Actively Recruiting
A Multi-Center, Open-Label Phase 2 Trial Evaluating CartiLife4 for Knee Articular Cartilage Defects
Led by Biosolution Co., Ltd. · Updated on 2023-08-28
25
Participants Needed
5
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
The trial investigates the use of pellet-type extracellular matrix-associated autologous chondrocytes called CartiLife4 for adults with articular cartilage defects in the knee caused by trauma or degeneration. This open-label, phase 2 study aims to assess the safety and effectiveness of CartiLife4 by observing structural cartilage regeneration and improvements in knee function and pain over 48 weeks. CartiLife4 is made of small beads derived from a patient's own costal chondrocytes, cultured and formed into pellets. These pellets are implanted into the knee cartilage defect using a minimal arthrotomy with fibrin adhesive to hold them in place. The dose depends on the size of the cartilage defect, with one pre-filled syringe implanted per cubic centimeter of defect volume. Participants will be evaluated before and up to 48 weeks after implantation using various assessments such as the Knee Injury and Osteoarthritis Outcome Score (KOOS), Lysholm Score, IKDC Score, pain scales, and imaging techniques like MOCART and T2 mapping. Safety will be monitored for up to 24 months post-operation, including tracking any treatment-related adverse events and changes in pain medication use. Participants must follow a rehabilitation and follow-up program during the study.
CONDITIONS
Brief Title
Phase 2 Clinical Trial of CartiLife® in the United States
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female subjects aged over 18 at the time of signing the Informed Consent form
- Cartilage lesion size between 2 cm2 and 10 cm2 with defect volume 4 cm3
- Isolated International Cartilage Repair Society (ICRS) Grade III or IV chondral lesion on articular cartilage
- Lower extremity alignment within 5 degrees of neutral weight bearing axis
- Ability to move independently with a mechanically stable knee (normal ligament status)
- Intact or partial meniscus status (>50% of meniscus)
- KOOS pain value less than 60 at baseline
- Willingness to follow rehabilitation and follow-up program
- Ability to provide informed consent and comply with study requirements
- Willingness to discontinue nonsteroidal anti-inflammatory drugs except limited rescue medication 7 days prior to visit
- Body Mass Index (BMI) 37 kg/m2
- Female and male subjects of childbearing potential willing to use adequate contraception for the trial duration
You will not qualify if you...
- Inflammatory articular diseases such as rheumatoid arthritis, gout, or pseudogout
- Radiographic evidence of grade 4 osteoarthritis based on Kellgren and Lawrence criteria
- Intra-articular treatment within the last 3 months
- Knee surgery within the last 6 weeks (may be considered by investigator)
- Condition in other lower extremity joint interfering with index knee function
- Planned concomitant surgical procedure on knees at treatment time
- Asymptomatic articular cartilage defect
- Clinically significant diseases affecting trial participation, including uncontrolled diabetes, bleeding disorders, cardiovascular or renal disease, autoimmune or inflammatory arthritis, and infections
- Other diseases including tumors except cartilaginous joint defects
- History of hypersensitivity to gentamicin, aminoglycosides, or porcine/bovine products
- Participation in other trials within 30 days before consent
- Radiation therapy or chemotherapy within 2 years prior to screening
- Current pregnancy or nursing
- Degenerative muscular, connective tissue, neurological conditions interfering with healing or evaluation
- Known HIV infection, active hepatitis B or C infection
- Ligament instability greater than Grade 1
- Active drug or alcohol abuse within last two years
- Significant lab abnormalities outside specified limits
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 48 weeks post-operation
Participants receive an injection of CartiLife® pellets implanted through minimal arthrotomy to treat knee articular cartilage defects.
1 baseline visit (pre-operation) and multiple follow-up visits at Weeks 8, 24, and 48 (post-operation)
Duration - Up to 24 months post-operation
Participants are monitored for safety, efficacy, and recovery after treatment with CartiLife®.
Periodic visits for safety assessments up to 24 months post-operation
Trial Site Locations
Total: 5 locations
1
Tilda Research
Irvine, California, United States, 92612
Not Yet Recruiting
2
Biosolutions Clinical Research Center
La Mesa, California, United States, 91942
Actively Recruiting
3
Horizon Clinical Research
La Mesa, California, United States, 91942
Actively Recruiting
4
Lafayette General Health
Lafayette, Louisiana, United States, 70506
Actively Recruiting
5
Ohio State University
Columbus, Ohio, United States, 43210
Actively Recruiting
Research Team
T
TaeKyung Kim, MA
J
Jungsun Lee, Ph.D
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here