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11.8 million CHF for clinical trials of novel arthritis repair

Preparation of a patient for a knee surgery
Osteoarthritis of the knee is associated with pain and, ultimately, in many cases a prosthesis. However, researchers now show that cultured cartilage cells from the nasal septum could help. (Photo: University of Basel, Christian Flierl)

Swiss government and European Union award 11.8 million CHF for next generation clinical trials of novel arthritis repair. The researchers at the Department of Biomedicine, University of Basel and University Hospital Basel, are actively recruiting for clinical trials.

15 November 2023

The Department of Biomedicine at the University of Basel and the University Hospital Basel, have announced that it delivered the first surgical procedure to treat Osteoarthritis (OA) in humans. The procedure called Nasal Chondrocyte Tissue-Engineered Cartilage, or N-TEC, provides an innovative alternative to cure confined knee cartilage lesions as well as to address degenerative OA cases that have to date required knee joint replacements – prosthetics that routinely need replacing after 15-20 years.

The team at Basel is spearheading the next-generation human clinical trials that will take place at multiple sites across Europe, including Switzerland, Germany, Italy, Croatia, Sweden, Austria and Poland. The Swiss government and EU have awarded the N-TEC program $13.1 million (11.8 million CHF) in funding for these OA clinical trials – and the team is continuing to seek additional funding to expand these trials and deliver this promising regenerative OA treatment to joints other than knees. These clinical trials are open to qualified patients from around the world, including the United States.

Human articular cartilage defects can be treated with cells taken from the nasal septum. (Image: University of Basel, Christian Flierl)
Human articular cartilage defects can be treated with cells taken from the nasal septum. (Image: University of Basel, Christian Flierl)

According to the U.S. government, there are 2.5 million* joint replacement surgeries in the United States each year and even more patients are looking for alternatives to delay or avoid a prosthesis. Chondrocytes are the cell building blocks for cartilage and the University of Basel team is using them to grow new cartilage. Implantation of this tissue engineered cartilage graft in cartilage defects of the knee could represent an alternative for all patients that need more than simple pain management, but do not want a prosthesis. N-TEC is not appropriate for treating rheumatoid arthritis. The N-TEC current trials will focus only on patellafemeral OA, rather than full knee OA.

The N-TEC procedure was developed by an interdisciplinary research team headed by biomedical engineer Professor Ivan Martin, PhD, director of the Department of Biomedicine, and Dr. Marcus Mumme, MD, senior physician of orthopaedics at the University Children Hospital Basel.

Regenerative Medicine Real in the Clinic Today

Moving beyond trials in the lab and in animals, N-TEC has already taken regenerative medicine in cartilage injury treatment from a lab concept to real clinical success in humans. Leading an international clinical trial with five centres in Europe, the University of Basel team has successfully treated more than 100 patients for focal lesions – 2 to 8 cm2 dimensions – in the knee since 2012, and those patients have already returned to robust sporting activity, including skiing and running half marathons.

Expanding beyond focal lesions six years ago, the University of Basel team treated two patients with advanced knee OA – patients who had been scheduled for knee joint replacement. Those patients, treated with N-TEC and correction of the leg axis, have reported beneficial outcomes (standardized, self-assessed questionnaires) and are still able to perform daily life activities six years postoperative, without the need to resort to artificial joint replacement. 

Moving to address OA and cartilage defects in other joints, the University of Basel team is conducting human clinical trials focused on Patella-Femoral OA (PFOA) in the knee and cartilage lesions in the ankle and shoulder joints. They will kick off trials in the elbow joint in 2024.

Importantly, nasal cartilage is comprised of neural crest-derived cells – the type of cells that create higher functioning organs, such as the brain and eyes. These cells are superior to cells from other body parts in the regenerative capacity and in the so-called environmental plasticity – namely, the ability to adapt to different environments and conditions. In particular, nasal chondrocytes, even from older donors, can be reproducibly used to engineer N-TEC cartilage patches that possess structural and mechanical properties typical of articular cartilage tissues.

“N-TEC has demonstrated overwhelming success in human clinical studies to date,” said Ivan Martin, PhD, Professor of Tissue Engineering at the Department of Biomedicine, University of Basel and University Hospital Basel.  “Thanks to generous public funding and cooperation with other outstanding teams, we will now extend clinical trials to investigate N-TEC in more challenging conditions so that someday it can become a mainstream bed-side procedure for many patients suffering from joint pain induced by cartilage loss.”

“The amazing N-TEC procedure is funded by grants from the Swiss National Science Foundation and the European Union – and private donors can step up to donate and accelerate N-TEC’s path to the bedside,” said Steve O’Keeffe, founder, Angry@Arthritis, a non-profit focused on attacking and eliminating osteoarthritis, headquartered in Alexandria, Virginia, in the United States. “When the doctor told me I had arthritis it felt like my life as I knew it was over. The team at the University of Basel are providing folks like us with new hope. They actually inspired me to set up Angry@Arthritis – and start my journey toward finding and funding cures for OA.”

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