Phase 3 Clinical Trial of CartiLife® in Korea

NCT05051332 | Unknown Phase 3

• 1 other identifier: BS-CTL-III
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 18

Brief Summary

To evaluate the safety and efficacy of pellet-type extracellular matrix-associated autologous chondrocytes (CartiLife®) obtained by cultivating costal chondrocytes of the subject implanted into articular cartilage defects of the knee resulting from trauma or degeneration.

Conditions

Articular Cartilage Defect; Articular Cartilage Degeneration

Outcome Measures

Primary Outcomes (2)

• MOCART (Magnetic Resonance Observation of Cartilage Repair Tissue)

  MOCART is a validated tool that provides reliable, reproducible, and accurate assessment of cartilage repair tissue (Marlovits et al, 2006 that; Trattnig et al, 2011).

  At Week 48, post-operation

• KOOS Total Score

  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 Sport and Recreation (Sport/Rec), and knee-related QOL may enrich clinical and research data interpretation (Roos and Lohmander, 2003; Collins et al, 2011). In the 'Knee injury and Osteoarthritis Outcome Score', scores range from 0 to 100 with a score of 0 indicating the worst possible knee symptoms and 100 indicating no knee symptoms.

  From Week 0 to Week 48, post-operation

Secondary Outcomes (8)

• MOCART Score

  At Week 24 and Week 96, post-operation

• Lysholm Score

  At Week 0 to Week 8, 24, 48 and 96, post-operation

• IKDC Score

  At Week 0 to Week 8, 24, 48 and 96, post-operation

• KOOS Score (Pain, Other symptoms, Function in daily living, Function in sport and recreation, and knee-related QOL subscales)

  At Week 0 to Week 8, 24, 48 and 96, post-operation

• VAS (100mm Pain Visual Analogue Scale)

  At Week 0 to Week 8, 24, 48 and 96, post-operation

Study Arms (2)

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 cm\^3 of defect volume, and fibrin adhesive is applied to fix pellets in place through minimal arthrotomy.

Drug: Autologous Chondrocyte Implantation (CartiLife®)

Microfracture Surgery

ACTIVE COMPARATOR

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.

Procedure: Microfracture Surgery

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: CartiLife

CartiLife®

Microfracture Surgery PROCEDURE

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

Microfracture Surgery

Eligibility Criteria

• Age: 18 Years - 65 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:
• Patients over the age of 18.
• Defect size: 2 to 10 cm\^2 on the unilateral knee cartilage (up to 4 ㎤ in volume).
• Defect: isolated ICRS (International Cartilage Repair Society) grade III or IV single defect chondral lesion on articular cartilage with comparatively healthy cartilage present near the lesion site (ICRS Grade 1 \~ 2).
• Patients with a KOOS total score below 55.
• Patients able to walk without aid.
• Patients who agree to abide by rehabilitation protocols and follow-up programs, including residential exercise routines.
• Patients who provide written consent to the application of the clinical trial.

You may not qualify if:

• Individuals who meet any of the following will be excluded from participation in this study:
• Patients with inflammatory articular diseases such as rheumatoid arthritis or gouty arthritis.
• Patients scoring 3 or above on the Kellgren-Lawrence Grading Scale.
• Patients with inflammatory articular diseases related to autoimmune diseases.
• Patients hypersensitive to bovine derived proteins or any of the components in this product.
• Patients hypersensitive to Gentamycin.
• Patients with Haemophilia or markedly reduced immune function.
• Patients with arterial bleeding and severe venous bleeding.
• Patients with other diseases including tumors except for cartilaginous defects of joints.
• Patients with a history of radiation treatment and chemotherapy within the past two years.
• Patients who are pregnant, or nursing a baby.
• Patients who participate in concurrent clinical trials or previous clinical trials within 30 days of administration.
• Other cases where the investigator deems the patient ineligible for participation.

Sponsors & Collaborators

• Biosolution Co., Ltd.: lead

Study Sites (18)

Inje University Haeundae Paik Hospital

Busan, 48108, South Korea

Location

Kosin University Gospel Hospital

Busan, 49267, South Korea

Location

Chungnam National University Hospital

Daejeon, 35015, South Korea

Location

Chonnam National University Hwasun Hospital

Gwangju, 58128, South Korea

Location

Chosun University Hospital

Gwangju, 61453, South Korea

Location

Pusan National University Hospital

Pusan, 35015, South Korea

Location

Seoul National University Bundang Hospital (1)

Seongnam-si, 13620, South Korea

Location

Seoul National University Bundang Hospital (2)

Seongnam-si, 13620, South Korea

Location

Kyung Hee University Hospital

Seoul, 02447, South Korea

Location

Seoul National University Hospital

Seoul, 03080, South Korea

Location

Severance Hospital

Seoul, 03722, South Korea

Location

Kyung Hee University Hospital at Gangdong

Seoul, 05278, South Korea

Location

Gangnam Severance Hospital

Seoul, 06230, South Korea

Location

Samsung Medical Center

Seoul, 06351, South Korea

Location

Ewha Womans University Mokdong Hospital

Seoul, 07985, South Korea

Location

Korea University Guro Hospital

Seoul, 08308, South Korea

Location

The Catholic UNIV. of Korea Seoul St. Mary's Hospital

Seoul, 16591, South Korea

Location

The Catholic UNIV. of Korea Uijeongbu St. Mary's Hospital

Uijeongbu-si, 11765, South Korea

Location

Related Publications (2)

• Yoon KH, Park JY, Lee JY, Lee E, Lee J, Kim SG. Costal Chondrocyte-Derived Pellet-Type Autologous Chondrocyte Implantation for Treatment of Articular Cartilage Defect. Am J Sports Med. 2020 Apr;48(5):1236-1245. doi: 10.1177/0363546520905565. Epub 2020 Mar 3.

  PMID: 32125878 BACKGROUND

• Yoon KH, Yoo JD, Choi CH, Lee J, Lee JY, Kim SG, Park JY. Costal Chondrocyte-Derived Pellet-Type Autologous Chondrocyte Implantation versus Microfracture for Repair of Articular Cartilage Defects: A Prospective Randomized Trial. Cartilage. 2021 Dec;13(1_suppl):1092S-1104S. doi: 10.1177/1947603520921448. Epub 2020 Jun 1.

  PMID: 32476445 BACKGROUND

Study Officials

• Jungsun Lee, Ph.D

  Biosolution Co., Ltd.

  STUDY DIRECTOR

• Kyoung Ho Yoon, MD

  Kyung Hee University Hospital

  PRINCIPAL INVESTIGATOR

• Jae Doo Yoo, MD

  Ewha Womans University Mokdong Hospital

  PRINCIPAL INVESTIGATOR

• Sang Hak Lee, MD

  Kyung Hee University Hospital at Gangdong

  PRINCIPAL INVESTIGATOR

• Sung-Hwan Kim, MD

  Gangnam Severance Hospital

  PRINCIPAL INVESTIGATOR

• Ji Hoon Bae, MD

  Korea University Guro Hospital

  PRINCIPAL INVESTIGATOR

• Hyuk-Soo Han, MD

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

• Joon Ho Wang, MD

  Samsung Medical Center

  PRINCIPAL INVESTIGATOR

• Min Jung, MD

  Severance Hospital

  PRINCIPAL INVESTIGATOR

• Yong In, MD

  The Catholic UNIV. of Korea Seoul St. Mary's Hospital

  PRINCIPAL INVESTIGATOR

• Chong Bum Chang, MD

  Seoul National University Bundang Hospital (1)

  PRINCIPAL INVESTIGATOR

• Yong Seuk Lee, MD

  Seoul National University Bundang Hospital (2)

  PRINCIPAL INVESTIGATOR

• Seok Jung Kim, MD

  The Catholic UNIV. of Korea Uijeongbu St. Mary's Hospital

  PRINCIPAL INVESTIGATOR

• Jong Geun Seon, MD

  Chonnam National University Hospital

  PRINCIPAL INVESTIGATOR

• Dong Hwi Kim, MD

  Chosun University Hospital

  PRINCIPAL INVESTIGATOR

• Young-Mo Kim, MD

  Chungnam National University Hospital

  PRINCIPAL INVESTIGATOR

• Seung Joon Rhee, MD

  Pusan National University Hospital

  PRINCIPAL INVESTIGATOR

• Sang Won Moon, MD

  Haeundae Paik Hospital, Inje University

  PRINCIPAL INVESTIGATOR

• Young Choi, MD

  Kosin University Gospel Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Investigational Group : CartiLife® Procedure: 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 cm\^3 of defect volume, and fibrin adhesive is applied to fix pellets in place through minimal arthrotomy. Active comparator: Microfracture Surgery Procedure : 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 Record Dates

• First Submitted: August 4, 2021
• First Posted: September 21, 2021
• Study Start: March 19, 2020
• Primary Completion: September 30, 2023
• Study Completion: September 30, 2024
• Last Updated: May 17, 2022

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

KR (18)