Phase 2 Clinical Trial of CartiLife® in the United States
NCT ID: NCT04744402
Last Updated: 2023-08-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
25 participants
INTERVENTIONAL
2020-10-28
2023-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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CartiLife®
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.
Autologous Chondrocyte Implantation (CartiLife®)
CartiLife consists of small beads (1 mm in diameter) in suspension, developed from pellet culture of autologous costal chondrocytes after multiplication. The beads are implanted in an injective manner with fibrin glue through minimal arthrotomy. The dose depends on the size (volume) of the defect, recommended dose is 480 pellets/cm\^3 defect
Interventions
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Autologous Chondrocyte Implantation (CartiLife®)
CartiLife consists of small beads (1 mm in diameter) in suspension, developed from pellet culture of autologous costal chondrocytes after multiplication. The beads are implanted in an injective manner with fibrin glue through minimal arthrotomy. The dose depends on the size (volume) of the defect, recommended dose is 480 pellets/cm\^3 defect
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
1. Male or female subjects aged over 18 at the time of signing the Informed Consent form
2. Subject who has a size of the relevant cartilage lesion ≥ 2 cm2 and ≤ 10 cm2 but with a defect area total volume ≤ 4 cm3
3. Subject with isolated International Cartilage Repair Society (ICRS) Grade III or IV chondral lesion on articular cartilage
4. Subject who has a lower extremity alignment within 5 degrees of the neutral weight bearing axis
5. Subject who can move independently and has a mechanically stable knee (normal ligament status)
6. Subject with intact or partial meniscus status (\>50% of meniscus)
7. Subject who has KOOS pain value less than 60 at baseline
8. Subject who agrees to actively participate in a rehabilitation protocol and follow-up program
9. Subject who is able to provide informed consent and comply with study requirements
10. 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
11. Subject who has Body Mass Index (BMI) ≤ 37 kg/m2
12. Female and male subjects of childbearing potential who are willing to use adequate contraception methods for the duration of the trial.
Exclusion Criteria
1. Subject who has inflammatory articular diseases such as rheumatoid arthritis or gout or pseudogout
2. Subject who has radiographic evidence of grade 4 osteoarthritis based on the Kellgren and Lawrence criteria
3. Subject who has received an intra-articular treatment within the last 3 months
4. 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)
5. Subject who has a condition in another lower extremity joint that interferes with the function of the index knee
6. Subject who would receive a concomitant surgical procedure on the knees at the time of the study treatment
7. Subject whose articular cartilage defect is asymptomatic
8. Subject who has any clinically significant disease, which is judged by the investigator to affect this clinical trial, including but not limited to diabetes not adequately controlled, bleeding diathesis or hematologic disease, endocrinopathies, cardiovascular disease, renal disease (severe renal impairment), autoimmune disease, inflammatory arthritis, and current infectious disease
9. Subject with other diseases including tumors except for cartilaginous defects of joints
10. Subject who has a history of hypersensitivity to gentamicin, other aminoglycosides, or products of porcine or bovine origin
11. Subject who participates in concurrent trials or in previous trial within 30 days of signing informed consent
12. Subject who has any radiation therapy or chemotherapy within 2 years prior to screening
13. Subject who is currently pregnant or nursing
14. Subject who has any degenerative muscular, connective tissue or neurological condition or other disease process that would interfere with healing or the evaluation of outcome measures.
15. Subject with known HIV infection, active hepatitis C and/or hepatitis B infection
16. Subject who has ligament instability \> Grade 1
17. Subject who is an active drug/alcohol abuser or has a history of alcohol or drug abuse during the last two years.
18. Subject who has significant lab abnormalities for the following parameters (If the value is within 10% of the listed laboratory exclusion criterion value and the value is considered not to be clinically significant by the investigator, the subject can be considered for enrollment):
* Serum ALT and AST \> 3 x upper limit of normal
* Serum creatinine \> 1.5 x upper limit of normal
* PT/INR out of normal range
* Hemoglobin \< 10 g/dL for female subject and hemoglobin \< 11 g/dL for male subject
* Platelets out of normal range
* Hemoglobin A1c levels \> 9%
18 Years
ALL
No
Sponsors
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Biosolution Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Jungsun Lee, Ph.D
Role: STUDY_DIRECTOR
Biosolution Co., Ltd.
Locations
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Tilda Research
Irvine, California, United States
Biosolutions Clinical Research Center
La Mesa, California, United States
Horizon Clinical Research
La Mesa, California, United States
Lafayette General Health
Lafayette, Louisiana, United States
Ohio State University
Columbus, Ohio, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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BS-CTL-II
Identifier Type: -
Identifier Source: org_study_id
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