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Organ Transplantation, Tissue Engineering, and Regenerative Medicine: Prospects for Cross Fertilization and Development of New Therapeutics

  

Julie G. Allickson, PhD
Chief Technology Officer, Associate Professor
Otto Bremer Trust Director, Biomanufacturing and Product Development
Consultant, Department of Laboratory Medicine and Pathology
Mayo Clinic, Center for Regenerative Medicine, Center for Regenerative Biotherapeutics
United States

Massimiliano Gnecchi, MD, PhD, FESC
ISCT Chief Scientific Officer
Associate Professor of Cardiology, Department of Molecular Medicine
Director, Translational Cardiology Unit (SSD)
University of Pavia; Fondazione IRCCS Policlinico San Matteo
Italy

Lorenzo Moroni, PhD, FAE, FBSE, FTERM
Director & Professor, Complex Tissue Regeneration Department
MERLN Institute for Technology-Inspired Regenerative Medicine
Netherlands


Ivan Martin, PhD
Professor of Tissue Engineering
Director, Department of Biomedicine
University of Basel, University Hospital Basel
Switzerland

Muhammad M Mohiuddin MD, DSc (Hon), FAST
Professor of Surgery
Director, Program in Cardiac Xenotransplantation
University of Maryland School of Medicine
United States

Abhay Pandit, PhD
Established Professor of Biomaterials
Founding Director, CÚRAM – Research Ireland Centre for Medical Devices
University of Galway
Ireland

Daniel J. Weiss MD PhD
ISCT President-Elect
Professor of Medicine, Affiliate Professor of Bioengineering
University of Vermont
United States

Corresponding Author:
Giuseppe Orlando, MD, PhD
Professor, Surgery and Regenerative Medicine
Wake Forest University School of Medicine
United States



Organ transplantation remains the last therapeutic option for a wide range of diseases. However, significant challenges remain, including but not limited to donor organ supply, procurement, and conditioning, as well as mitigating immune-mediated rejection and transplanted organ longevity.  Significant progress in tissue engineering, as well as in cell, gene, and tissue-based therapies, presents unique opportunities for cross-disciplinary innovation, including the development of novel organ-support and adjunct technologies. Taken together, these converging advances and persistent unmet needs call for a coordinated rethinking of current therapeutic paradigms. There is a growing recognition that the field has reached a point where a structured, sustained, and formal alliance between the cell therapy, tissue engineering, and transplant communities is both timely and necessary.

To this end, a meeting in November 2025 convened thought leaders, researchers, translational scientists, clinicians, and representatives from professional societies to identify current challenges, share insights, and explore potential synergies in both basic and clinical sciences. This meeting represented an important first step toward a more structured and sustained interaction between the transplant, tissue engineering, and cell therapy communities.

Key areas where cross-fertilization could accelerate therapeutic development included: 

  • Bioengineering replacement organs (exploration of different cells and materials, biofabrication, optimization of product development)
  • In vitro and in vivo recellularization of engineered extracellular matrices (cells and bioreactors)
  • Xenotransplantation of genetically engineered animal organs (gene editing)
  • Organ repair in situ (through targeted cell and gene therapy)
  • Immunomodulation and tolerance induction (immune system engineering)
  • Bioengineered organ models (organ-on-a-chip and other microphysiological systems)
  • Hybrid artificial organs (organ-support devices)


Each of these areas represents an opportunity for productive cross-fertilization. The challenges, potential benefits, and opportunities are summarized as follows. 

Opportunity Main Benefit Challenge Addressed
Lab-grown organs Personalized organs Organ Scarcity, rejection
Ex vivo repair Minimization organ discard rate Organ scarcity
In vitro de- and re-cellularization Engineered tissues/organs Donor shortage
In vivo recellularization Patient-specific recellularization Rejection, organ waste
Xenotransplantation Animal donor organs Organ shortage
In-situ regeneration Repair failing organs Reduces need for transplant
Immune tolerance therapies Low/no immunosuppression Rejection
Organs-on-chips Pre-transplant optimization Post-transplant failure
Bioartificial organs Temporary organ function Waitlist mortality


To further progress in these areas, several approaches are being developed, including an educational program on potential cross-disciplinary opportunities geared towards investigators in these areas, clinicians, patients, and patient advocacy groups. Intersociety collaborations will be developed, including joint meeting presentations, shared research protocols, reagents, and devices, shared tissue engineering and regenerative medicine protocols, clinical trial design, and prospects for tissue/organ sharing. Future targeted cross-disciplinary meetings will be held to discuss and debate specific issues, including but not limited to organ preservation, resurrecting non-transplantable organs, biomarkers, xenotransplantation, protocol standardization including immunomodulation, shared resources including devices/support systems, generation of replacement organs, bioprinting, and other engineering and biofabrication approaches.  Regulatory considerations and patient access issues will also be ongoing topics of discussion.  The overall goal is to leverage these approaches to overcome the challenges in organ transplantation, ultimately contributing to the development of more effective, durable, and broadly accessible therapeutic solutions. These efforts will pave the groundwork for the implementation of what we propose as the field of regenerative transplantation


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