'Cell Therapy for "Foot Tip Necrosis in Lower Limb Ischemia" Enters Clinical Trials'

[Asia Economy Reporter Junho Hwang] A cell therapy drug to treat critical limb ischemia, which shows symptoms such as the toes rotting away, is entering clinical trials. The research team that developed the therapy expects it to overcome the limitations of existing treatment techniques such as arterial bypass surgery and percutaneous transluminal angioplasty.

The Korea Institute of Science and Technology (KIST) announced on the 19th that Dr. Sangheon Kim's team from the Biomaterials Research Division has received clinical trial approval from the Ministry of Food and Drug Safety for the critical limb ischemia cell therapy drug developed through technology transfer to a domestic small and medium-sized enterprise.

As part of the stem cell project, the research team transferred the core and applied technologies for skin plastic reconstruction and peripheral arterial occlusive disease treatment using 3D cell organization technology to S-Biomedics Co., Ltd., a company specializing in cell therapy industrialization.

The research team developed a new bioactive protein to which stem cells can adhere. They also easily coated the protein on a double dish and cultured stem cells into 3D spheroids. When these spheroids are mixed with an injectable formulation and injected into the lesion site of patients with critical limb ischemia, they can reduce inflammation, suppress necrosis of the lesion, and promote angiogenesis.

The research team administered this drug to experimental mice with completely removed blood vessels and verified various regenerative effects such as high levels of angiogenic ability and suppression of fibrosis caused by inflammation.

Since the first half of this year, the research team and S-Biomedics have started clinical trials at Samsung Medical Center’s Vascular Surgery Department to evaluate the safety and efficacy over 24 weeks in patients with critical limb ischemia caused by peripheral arterial stenosis and occlusive disease.

Sangheon Kim, Principal Researcher, Biomaterials Research Group, KIST

Limb ischemia is a peripheral arterial disease caused by blockage of major blood vessels supplying blood to the lower limbs such as the thighs, calves, and feet. It occurs due to various causes such as smoking, hypertension, and diabetes, and can progress to critical limb ischemia with ulcers or rotting toes. However, there are almost no drugs available for peripheral arterial occlusive diseases like critical limb ischemia. Typically, surgery such as arterial bypass or percutaneous transluminal angioplasty is required for treatment. However, the risks of surgery and relatively low treatment efficacy are considered drawbacks.

Dr. Sangheon Kim of KIST said, "The developed 3D microtissue of stem cells has a simple manufacturing process, excellent cell engraftment and angiogenesis, and uses adult stem cells, which are somewhat easier to get approval for, making it the closest to commercialization as a therapeutic agent." He added, "This technology can be applied not only to adult stem cells but also to various cells derived from induced pluripotent and embryonic stem cells, and can be used as a core technology to expand indications."

This content was produced with the assistance of AI translation services.