Repairon
Developer of induced pluripotent stem cell (iPSC)-derived, tissue-engineered contractile heart muscle for remuscularization of failing hearts. Activities cover iPSC line generation and characterization, preclinical safety and functional testing, GMP-compliant manufacturing and cell-banking, process scale-up, and early clinical development (first-in-patient Phase I/II trial).
Industries
Nr. of Employees
small (1-50)
Repairon
Rudolf-Wissell-Str. 28a, D-37079 Göttingen, Germany
Products
Engineered heart muscle patch (collagen-based)
A collagen-based engineered cardiac tissue patch manufactured from iPSC-derived cardiomyocytes and stromal cells. Individual unit dimensions approx. 40 x 40 x 1 mm constructed from ~40 million cardiomyocytes and stromal cells; units can be stacked/fused to achieve higher doses (up to 20 units described). Intended as an off-the-shelf allograft for surgical implantation onto the beating heart.
Engineered heart muscle patch (collagen-based)
A collagen-based engineered cardiac tissue patch manufactured from iPSC-derived cardiomyocytes and stromal cells. Individual unit dimensions approx. 40 x 40 x 1 mm constructed from ~40 million cardiomyocytes and stromal cells; units can be stacked/fused to achieve higher doses (up to 20 units described). Intended as an off-the-shelf allograft for surgical implantation onto the beating heart.
Expertise Areas
- Cardiac tissue engineering
- iPSC-derived cell therapy development
- ATMP manufacturing and GMP compliance
- Bioprocess scale-up and bioreactor manufacturing
Key Technologies
- Induced pluripotent stem cells (iPSC)
- Master and working cell bank (MCB/WCB) systems
- Collagen hydrogel tissue formulation
- Three-dimensional engineered myocardium (contractile tissue)
News & Updates
Phase I/II open-label, non-randomized, multi-center adaptive clinical trial investigating safety and efficacy of iPSC-derived engineered myocardium in advanced heart failure (EudraCT: 2019-000885-39; ClinicalTrials.gov: NCT04396899).
Announcement of positive clinical outcomes of engineered heart muscle as reparative therapy for advanced heart failure reported at the American Heart Association Scientific Sessions.
Completion of dose-finding part of the BioVAT-HF Phase 1/2 trial and reporting of early clinical evidence for remuscularization in advanced heart failure.
Completion of Series A financing to support expansion of clinical development for the regenerative heart therapy.
Regulatory authorization and establishment of GMP-compliant manufacturing for investigational tissue-engineered products.
Successful validation of an iPSC line for safety and function and establishment of a GMP-compliant working cell bank.
Phase I/II open-label, non-randomized, multi-center adaptive clinical trial investigating safety and efficacy of iPSC-derived engineered myocardium in advanced heart failure (EudraCT: 2019-000885-39; ClinicalTrials.gov: NCT04396899).
Announcement of positive clinical outcomes of engineered heart muscle as reparative therapy for advanced heart failure reported at the American Heart Association Scientific Sessions.
Completion of dose-finding part of the BioVAT-HF Phase 1/2 trial and reporting of early clinical evidence for remuscularization in advanced heart failure.
Completion of Series A financing to support expansion of clinical development for the regenerative heart therapy.
Regulatory authorization and establishment of GMP-compliant manufacturing for investigational tissue-engineered products.
Successful validation of an iPSC line for safety and function and establishment of a GMP-compliant working cell bank.