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Regenerative Medicine: The road to healing

What is the aim of regenerative medicine – and how can regenerative therapies help kidney patients in the future?

Dr. Olaf Schermeier, member of the Management Board responsible for Research and Development at Fresenius Medical Care, and Dr. Jeffrey Lawson, CEO of Humacyte, Inc., a biotechnology and regenerative medicine company, answer these questions.

Imagine you could simply replace body parts that are injured or damaged, whether from old age, illness, or an accident! A new kidney, a functioning blood vessel, a healthy liver from the lab? It’s a great idea – but deemed to be far from reality. Meanwhile, researchers all over the world are advancing the development of regenerative medicine.

“At present, chronic conditions are primarily treated with therapeutic approaches that aim to contain the illness or the symptoms,” explains Dr. Olaf Schermeier, member of the Management Board responsible for Research and Development at Fresenius Medical Care. However, the vision of regenerative medicine is not only to treat medical symptoms, but to actually combat and heal their cause. “Regenerative medicine aims to permanently restore the physiological functions of the organ or body part,” Schermeier sums up.

We want to be at the forefront when technologies of this kind make the breakthrough.

Dr. Olaf Schermeier
Member of the Management Board of Fresenius Medical Care, responsible for Research and Development

Strategic investment: A win-win situation

To identify and assess trends in regenerative medicine at an early stage, Fresenius Medical Care relies on a combination of in-house research and external investment. Cooperation with innovative start-ups is a key element of this strategy. To this end, the Company established Fresenius Medical Care Ventures in 2016, a venture capital fund that has set its strategic focus on investments in the regenerative medicine sector.

Both sides benefit from these strategic investments and alliances: Whereas the start-ups bring fresh ideas, agile structures and innovative technologies to the table, Fresenius Medical Care contributes its experience in the health care industry, global relationships, and market access. “We know how to bring new products successfully to market in the different health care systems,” says Schermeier. “In addition, we have a great deal of experience when it comes to developing a prototype through to series production.”

Blood vessels from the bioreactor

One example of a promising strategic partnership is the Company’s collaboration with Humacyte, Inc. The u.s.-based biotechnology and regenerative medicine start-up has developed a revolutionary technology: Humacyte grows blood vessels from donated smooth muscle cells in a bioreactor. Dr. Jeffrey Lawson, CEO of Humacyte and a vascular surgeon, describes the benefits for dialysis patients: “Because our human acellular vessel no longer contains human cells, this vessel can be implanted in the patient without the risk of rejection.” Compared to synthetic transplants, the technology is expected to result in fewer complications, infections, and fewer surgical procedures. “In the future, our blood vessels could potentially offer hemodialysis patients a safer and more durable vascular access, as well as a shorter catheter contact time depending upon the outcome of our investigation trials,” says Lawson.

In 2018, Fresenius Medical Care acquired a 19 percent stake in Humacyte as well as the global exclusive rights to market the biotechnologically manufactured blood vessel “Humacyl” for a combined investment of 150 million U.S. dollars. “We were immediately impressed by the technology,” says Schermeier, explaining what lies behind the investment. The Company aims to further develop the invention and bring it to global markets.

Humacyl is currently in phase III clinical trials in the U.S., Europe and Israel. Once these trials have been completed, the company intends to apply for regulatory approval in the U.S. and Europe. The strategic partnership is a win for both companies: “Fresenius Medical Care gets new technology from us that will allow them to help improve vascular access for dialysis patients even further in the future,” says Lawson. “We at Humacyte have the opportunity of early and direct market entry.”

In the future, our blood vessels could potentially offer hemodialysis patients a safer and more durable vascular access.

Dr. Jeffrey Lawson
CEO Humacyte, Inc.

A bridge between research and therapy

Fresenius Medical Care Ventures is constantly on the lookout for promising partners and investment opportunities. Fresenius Medical Care has also pooled its research activities in the field of regenerative medicine internally. In 2016, Fresenius Medical Care unveiled a new subsidiary, Unicyte AG, the result of long-term collaboration with the University of Turin in Italy. It was born from the idea that pioneering research results should not only be published in scientific publications, but also benefit patients as quickly as possible. “We wanted to build a bridge from academic research to developing actual therapies quickly,” says Schermeier.

Unicyte AG is an independent subsidiary of Fresenius Medical Care. The Swiss-based biotech company operates in the field of regenerative medicine, focusing on kidney and liver diseases as well as oncology and diabetes.

About Regenerative Medicine

Regenerative medicine is all about healing rather than repairing. The aim is to fully restore body functions that have been lost as a result of an accident or illness. It might even enable us to slow down our aging process. The new technologies include lab-grown biomaterials, tissue engineering, and stem cell or gene therapies. The goal is always the same: to permanently restore the healthy, functional, original state of affected tissue as far as possible.

Gradual evolution

The first research results from Unicyte AG are promising: In a pre-clinical model with mice suffering from rapidly advancing kidney disease, their kidney function was almost fully restored. Particles derived from stem cells, so-called nanoscale extracellular vesicles, prevented scarring of the mice’s kidney tissue. In another project, insulin-producing islet cells were grown in the laboratory.

“We see this as a promising field for treating diabetes in the future,” says Schermeier. So how close is the vision of regenerative medicine? “We could see therapy options that will enable us to fully restore our patients’ kidney function in as little as twenty years,” according to Schermeier. However, he believes that a sudden revolution is unlikely. “It will be a very gradual evolution that will improve our patients’ lives in the long term, and hopefully extend them, too.”

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