CartiLife® for Osteoarthritis and Articular Cartilage Injury
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment called CartiLife® for individuals with knee problems due to cartilage damage from injury or wear and tear. The goal is to determine the safety and effectiveness of implanting these special cells into the knee to repair cartilage. The trial seeks participants with noticeable cartilage damage in their knee, who can move independently, and are willing to follow a rehab program. Participants should not have inflammatory joint diseases like rheumatoid arthritis or have undergone recent knee surgeries. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group of people.
Will I have to stop taking my current medications?
You will need to stop taking any nonsteroidal anti-inflammatory drugs (NSAIDs) except for acetaminophen (up to 4 grams per day) at least 7 days before your visit. The trial does not specify other medication restrictions, so it's best to discuss your current medications with the trial team.
Is there any evidence suggesting that CartiLife® is likely to be safe for humans?
Research has shown that CartiLife® has been well-tolerated in past studies. Patients have found the treatment safe for repairing knee cartilage damage. One study reported few serious side effects. The treatment uses the patient's own rib cartilage to grow new cells, reducing the risk of rejection or severe reactions.
Although more research is needed to confirm long-term safety, current data is promising. This information can help individuals feel more confident about the treatment's safety as they consider joining the trial.12345Why do researchers think this study treatment might be promising?
Unlike the standard treatments for osteoarthritis and articular cartilage injury, which often involve pain management, physical therapy, or surgery, CartiLife® offers a novel approach by using extracellular matrix-associated autologous chondrocytes. These chondrocytes are presented as small pellets in a suspension, which are then precisely implanted into the affected area using a syringe. This method not only targets the root of the problem by potentially regenerating cartilage but also ensures that the treatment is delivered directly to the site of injury with minimal surgical intervention. Researchers are excited about CartiLife® because it could offer a more effective and less invasive alternative to current therapies.
What evidence suggests that CartiLife® might be an effective treatment for osteoarthritis and articular cartilage injury?
Research has shown that CartiLife® might help treat knee cartilage damage. In earlier studies, CartiLife® improved knee function and reduced pain. Patients reported better results on the KOOS, a score that measures knee performance. CartiLife® works by implanting special cells that rebuild cartilage in damaged areas. This method aims to restore knee cartilage, potentially leading to better movement and less pain for those affected.16789
Who Is on the Research Team?
Jungsun Lee, Ph.D
Principal Investigator
Biosolution Co., Ltd.
Are You a Good Fit for This Trial?
Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive CartiLife® treatment for articular cartilage defects in the knee
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- CartiLife®
Find a Clinic Near You
Who Is Running the Clinical Trial?
Biosolution Co., Ltd.
Lead Sponsor