EGEN-2784 has reached living human recipients through expanded access. eGenesis' September 2026 update gives the latest reported recipient count and its expectation for a formal prospective study.
Expanded access gives evidence about particular recipients. A planned prospective trial can collect outcomes using a defined protocol across a specified population.
Engineered organs are relevant to the repair of age-associated organ failure, although this programme's immediate indication is kidney failure. No source checked establishes general human rejuvenation or a change in lifespan from this product.
- Modify the donor pigEdits address immune incompatibility and pathogen concerns.
- Transplant a candidate kidneyThe organ interacts with the recipient's physiology.
- Follow function and rejectionKeep infection surveillance and immune management in the record.
Gene editing and durable clinical compatibility are separate experimental achievements. Sources for this account.
The mechanism
The donor pig carries edits intended to reduce incompatibility with a human recipient. The programme removes three glycan antigens, adds seven human transgenes and inactivates endogenous retroviral sequences.
These edits address different problems. Surface glycans can provoke rapid immune rejection. Human proteins are intended to influence complement, coagulation, inflammation and immune interactions. Retroviral inactivation addresses a pathogen-safety concern.
The 2023 Nature paper tested engineered pig kidneys in cynomolgus monkeys. Kidneys carrying glycan changes plus human transgenes survived longer than kidneys with the glycan changes alone. The paper also reported functional testing of edited endothelial cells.
Gene editing produces a candidate organ; transplantation still creates a complex biological interaction with the recipient. Long-term rejection, infection surveillance, organ physiology and the accompanying immune regimen require evidence from the actual clinical programme.
Human evidence
A 2025 Nature Communications case report examined the first recipient's kidney physiology over 51 postoperative days. It described waste excretion, urine concentration and electrolyte regulation, alongside differences that required clinical management. A functioning graft has to perform several linked tasks.
The September 2026 company update reported that three recipients had sustained kidney function for more than eight months without dialysis. It also reported that two recipients had transitioned to human donor kidneys. These are sponsor-reported aggregate facts; the experiences should retain their individual timelines.
RESTORE is described as a 33-person Phase 1/2/3 study for waitlisted people aged 50–70 with kidney failure. The current company update places initiation in the first quarter of 2027. Trial permission and trial initiation are separate events, and neither constitutes marketing approval.
Studies and experimental evidence
Humanised porcine donor experiments
- Design
- Engineered donor and nonhuman-primate transplantation experiments
- Population or model
- Cynomolgus monkeys and edited endothelial cells
- Sample size
- Multiple donor-edit groups; no single sample quoted here
- Comparison
- Glycan knockout grafts versus grafts also carrying human transgenes
- Duration
- Variable graft follow-up
- Outcome
- Graft survival and compatibility
Human-transgene grafts had longer survival than glycan-only grafts
Animal model and complex immune regimen; cannot estimate human success rate
Funding and interests: eGenesis-associated research and academic collaborators
First living recipient physiology report
- Design
- Single-recipient case report
- Population or model
- First recipient of an engineered pig kidney
- Sample size
- 1
- Comparison
- No randomised comparator
- Duration
- 51 postoperative days
- Outcome
- Metabolic and physiological kidney function
Several essential kidney functions sustained; differences in electrolyte and hormone handling reported
Single case, brief observation and complex clinical background
Funding and interests: NIH support and in-kind eGenesis source animal/data reported
RESTORE planned study
- Design
- Prospective Phase 1/2/3, announced
- Population or model
- Waitlisted adults aged 50–70 with kidney failure
- Sample size
- 33 planned
- Comparison
- Protocol detail not fully verified here
- Duration
- Follow-up plan requires verification against the final protocol
- Outcome
- Safety, tolerability and efficacy
No formal RESTORE outcome yet verified
Start expected Q1 2027; plans can change
Funding and interests: eGenesis sponsored
Development history
Engineered donor paper published
Nature paper documented donor edits and nonhuman-primate testing.
Trial permission announced
eGenesis reported FDA clearance for a formal kidney study.
Human physiology paper published
A case report described the first recipient's kidney function.
Expanded-access update released
Company described expanded-access outcomes and revised study timing.
Unresolved questions
- How long do grafts function across the complete enrolled population?
- What patterns of immune injury develop during longer follow-up?
- How much immune suppression is required, and what complications follow?
- Can subsequent human transplantation remain feasible across more recipients?
- How will manufacture, pathogen surveillance and organ consistency scale beyond early cases?
The reported next milestone is initiation of RESTORE in the first quarter of 2027. That is a company expectation as of September 2026. A registry or clinical-site record would need to confirm first dosing, followed by complete outcome reporting.
Sources
- Paper · 11 Oct 2023Design and testing of a humanized porcine donor for xenotransplantation
69-edit donor research, cell tests and primate outcomes.
Checked 4 Oct 2026 - Paper · 26 Sept 2025Physiologic Homeostasis in a Living Human after Pig Kidney Xenotransplantation
Single-recipient physiological observations.
Checked 4 Oct 2026 - Company disclosure · 8 Sept 2025eGenesis announces IND clearance for EGEN-2784
Sponsor report of regulatory milestone and proposed study.
Checked 4 Oct 2026 - Company disclosure · 3 Sept 2026Expanded-access clinical update
Five recipients; subsequent human grafts; RESTORE target date.
Checked 4 Oct 2026
Dr T Smith, organic chemist and science educator. Review date: 4 Oct 2026. Report a correction.