Actively Recruiting
Phase 2 Clinical Trial of CartiLife® in the United States
Led by Biosolution Co., Ltd. · Updated on 2023-08-28
25
Participants Needed
5
Research Sites
161 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
To evaluate the safety and efficacy of implanting pellet-type extracellular matrix-associated autologous chondrocytes (CartiLife®) obtained by cultivating costal chondrocytes of the subject with articular cartilage defects of the knee as a result of trauma or degeneration.
CONDITIONS
Official 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 total defect volume up to 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 with more than 50% of meniscus remaining
- KOOS pain score less than 60 at baseline
- Willingness to actively participate in rehabilitation and follow-up program
- Ability to provide informed consent and comply with study requirements
- Willingness to discontinue NSAIDs except rescue medication (acetaminophen under 4 g per day) 7 days prior to visit
- Body Mass Index (BMI) of 37 kg/m2 or less
- Female and male subjects of childbearing potential willing to use adequate contraception during the trial
You will not qualify if you...
- Inflammatory articular diseases such as rheumatoid arthritis, gout, or pseudogout
- Radiographic evidence of grade 4 osteoarthritis per Kellgren and Lawrence criteria
- Intra-articular treatment received within the last 3 months
- Surgical procedure on knees within the last 6 weeks (enrollment may be considered at investigator's discretion)
- Condition in another lower extremity joint interfering with index knee function
- Concomitant surgical procedure on knees planned at study treatment time
- Asymptomatic articular cartilage defect
- Clinically significant diseases affecting the trial, including uncontrolled diabetes, bleeding or hematologic disorders, endocrinopathies, cardiovascular or renal disease, autoimmune or inflammatory arthritis, infections
- Other diseases including tumors except cartilaginous joint defects
- History of hypersensitivity to gentamicin, aminoglycosides, or porcine/bovine products
- Participation in other clinical trials within 30 days of consent
- Radiation therapy or chemotherapy within 2 years prior to screening
- Currently pregnant or nursing
- Degenerative muscular, connective tissue, neurological conditions interfering with healing or evaluation
- Known HIV infection or active hepatitis B or C infection
- Ligament instability greater than Grade 1
- Active drug or alcohol abuse or history within last 2 years
- Significant lab abnormalities including elevated liver enzymes, creatinine, abnormal coagulation, low hemoglobin, abnormal platelets, or high hemoglobin A1c levels
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
J
Jungsun Lee, Ph.D
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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