CartiLife® for Osteoarthritis and Articular Cartilage Injury

Phase 2

Recruiting

Research Sponsored by Biosolution Co., Ltd.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 0 (pre-operation), and up to 24 months (post-operation)

Awards & highlights

No Placebo-Only Group

Summary

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.

Eligible Conditions

Articular Cartilage Injury
Osteoarthritis

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 0 (pre-operation), and up to 24 months (post-operation)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~week 0 (pre-operation), and up to 24 months (post-operation)

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 0 (pre-operation), and up to 24 months (post-operation) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Knee

Cartilage

Secondary study objectives

Change in IKDC (International Knee Documentation Committee) Score

Knee

+10 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: CartiLife®Experimental Treatment1 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.

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