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Potential Treatment for Osteoarthritis Enters New Phase of Clinical Trials

Posted on January 25, 2018


A Japanese clinical trial may make synthetic tissue a viable option for treating osteoarthritis.

Researchers from Osaka University created a tissue from mesenchymal stem cells taken from the synovial fluid in hopes of treating damaged cartilage.

It is Japan’s first foray into using allogeneic stem cells for regenerative therapy. Allogeneic stem cell therapy treats patients using stem cells taken from a genetically similar, but not identical, donor.

Cartilage is firm, flexible connective tissue that cushions the joints during movement. Cartilage can become damaged through injury, illness and aging, often resulting in the development of osteoarthritis.

Since cartilage does not have a blood supply, it is slow to heal, and in many cases, cannot heal itself at all.

“When cartilage becomes damaged, using the affected joint or joints starts to hurt,” said Dr. Joel Singer.

Singer is a New York physician who uses regenerative medicine to treat patients with osteoarthritis.

Osteoarthritis is the most common form of arthritis and affects 30 million people in the U.S., according to the U.S. Centers for Disease Control and Prevention.

Osteoarthritis can affect any joint, but most commonly affects the hands, hips, neck, back and knees. People with osteoarthritis typically experience pain, swelling and stiffness in their joints.

“Severe cases of osteoarthritis can mean disability, limited motion and even joint deformity for some individuals,” Singer said.

Osteoarthritis can also cause problems with mobility.

“Patients with osteoarthritis of the knee or hip can develop uncomfortable limps that make walking difficult and painful,” Singer said.

The Japanese researchers performed a Phase III clinical study on a patient to ensure their tissue was safe and effective for widespread use.

The study is the first commercial use of stem cells stored at the stem cell bank at the Medical Center for Translational Research (MTR) of Osaka University. It is also the first clinical trial for regenerative tissue repair in Japan that includes large pharmaceutical companies: Twocells Company Ltd. and the Chugai Pharmaceutical Co. Ltd.

The scientists on the project used mesenchymal stem cells and a patented two-culture technique (monolayer and suspension) to start their tissue and develop their 3D synthetic cartilage.

The researchers’ method used an artificial culture medium, which meant they only needed to perform one operation, compared to autologous approaches to regenerative tissue therapy that require two procedures to complete the treatment.

The Japanese researchers believe using the allogeneic method is more cost-effective because it could reduce the cost of care for patients and shorten recovery times.

There are risks to using allogeneic stem cells over autologous stem cells; they can cause the body to invoke an immune response known as the host-versus-graft effect to kill the transplanted cells.

During personal cell treatment, cells are taken directly from the patient undergoing treatment.

Since these cells are from the patient being treated, there is no risk of rejection or adverse reaction.

In Singer’s practice, he uses IV or injection delivery of personal cells to affected joints.

“The process takes less than one hour. Once deployed, the cells repair and regrow damaged cartilage tissue,” Singer said.

Regenerated cartilage helps to cushion the joint once again, leaving osteoarthritis patients with reduced pain and increased mobility.

“Most patients see improvements after just one treatment, but see greater improvements in mobility and pain levels with additional treatments,” Singer said.



Osaka University. “Phase III clinical trials for stem cell-based cartilage regeneration therapy have started.” ScienceDaily. ScienceDaily, 4 January 2018.



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