigator: Francisco Jesús Fernández-Avilés Díaz Hospital General Universitario Gregorio Marañón
PRS Account Viscofan
Verification Date November 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP