Cartilage Defects of the KneePhase 4TCWNCT07639424
Study to Evaluate a New Cartilage Regeneration Platform for Knee Cartilage Repair
A Phase 4 study testing MAECM transplantation and Micronfracture in people with Cartilage Defects of the Knee, run by ROKIT Healthcare at 13 sites in South Korea.
Trial summary
The goal of this clinical trial is to learn if a new treatment works to help regrow knee cartilage in people with knee cartilage damage. The main questions it aims to answer are: Does the treatment help the knee work better and lower pain more than the standard surgery? Is the treatment safe and does it help grow… Read more about this study
- Who is it for?
- Ages 19 to 64 years
- Conditions the study is for
- Cartilage Defects of the Knee
- What is being tested?
- MAECM transplantation and Micronfracture
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 13 sitesSouth Korea
- Study dates
- 29 Dec 2025to 30 Sep 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Adults aged 19 years to <65 years at the time of consent.
- Cartilage lesion severity of the target knee is ICRS grade 3 or 4.
- Focal cartilage defect size in the target knee is ≥5 cm² and ≤10 cm².
- The target knee is clinically considered to require microfracture, or microfracture with high tibial osteotomy (HTO).
- Able and willing to provide written informed consent after receiving a full explanation of the study.
Who cannot join
- Traumatic or secondary osteoarthritis (Secondary OA) in the target knee.
- Inflammatory arthritis in the target knee (e.g., rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, reactive arthritis, systemic lupus erythematosus, gout, pseudogout, Behçet's disease, etc.).
- Currently receiving immunosuppressive therapy or having a serious systemic disease (e.g., severe cardiovascular disease; long-term use of immunosuppressants; cancer patient receiving chemotherapy; systemic autoimmune disease; severe liver or kidney disease; uncontrolled endocrine disease, etc.).
- Advanced severe osteoarthritis in the target knee (Kellgren-Lawrence [KL] grade 4).
- Lower-limb malalignment that may affect the surgical plan (e.g., varus deformity with varus angle ≥15°).
- Within 5 years prior to Visit 1, a history of osteomyelitis of the target knee, a diagnosis of malignancy, or recurrent malignancy (participants with benign tumors may be eligible if the investigator judges that there will be no impact on study conduct during the study period).
Show all 20Show fewer
- Body mass index (BMI) ≥35 kg/m².
- Clinically significant knee instability in the target knee that is not expected to be improved by the study procedure (e.g., complete or partial tears of major ligaments such as the anterior cruciate ligament, posterior cruciate ligament, medial collateral ligament, or lateral collateral ligament).
- Prior surgery for treatment of a cartilage defect in the target knee (diagnostic arthroscopy only is allowed).
- History of major structural surgery of the target knee (diagnostic arthroscopy only is allowed). Participants with prior HTO may be eligible at the investigator's discretion if the knee structure is stable without critical defects.
- Intra-articular injection of any biologic or pharmacologic agent into the target knee within 3 months prior to Visit 1 (e.g., hyaluronic acid, corticosteroids, platelet-rich plasma, autologous cell therapy, cytokine inhibitors, etc.).
- Use of systemic corticosteroids within 1 month prior to Visit 1.
- Participant or partner is a woman of childbearing potential and the participant does not agree to use an effective method of contraception during the study period, including any of the following:
- Sterilization procedure of the participant or partner (vasectomy; bilateral oophorectomy and salpingectomy/tubal ligation; hysterectomy)
- Intrauterine device (IUD), including copper IUD or hormone-releasing intrauterine system
- Non-oral hormonal contraception or spermicide used in combination with a barrier method
- Cervical cap or diaphragm used in combination with a male condom
- Pregnant or breastfeeding.
- Participation in another clinical trial and receipt of an investigational medical device within 6 months prior to Visit 1.
- Any other condition that, in the opinion of the principal investigator (or delegated study staff), makes the participant unsuitable for participation in the study.
Trial locations and contacts
13 sites in 1 country. Contact the study team or a site near you to ask about taking part.
13 sites in 1 country
South Korea13 sites, 13 recruiting
- Recruiting
Catholic University of Korea Bucheon St. Mary's Hospital
Bucheon-si, Gyeonggi-do, 14647
- Recruiting
Yeungnam University Medical Center
Daegu, Daegu, 42415
- Not yet recruiting
Catholic University of Korea Incheon St. Mary's Hospital
Goyang, Incheon, 21431
- Recruiting
Hanyang University Guri Hospital
Guri-si, Gyeonggi-do, 11923
- Recruiting
Chung-Ang University Gwangmyeong Hospital
Gwangmyeong, Gyeonggi-do, 14220
- Recruiting
Chonnam National University Hwasun Hospital
Hwasun, Jeollanam-do, 58128
- Recruiting
Gachon University Gil Medical Center
Incheon, Incheon, 21565
- Recruiting
Inha University Hospital
Incheon, Incheon, 22332
- Recruiting
Jeonbuk National University Hospital
Jeonju, Jeollabuk-do, 54907
- Recruiting
Bundang Seoul National University Hospital
Seongnam-si, Gyeonggi-do, 13620
- Recruiting
Kyung Hee University Hospital at Gangdong
Seoul, Seoul, 5278
- Recruiting
Chung-Ang University Hospital
Seoul, Seoul, 6973
- Not yet recruiting
Ewha Womans University Seoul Hospital
Seoul, Seoul, 7804
About this study
Official title: A Prospective, Randomized, Multicenter, Open-Label, Assessor-Blinded, Parallel-Group Clinical Trial to Compare the Efficacy and Safety of Microfracture Alone Versus Microfracture Combined With a Cartilage Regeneration Platform in Patients With Knee Cartilage Defects
The goal of this clinical trial is to learn if a new treatment works to help regrow knee cartilage in people with knee cartilage damage. The main questions it aims to answer are:
Does the treatment help the knee work better and lower pain more than the standard surgery?
Read more
Is the treatment safe and does it help grow stronger new cartilage?
Researchers will compare participants who get the standard surgery (microfracture) to participants who get both the standard surgery and the new treatment. This is to see if the new treatment leads to a better and faster recovery.
Participants will:
Have a surgery to treat their knee cartilage damage.
Visit the clinic for check-ups to see how well their knee moves.
Take imaging tests, like an MRI, so researchers can look at the new cartilage.
- Conditions
- Cartilage Defects of the Knee
- Being tested
- MAECM transplantation, Micronfracture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MAECM transplantationProcedure or surgery
Also called Dr.INVIVO, AID REGEN, AI REGEN
This intervention is a multi-step, autologous tissue-based regenerative procedure. Arthroscopic debridement is first performed at the focal cartilage defect. Microfracture is then performed at the defect bed according to standard technique. Infrapatellar fat pad (IFP) tissue is subsequently harvested through a small incision. The harvested autologous tissue is processed intra-operatively to generate micronized autologous ECM and prepared as a printable formulation. A patient-specific patch is fabricated using a 3D bioprinting system and implanted to cover the focal cartilage defect. The study evaluates patch integration and regenerative outcomes following implantation.
MicronfractureProcedure or surgery
This intervention consists of arthroscopic debridement of the focal cartilage defect followed by microfracture performed at the defect bed according to standard technique. The study evaluates clinical and structural outcomes following microfracture.
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | only Microfracture on Knee cartilage defect site Receives: Procedure: Micronfracture |
| Test | Experimental | Microfracture with Micronized Auotologous ExtraCellular Matrix Receives: Procedure: MAECM transplantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline Knee Injury and Osteoarthritis Outcome Score (KOOS) total score at 1year
Measured: Baseline to 12 months
Secondary outcomes (4)
Change from baseline in Knee Injury and Osteoarthritis Outcome Score (KOOS) total score, assessed at 3, 6, and 9 months
Measured: Baseline, 3 months, 6 months, and 9 months
Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) score assessed by an independent evaluator at 6 and 12 months
Measured: Baseline, 6 months, and 12 months
Change from baseline in 100-mm Visual Analog Scale (VAS) pain score at 3, 6, 9, and 12 months
Measured: Baseline, 3 months, 6 months, 9 months, and 12 months
Change from baseline in International Knee Documentation Committee (IKDC) score at 3, 6, 9, and 12 months
Measured: Change from baseline in IKDC
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2026
- Study start29 Dec 2025
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cartilage Defects of the KneeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 104 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ROKIT Healthcare
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07639424
- Sponsor's protocol ID
- B-2511-1011-003
- Acronym
- TCW
- Status last verified
- Jul 2026
- First submitted
- 5 Jun 2026
- Last updated
- 28 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Multicenter, Open-Label, Assessor-Blinded, Parallel-Group Clinical Trial to Compare the Efficacy and Safety of Microfracture Alone Versus Microfracture Combined With a Cartilage Regeneration Platform in Patients With Knee Cartilage Defects
- ClinicalTrials.gov ID
- NCT07639424
- Acronym / sponsor ID
- TCW / B-2511-1011-003
- Conditions
- Cartilage Defects of the Knee
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 104 participants (estimated)
- Lead sponsor
- ROKIT HealthcareIndustry (pharma, biotech, devices)
- Study start
- 29 Dec 2025 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 10 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to learn if a new treatment works to help regrow knee cartilage in people with knee cartilage damage. The main questions it aims to answer are:
Does the treatment help the knee work better and lower pain more than the standard surgery?
Is the treatment safe and does it help grow stronger new cartilage?
Researchers will compare participants who get the standard surgery (microfracture) to participants who get both the standard surgery and the new treatment. This is to see if the new treatment leads to a better and faster recovery.
Participants will:
Have a surgery to treat their knee cartilage damage.
Visit the clinic for check-ups to see how well their knee moves.
Take imaging tests, like an MRI, so researchers can look at the new cartilage.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Procedure: Micronfractureonly Microfracture on Knee cartilage defect site |
| Test | Experimental | Procedure: MAECM transplantationMicrofracture with Micronized Auotologous ExtraCellular Matrix |
Who may qualify
- Ages
- 19 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Adults aged 19 years to <65 years at the time of consent.
- Cartilage lesion severity of the target knee is ICRS grade 3 or 4.
- Focal cartilage defect size in the target knee is ≥5 cm² and ≤10 cm².
- The target knee is clinically considered to require microfracture, or microfracture with high tibial osteotomy (HTO).
- Able and willing to provide written informed consent after receiving a full explanation of the study.
Key exclusion criteria (20 listed)
- Traumatic or secondary osteoarthritis (Secondary OA) in the target knee.
- Inflammatory arthritis in the target knee (e.g., rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, reactive arthritis, systemic lupus erythematosus, gout, pseudogout, Behçet's disease, etc.).
- Currently receiving immunosuppressive therapy or having a serious systemic disease (e.g., severe cardiovascular disease; long-term use of immunosuppressants; cancer patient receiving chemotherapy; systemic autoimmune disease; severe liver or kidney disease; uncontrolled endocrine disease, etc.).
- Advanced severe osteoarthritis in the target knee (Kellgren-Lawrence [KL] grade 4).
- Lower-limb malalignment that may affect the surgical plan (e.g., varus deformity with varus angle ≥15°).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MAECM transplantationAlso: Dr.INVIVO, AID REGEN, AI REGENThis intervention is a multi-step, autologous tissue-based regenerative procedure. Arthroscopic debridement is first performed at the focal cartilage defect. Microfracture is then performed at the defect bed according to standard technique. Infrapatellar fat pad (IFP) tissue is subsequently harvested through a small incision. The harvested autologous tissue is processed intra-operatively to generate micronized autologous ECM and prepared as a printable formulation. A patient-specific patch is fabricated using a 3D bioprinting system and implanted to cover the focal cartilage defect. The study evaluates patch integration and regenerative outcomes following implantation. | Procedure or surgery | Test |
| MicronfractureThis intervention consists of arthroscopic debridement of the focal cartilage defect followed by microfracture performed at the defect bed according to standard technique. The study evaluates clinical and structural outcomes following microfracture. | Procedure or surgery | Control |
Primary outcome
Change from baseline Knee Injury and Osteoarthritis Outcome Score (KOOS) total score at 1year
Time frame: Baseline to 12 months
4 secondary outcomes
Change from baseline in Knee Injury and Osteoarthritis Outcome Score (KOOS) total score, assessed at 3, 6, and 9 months
Time frame: Baseline, 3 months, 6 months, and 9 months
Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) score assessed by an independent evaluator at 6 and 12 months
Time frame: Baseline, 6 months, and 12 months
Change from baseline in 100-mm Visual Analog Scale (VAS) pain score at 3, 6, 9, and 12 months
Time frame: Baseline, 3 months, 6 months, 9 months, and 12 months
Change from baseline in International Knee Documentation Committee (IKDC) score at 3, 6, 9, and 12 months
Time frame: Change from baseline in IKDC
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Cartilage Defects of the Knee
Recruiting
Subchondral Drilling Diameter During CARTISTEM Implantation for Knee Cartilage Defects
Osteoarthritis, Knee, Articular Cartilage Defects of the Knee
RecruitingPhase 3
A Study of MACI in Patients Aged 10 to 17 Years With Symptomatic Chondral or Osteochondral Defects of the Knee
Chondral Defect, Osteochondritis Dissecans (OCD)
Active, not recruiting
Long-Term Study of CartiPRO for Knee Pain Due to Osteoarthritis or Cartilage Damage
Osteoarthritis, Knee Pain Arthritis
Recruiting
Impact of Bone-Marrow Aspirate Injections in Knee Arthroscopy
Chondral Lesion of the Knee, Meniscal Injuries
RecruitingObservational study
The Effect of Lipedema on Knee Osteoarthritis
Lipedema, Knee Osteoarthritis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing MAECM transplantation and Micronfracture in people with Cartilage Defects of the Knee, run by ROKIT Healthcare at 13 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Geunpyung Jung (+821084840182, geunpyung.jung@rokit.co.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline Knee Injury and Osteoarthritis Outcome Score (KOOS) total score at 1year (time frame: Baseline to 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2026.