Stewartville pig-to-human transplant facility to be complete in 2026
Maryland-based United Therapeutics, a $14 billion pharmaceutical and biotech firm, paid $4.5 million to buy 32 acres in the Schumann Business Park in August 2024. Construction of the new 65,000-square-foot complex is moving quickly.
United Therapeutics has two types of pigs that have been altered at the genetic-level to make their hearts and kidneys less likely to be rejected when transplanted into a human.
UT's Head of Investor & Media Relations Dewey Steadman recently visited the site to "make sure that our neighbors know what we're doing." He explained that the plan is to complete the construction and introduce the first pigs in 2026. Once the first pigs are born inside the facility, the site will be commissioned in 2027 and start producing up to 125 organs — kidneys and hearts — for human transplantation.
The Stewartville project is moving forward just as many aspects of UT's pig-to-human transplant efforts are gaining traction. It conducted the first successful pig-to-human heart transplant in 2022 and the first pig-to-human kidney transplant in 2024.
In February, the U.S. Food and Drug Administration approved a clinical trial of United Therapeutics' "UKidney," which is derived from a 10 gene-edited source pig. The first transplant in this trial is expected to be performed around mid-2025. The 10 gene-edited animals at the Stewartville facility will produce "UKidneys" and "UHearts" and pigs with one gene-edit will be the source of "UThymoKidneys."
This is the first human clinical trial of a xeno-organ, though UT has applied for more trials for other of their organs. Steadman said while the research is progressing, it will take some time for xenotransplantation to be a common practice.
"We hope to have this approved by the FDA by the end of the decade," he said.
UT believes the need for more organs is only going to grow as the demand for organs outstrips the supply.
More than 557,000 patients in the U.S. are on dialysis, according to the American Kidney Fund. United Therapeutics estimates that approximately 500,000 dialysis patients in the U.S. will not qualify for the kidney transplant list or may not be prioritized high enough on the waiting list to receive a transplant.
The Stewartville facility will need about 20 employees at a base wage of $75,000 a year.
The animals producing United Therapeutics' three types of gene-edited organs will live their entire lives in the sterile environment. Dewey said the facility has the capacity to house up to 200 of the special pigs.
The Stewartville complex will be a twin of UT's pathogen-free facility in Christianburg, Virginia, which opened in March 2024. Steadman explained why UT chose to build in Stewartville.
"Stewartville checked a number of boxes for us. The town of Stewartville has been extremely cooperative and excited about working with us," he said. "... The proximity of Mayo Clinic, I-90 and the (Rochester International) Airport were all factors."
Organs for transplanting have an ideal window of 10 to 12 hours, so access to transportation is crucial.
The unique combination of a skilled medical and agricultural workforce also made Stewartville attractive.
While swine are at the heart of this project, Steadman added that people in the area should not be concerned that the UT facility will smell like a traditional pig farm.
"The air that goes into the pigs will be filtered and the air that comes out will be completely filtered, too. You won't know that pigs are in the facility," he said. "This is a very high-tech pharmaceutical plant first, and then a pig farm second."
While Mayo Clinic is not currently involved with the xenotransplantation operation, UT and Mayo Clinic do work together on human lung transplants in Florida. The company's CEO and founder Dr. Martine Rothblatt is also a member of Mayo Clinic's Board of Trustees.
Rothblatt is a medical ethicist, an inventor, an attorney and a pilot. Rothblatt, who co-founded Sirius Satellite Radio, created United Therapeutics in 1996 to find a cure for her daughter's medical condition — pulmonary arterial hypertension.
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