Clinical trial NCT03517046: Study to Assess the Safety of Treatment of Articular Cartilage Lesions With CartiLife®
Official title: A Multi-center, Open-label, Phase I Trial to Assess the Safety for Treatment of Autologous Chondrocytes Implantation With CartiLife for Patients With Chondral Defects in the Knee
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Articular Cartilage Lesion of Knee
Keywords: Arthritis
Articular Cartilage
Autologous Chondrocyte Implantation
Degenerative Arthritis
Cartilage Lesion
Cartilage Defect
Lead sponsor: Biosolution Co., Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Kyung Hee University Hospital
First posted: 2018-05-07
Enrollment: 6
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the safety and efficacy of implanting bead-type autologous chondrocytes (CartiLife®) obtained by culturing expanded costal chondrocytes of the patient with a chondral defect in the knee. The patients will be assessed clinically using clinical, biochemical and IKDC (International Knee Documentation Committee) outcomes preoperatively as well as 4, 8, 24 and 48 weeks postoperatively to assess the relief of symptoms and joint function.


Eligibility criteria: Inclusion Criteria:

* Patients at least 19 years old
* Defect size: 2 to 10 ㎠ 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
* 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
* Patients with arthritis associated with autoimmune disease
* Patients hypersensitive to bovine protein
* Patients with Haemophilia or markedly reduced immune function
* Patients hypersensitive to antibiotics such as 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: Adverse events
timeFrame: 48 weeks
Secondary outcomes:
measure: IKDC (International Knee Documentation Committee)
timeFrame: Baseline to 48 weeks
measure: X-ray
timeFrame: Baseline 48 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Kyunghee University Medical Center
name: Kyoung Ho Yoon, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.