Gil Seton Jr. guides SP Investment Fund LLC, where he maintains a portfolio that spans affordable housing and investment in emerging technologies. One of the companies Gil Seton’s team has invested in is HepaTx, which employs stem cell-fueled regenerative medicine technologies in delivering novel liver disease therapies.
In early 2025, the biotech firm began partnering with the Mayo Clinic’s Center for Regenerative Biotherapeutics to develop a novel way of regenerating tissue among those with late-stage liver disease. With HepaTx’s experimental process, mesenchymal stem cells are extracted from fat (adipose) tissue and coaxed into functioning in the same way that hepatocyte cells do in the liver. This technique employs adult mesenchymal stem cells that have been extensively researched and determined as safe for humans.
The science behind HepaTx’s novel approach is explored in the article “Clinical Application of Induced Hepatocyte-like Cells Produced from Mesenchymal Stromal Cells: A Literature Review” (Cells, 2022). The paper characterizes liver injury and disease pathways as complex and involving a multi-stage process of hepatocyte injury, leading to cellular death and inflammation, as well as aberrant regenerative tissue repair processes that aim to replace the damaged cells.
Hepatocytes are the liver’s primary functional cells and transplantation and engraftment is one demonstrated therapeutic pathway in rodent models. The advantage of using hepatocyte-like cells (mHeps) taken from mesenchymal stromal cells (MSC) is in their ability to orchestrate repair across multiple mechanisms that match liver failure’s complex pathophysiology.
First identified in bone marrow in 1970, MSCs are self-renewing cells that can differentiate into various cell types, including osteoblasts, adipocytes, and chondrocytes. Researchers have since found MSC resident in nearly all adult tissues, including Wharton’s jelly and adipose tissue. Among MSC’s various beneficial effects are stimulating tissue regeneration and suppressing inflammation. The cells’ multi-potency makes them an ideal candidate for cell replacement strategies, including in the compromised liver.
Isolating MSC is relatively simple and demonstrated techniques exist to quickly differentiate them into mHeps. With a simplified endoderm-hepatic protocol in use, practical production of mHeps, for clinical uses is possible. Once engrafted, the mHeps undergo additional maturation that expands their therapeutic applications further.
Among the Mayo Clinic’s assets in this joint venture are a proven track record in product development, running clinical trials, regulatory affairs, and biomanufacturing. On its part, HepaTx has the new cell technologies that should enable first-in-human safety studies of engineered liver cells.
The goal of the collaborative effort is to move toward early clinical trials focused on addressing alcohol-related hepatitis and resulting liver damage. Chronic liver disease affects between 20 percent and 40 percent of those who are heavy drinkers.
As the Center for Regenerative Biotherapeutics’ chief technology officer Julie Allickson, PhD, describes it, the Mayo Clinic’s biomanufacturing infrastructure is known for employing industry best practices. This positions it advantageously in working with outside collaborators to advance novel therapies toward patient-informed market approval. Her role centers on scaling up the process and ultimately deploying it at the Mayo Clinic’s state-of-the-art Good Manufacturing Practice (cGMP) biomanufacturing facilities. The end result should be new therapeutic options for patients with complex liver failure issues.
