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

NCT03517046 | Completed Phase 1

• 1 other identifier: MCTT-CTL-I
• Study Type: interventional
• Target: 6
• 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 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.

Conditions

Articular Cartilage Lesion of Knee

Keywords

Arthritis; Articular Cartilage; Autologous Chondrocyte Implantation; Degenerative Arthritis; Cartilage Lesion; Cartilage Defect

Outcome Measures

Primary Outcomes (1)

• Adverse events

  Number of adverse events

  48 weeks

Secondary Outcomes (2)

• IKDC (International Knee Documentation Committee)

  Baseline to 48 weeks

• X-ray

  Baseline 48 weeks

Study Arms (2)

CartiLife (low-dose group)

EXPERIMENTAL

Total defect volume in low-dose group is less than 2 ㎤. Low- and high-dose group are sequentially processed.

Drug: CartiLife

CartiLife (high-dose group)

EXPERIMENTAL

Total defect volume in High-dose group is 2 \~ 4 ㎤.

Drug: CartiLife

Interventions

CartiLife DRUG

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 with a fibrin adhesive through minimal arthrotomy.

CartiLife (high-dose group); CartiLife (low-dose group)

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Biosolution Co., Ltd.: lead
• Kyung Hee University Hospital: collaborator

Related Publications (1)

• 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 DERIVED

MeSH Terms

Conditions

Arthritis; Osteoarthritis

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Kyoung Ho Yoon, MD, PhD

  Kyunghee University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 8, 2018
• First Posted: May 7, 2018
• Study Start: July 17, 2012
• Primary Completion: December 10, 2013
• Study Completion: December 10, 2013
• Last Updated: May 7, 2018

Record last verified: 2018-03