Columbus, Ohio 43210

  • Articular Cartilage Degeneration

Purpose:

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.


Study summary:

This open-label, phase 2 study is being conducted to evaluate the safety and efficacy of pellet-type extracellular matrix-associated autologous chondrocytes (CartiLife®) compared with microfracture surgery 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.


Criteria:

Inclusion Criteria: In order to be eligible to participate in this study, an individual must meet all of the following: 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 55 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) ≤ 35 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: Individuals who meet any of the following will be excluded from participation in this study: 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 2 months 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%


Study is Available At:


Original ID:

BS-CTL-II


NCT ID:

NCT04744402


Secondary ID:


Study Acronym:


Brief Title:

Phase 2 Clinical Trial of CartiLife® in the United States


Official Title:

A Multi-Center, Active-Controlled, Open-Label, Phase 2 Trial to Compare the Efficacy and Safety of CartiLife®, and Microfracture for Patients With Articular Cartilage Defects in the Knee


Overall Status:

Recruiting


Study Phase:

Phase 2


Genders:

N/A


Minimum Age:

19 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Biosolution Co., Ltd.


Oversight Authority:

There was an error processing this request


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

50


Enrollment Type:

Anticipated


Overall Contact Information

Official Name:Jungsun Lee, Ph.D
Study Director
Biosolution Co., Ltd.
Primary Contact:Minkyu Woo, B.A
+82234468884 ext. 6620
+82234468884
christinelee@kcrnresearch.com
Backup Contact:Jungsun Lee, Ph.D
+82234468884 ext. 6603
+82234468884
dvmljs@biosolutions.co.kr

Study Dates

Start Date:October 28, 2020
Completion Date:December 2023
Completion Type:Anticipated
Primary Completion Date:December 2022
Primary Completion Type:Anticipated
Verification Date:March 2021
Last Changed Date:March 22, 2021
First Received Date:January 18, 2021

Study Outcomes

Outcome Type:Primary Outcome
Measure:Change in KOOS (Knee Injury and Osteoarthritis Outcome Score) function (sports and recreational activities)
Time Frame:Week 0 (pre-operation) to Week 48 (post-operation)
Safety Issues:False
Description:The KOOS (Knee Injury and Osteoarthritis Outcome Score) is a reliable and valid patient-reported outcome measurement tool that evaluates both short-term and long-term consequences of knee injury. The 5 separately scored subscales of Pain, other Symptoms,
Outcome Type:Primary Outcome
Measure:Change in volume fill of cartilage defect score
Time Frame:Week 0 (pre-operation) to Week 48 (post-operation)
Safety Issues:False
Description:Volume fill of cartilage defect score from MOCART 2.0 Criteria (Schreiner, et al, 2019). The score is from 0 to 20, with 0 representing "<25% filling of total defect volume OR complete delamination in situ" and 20 representing "Complete fill OR minor h
Outcome Type:Secondary Outcome
Measure:Change in Lysholm Score
Time Frame:Week 0 (pre-operation) to Week 8, 24 and 48 (post-operation)
Safety Issues:False
Description:The Lysholm scale is a broadly applicable, validated tool for measuring changes following nonsurgical and surgical intervention, as well as deterioration over time in patients with various knee pathologies (Collins et al, 2011). The score is from 0 to 100
Outcome Type:Secondary Outcome
Measure:Change in IKDC (International Knee Documentation Committee) Score
Time Frame:Week 0 (pre-operation) to Week 8, 24 and 48 (post-operation)
Safety Issues:False
Description:The IKDC (International Knee Documentation Committee) Knee form covers domains likely to be important to patients and has adequate consistency and broad applicability across mixed groups of patients (Collins et al, 2011). The score is from 0 to 100, with
Outcome Type:Secondary Outcome
Measure:Change in KOOS (Knee injury Osteoarthritis Outcome Score) subscale scores (Pain, Other symptoms, Function in daily living, and knee-related Quality of Life)
Time Frame:Week 0 (pre-operation) to Week 8, 24 and 48 (post-operation)
Safety Issues:False
Description:The KOOS (Knee injury Osteoarthritis Outcome Score) is a reliable and valid patient-reported outcome measurement tool that evaluates both short-term and long-term consequences of knee injury. The 5 separately scored subscales of Pain, other Symptoms, Func
Outcome Type:Secondary Outcome
Measure:Change in KOOS (Knee injury Osteoarthritis Outcome Score) Total Score
Time Frame:Week 0 (pre-operation) to Week 8, 24 and 48 (post-operation)
Safety Issues:False
Description:The KOOS is a reliable and valid patient-reported outcome measurement tool that evaluates both short-term and long-term consequences of knee injury. The 5 separately scored subscales of Pain, other Symptoms, Function in daily living (ADL), Function in Spo
Outcome Type:Secondary Outcome
Measure:Change in VAS (100mm Pain Visual Analogue Scale)
Time Frame:Week 0 (pre-operation) to Week 8, 24 and 48 (post-operation)
Safety Issues:False
Description:The VAS is a validated, ubiquitous tool for patient-reported measurement of pain at a given point in time (Kersten et al, 2014). The score is from 0 to 100, with 0 representing no pain and 100 representing extreme pain.
Outcome Type:Secondary Outcome
Measure:Change in Tegner Activity Score
Time Frame:Week 0 (pre-operation) to Week 8, 24 and 48 (post-operation)
Safety Issues:False
Description:The Tegner activity score is a frequently used patient-administered activity rating system for patients with various knee activity functions. The instrument scores a person's activity level between 0 and 10 where 0 is 'on sick leave/disability' and 10 is
Outcome Type:Secondary Outcome
Measure:Change in WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) Score
Time Frame:Week 0 (pre-operation) to Week 8, 24 and 48 (post-operation)
Safety Issues:False
Description:The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) is a widely used, proprietary set of standardized questionnaires used by health professionals to evaluate the condition of patients with osteoarthritis of the knee and hip, includi
Outcome Type:Secondary Outcome
Measure:Evaluations of MOCART Score
Time Frame:Week 24 and 48 (post-operation)
Safety Issues:False
Description:MOCART provides a reliable, reproducible, and accurate method of assessment of cartilage repair tissue. The total score is determined by adding the following subscale scores : Volume fill of cartilage defect (0~20 points, 20:Complete filling, 0:<25% f
Outcome Type:Secondary Outcome
Measure:Evaluation of T2 mapping
Time Frame:Week 24 and 48 (post-operation)
Safety Issues:False
Description:In vivo, the visualization of collagen architecture, and possibly the maturation of this architecture over time in cartilage repair tissue, can be seen when assessing the spatial variation of T2 values. Histologically validated animal studies report this
Outcome Type:Secondary Outcome
Measure:Change in pain medication dosage
Time Frame:Week 0 (pre-operation) to Week 8, 24 and 48 (post-operation)
Safety Issues:False
Description:Pain medication history is an indicator of patient pain. The amount of analgesic ingestion is measured for the specified duration over the course of the clinical trial, and changes in analgesic ingestion are assessed to analyze the efficacy of the clinica
Outcome Type:Secondary Outcome
Measure:Change in pain medication frequency
Time Frame:Week 0 (pre-operation) to Week 8, 24 and 48 (post-operation)
Safety Issues:False
Description:Pain medication history is an indicator of patient pain. The frequency of analgesic ingestion is measured for the specified duration over the course of the clinical trial, and changes in analgesic ingestion in terms of frequency are assessed to analyze th
Outcome Type:Secondary Outcome
Measure:Number of subjects with treatment-related adverse events
Time Frame:Week 0 (pre-operation), and up to 24 Months (post-operation)
Safety Issues:False
Description:Number of subjects with treatment related adverse events as assessed by analysis of adverse events including symptoms, and abnormal findings on physical examination, vital signs, ECG, and standard laboratory examination results
Outcome Type:Secondary Outcome
Measure:Number of subjects with treatment-emergent serious adverse events
Time Frame:Week 0 (pre-operation), and up to 24 Months (post-operation)
Safety Issues:False
Description:Number of subjects with treatment-emergent serious adverse events defined as one or more of the following untoward medical occurrences happening during study period. Life-threatening event (e.g., stroke or non-fatal pulmonary embolism). Requires inpatie

Study Interventions

Intervention Type:Drug
Name:Autologous Chondrocyte Implantation (CartiLife®)
Description: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
Arm Name:CartiLife®
Other Name:CCP-ACI
Intervention Type:Procedure
Name:Microfracture Surgery
Description:Microfracture surgery, performed by arthroscopy after the joint is cleaned of calcified cartilage, will be conducted using an awl or drill to create tiny fractures in the subchondral bone plate.
Arm Name:Microfracture surgery

Study Arms

Study Arm Type:Experimental
Arm Name:CartiLife®
Description: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.
Study Arm Type:Active Comparator
Arm Name:Microfracture surgery
Description:Microfracture surgery, performed by arthroscopy after the joint is cleaned of calcified cartilage, will be conducted using an awl or drill to create tiny fractures in the subchondral bone plate.

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Biosolution Co., Ltd.

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: September 23, 2021

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