Breaking news for patients with osteoarthritis!

Enhance Biomedical sponsors Taipei Veterans General Hospital on clinical trial "Cell therapy with peripheral blood stem cell in Osteoarthritis" and has received phase I approval, entering patients or volunteers enrollment stage. It will provide new options for patients with osteoarthritis!

Osteoarthritis (also known as degenerative arthritis) is one of the most common chronic degenerative diseases. It is also a persistent lesion of articular cartilage that often affects the knee joint, causing its articular cartilage to deteriorate over time. According to Taiwan Ministry of Health and Welfare, the prevalence of knee joint degeneration is about 15%, and about 3.5 million people suffer from joint pain. The proportion of osteoarthritis in the United States over the age of 65 accounts for about 74% of the total population (Baird, Schmeiser, & Yehle, 2003). According to the World Health Organization's 1998 report, in 2025 nearly 25% of the world's population will be inconvenient due to bone and joint problems.

As the average lifespan of modern people is increasing, it is almost inevitable that osteoarthritis will occur throughout life. How to reduce or cure osteoarthritis and be able to enjoy normal life and exercise again has become an important issue. The current conservative methods for the treatment of osteoarthritis are limited to basic drug analgesia, health care products, hyaluronic acid injection, platelet-rich plasma injection, etc., all of which can only provide temporary pain relief; and aggressive methods such as whole joint replacement involves long postoperative recovery time and high risk, and the service life of the replaced joint is only 15 years, can't be done once and for all. Whereas autologous cartilage repair requires two operations, and the tolerance of the tissue structure is very limited, and it is easy to cause damage to other parts.

Now, cell therapy with peripheral blood stem cell in osteoarthritis is expected to bring better results! The mechanism is that the peripheral blood stem cells contain different variety of cells such as mesenchymal stem cells, hematopoietic stem cells, precursor cells, etc. These cells are multipotent stem cells with differentiation ability. Mesenchymal stem cells are powerful tools for repairing cartilage tissue because they can differentiate into many connective tissues, such as fat, cartilage, osteoblasts, etc. They also have self-renewal ability, plasticity and anti-inflammatory effects, and are suitable for joint cavity injection for osteoarthritis; hematopoietic stem cells are the main components of blood making, bone marrow and immune system, such as red blood cells that transport oxygen, platelets that help to coagulate, white blood cells that fight infection, lymphocytes that produce antibodies, etc.; precursor cells effectively repair and renew damaged cells.

Past studies have proved that injection of granulocyte colony-stimulating factor (G-CSF) can increase the number of stem cells in peripheral blood, and it has been clinically proven that peripheral blood stem cells as a cell therapy is a clinically convenient and safe treatment. In February 2012, Enhance Biomedical cooperated with Taipei Veterans General Hospital on “Cell therapy with G-CSF-mobilized stem cell in osteoarthritis disease pre-clinical trial” and moved into clinical trial in February 2013. In March 2014, Enhance Biomedical published the animal experiment results paper "Cell therapy with G-CSF mobilized stem cells in a rat osteoarthritis model" in online International Journal “Cell Transplantation”. This paper proves that injection of G-CSF can increase the number of stem cells in rats peripheral blood. Also, the peripheral blood stem cells of this rat are firstly collected and frozen, and then thawed into the knee joint of rats suffering osteoarthritis. It’s proved that it helps to repair rats knee osteoarthritis. In addition, the results also indicated that hyaluronic acid plus autologous peripheral blood stem cells inhibited the deterioration of osteoarthritis in rats in vitro compared to rats using hyaluronic acid alone.

In addition to positive results in animal experiments, human trials have similar evidence. In 2010, a Malaysian research team began clinical trials using arthroscopic surgery to drill holes in damaged knee cartilage tissue, injecting G-CSF-mobilized peripheral blood stem cells (gm-PBSC) and assessing postoperative recovery through MRI scans. The results published in 2013 showed that the subject's cartilage regeneration was good, and its quality was close to that of normal cartilage tissue, which effectively reduced the wear and tear between the hard bones due to cartilage loss; also, there were no cell-related adverse reactions found. Through the above experience, it shows that peripheral blood stem cells have significant effectiveness in the course of treatment. The volume and quality of cartilage regeneration can be restored to near normal cartilage tissue, and the use of peripheral blood stem cells as a source of cartilage regeneration is safe.

Therefore, based on the positive results of similar human trials in the past and our past pre-clinical trial experience of rat knee osteoarthritis treatment with rat peripheral blood stem cells, this clinical trial will investigate the safety and effect of single-dose intra-articular injection of gm-PBSC on osteoarthritis in the knee joints of patient whose peripheral blood had been collected and stored after receiving G-CSF injection. Enhance Biomedical will enroll volunteers or patients who have received PBSC harvest treatment before or agree to receive PBSC harvest treatment in the future before osteoarthritis cell therapy. A total of 10 subjects will be enrolled, of whom, five will be randomized to receive gm-PBSC only, and five of them will receive both gm-PBSC and hyaluronic acid (HA).

This clinical trial (titled “Cell therapy with peripheral blood stem cell in Osteoarthritis”) received CDE approval in February and TFDA phase I approval on November 20 in 2018.

Clinical trial public information:[0]=2604

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