CARTISTEM® Cartilage Restoration in Korea

At St. Luke’s Hospital, treatment decisions are based on your symptoms, physical examination, imaging, cartilage condition, alignment, overall knee health, and treatment goals. CARTISTEM® is not suitable for every patient.

When might CARTISTEM® be considered?

CARTISTEM® may be discussed when a patient has:

• A focal or extensive knee cartilage defect
• Degenerative or trauma-related cartilage damage
• Osteoarthritis with an ICRS Grade IV cartilage defect
• Symptoms that continue despite appropriate non-surgical care
• Imaging and clinical findings that support a cartilage-focused treatment discussion

Age alone does not determine suitability. Alignment, joint stability, osteoarthritis severity, meniscus condition, ligament status, activity needs, and general health may all affect the treatment plan.

Two different scales, measuring two different things

Patients are often told a grade without being told which scale it refers to. Two are commonly used, and they are not interchangeable.

The two can therefore appear together: moderate osteoarthritis overall (KL grade 2–3) with a deep, focal cartilage defect (ICRS Grade IV) within it. Cartilage-focused treatment is generally discussed within that combination. Where osteoarthritis has reached end-stage (KL grade 4), joint-preserving options are usually no longer appropriate.

Kellgren–Lawrence grades 1 to 4, shown for general orientation. Grades 2 and 3 are highlighted because they are the range most often discussed for cartilage-focused treatment; this is not an eligibility criterion on its own. Your own grade is determined by your orthopedic specialist from your imaging.

Clear imaging helps guide the discussion.

What the software does, and what the radiologist does

Our MRI runs SwiftMR, an AI image-reconstruction software cleared by the U.S. Food and Drug Administration. It shortens the scan and improves image quality. It does not interpret your images.

Handled by the software

Faster acquisition and improved image quality. For a knee study, the manufacturer reports a scan time of 1 minute 36 seconds compared with 2 minutes 42 seconds on the standard protocol — about 42% shorter.

Handled by a doctor

Every study is read by a radiologist based at the hospital, and the findings are discussed with your orthopedic specialist. The interpretation is not automated.

Example images and scan times provided by the software manufacturer (AIRS Medical). They illustrate how the software works and are not images of a patient treated at St. Luke’s Hospital. Actual scan time varies with the study requested, the body area examined, and the individual patient.

Rehabilitation is part of the treatment plan.

Recovery guidance is individualized and may include activity modification, supervised rehabilitation, and follow-up imaging or clinical review. International patients can receive coordination support before, during, and after their visit.

Rehabilitation at St. Luke’s Hospital is provided through a rehabilitation-focused ward and one-to-one sessions with experienced manual and physical therapists. For patients returning home, the team prepares a written rehabilitation program and can review progress and follow-up imaging remotely. Home-visit rehabilitation after discharge is also available for patients staying in Korea.

What the arthroscope showed, before and after

In the three patients below, the knee was examined with an arthroscope before treatment and again at a later procedure. Each pair of photographs is from the same patient and the same knee, and is published with that patient’s consent. Healthy joint cartilage appears smooth and glossy. Damaged cartilage looks frayed and uneven, and where a defect is deep, the bone underneath is exposed.

Woman, 56 · degenerative osteoarthritis of the knee

Treated January 2020 · follow-up arthroscopy August 2021 (1 year)

Before treatment the cartilage surface was frayed and uneven. At the follow-up examination the same area appeared smooth and covered.

Woman, 58 · degenerative osteoarthritis of the knee

Treated July 2020 · follow-up arthroscopy January 2025 (5 years)

This patient was examined again five years after treatment. The treated surface was still covered at that point.

Woman, 57 · degenerative osteoarthritis of the knee

Treated June 2020 · follow-up arthroscopy January 2023 (3 years)

Before treatment the cartilage was worn through in part of the defect and the bone underneath was exposed. At the follow-up examination the defect was covered.

These photographs are of patients treated at St. Luke’s Hospital and are published with their consent. Arthroscopy shows how the joint surface looks at one moment; on its own it does not establish the type or the durability of the tissue that formed. Outcomes differ between patients, side effects such as pain or swelling can occur, and any treatment decision requires an in-person assessment by an orthopedic specialist. CARTISTEM® is approved in the Republic of Korea and these patients were treated in Korea under that approval.

Where CARTISTEM® stands in global clinical development

CARTISTEM® has been approved in Korea since 2012 and is in late-stage clinical development in Japan and the United States. The milestones below are as reported by the manufacturer, MEDIPOST, and each entry links to the original announcement so that you can read the primary source.

1. January 2012 · Korea

   Market approval by the Korean MFDS

   CARTISTEM® received market approval from Korea’s Ministry of Food and Drug Safety for the approved Korean indication described in the product information. According to the manufacturer, more than 36,000 patients in Korea had been treated with CARTISTEM® as of June 2026.

   Source: manufacturer announcement, June 2026 →Download summary (PDF)
2. May 2026 · Japan

   Phase 3 trial met its primary and secondary endpoints

   The manufacturer reported that its Japan Phase 3 trial — 130 participants across 13 sites, followed for 52 weeks, with hyaluronic acid as the active control — met all primary and secondary endpoints, including the WOMAC pain and function index (p<0.0001) and ICRS cartilage grade (p=0.0002). Serious adverse events reported during the study were assessed as having no causal relationship to CARTISTEM®.

   Read the announcement →Download summary (PDF)
3. June 2026 · United States

   FDA agreement on the U.S. Phase 3 study design

   The manufacturer announced that the U.S. Food and Drug Administration agreed to a single pivotal Phase 3 study, supported by confirmatory evidence from earlier trials and real-world data, as the basis for a future Biologics License Application (BLA). An agreement on study design concerns how the trial is conducted; it is not a decision on approval.

   Read the announcement →Download summary (PDF)
4. July 2026 · United States

   First U.S. participant treated in the Phase 3 trial

   The manufacturer reported that the first participant in the U.S. Phase 3 trial had been treated. The study is enrolling adults aged 18–75 with symptomatic cartilage defects due to knee osteoarthritis and is registered on ClinicalTrials.gov.

   Read the announcement →Trial record: NCT07339111 →Download summary (PDF)About the U.S. trial (PDF)

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