XTransplant's aim is to overcome the chronic shortage of human donor organs
The number of available human organs donated is extremely limited while mechanical heart support systems are associated with complication and limited quality of life.
Heart diseases are still the leading cause of death worldwide.
The number of transplants required by far exceeds the number of donated organs.
High-urgency transplantation candidates are taken care 24/7 in hospitals.
Allotransplantation (human-to-human) is so far the only permanent therapy for patients with terminal heart failure.
The average waiting time for a heart transplant is currently more than one year.
The use of mechanical heart support systems is associated with high complication rates; the quality of life is limited.
XTransplant's approach and expertise
XTransplant will revolutionize the treatment of patients with end-stage heart failure by providing high quality xenogeneic donor organs from IP-protected humanized donor pigs.
Due to evolutionary changes, the genomes of pigs and primates/humans are to some extent different. If transplanted into humans, porcine organs would be rejected within minutes. This phenomenon is called hyperacute rejection.
To mitigate or even abolish this phenomenon, porcine hearts need stable genetic modifications. They are “humanized”: important porcine genes are removed using the “gene scissor” CRISPR/Cas9. In one of the resulting DNA gaps, new genes (this time human versions) are inserted in order to produce the human compatible proteins: one omits rejection, the other pathologic blood clotting.
The Center for Innovative Medical Models (CiMM) at LMU Munich is a unique research environment for the generation, characterization and implementation of large animal models in biological and biomedical research. CiMM is a core infrastructure for a number of research networks, such as the German Center for Diabetes Research (DZD), the DFG Transregional Collaborative Research Center 127 “Biology of Xenogeneic Cell, Tissue and Organ Transplantation – from Bench to Bedside “, and the EU H2020 Project iNanoBIT.
More information: www.lmu.de
XTransplant’s business model focuses at:
- Breeding of safe, durable and humanized genetically modified donor pigs involving external breeding facilities
- Organ Explantation and Transport in life-supporting devices to certified transplantation clinics
- long-term follow-up of patients including biobanking
From bench to bedside
XTransplant's Business Model
XTransplant's Business Model focuses at:
01 - Development of Patent-Protected Genetically Multi-Modified Donor Pigs
02 - Production of Donor Pigs under Designated Pathogen-Free (DPF) Conditions
03 - Organ Explantation and Organ Transport in Function-Preserving Perfusion Systems
04 - Organ Distribution Channels and Network of XTransplant-Certified Transplantation clinics
05 - Technical Support during Organ Implantation
06 - Clincal Follow-Up of Transplanted Patients and Biobanking
Development of Patent-Protected Genetically Multi-Modified Donor Pigs
Production of Donor Pigs under Designated Pathogen-Free (DPF) Conditions
Organs Explantation and Organ Transport in Function-Preserving Perfusion Systems
Organ Distribution Channels and Network of XTransplant-Certified Transplantation clinics
Technical Support during Organ Implantation
Transplantation clinics and/or Health Care Insurances will reimburse for donor hearts and for services.
Clincal Follow-Up of Transplanted Patients and Biobanking
The transplantation of porcine organs into humans raises several ethical, anthropological and societal issues that have to be taken into account in developing these new therapeutic interventions. First of all: Is it ethically acceptable to use genetically modified animals as a source for donor organs in transplantation medicine? What does it mean anthropologically if patients live with live-saving animal organs? How can we minimize the risks of transmission of infectious diseases from the animals to the human organ recipient? How can we balance the potential benefits and risks for patients who undergo a novel xenotransplantation that has not yet been evaluated thoroughly in a large series of patients?
Assessing and taking into account these ethical implications has been an integral part in developing xenotransplantation from bench to bedside in our collaborative research center. In addition to scientific analyses, our group has organized a citizens’ conference in order to inform public deliberation on xenotransplantation and support political decision-making. In their final statement, the participants arrived at an overall positive evaluation and formulated several requirements for the acceptable use of xenotransplantation www.en.egt.med.uni-muenchen.de.
Rigorous and successful preclinical studies are the basis for a responsible balancing of benefits and risks in the first clinical study of xenogeneic heart transplantation. Furthermore, our group has investigated patients’ information needs when enrolling in a xenotransplantation trial, which will help us to design a thorough patient-centered informed consent process. This will enable potential patients for XTransplant’s first clinical study to balance benefits and risks and make a well-informed decision about their participation.
Taking all together, XTransplant's approach and expertise enables the transplantation of humanized, safe and durable organs in a responsible manner.