NCT03746938

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Nov 2018

Typical duration for phase_1

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 13, 2018

Completed
Same day until next milestone

Study Start

First participant enrolled

November 13, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 20, 2018

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2020

Completed
Last Updated

November 20, 2018

Status Verified

November 1, 2018

Enrollment Period

2 years

First QC Date

November 13, 2018

Last Update Submit

November 15, 2018

Conditions

Heart Failure With Reduced Ejection Fraction

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (29)

  • Incidence of all-cause death

    During the first year after implantation

  • Incidence of cardiovascular death

    During the first year after implantation

  • Incidence of re-infarction

    During the first year after implantation

  • Incidence of need for revascularization

    During the first year after implantation

  • Incidence of hospitalization for heart failure

    During the first year after implantation

  • +24 more secondary outcomes

Study Arms (1)

VB-C01

EXPERIMENTAL

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.

Device: VB-C01

Interventions

VB-C01DEVICE

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

VB-C01

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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%).

You may not qualify if:

  • Prior treatment with cell or gene therapy.
  • 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 autoimmune disease.
  • Respiratory compromise or need for home oxygen therapy.
  • Life expectancy of less than 1 year for any reason.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Clínica Universidad de Navarra

Pamplona, Navarre, 31008, Spain

NOT YET RECRUITING

Hospital General Universitario Gregorio Marañón

Madrid, 28007, Spain

RECRUITING

Study Officials

  • Francisco Jesús Fernández-Avilés Díaz

    Hospital General Universitario Gregorio Marañón

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ana Casado Plasencia

CONTACT

+34 683 375 694casadoa@viscofan.com

Blanca Jáuregui

CONTACT

+34 620 853 544JaureguiB@viscofan.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 13, 2018

First Posted

November 20, 2018

Study Start

November 13, 2018

Primary Completion

October 30, 2020

Study Completion

October 30, 2020

Last Updated

November 20, 2018

Record last verified: 2018-11

Locations

ES(2)