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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-13

Study Completion Date

2020-10-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Heart Failure With Reduced Ejection Fraction

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

VB-C01

Intervention Type DEVICE

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

Interventions

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VB-C01

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

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No