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| Name | Class |
|---|---|
| Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK) | OTHER |
| University Medical Center Freiburg | OTHER |
| Repairon GmbH | UNKNOWN |
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The BioVAT-HF trial will test the hypothesis that cardiomyocyte implantation via engineered heart muscle (EHM), the proposed investigational medicinal product (IMP; designated "Biological Ventricular Assist Tissue" or BioVAT), results in sustainable remuscularization and biological enhancement of myocardial performance in the failing heart. EHM are constructed from defined mixtures of induced pluripotent stem cell (iPSC)-derived cardiomyocytes and stromal cells in a bovine collagen type I hydrogel. Comprehensive preclinical testing confirmed the rationale for the clinical translation of the myocardial remuscularization strategy by EHM implantation. The patient target population for EHM therapy is patients suffering from advanced heart failure with reduced ejection fraction (HFrEF; EF: ≤35%) and no realistic option for heart transplantation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EHM Implantation | Other | All patients will receive EHM implant |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EHM implantation | Biological | Implantation of EHM on dysfunctional left or right ventricular myocardium in patients with HFrEF (EF <35%). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events | Number of Adverse events related to the procedure, including in particular arrhythmic events and worsening of disease progression within 28 days (Part A) and the whole study duration (Part B) | 12 months |
| Heart target heart wall thickness | Change of target heart wall thickness (TWTh in mm) Echo or cCT or cMRI | 12 months |
| LV/RV-ejection fraction | Change of LV/RV-ejection fraction (LV/RV-EF in %) Echo or cCT or cMRI | 12 months |
| Patient reported outcome | Patient reported outcome Change of KCCQ-23 OSS (Overall Summary Score) | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Major adverse cardiac events | Frequency of major adverse cardiac events (MACE; non-fatal myocardial infarction, non-fatal stroke, and cardiovascular death) | 12 months |
| Arrhythmic events | Frequency and severity of arrhythmic events |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wolfram-Hubertus Zimmermann, Prof. | Contact | +49 551 / 3965781 | sekretariat.pharma@med.uni-goettingen.de | |
| Florian Walker, Dr. | Contact | +49 551 / 3960825 | biovat@med.uni-goettingen.de |
| Name | Affiliation | Role |
|---|---|---|
| Tim Seidler, Prof. | University Medical Center Goettingen | Principal Investigator |
| Wolfram-Hubertus Zimmermann, Prof. | University Medical Center Goettingen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Medical Center Göttingen | Recruiting | Göttingen | Lower Saxony | 37075 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42202318 | Derived | Zimmermann WH, Ensminger S, Kutschka I, Paitazoglou C, Seidler T, Brandenburg S, Anker SD, Bader N, Bergau L, Bremmer F, Diogo PG, Eitel I, Fujita B, Gerecke B, Hasenfuss G, Hellenkamp K, Hermann-Lingen C, Jebran AF, Jurczyk D, Knaus R, Legler T, Lotz J, Placzek M, Puhler T, Riggert J, Sadlonova M, Saraei R, Strobel P, Tiburcy M, Ullrich C, Voigt JU, Walker F, Wollnik B, Yigit G, Friede T; BioVAT-HF Investigators. Stem-Cell-Derived Biologic Ventricular Assist Tissue in Heart Failure. N Engl J Med. 2026 May 28;394(20):1991-2001. doi: 10.1056/NEJMoa2513525. | |
| 40334814 |
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| 12 months |
| Immune rejection | Incidence of immune rejection (DSA, CK/CK-MB, hs-cTnT, circulating cell-free allograft DNA) | 12 months |
| Mechanical perturbation of ventricular function | Incidence of mechanical perturbation of ventricular function by EHM graft | 12 months |
| Recurrent hospitalizations for heart failure | Frequency of recurrent hospitalizations for heart failure | 12 months |
| Mechanical circulatory assist device implantation | Time to mechanical circulatory assist device implantation | 12 months |
| Heart transplantation | Time to heart transplantation. | 12 months |
| Cardiopulmonary stress testing (VO2max) | Functional status in patients as determined by cardiopulmonary stress testing (VO2max) | 12 months |
| Cardiopulmonary stress testing six-minute walk test (6MWT) | Functional status in patients as determined by cardiopulmonary stress testing six-minute walk test (6MWT) - distance (in m) | 12 months |
| Hand-grip strength | Functional status in patients as determined by and hand-grip strength measurements | 12 months |
| NYHA classification | Patient reported outcomes assessed by NYHA classification | 12 months |
| Quality of life score (EQ-5D-5L) | Patient reported outcomes assessed by quality of life score (EQ-5D-5L) | 12 months |
| Hospital Anxiety and Depression Scale (HADS) | Patient reported outcomes assessed by study adherence motivation according to following questionnaire: HADS | 12 months |
| Mortality | All-cause and cardiovascular mortality | 12 months |
| Montreal Cognitive Assessment (MoCA) | Patient reported outcomes assessed by study adherence motivation according to following questionnaire: MoCA | 12 months |
| Medication adherence | Patient reported outcomes assessed by study adherence motivation according to medication adherence questionnaire. | 12 months |
| Brief Illness Perception Questionnaire (B-IPQ) | Patient reported outcomes assessed by study adherence motivation according to following questionnaire: B-IPQ | 12 months |
| Treatment Expectation Questionnaire (TEX-Q) | Patient reported outcomes assessed by study adherence motivation according to following questionnaire: TEX-Q | 12 months |
| Herz- und Diabeteszentrum Nordrhein-Westfalen | Not yet recruiting | Bad Oeynhausen | North Rhine-Westphalia | 32545 | Germany |
|
| University Medical Center Schleswig-Holstein | Recruiting | Lübeck | Schleswig-Holstein | 23562 | Germany |
|
| Derived |
| Montague EC, Ozcan B, Sefton E, Wulkan F, Alibhai FJ, Laflamme MA. Human pluripotent stem cell-based cardiac repair: Lessons learned and challenges ahead. Adv Drug Deliv Rev. 2025 Jul;222:115594. doi: 10.1016/j.addr.2025.115594. Epub 2025 May 5. |
| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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