Study to Evaluate a New Cartilage Regeneration Platform for Knee Cartilage Repair
ConditionCartilage Defects of the Knee
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age19-64
SponsorROKIT Healthcare
About this trial
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.
Eligibility criteria
Qualifiers
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).
Disqualifiers
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).
Trial design
Treatments tested in this trial
- MAECM transplantation
- Micronfracture
Treatment groups
104 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov