VB-C01 cellularised patch: surgical epicardial implantation of a membrane seeded with allogeneic adipose tissue derived stem cells in patients scheduled to undergo coronary revascularisation surgery and at high risk of developing heart failure
Study summary
* The Cardiomesh II clinical trial is a phase I open label study intended to enrol 10 patients to evaluate the safety and efficacy of surgical epicardial implantation of a membrane seeded with allogeneic adipose tissue derived stem cells in patients scheduled to undergo coronary revascularisation surgery and at high risk of developing heart failure.
* The primary objective of the study is to evaluate the safety of surgical implantation of this membrane in patients with large ischaemic myocardial scars scheduled to undergo coronary revascularisation surgery. The secondary objective is to investigate the efficacy of the above treatment in terms of reduction of scar size and ventricular function parameters.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
1. Patients planning to undergo coronary revascularisation surgery within one month of study entry.
2. LVEF ≤45% by CMRI.
3. History of myocardial infarction at least 3 months prior to inclusion.
4. Scar covering at least 15% of the total left ventricular myocardial mass defined by late enhancement on CMRI.
Exclusion Criteria:
1. Participation in another clinical trial within 30 days prior to inclusion.
2. Prior treatment with cell or gene therapy.
3. Be a candidate for heart transplant at the time of study entry.
4. Diagnosis of acute myocardial infarction with 3 months prior to inclusion.
5. Need for urgent revascularisation surgery.
6. Strict contraindication for the use of CMRI (pacemaker or implantable automatic defibrillator carriers, previous reactions to gadolinium contrast, claustrophobia, cochlear implants, etc.).
7. Presence of uncontrolled ventricular arrhythmias (ventricular tachycardia or ventricular fibrillation) at the time of implant surgery.
8. Active systemic infection.
9. Women who are pregnant or breastfeeding.
10. Mental disease or psychological condition that impedes the subject from understanding the nature of the protocol and granting his/her consent
11. Advanced dementia according to the Barthel index.
12. 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).
13. Tumour disease, except that eradicated at least 5 years prior to inclusion in the study and without receiving chest radiotherapy. Completely eradicated non melanoma skin tumours (at any time) not requiring chest chemotherapy or radiotherapy are permitted.
14. History of autoimmune disease.
15. Stroke within 12 months prior to inclusion.
16. Respiratory compromise or need for home oxygen therapy.
17. Life expectancy of less than 1 year for any reason
Primary outcome measure(s)
combination of MACCEs at all follow up visits during the first year after treatment — 12 months combination of MACCEs at all follow up visits during the first year after treatment (after surgery, at 1, 3, 6, 9 and 12 months). MACCEs are defined as all cause death, myocardial infarction requiring target vessel revascularisation, hospitalisation for heart failure, cardiac tamponade or pericardial constriction, sustained ventricular tachycardia, ventricular fibrillation, and stroke.
Trial sites (1)
Facility
City
Region
Status
Górnośląskie Centrum Medyczne im. prof. Leszka Gieca Śląskiego Uniwersytetu Medycznego w Katowicach
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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