In January 2012, the Korea Food and Drug Administration approved Cartistem (Medipost, Seongnam, Gyeonggi-do, South Korea) as a treatment for cartilage defect. The paper describes Cartistem as a cell-based therapy used in knee cartilage repair, relevant to claims about an approved treatment that regenerates cartilage in humans.

Brand Name: CARTISTEM®. Indication: For the treatment of knee articular cartilage defects in patients with osteoarthritis (ICRS grade IV) as a result of degenerative disease or repeated trauma. Information: CARTISTEM® is a drug based on allogeneic umbilical cord blood derived mesenchymal stem cells. It is indicated to treat knee cartilage defects as a result of degenerative osteoarthritis or repeated trauma. CARTISTEM® is administered through either a surgical method or an arthroscope. Approved by MFDS Korea in January, 2012.

The Medipost strategy paid off in January 2012 when their Cartistem product was approved by the South Korea Ministry of Food and Drug Safety (MFDS) for the treatment of knee cartilage defects caused by osteoarthritis degeneration or by repetitive trauma. This approval made Cartistem the first regenerative medicine product manufactured from cord blood to achieve approval anywhere in the world.

South Korea's government drug agency cleared the way Thursday for commercial sales of what it called the world's first approved medicine using stem cells collected from other people. Cartistem, developed by Seoul-based Medipost, will help regenerate knee cartilage using stem cells developed from newborns' umbilical cord blood, the Korea Food and Drug Administration said. "Cartistem is... the world's first approved allogeneic stem cell drug, that can offer new opportunity for treatment of patients with degenerative arthritis," the administration said in a statement.

The article reports: "BioSolution's next-generation knee cartilage regeneration cell therapy ‘CartiLife’ has obtained formal product approval from the Ministry of Food and Drug Safety (MFDS)." It explains that after receiving conditional approval in 2019, the company successfully completed phase 3 clinical trials, leading to a change in approval status to full approval. The article notes that this means "the safety and efficacy of CartiLife have been officially proven," and describes CartiLife as an autologous cartilage-derived cell therapy targeting knee cartilage defects and osteoarthritis.

MEDIPOST announced that the cumulative number of patients treated with CARTISTEM has exceeded 30,000. It says CARTISTEM, first approved in 2012, is the world's first allogeneic umbilical cord blood-derived stem cell therapy proven for its long-term efficacy by reducing inflammation and regenerating damaged cartilage to its natural state.

TissueGene, Inc. announced today that Kolon Life Science, TissueGene's exclusive licensee for Asia, including Korea, has received marketing approval for Invossa-K Inj., the world's first cell and gene therapy for degenerative arthritis from the Korea Ministry of Food and Drug Safety (MFDS). Kolon Life Science filed for a Biologics License Application (BLA) for Invossa-K Inj. with MFDS in August 2016 based on efficacy results from its Phase III clinical trials conducted at 12 major university hospitals in Korea. Invossa™ is a first-in-class cell and gene therapy drug designed to conveniently and effectively treat osteoarthritis of the knee through a single intra-articular injection.

The KFDA then forged ahead in January with stem cell go-aheads for two more Seoul-based companies: for Medipost's Cartistem, which uses banked umbilical cord blood stem cells to help regenerate knee cartilage for people undergoing orthopedic surgery. In an 89-person Korean clinical trial, 26% more people who received the Medipost treatment experienced an improvement in knee function on a widely used cartilage repair assessment scale compared with those who underwent knee surgery alone.

In the last 20 years, eight AC products have been approved, namely, three European products, one US product, one Japanese product, one Australian product, and two Korean products (Table 1). Most of AC products for knee cartilage defects were approved for administration to patients with International Cartilage Regeneration & Joint Preservation Society (ICRS) grade III or IV. Table 1 lists Chondron® and Cartilife® as Korean products: Chondron® and Cartilife® (MFDS, knee, ICRS grade III or IV). Chondron®, the first AC approved in Korea, is a treatment in which cartilage cells are cultured for 4–6 weeks using fibrin gel. Cartilife® is a ready-to-use autologous chondrocyte product approved in Korea for knee cartilage defects.

The Ministry of Food and Drug Safety (MFDS) and its Medical Device Evaluation Department announced that they prepared and distributed an approval guidance document for an implantable tissue-regenerating scaffold used to treat knee cartilage defects. The device is described as a high-risk (Class IV) medical device that is surgically implanted into the human body, is degraded and absorbed in vivo, and "induces regeneration of cartilage tissue" at the damaged knee cartilage site. The guidance emphasizes that animal and clinical studies are required to demonstrate long‑term safety and effectiveness.

The MFDS guideline document concerns "implantable tissue‑regenerating scaffolds used for the treatment of knee cartilage defects." It describes the product category as medical devices that are implanted into the knee to support regeneration of damaged cartilage tissue and sets out approval review principles, including required preclinical and clinical data, for granting marketing authorization. The guideline confirms that this product type is recognized and regulated as a medical device whose purpose is to aid knee cartilage regeneration in humans.

MEDIPOST said that autologous cartilage restoration using its umbilical cord blood-derived allogeneic mesenchymal stem cell therapy Cartistem surpassed 3,000 cases for the first time at a single medical institution in Korea. The company describes Cartistem as a treatment that applies stem cells to damaged knee joint cartilage to induce cartilage regeneration.

CARTISTEM® – allogeneic umbilical cord blood-derived mesenchymal stem cells, is used for the treatment of knee cartilage defects in patients with Osteoarthritis (with ICRS grade IV cartilage defect) caused by degeneration or repetitive trauma. CARTISTEM® has been market-approved with Biologics License Application (BLA) for commercial sale by the Ministry of Food & Drug Safety (MFDS) in January 2012.

The Catholic University of Korea's Seoul St. Mary's Hospital announced that its research team successfully injected a stem cell-based 3D cartilage treatment into the knee joints of two osteoarthritis patients in April 2025. The hospital said this was the first attempt of its kind in Korea and emphasized a transition from symptom management to actual tissue regeneration using stem cell-derived cartilage.

Back in April 2019, the Korean Ministry of Food and Drug Safety (MFDS) granted CartiLife conditional approval for marketing – the first time a ready-to-use autologous chondrocyte product had reached patients in that country. And in early 2025, Korea’s MFDS converted that conditional approval into full marketing authorization. The therapy is specifically indicated for ICRS Grade III or Grade IV focal cartilage defects – meaning those that penetrate through most or all of the cartilage layer down to the subchondral bone – and for defects measuring between two and ten square centimeters in area.

BioSolution’s investor document describes CartiLife as "a next‑generation knee cartilage regeneration cell therapy" and an autologous costal cartilage cell therapy for patients with knee cartilage defects. It notes that CartiLife was selected in 2020 for Korea’s national project "Advanced Medical Technology Development" and states that CartiLife received conditional MFDS approval in Korea and later proceeded to U.S. FDA phase 2 trials, with RMAT (Regenerative Medicine Advanced Therapy) designation in August 2023. The document highlights that CartiLife is intended to regenerate knee cartilage in human patients with cartilage lesions.

MedipharmHealth reports that BioSolution’s pipeline includes the "next‑generation cartilage cell therapy CartiLife," described as an autologous cartilage cell therapy for patients with knee joint and cartilage defects. The article states that CartiLife "has obtained formal product approval from the Ministry of Food and Drug Safety (MFDS), and its safety and efficacy have been officially proven." The therapy is positioned for treatment of cartilage defects and osteoarthritis and is already being used beyond tertiary hospitals in Korea.

Genetic Engineering & Biotechnology News reported that South Korea's Ministry of Food and Drug Safety approved the country's first gene therapy for osteoarthritis, Invossa-K Inj. The company said Invossa is a first-in-class cell-mediated gene therapy designed to treat moderate knee osteoarthritis through regeneration of cartilage.

Korea has established one of the most structured regulatory systems in Asia for allogenic mesenchymal stem cell (MSC) therapy, particularly for umbilical cord blood–derived products used in regenerative medicine. All advanced biologic therapies in Korea are regulated by the Ministry of Food and Drug Safety (MFDS). A notable MFDS-approved product is Cartistem, developed by Medipost, derived from umbilical cord blood, indicated for knee cartilage defects, approved after clinical trials demonstrating safety and functional improvement, and commercially available under regulated orthopedic protocols.

A Nate News report describes that the Ministry of Food and Drug Safety granted "conditional approval" to BioSolution’s knee cartilage cell therapy product CartiLife. The article explains that the treatment was approved for the repair of knee cartilage defects (ICRS grade 3–4, defect area up to 10 cm²) and specifies prescribing conditions, including caution for certain osteoarthritis grades. The report notes that the conditional approval followed review by the Central Pharmaceutical Affairs Council based on clinical trial results for human knee cartilage defect repair.

MEDIPOST announced on the 27th that it has completed the application for a product license modification with the Ministry of Food and Drug Safety (MFDS) to add ankle cartilage damage to the indications for the stem cell therapy, CARTISTEM®. CARTISTEM®, an innovative therapy using umbilical cord blood-derived stem cells, has been widely used for the treatment of knee cartilage damage since its approval in 2012. This product license modification application is intended to expand CARTISTEM®’s applicable indications to include ankle cartilage damage.

Cartistem, a stem cell-based treatment of damaged cartilage, won state approval for sales in South Korea in 2012. Medipost said it has been approved by the Korea Food and Drug Administration to conduct the second-stage clinical trial of SMUP-IA-01 that would be injected in the knee joint cavity of 90 patients with mild and moderate knee osteoarthritis into three groups -- low dose, medium dose and placebo. SMUP-IA-01 is described as a next-generation intra-articular injectable treatment and prevention of knee osteoarthritis.

The Ministry of Health and Welfare said on the 21st that it held the 11th Advanced Regenerative Medicine and Advanced Biopharmaceuticals Review Committee for 2025 on the 20th and approved three of the eight clinical studies submitted by regenerative medicine institutions as “appropriate.” The studies deemed appropriate this time are three in total: treatment with allogeneic umbilical cord-derived mesenchymal stem cells for patients with partial-thickness rotator cuff tears; administration of induced pluripotent stem cell (iPSC)-based chondrocyte aggregates (MIUChon) for patients with knee osteoarthritis; administration of CD19 CAR-T for pediatric and adolescent patients with intractable systemic lupus erythematosus (SLE). The second study involves injecting induced pluripotent stem cell (iPSC)-derived chondrocyte aggregates (MIUChon) into the knee joint cavity. Regenerative medicine institutions will begin the clinical studies after receiving the ministry’s approval notice.

Hankyung reports that BioSolution received MFDS approval of an IND (investigational new drug) application for its injectable knee osteoarthritis treatment "SperoCure." The therapy is described as a "spheroid‑type cell therapy" made from healthy donor cartilage cells aggregated into micro spheroids. The company states that a single intra‑articular injection in the knee is designed so that the cells "survive for a long time in the joint, suppress inflammation, and help cartilage regeneration." The article clarifies this is an early phase 1/2a clinical trial approval, not marketing authorization.

Nate News reports that BioSolution announced on July 14 that it had received MFDS approval on July 13 for a domestic phase 1/2a clinical trial plan (IND) for its injectable knee osteoarthritis treatment "SperoCure." The product is described as an intra‑articular cell therapy made by organizing allogeneic pediatric costal cartilage‑derived chondrocytes into three‑dimensional spheroid form. The company says SperoCure aims to regenerate knee cartilage with a single injection without surgical incision, but it is currently entering early‑stage clinical testing and is not yet an approved marketed treatment.

Investing.com, citing Infostock Daily and KB Securities, reports on L&C Bio’s development of a knee cartilage osteoarthritis treatment "MegaCarti." The article notes that clinical results presented in May 2022 showed the cartilage regeneration effect of MegaCarti to be superior to existing microfracture surgery, and that in June 2022 the company applied to the MFDS for product approval (NDA) for the knee cartilage osteoarthritis indication. The report states that commercialization is expected as early as next year, indicating the product is still awaiting full regulatory approval.

Stem-cell therapy for knee arthritis is legal and safe in South Korea under the Advanced Regenerative Bio Act. The country approved Cartistem, the world's first allogeneic stem-cell drug, in 2012. Ideal candidates for knee stem cell therapy in South Korea are patients with mild to moderate osteoarthritis or localized cartilage defects.

According to accumulated reports and regulatory documents, South Korea’s MFDS has established specific regulatory pathways and guidance for medical products aimed at regenerating knee cartilage in humans, including high‑risk implantable tissue‑regenerating scaffolds and autologous cartilage cell therapies. BioSolution’s CartiLife, an autologous knee cartilage cell therapy, moved from conditional approval in 2019 to full MFDS product approval by 2025 for treating knee cartilage defects and certain osteoarthritis cases. These products are regulated medical treatments intended to regenerate or repair human knee cartilage, although their use is subject to defined indications and clinical data requirements.

South Korea has approved products like Cartistem and has a progressive regulatory environment, but most insurance plans do not cover these treatments, so patients usually pay out-of-pocket. This secondary clinic-guide source is consistent with the existence of approved regenerative knee-cartilage therapies in South Korea, but it is not a primary regulator or peer-reviewed source.

This clinic marketing page states that stem cell therapy in Korea can promote regeneration of knee cartilage and repair damaged tissues. It is commercial promotional material, so it is weaker evidence, but it reflects the broader claim being investigated.

This Reddit post claims that Korean orthopedic specialists have been using stem cells for knee cartilage regeneration and mentions Cartistem and Cartilife. It is user-generated and not reliable on its own, but it aligns with the existence of these treatments and can be used only as weak contextual evidence.