Study to Assess the Efficacy and Safety of Treatment of Articular Cartilage Lesions With CartiLife®

NCT03545269 | Completed Phase 2

• 1 other identifier: MCTT-CTL-021
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to assess the safety and efficacy of implanting bead-type autologous chondrocyte (CartiLife®) obtained by culturing expanded costal chondrocytes of the patient with a chondral defect in the knee. The patients will be assessed clinically using MRI, clinical, biochemical and International Knee Documentation Committee(IKDC) outcomes preoperatively as well as 8, 24 and 48 weeks postoperatively to assess the relief of symptoms and joint function.

Conditions

Articular Cartilage Lesion of the Knee

Keywords

Degenerative Arthritis; Autologous Chondrocyte Implantation; Cartilage defects; Cartilage lesion; Arthritis

Outcome Measures

Primary Outcomes (1)

• MOCART (Magnetic Resonance Observation of Cartilage Repair Tissue)

  Changes in MOCART scores during each visit

  Baseline to 48 weeks

Secondary Outcomes (7)

• Lysholm Score

  Baseline to 48 weeks

• IKDC (International Knee Documentation Committee Score)

  Baseline to 48 weeks

• KOOS (Knee injury Osteoarthritis Outcome Score)

  Baseline to 48 weeks

• VAS (100 mm Pain Visual Analogue Scale)

  Baseline to 48 weeks

• ROM (Range Of Motion)

  Baseline to 48 weeks

Study Arms (2)

CartiLife®

EXPERIMENTAL

Drug: CartiLife®

Microfracture

ACTIVE COMPARATOR

Procedure: Microfracture

Interventions

CartiLife® DRUG

CartiLife® is beads (1.0 to 1.5 mm in diameter) in suspension, developed from autologous chondrocytes. The beads are implanted the volume of 1 cm3 per the capacity of the syringe to the affected area through injection with fibrin adhesive through minimal arthrotomy.

CartiLife®

Microfracture PROCEDURE

The surgery is performed by arthroscopy, after the joint is cleaned of calcified cartilage. Through use of an awl, the surgeon creates tiny fractures in the subchondral bone plate.

Microfracture

Eligibility Criteria

• Age: 19 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult men and women aged between 19 and 65
• Defect size: 2 to 10 ㎠ on the unilateral knee cartilage (up to 4 ㎤ in volume)
• Defect: isolated International Cartilage Repair Society(ICRS) Grade III or IV single defect chondral lesion on articular cartilage
• The joint space is maintained over 50% relative to baseline
• Patients that are able to walk without aid
• Patients that agree to abide by strict rehabilitation protocols and follow-up programs
• Patients who provide written consent to the participation of the clinical trial

You may not qualify if:

• Patients with inflammatory articular diseases such as rheumatoid arthritis or gouty arthritis
• Kellgren and Lawrence grade ≥ 3
• Patients with arthritis associated with autoimmune diseases
• Patients hypersensitive to bovine protein
• Patients with Haemophilia or markedly reduced immune function
• Patients hypersensitive to antibiotics like gentamicin
• 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, nursing a baby or likely to get pregnant
• 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
• Kyunghee University Medical Center: collaborator
• Gangnam Severance Hospital: collaborator
• Severance Hospital: collaborator
• Ewha Womans University: collaborator

Related Publications (2)

• Yoon KH, Lee J, Park JY. Costal Chondrocyte-Derived Pellet-Type Autologous Chondrocyte Implantation Versus Microfracture for the Treatment of Articular Cartilage Defects: A 5-Year Follow-up of a Prospective Randomized Trial. Am J Sports Med. 2024 Feb;52(2):362-367. doi: 10.1177/03635465231222797. Epub 2024 Jan 17.

  PMID: 38230875 DERIVED

• 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 DERIVED

MeSH Terms

Conditions

Osteoarthritis; Arthritis

Interventions

Arthroplasty, Subchondral

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Arthroplasty; Orthopedic Procedures; Surgical Procedures, Operative; Plastic Surgery Procedures

Study Officials

• Kyoung Ho, MD, PhD

  Kyunghee University Medical Center

  PRINCIPAL INVESTIGATOR

• Jong Hyeok Choi, MD, PhD

  Severance Hospital

  PRINCIPAL INVESTIGATOR

• Jae-Doo Yoo, MD, PhD

  Ewha Womans University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

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

Model Details: Biological: CartiLife® Procedure: CartiLife® is beads (1.0 to 1.5 mm in diameter) in suspension, developed from autologous chondrocytes. The beads are implanted in a volume of 1 cm3 per the capacity of the syringe to the affected area through injection along with a fibrin adhesive through minimal arthrotomy. Active comparator: Microfracture The surgery is performed by arthroscopy, after the joint is cleaned of calcified cartilage. Through use of an awl, the surgeon creates tiny fractures in the subchondral bone plate.

Study Record Dates

• First Submitted: March 8, 2018
• First Posted: June 4, 2018
• Study Start: February 3, 2014
• Primary Completion: February 23, 2017
• Study Completion: February 23, 2017
• Last Updated: June 4, 2018

Record last verified: 2018-05