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

Articular Cartilage Lesion of Knee Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03517046
• Other study ID #: MCTT-CTL-I
• Status: Completed
• Phase: Phase 1
• Start date: July 17, 2012
• Est. completion date: December 10, 2013

Study information

• Verified date: March 2018
• Source: Biosolution Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: December 10, 2013
• Est. primary completion date: December 10, 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Articular Cartilage Lesion of Knee

Intervention

Drug:
• CartiLife
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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Biosolution Co., Ltd.	Kyung Hee University Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse events	Number of adverse events	48 weeks
Secondary	IKDC (International Knee Documentation Committee)	Changes in IKDC scores during each visit; The IKDC Score is a subjective questionnaire filled out by the patient ranges from 0-100, where a score of 100 is interpreted to mean no limitation with sporting activities or daily living and the complete absence of symptoms	Baseline to 48 weeks
Secondary	X-ray	Changes in structure during each visit	Baseline 48 weeks