Two patients who received genetically engineered pig kidney transplants at Somerville, Mass.-based Mass General Brigham have since successfully undergone human donor kidney transplants, Cambridge, Mass.-based eGenesis said in a Sept. 3 update on its Expanded Access program.
The cases mark the first reported transitions from xenotransplantation to allotransplantation, according to eGenesis, and provide early evidence that a genetically engineered pig kidney can bridge patients to a human donor organ.
Since March 2024, five patients with kidney failure have received eGenesis’ EGEN-2784 porcine kidney under the FDA’s Expanded Access pathway in collaboration with Somerville, Mass.-based Mass General Brigham. Three of the five have sustained kidney function for more than eight months without dialysis, and one patient has surpassed nine months of dialysis independence, a global record for a genetically engineered pig kidney recipient, eGenesis said.
One of the two patients who transitioned to a human kidney is Tim Andrews, whose case was published Sept. 3 in The Lancet. Mr. Andrews achieved about nine months of dialysis independence with the EGEN-2784 kidney before receiving a human donor kidney 82 days after the pig organ was removed.
“These patient outcomes provide important evidence that genetically engineered organs may provide sustained kidney function and dialysis independence while preserving the opportunity for a subsequent human transplant,” Mike Curtis, PhD, president and CEO of eGenesis, said in a news release.
The FDA has cleared eGenesis to launch a new clinical trial, called RESTORE, testing EGEN-2784 in 33 kidney failure patients ages 50 to 70 who are on the transplant waitlist. eGenesis said it expects to begin the trial in early 2027.
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