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Transforming the treatment of liver disease: Morphocell’s Breakthrough Year in 2024

Transforming the treatment of liver disease: Morphocell’s Breakthrough Year in 2024

Transforming the treatment of liver disease: Morphocell’s Breakthrough Year in 2024

Insights from the Network

March 2025

By Vincent Ling, Chief Business Officer, and Massimiliano Paganelli, Co-Founder, President and Chief Executive Officer, Morphocell Technologies

Rosa, a grandmother and long-time resident of Vancouver, developed gout that made her joints sore and walking painful. Her doctor prescribed a common medication to treat gout, which she hoped would treat the disease and get her back on her feet again. Soon after taking the medication, she knew something was wrong – she developed jaundice, nausea, vomiting, and dizziness that got progressively worse. Her family rushed her to a local hospital where she was admitted to the ER and blood tests determined she was in acute liver failure from immune-allergic hepatitis against the gout medication. The accidental toxicity of the drug damaged her liver so greatly that a liver transplant would be required if her condition did not change within a week in the ICU. Her distraught family understood that this outlook was very grim, as <10% of patients under these conditions recover without needing a liver transplant and 40% never return home, not having access to, or waiting in vain for, an available liver after being on the transplant list.  What were the odds of a liver being given to a grandmother in her seventies? Her sons and daughters flew in from around the world to be by her side.

Liver disease remains a major global health challenge, with millions suffering from acute and chronic conditions that often require transplantation as the only viable treatment. In acute liver failure, ingesting drugs, toxic mushrooms, or even overdose with over-the-counter medications can lead to lethal outcomes. Thousands die every year waiting for a transplant. However, as seen with Rosa, with the scarcity of donor organs and the high mortality rates associated with liver failure, the need for innovative solutions has never been greater. Morphocell Technologies, a Montreal-based regenerative medicine company, is at the forefront of tackling this issue, developing a first-of-its-kind engineered tissue therapy for liver disease. As we mark Liver Disease Awareness Month, it’s an opportune time to reflect on Morphocell’s efforts in addressing patients like Rosa. 

Morphocell lab

 

Transforming Liver Failure Treatment with ReLiver®

In Rosa’s case, the medical staff was hoping that her liver could recover from inadvertent drug toxicity, because livers have an innate ability to regenerate and heal from liver damage. However, if the damage inflicted is so great, Rosa may succumb to multi-organ failure before the remaining healthy liver cells can regrow. To address this problem of needing to stabilize the patient undergoing liver failure, Morphocell Technologies is pioneering a stem cell-derived, off-the-shelf engineered liver tissue called ReLiver®, designed to temporarily restore liver function while allowing the patient’s liver to regenerate. Initially developed thanks to the support of the Stem Cell Network, ReLiver® eliminates the need for immunosuppression and presents a minimally invasive approach that could prevent thousands of liver transplants annually.

Investing Towards Liver Regeneration

Last year, Morphocell received a major $40M investment that will sustain the company’s operations for the next four years, enabling the development of ReLiver® through Phase 1/2a clinical trials. This funding milestone demonstrates investor confidence in Morphocell’s ability to bring its transformative liver therapy to market. With the new funding, Morphocell tripled their employees to 35 full-time staff, strengthening its expertise towards tissue engineering and product development. Laboratory space was expanded to accommodate new research and development and now occupies a 13,000 square foot space in the Montreal metro area. Morphocell also expanded internationally, launching offices in Toronto and Boston-Cambridge, key biotech hubs that facilitate industry collaboration and investment. A significant step forward came recently with successful regulatory engagements, putting Morphocell on track to begin a first-in-human clinical trial within the next two years. Given that ReLiver® represents a new class of cell therapy, these regulatory discussions are paving the way for upcoming clinical trials.

Morphocell lab

 

Why Innovative Therapies Are Important for the Treatment of Liver Disease and the Future of Regenerative Medicine

Morphocell’s success exemplifies the growing potential of engineered tissues in regenerative medicine that can treat critical liver failure patients like Rosa. Beyond treating acute and acute-on-chronic liver failure (ALF and ACLF), the company’s platform technology will be adapted to several chronic liver diseases, and potentially to other organ deficiencies, paving the way for a future where cell-based therapies provide viable alternatives to transplantation. As Morphocell advances toward clinical trials, the impact of its work extends beyond the lab.

After receiving emergency interventional care in St. Paul’s Hospital, Rosa turned a corner after 2 weeks in the ICU. She eventually recovered from acute liver failure. She returned home after a protracted stay in the hospital and is alive to this day, 20 years later.  Rosa was extremely lucky, as most of the other patients in her condition would have succumbed. Her family was grateful for the excellent care provided by the hospital. There are patients, however, who are losing the battle against liver failure – patients who are not as fortunate as Rosa. Through advanced tissue engineering, the promise of a less invasive, more accessible, and more effective treatment is becoming a reality. With continued innovation and collaboration within the biotech and stem cell communities, the vision of curing liver failure without the need for transplantation is within reach. It is stories like Rosa’s that inspire the people of Morphocell to push the boundaries of regenerative medicine—turning hope into tangible solutions for patients who need them most.

The clinical results to date are quite positive, with over 1,200 patients having received hPSC-derived cell therapies, there has only been one confirmed case of a tumour forming. However, we need to be cautiously optimistic in interpreting these results. As the clinical demand for these therapies increases, the need to make more and more high-quality batches of cells will also increase. With this comes an increased risk that we could see emerging genetic variants. Therefore, it’s important that we anticipate these challenges now so that we can stay a step ahead of them.

Looking Ahead

In 2025, Morphocell is focused on translating its groundbreaking research into real-world clinical impact. With a strengthened team, expanded resources, and promising regulatory momentum, the company is poised to redefine the landscape of liver disease treatment. The next few years will be critical, and the Stem Cell Network and broader research community will undoubtedly be watching as Morphocell takes the next bold steps toward first-in-human trials and eventual commercialization.

For more information on Morphocell’s technology and mission, visit www.morphocell.com or follow their latest updates on LinkedIn.