Phase 2 Clinical Trial of CartiLife® in the United States

NCT04744402 | Unknown Phase 2 FDA Drug

• 1 other identifier: BS-CTL-II
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 5

Brief 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.

Conditions

Articular Cartilage Defect; Articular Cartilage Degeneration

Outcome Measures

Primary Outcomes (2)

• Change in KOOS (Knee Injury and Osteoarthritis Outcome Score) function (sports and recreational activities)

  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, Function in daily living (ADL), Function in Sport and Recreation (Sport/Rec), and knee-related QOL may enrich clinical and research data interpretation (Roos and Lohmander, 2003; Collins et al, 2011). The score ranges from 0 to 100, with 0 representing extreme problems and 100 representing no problems.

  Week 0 (pre-operation) to Week 48 (post-operation)

• Change in volume fill of cartilage defect score

  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 hypertrophy (100% to 150% filling of total defect volume).

  Week 0 (pre-operation) to Week 48 (post-operation)

Secondary Outcomes (13)

• Change in Lysholm Score

  Week 0 (pre-operation) to Week 8, 24 and 48 (post-operation)

• Change in IKDC (International Knee Documentation Committee) Score

  Week 0 (pre-operation) to Week 8, 24 and 48 (post-operation)

• Change in KOOS (Knee injury Osteoarthritis Outcome Score) subscale scores (Pain, Other symptoms, Function in daily living, and knee-related Quality of Life)

  Week 0 (pre-operation) to Week 8, 24 and 48 (post-operation)

• Change in KOOS (Knee injury Osteoarthritis Outcome Score) Total Score

  Week 0 (pre-operation) to Week 8, 24 and 48 (post-operation)

• Change in VAS (100mm Pain Visual Analogue Scale)

  Week 0 (pre-operation) to Week 8, 24 and 48 (post-operation)

Study Arms (1)

CartiLife®

EXPERIMENTAL

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.

Drug: Autologous Chondrocyte Implantation (CartiLife®)

Interventions

Autologous Chondrocyte Implantation (CartiLife®) DRUG

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

Also known as: CCP-ACI

CartiLife®

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• In order to be eligible to participate in this study, an individual must meet all of the following:
• Male or female subjects 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 subjects of childbearing potential who are willing to use adequate contraception methods for the duration of the trial.

You may not qualify 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 (Subjects 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 disease, endocrinopathies, cardiovascular disease, renal disease (severe renal impairment), autoimmune disease, inflammatory arthritis, and current infectious disease
• 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.

Sponsors & Collaborators

• Biosolution Co., Ltd.: lead

Study Sites (5)

Tilda Research

Irvine, California, 92612, United States

NOT YET RECRUITING

Biosolutions Clinical Research Center

La Mesa, California, 91942, United States

RECRUITING

Horizon Clinical Research

La Mesa, California, 91942, United States

RECRUITING

Lafayette General Health

Lafayette, Louisiana, 70506, United States

RECRUITING

Ohio State University

Columbus, Ohio, 43210, United States

RECRUITING

Study Officials

• Jungsun Lee, Ph.D

  Biosolution Co., Ltd.

  STUDY DIRECTOR

Central Study Contacts

TaeKyung Kim, MA

CONTACT

+82234468884; taekyung1215@biosolutions.co.kr

Jungsun Lee, Ph.D

CONTACT

+82234468884; dvmljs@biosolutions.co.kr

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Investigational group: 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.

Study Record Dates

• First Submitted: January 18, 2021
• First Posted: February 9, 2021
• Study Start: October 28, 2020
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: August 28, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)