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New treatment option for Articular Cartilage Defect
Official title Phase 2 Clinical Trial of CartiLife® in the United States
ClinicalTrials.gov ID: NCT04744402
What this study is testing
What is Autologous Chondrocyte Implantation (CartiLife®)?
Autologous Chondrocyte Implantation (CartiLife®) is an investigational medicine, being studied as a potential treatment for articular cartilage defect.
Also referred to as CCP-ACI.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- In order to be eligible to participate in this study, an individual must meet all of the following:
- Male or female people aged over 18 at the time of signing the Informed Consent form
- Subject who has a size of the relevant cartilage lesion ≥ 2 cm2 and ≤ 10 cm2 but with a defect area total volume ≤ 4 cm3
- Subject with isolated International Cartilage Repair Society (ICRS) Grade III or IV chondral lesion on articular cartilage
- Subject who has a lower extremity alignment within 5 degrees of the neutral weight bearing axis
You likely can't join if
- Individuals who meet any of the following will be excluded from participation in this study:
- Subject who has inflammatory articular diseases such as rheumatoid arthritis or gout or pseudogout
- Subject who has radiographic evidence of grade 4 osteoarthritis based on the Kellgren and Lawrence criteria
- Subject who has received an intra-articular treatment within the last 3 months
- Subject who has had a surgical procedure on the knees within the last 6 weeks (people can be considered enrollment per the investigator's discretion)
- Subject who has a condition in another lower extremity joint that interferes with the function of the index knee
See the full eligibility criteria
- In order to be eligible to participate in this study, an individual must meet all of the following:
- Male or female people aged over 18 at the time of signing the Informed Consent form
- Subject who has a size of the relevant cartilage lesion ≥ 2 cm2 and ≤ 10 cm2 but with a defect area total volume ≤ 4 cm3
- Subject with isolated International Cartilage Repair Society (ICRS) Grade III or IV chondral lesion on articular cartilage
- Subject who has a lower extremity alignment within 5 degrees of the neutral weight bearing axis
- Subject who can move independently and has a mechanically stable knee (normal ligament status)
- Subject with intact or partial meniscus status (\>50% of meniscus)
- Subject who has KOOS pain value less than 60 at baseline
- Subject who agrees to actively participate in a rehabilitation protocol and follow-up program
- Subject who is able to provide informed consent and comply with study requirements
- 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
- Subject who has Body Mass Index (BMI) ≤ 37 kg/m2
- Female and male people of childbearing potential who are willing to use adequate contraception methods for the duration of the trial.
- Individuals who meet any of the following will be excluded from participation in this study:
- Subject who has inflammatory articular diseases such as rheumatoid arthritis or gout or pseudogout
- Subject who has radiographic evidence of grade 4 osteoarthritis based on the Kellgren and Lawrence criteria
- Subject who has received an intra-articular treatment within the last 3 months
- Subject who has had a surgical procedure on the knees within the last 6 weeks (people can be considered enrollment per the investigator's discretion)
- Subject who has a condition in another lower extremity joint that interferes with the function of the index knee
- Subject who would receive a concomitant surgical procedure on the knees at the time of the study treatment
- Subject whose articular cartilage defect is asymptomatic
- 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...
- Subject with other diseases including tumors except for cartilaginous defects of joints
- Subject who has a history of hypersensitivity to gentamicin, other aminoglycosides, or products of porcine or bovine origin
- Subject who participates in concurrent trials or in previous trial within 30 days of signing informed consent
- Subject who has any radiation therapy or chemotherapy within 2 years prior to screening
- Subject who is currently pregnant or nursing
- 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.
- Subject with known HIV infection, active hepatitis C and/or hepatitis B infection
- Subject who has ligament instability \> Grade 1
- Subject who is an active drug/alcohol abuser or has a history of alcohol or drug abuse during the last two years.
- 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...
- 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%
The study team makes the final eligibility decision.
Where it's taking place
- Irvine, California, United States
- La Mesa, California, United States
- Lafayette, Louisiana, United States
- Columbus, Ohio, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Irvine, California, United States; La Mesa, California, United States; Lafayette, Louisiana, United States; Columbus, Ohio, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.