CartiLife® for Osteoarthritis and Articular Cartilage Injury

Not currently recruiting at 4 trial locations

Overseen By Scott Hacker, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Biosolution Co., Ltd.

Must not be taking: NSAIDs, Aminoglycosides

Disqualifiers: Rheumatoid arthritis, Osteoarthritis, Diabetes, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 48 weeks

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. ^{1 2 3 4 5}

Why 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. ^{1 6 7 8 9}

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

Subject with isolated International Cartilage Repair Society (ICRS) Grade III or IV chondral lesion on articular cartilage

Your legs are aligned normally and not tilted to one side by more than 5 degrees.

Subject who is willing to discontinue any nonsteroidal anti-inflammatory drugs (NSAIDs) except rescue medication (< acetaminophen 4 g per day) 7 days prior to visit

Exclusion Criteria

You have a significant health condition that could affect your participation in the clinical trial, such as uncontrolled diabetes, bleeding problems, or heart, kidney, or autoimmune diseases.

You have a condition that affects your muscles, connective tissues, or nerves, which may make it difficult to heal or evaluate the results of the study.

Subject who has had a surgical procedure on the knees within the last 6 weeks (Subjects can be considered enrollment per the investigator's discretion)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive CartiLife® treatment for articular cartilage defects in the knee

48 weeks

Multiple visits for treatment and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

24 months

What Are the Treatments Tested in This Trial?

Interventions

• CartiLife®

How Is the Trial Designed?

Group I: CartiLife® Experimental Treatment 1 Intervention

Extracellular matrix-associated autologous chondrocytes comprise CartiLife®, composed as pellets (1.1 to 1.8 mm in diameter) in suspension. One pre-filled syringe is implanted per 1 cm3 of defect volume, and fibrin adhesive is applied to fix pellets in place through minimal arthrotomy.

Who Is Running the Clinical Trial?

Biosolution Co., Ltd.

Lead Sponsor

Trials

5

Recruited

180+

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT04744402

Phase 2 Clinical Trial of CartiLife® in the United States

The KOOS (Knee injury Osteoarthritis Outcome Score) is a reliable and valid patient-reported outcome measurement tool that evaluates both short-term and long- ...

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11201646/

Latest Advances in Chondrocyte-Based Cartilage Repair

Clinical outcomes after first-generation ACI over a 20-year follow-up reported that 93% of twenty-three patients (24 knees) showed good to ...

3.

clinicaltrials.gov

clinicaltrials.gov/study/NCT03545269

NCT03545269 | Study to Assess the Efficacy and Safety of ...

The purpose of this study is to assess the safety and efficacy of implanting bead-type autologous chondrocyte (CartiLife®) obtained by culturing expanded costal ...

4.

sciencedirect.com

sciencedirect.com/science/article/pii/S2214031X24001396

Charting a quarter-century of commercial cartilage ...

This paper, for the first time, comprehensively reviews the properties of commercial products covering the last 25 years.

5.

trial.medpath.com

trial.medpath.com/clinical-trial/4c987047fe7c03ae/nct03545269-multi-center-trial-chondrocytes-implantation-knee

Study to Assess the Efficacy and Safety of Treatment of ...

The purpose of this study is to assess the safety and efficacy of implanting bead-type autologous chondrocyte (CartiLife®) obtained by culturing expanded ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC9079100/

Advanced Therapy medicinal products for autologous ...

Cartilife® is a product in which donor tissue is collected from the rib cartilage of a patient and then cultured for 6–7 weeks to generate ...

7.

clinicaltrials.gov

clinicaltrials.gov/study/NCT05051332

NCT05051332 | Phase 3 Clinical Trial of CartiLife® in Korea

This open-label, phase 3 study is being conducted to evaluate the safety and efficacy of pellet-type extracellular matrix-associated autologous chondrocytes ...

8.

ctv.veeva.com

ctv.veeva.com/study/phase-2-clinical-trial-of-cartilife-r-in-the-united-states

Phase 2 Clinical Trial of CartiLife® in the United States

To evaluate the safety and efficacy of implanting pellet-type extracellular matrix-associated autologous chondrocytes (CartiLife®) obtained by cultivating ...

9.

journals.sagepub.com

journals.sagepub.com/doi/10.1177/23259671211053380

A 5-Year Follow-up of a Phase 2, Dose-Confirmation Trial

ACI using spheroids was safe and effective for defect sizes up to 10 cm 2 and showed maintenance of efficacy up to 5 years for all 3 doses that were ...