Clinical trial NCT03545269: Study to Assess the Efficacy and Safety of Treatment of Articular Cartilage Lesions With CartiLife®
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Articular Cartilage Lesion of the Knee
Keywords: Degenerative Arthritis
Autologous Chondrocyte Implantation
Cartilage defects
Cartilage lesion
Arthritis
Lead sponsor: Biosolution Co., Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Kyunghee University Medical Center
name: Gangnam Severance Hospital
name: Severance Hospital
name: Ewha Womans University
First posted: 2018-06-04
Enrollment: 30
Sex: ALL
Minimum age (years): 19
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: MOCART (Magnetic Resonance Observation of Cartilage Repair Tissue)
timeFrame: Baseline to 48 weeks
Secondary outcomes:
measure: Lysholm Score
timeFrame: Baseline to 48 weeks
measure: IKDC (International Knee Documentation Committee Score)
timeFrame: Baseline to 48 weeks
measure: KOOS (Knee injury Osteoarthritis Outcome Score)
timeFrame: Baseline to 48 weeks
measure: VAS (100 mm Pain Visual Analogue Scale)
timeFrame: Baseline to 48 weeks
measure: ROM (Range Of Motion)
timeFrame: Baseline to 48 weeks
measure: Adverse events
timeFrame: Baseline to 48 weeks
measure: X-ray
timeFrame: Baseline to 48 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Kyunghee University Medical Center
name: Kyoung Ho, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Severance Hospital
name: Jong Hyeok Choi, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Ewha Womans University Hospital
name: Jae-Doo Yoo, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.