Phase 2 Clinical Trial of CartiLife® in the United States

Last updated: August 24, 2023
Sponsor: Biosolution Co., Ltd.
Overall Status: Active - Recruiting




Musculoskeletal Diseases


Autologous Chondrocyte Implantation (CartiLife®)

Clinical Study ID

  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria


Inclusion Criteria: In order to be eligible to participate in this study, an individual must meet all of thefollowing:

  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 witha defect area total volume ≤ 4 cm3
  3. Subject with isolated International Cartilage Repair Society (ICRS) Grade III or IVchondral lesion on articular cartilage
  4. Subject who has a lower extremity alignment within 5 degrees of the neutral weightbearing axis
  5. Subject who can move independently and has a mechanically stable knee (normal ligamentstatus)
  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-upprogram
  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 adequatecontraception methods for the duration of the trial.


Exclusion Criteria: Individuals who meet any of the following will be excluded from participation in thisstudy:

  1. Subject who has inflammatory articular diseases such as rheumatoid arthritis or goutor pseudogout
  2. Subject who has radiographic evidence of grade 4 osteoarthritis based on the Kellgrenand 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 thefunction of the index knee
  6. Subject who would receive a concomitant surgical procedure on the knees at the time ofthe study treatment
  7. Subject whose articular cartilage defect is asymptomatic
  8. Subject who has any clinically significant disease, which is judged by theinvestigator to affect this clinical trial, including but not limited to diabetes notadequately 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 ofjoints
  10. Subject who has a history of hypersensitivity to gentamicin, other aminoglycosides, orproducts of porcine or bovine origin
  11. Subject who participates in concurrent trials or in previous trial within 30 days ofsigning informed consent
  12. Subject who has any radiation therapy or chemotherapy within 2 years prior toscreening
  13. Subject who is currently pregnant or nursing
  14. Subject who has any degenerative muscular, connective tissue or neurological conditionor other disease process that would interfere with healing or the evaluation ofoutcome 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 abuseduring the last two years.
  18. Subject who has significant lab abnormalities for the following parameters (If thevalue is within 10% of the listed laboratory exclusion criterion value and the valueis considered not to be clinically significant by the investigator, the subject can beconsidered 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%

Study Design

Total Participants: 25
Treatment Group(s): 1
Primary Treatment: Autologous Chondrocyte Implantation (CartiLife®)
Phase: 2
Study Start date:
October 28, 2020
Estimated Completion Date:
December 31, 2023

Study Description

This open-label, phase 2 study is being conducted to evaluate the safety and efficacy of pellet-type extracellular matrix-associated autologous chondrocytes (CartiLife®) in adults with articular cartilage defects due to trauma or degeneration of the knee. It is hypothesized that CartiLife® treatment will demonstrate structural regeneration and improvement in function and pain at Week 48 compared to baseline.

Connect with a study center

  • Tilda Research

    Irvine, California 92612
    United States

    Site Not Available

  • Biosolutions Clinical Research Center

    La Mesa, California 91942
    United States

    Active - Recruiting

  • Horizon Clinical Research

    La Mesa, California 91942
    United States

    Active - Recruiting

  • Lafayette General Health

    Lafayette, Louisiana 70506
    United States

    Active - Recruiting

  • Ohio State University

    Columbus, Ohio 43210
    United States

    Active - Recruiting

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