BioVAT / Repairon - LARVOL DELTA

BioVAT-HF: Safety and Efficacy of Induced Pluripotent Stem Cell-derived Engineered Human Myocardium as Biological Ventricular Assist Tissue in Terminal Heart Failure (clinicaltrials.gov) - P1/2 | N=53 | Recruiting | Sponsor: University Medical Center Goettingen | Trial completion date: Oct 2024 ➔ Dec 2027 | Trial primary completion date: Mar 2024 ➔ Dec 2027

Trial completion date • Trial primary completion date • Cardiovascular • Congestive Heart Failure • Heart Failure

Two-Center Surgical Experience from the First-in-Human BioVAT-HF-DZHK20 Clinical Trial (ISHLT 2025) - P1/2 | "All patients were maintained on immune suppression (tacrolimus or everolimus and methylprednisolone) following ISHLT-recommendations. An EHM dose of 10 million cells/kg (20x EHM; 20 mL wet-weight) was considered as safe maximal dose for continuation of clinical testing to obtain proof-of-conceptConclusion In conclusion, EHM implantation as biological ventricular assist tissue (BioVAT) is feasible and safe. Clinical testing is continuing to obtain data as to efficacy on EHM implantation-based heart remuscularization."

Clinical • P1 data • Cardiovascular • Congestive Heart Failure • Heart Failure

Engineered heart muscle allografts for heart repair in primates and humans. (PubMed, Nature) - "The obtained feasibility, safety and efficacy data provided the pivotal underpinnings for the approval of a first-in-human clinical trial on tissue-engineered heart repair. Our clinical data confirmed remuscularization by EHM implantation in a patient with advanced heart failure."

Journal • Cardiovascular • Congestive Heart Failure • Heart Failure • Myocardial Infarction • Oncology

Safety And Efficacy Of Induced Pluripotent Stem Cell-derived Engineered Human Myocardium As Biological Ventricular Assist Tissue In Terminal Heart Failure - BioVAT-HF-DZHK20 (AHA 2023) - P1/2 | "Initial signs of efficacy are presently under clinical scrutiny. Data presented as mean±SD."

Clinical • Cardiovascular • Congestive Heart Failure • Heart Failure • Transplantation

Safety and efficacy of induced pluripotent stem cell-derived engineered human myocardium as biological ventricular assist tissue in term. heart failure (BioVAT-HF):trial design and experience at UKSH (HEART FAILURE 2023) - "On behalf: BIOVAT HF trial Background: Based on constantly rising numbers of heart failure (HF) patients and the limited availability of donor hearts, the development of regenerative, cell-/tissue-based therapeutic approaches is warranted. Patients suffered from symptomatic HF despite optimal medical treatment and were stable on angiotensin receptor-neprilysin inhibitors (ARNI), beta-blockers, mineralocorticoid receptor antagonists (MRA), sodium-glucose co-transporter-2 (SGLT2) inhibitors and Vericiguat. Median age (Q1, Q3) was 63 (60, 66) years, all patients were male (100%). Baseline parameters were: NYHA class 3 (3, 3), INTERMACS level 6 (5.5, 7), left ventricle (LV) ejection fraction 20 (16, 20)%, LV enddiastolic-diameter 61 (54, 77) mm, TAPSE 22 (14, 23) mm, NT-proBNP 941 (643, 8618) ng/l, 6-minute walking distance 331 (302, 350) m, glomerular filtration rate 52 (35, 71) ml/min."

Clinical • Cardiovascular • Congestive Heart Failure • Heart Failure

Repairon Announces Completion of Dose-Finding Part of BioVAT-HF Phase 1/2 Trial in Advanced Heart Failure (GlobeNewswire) - "Repairon...today announced the completion of enrolment and follow-up of patients in the dose-finding cohort of the BioVAT-HF-DZHK20 Phase 1/2 trial. The clinical trial is evaluating the safety and efficacy of iPSC1 -derived engineered human myocardium (EHM) as Biological Ventricular Assist Tissue (BioVAT) in Advanced Heart Failure (NCT04396899)....The interim data readout from 15 patients receiving 800 million cells is anticipated for Q2 2024, with then first data on the primary efficacy endpoints (augmentation of the target heart wall with evidence for local and global enhancement of contractility). The completion of BioVAT-HF with 35 patients treated with the safe maximal dose is expected in H2 2025."

Enrollment closed • P1/2 data • Cardiovascular • Heart Failure