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OpenTrials
Completed

NCT Number: NCT03545269

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

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.

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Key information

Conditions

Articular Cartilage Lesion of the Knee Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Rheumatic Diseases

Age range

19 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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.

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.

Primary outcomes

  1. MOCART (Magnetic Resonance Observation of Cartilage Repair Tissue)

    Time frame: Baseline to 48 weeks

    Changes in MOCART scores during each visit

Secondary outcomes

  1. Lysholm Score

    Time frame: Baseline to 48 weeks

    Changes in Lysholm Scores during each visit

  2. IKDC (International Knee Documentation Committee Score)

    Time frame: Baseline to 48 weeks

    Changes in IKDC scores during each visit

  3. KOOS (Knee injury Osteoarthritis Outcome Score)

    Time frame: Baseline to 48 weeks

    Changes in KOOS during each visit

  4. VAS (100 mm Pain Visual Analogue Scale)

    Time frame: Baseline to 48 weeks

    Changes in VAS during each visit

  5. ROM (Range Of Motion)

    Time frame: Baseline to 48 weeks

    Changes in ROM during each visit

  6. Adverse events

    Time frame: Baseline to 48 weeks

    Number of adverse events

  7. X-ray

    Time frame: Baseline to 48 weeks

    Changes in structure during each visit

Sponsors and collaborators

Lead sponsor

Biosolution Co., Ltd.

Industry

Collaborators

  • Ewha Womans University
  • Gangnam Severance Hospital
  • Kyunghee University Medical Center
  • Severance Hospital

Registry information

Official study title

A Multi-Center, Active-Controlled, Open-Label, Phase Ⅱ Trial to Compare the Efficacy and Safety for Treatment of Autologous Chondrocytes Implantation With CartiLife Versus Microfracture for Patient With Chondral Defects in the Knee

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Jun 4, 2018
Registry last updated
Jun 4, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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