CartiLife® for Osteoarthritis and Articular Cartilage Injury

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

25 Participants Needed

Trial Summary

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.

What data supports the effectiveness of the treatment CartiLife® for osteoarthritis and articular cartilage injury?

The research suggests that treatments involving tissue-engineered grafts and scaffolds, similar to CartiLife®, have shown significant improvement in clinical scores for cartilage repair, with over 80% of patients experiencing excellent or good outcomes. However, more studies are needed to confirm these findings specifically for CartiLife®. ^{1 2 3 4 5}

How is the treatment CartiLife® different from other treatments for osteoarthritis and articular cartilage injury?

CartiLife® is unique because it likely involves a novel approach to cartilage repair, potentially using a scaffold-based system that supports cell growth and integration with existing cartilage, unlike traditional methods that may require more invasive procedures or have limited repair capabilities. ^{6 7 8 9 10}

What is the purpose of this trial?

This trial is testing a new treatment that uses small pellets made from a patient's own cartilage cells to repair knee damage. It targets adults with knee cartilage defects caused by injury or wear and tear. The treatment aims to reduce pain and improve knee function by helping the damaged cartilage heal and regrow.

Research Team

Jungsun Lee, Ph.D

Principal Investigator

Biosolution Co., Ltd.

Eligibility Criteria

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

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

Treatment Details

Interventions

• CartiLife®

Participant Groups

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+

References

1. United States pubmed.ncbi.nlm.nih.gov

ICRS Recommendation Document: Patient-Reported Outcome Instruments for Use in Patients with Articular Cartilage Defects. [2022]

2. Germany pubmed.ncbi.nlm.nih.gov

Clinical outcomes assessment for articular cartilage restoration. [2019]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Gel-type autologous chondrocyte implantation for cartilage repair in patients with prior ACL reconstruction: A retrospective two year follow-up. [2017]

4. Germany pubmed.ncbi.nlm.nih.gov

Clinical application of scaffolds for cartilage tissue engineering. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Cartilage Repair in the Inflamed Joint: Considerations for Biological Augmentation Toward Tissue Regeneration. [2016]

6. Israel pubmed.ncbi.nlm.nih.gov

[Autologous chondrocyte transplantation--from science fiction to routine clinical practice]. [2013]

7. United States pubmed.ncbi.nlm.nih.gov

A prospective multicenter study on the outcome of type I collagen hydrogel-based autologous chondrocyte implantation (CaReS) for the repair of articular cartilage defects in the knee. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Surgical treatment options for cartilage defects within the knee. [2019]

9. United States pubmed.ncbi.nlm.nih.gov

The use of scaffolds in the management of articular cartilage injury. [2019]

10. United States pubmed.ncbi.nlm.nih.gov

One-Stage Cartilage Repair Using a Hyaluronic Acid-Based Scaffold With Activated Bone Marrow-Derived Mesenchymal Stem Cells Compared With Microfracture: Five-Year Follow-up. [2019]