drugset / Trial / NCT06956807
Safety and Efficacy of Epicardial Implantation of Collagen Membranes With Allogeneic Adipose Derived Stem Cells
Phase 1
Not yet recruiting
10 enrolled
Viscofan
Clinica Universidad de Navarra, Universidad de Navarra · collabHospital General Universitario Gregorio Marañon · collabKCRI Sp. z o.o. · collabMedical University of Silesia · collab
NaSingle-groupOpen-labelTreatment
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.
Timeline
- Start
- 2025-09-01
- Primary completion
- 2026-12-31
- Completion
- 2027-06-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | VB-C01 cellularised patch | Cell therapy | — | Other |