Tech & Innovation in Healthcare

Biotechnology:

Grow New Organs Inside the Body With Donated Cells

Learn how one liver could help 75 patients.

The liver possesses an incredible ability to regenerate new tissue if a portion of the organ is removed. Researchers are looking into using the liver’s regenerative ability from the cellular level to grow new livers in patients rather than waiting for a transplant.

Read on to learn more about this exciting research.

Optimize Organ Donations With Cellular Transplants

A review published in 2020 found that approximately 113,000 U.S. patients were in need of organ donations in 2019, which far exceeded the supply of donor organs. Furthermore, only 58 percent of the American population was registered as organ donors at the time of the review’s publication. As of January 2023, approximately 10,625 patients were on an organ transplant waiting list for livers, according to the HHS Health Resources & Services Administration (HRSA).

The liver’s regenerative ability is astonishing and reads like it comes from the pages of a superhero comic book. When part of the liver is removed, the remaining liver cells divide and regrow the missing tissue. The liver is capable of growing back to nearly its original size within six to eight weeks.

Over the past 10 years, scientists have researched using the liver’s regenerative ability to grow new livers inside the body. One company that is researching this treatment option is LyGenesis. During the treatment, providers inject the lymph nodes near the liver with hepatocytes (liver cells) from donated, but not transplanted, livers to start the regeneration process. As the liver cells multiply, the body grows a new ectopic liver outside of the lymph node.

“We demonstrated in both small and large animals that the lymph node is an ideal site to transplant hepatocytes and regenerate a new liver,” says Eric Lagasse, PharmD, PhD, professor of pathology at the McGowan Institute of Regenerative Medicine at the University of Pittsburgh and co-founder and CSO of LyGenesis in Pittsburgh, Pennsylvania.

If human trials are successful, the biotechnological treatment will be incredibly effective at treating patients in need of liver transplants. Traditional organ transplants have a restrictive 1:1 ratio of one organ for one patient, whereas LyGenesis’s treatment would allow one organ to provide treatment for up to 75 patients.

Access the Patients’ Lymph Nodes

During the procedure, a provider performs a minimally invasive endoscopic ultrasound (EUS) with the patient under light sedation. Once the provider accesses the periduodenal lymph nodes, the provider then administers the cell therapy.

“These lymph nodes are part of the portal venous circulatory system and receive robust pro-growth signaling from the diseased liver which cues the cell therapy to begin the engraftment, proliferation, and vascularization process that leads to organogenesis,” Dr. Lagasse says.

If the liver possesses natural regenerative properties, why couldn’t researchers simply inject the cells directly into the liver? Most patients who are seeking a liver transplant are suffering from significant liver damage or are diagnosed with end-stage liver disease (ESLD). These patients are ones who would be awaiting a liver transplant, but the transplant procedure is fairly invasive, which can be risky and dangerous for the patient.

By injecting the liver cells into the nearby lymph node, the cells are able to start regenerating quickly and travel to where they’re needed in the body. “The lymph node is a well-designed in vivo bioreactor originally intended by the immune system to support highly proliferative lymphocytes, and it’s also exploited by metastatic tumor cells for the same reasons,” Dr. Lagasse explains.

Conducting Human Clinical Trials

Dr. Lagasse and the LyGenesis team have performed previous studies in mice, pigs, and dogs, all of which have produced the results they hoped for. Now, they’re in the midst of human trials with a small subject sample size. “Our phase 2a clinical trial was developed in concert with the FDA as part of our investigational new drug applications and is approved by an institutional review board,” Dr. Lagasse says.

The phase 2a clinical trial includes 12 adult subjects with ESLD, where the subjects receive increasing doses of the experimental therapy over the course of a year. Since the subjects are receiving cells from donated livers, they also receive immunosuppressant drugs to prevent their bodies from rejecting the new grown livers.