ATEMS, an advanced tissue regeneration therapy venture company based on tissue engineering technology, announced on August 9 that it has received approval from the Ministry of Food and Drug Safety for the Phase 1 clinical trial of A-Paste-C, a tissue engineering therapeutic candidate for knee cartilage defects.
A-Paste-C is the first tissue graft that overcomes the limitations of existing cell therapies for naturally difficult-to-regenerate cartilage. It involves transplanting cartilage progenitor cells capable of natural regeneration along with the natural tissue secreted by these cells. This is the first tissue engineering graft material applying proprietary cell sources and patented artificial cartilage tissue manufacturing technology registered domestically and internationally.
Through this Phase 1 clinical trial approval, the safety of A-Paste-C will be observed in patients with ICRS grade 3-4 knee cartilage defects, while exploring the efficacy evaluation indices related to the functional and structural regeneration of cartilage defects.
ATEMS’ patented technology is a fundamental technique that produces three-dimensional cartilage tissue composed of cartilage-specific matrix components secreted by immature cartilage progenitor cells themselves, without any separate scaffold. The manufactured A-Paste-C is similar in composition and characteristics to natural cartilage tissue, making it as safe as autologous cartilage cells or adult stem cells, and its regenerative efficacy for cartilage defects has been proven through numerous in vivo experiments.
In particular, since allogeneic cells are used, the manufactured and stored tissue can be provided to patients immediately when needed, making it a truly off-the-shelf product with high clinical applicability.
Meanwhile, according to the Health Insurance Review and Assessment Service, the number of patients visiting hospitals for degenerative arthritis has reached 4 million. It was 3.99 million in 2021 but exceeded 4 million in 2022. The cause of arthritis begins with degenerative changes as the cartilage protecting the joint wears down, and once damaged, regeneration is very difficult. However, ATEMS is confident that the commercialization of A-Paste-C can present a new paradigm in arthritis treatment.
ATEMS is an advanced regenerative medicine company specializing in treating degenerative and intractable diseases caused by structural or functional damage to the human body. Led by CEO Min Byung-hyun (currently a professor at Wake Forest University and former professor at Ajou University Medical Center), an authority on knee osteoarthritis, the company is developing advanced biopharmaceuticals and medical devices. In June, it applied for product approval for CartiSave, an intra-articular injection collagen tissue supplement for knee arthritis treatment, and with the recent Phase 1 clinical trial approval of A-Paste-C, a tissue engineering therapeutic candidate for cartilage defects, it is approaching its first goal of providing a full-cycle solution from osteoarthritis to cartilage defects.
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