The Post-marketing Surveillance to Evaluate the Efficacy of CHONDRON (Autologous Cultured Chondrocyte) by Arthroscopy

A Post-marketing Surveillance to Evaluate the Efficacy and Safety of CHONDRON (Autologous Cultured Chondrocyte) Through Arthroscopy in Patients With Knee Cartilage Defects

A clinical trial to evaluate the long-term efficacy and safety of Chondron (Autologous cultured Chondrocyte) administered through arthroscopy from the drug's 48 weeks efficacy and safety evaluation with 96 weeks follow-up in patients with knee cartilage defects.

Study Overview

• Status: Completed
• Conditions: Osteoarthritis; Traumatic Arthritis
• Intervention / Treatment: Device: Chondron Implantation

Detailed Description

This is an open trial, involving a total of 10 subjects. Subjects who give consent will be screened and those who meet trial criteria will receive CHONDRON (Autologous cultured Chondrocyte) by transplant. During the trial period, subjects must follow the instructions given by principal investigator. Subjects will make 8* hospital visits on a regular basis inclusive of hospitalization. During these visits subjects will be examined. For the evaluation of safety and efficacy of CHONDRON, examination with doctors, blood samples, x-ray, MRI tests, observation with the naked eyes and arthroscopy will be performed. *If tissue samples can be collected at screening visit, there will be only 7 visits.

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• South Korea
  • Seoul
    • Seoul, Seoul, South Korea
      • Yonsei University Severance Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Patients with cartilage defects in their knee (Including Knee OA and Knee TA) * For a single lesion, less than 15 cm2 cartilage defects; and for multiple lesions, less than 20 cm2
2. Patients with misalignment of their tibia and femur, unstable ligament in their knee, or bony defects in the lesions of their knee, and/or who had been treated for alignment
3. Patients which surrounding cartilage are normal
4. Patients who were 15 years old or older
5. Patients or their representative (for adults), or patients and their parent/guardian (for minors), who agreed to participate in the study and signed the informed consent form

Exclusion Criteria:

1. Patients hypersensitive to bovine protein
2. Patients hypersensitive to gentamicin antibiotics
3. Patients with inflammatory arthritis such as rheumatoid arthritis, gout arthritis
4. Patients with arthritis related to autoimmune disease
5. Pregnant, breast-feeding patients or those who have a possibility of pregnancy
6. Patients with accompanying diseases other than articular cartilage defects, including tumors (Exception: if the possibility of Chondron treatment is confirmed with doctor's clinical decision).
7. Patients who have a history of receiving radiotherapy, chemotherapy in the last 2 years (Exception: if the possibility of Chondron treatment is confirmed with doctor's clinical decision).
8. Patients with diabetes (however, patients whose blood sugar test results are normal and do not have any complication of diabetes, when a written opinion that CHONDRON administration is possible is appended by a doctor are excluded)
9. Patients with an infection that required hospitalization for antibiotics or the administration of antiseptic agents
10. Patients under adrenocorticoid therapy (Exception: if the possibility of Chondron treatment is confirmed with doctor's clinical decision).
11. Patients with psychiatric disorder and those who are considered to be inappropriate for this trial by the judgment of the clinical trial manager
12. Patients with cartilage defects in both knees (If the necessity of other surgery on the opposite side of knee joint using Chondron is confirmed with doctor's clinical decision).
13. Patients with liver, heart, or kidney disease (Those who show normal or insignificant test results may be enrolled in this study and receive the Chondron based on the investigator's judgment. Hypertension patients are allowed.)
14. Patients who had been infected with a virus (Those who show normal or insignificant test results may be enrolled in this study and receive the Chondron based on the investigator's judgment.)
15. Patients who had participated in another clinical trial (limited to those who participated in other studies on fracture within the last six months.)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Chondron Implantation; Chondron Implantation for the subject with cartilage defect through arthroscopy	Device: Chondron Implantation; In one vial (0.4 ml), Main ingredient: 1.2 million or more autologous chondrocytes Culture solution: Adequate amount of Dulbecco's modified Eagle medium (DMEM) The cells that fill the vial are sufficiently suspended, and a sufficient amount of suspension is grafted in the defect with fibrin glue.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
change in pain of 100mm Visual Analog Scale	The primary endpoint for the analysis is the change in the 100mmVAS at 48 weeks after the surgery compared to that at baseline.	48 weeks after the surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
change of IKDC (International Knee Documentation Committee)	The IKDC values of the affected knee at baseline and 48weeks after the surgery will be primarily compared based on the evaluations by the subjects and the investigators (and 12, 24 and 96 weeks after the surgery).	baseline and 48 weeks after the surgery and 12, 24 and 96 weeks after the surgery
Chnage of KSS(Knee Society Score)	The primary endpoint for the analysis is the change in the KSS before and 48 weeks after the surgery (and 12, 24 and 96 weeks after the surgery).	baseline and 48 weeks after the surgery and 12, 24 and 96 weeks after the surgery
Chnage of ICRS(International Cartilage Repair Society) score	The ICRS grades of the affected knee at baseline and 48 weeks after the surgery will be primarily compared.	baseline and 48 weeks after the surgery
Chnage of KOOS(Knee injury and osteoarthritis outcome) score	The primary endpoint for the analysis is the change in the KOOS at baseline and 48 weeks after the surgery (and 12, 24 and 96 weeks after the surgery).	baseline and 48weeks after the surgery and 12, 24 and 96 weeks after the surgery
Change of MRI and mMOCART result	The morphological improvement from MRI iamge of affected knee will be assessed at 48 weeks after the surgery from image at baseline (and 12, 24, and 96 weeks after the surgery). The primary endpoint for the analysis is the change in the mMOCART at baseline and 48 weeks after the surgery (and 12, 24 and 96 weeks after the surgery).	baseline and 48 weeks after the surgery and 12, 24 and 96 weeks after the surgery
change in pain of 100mm Visual Analog Scale	The change in the 100mmVAS at baseline, 12, 24 and 96 weeks after the surgery will be assessed.	baseline and 12, 24 and 96 weeks after the surgery

Collaborators and Investigators

• Sponsor: Cellontech Co., Ltd.
• Investigators: Principal Investigator: Sung Jae Kim, MD, Severance Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 23, 2012
• Primary Completion (Actual): January 15, 2016
• Study Completion (Actual): January 15, 2016

Study Registration Dates

• First Submitted: August 28, 2015
• First Submitted That Met QC Criteria: September 1, 2015
• First Posted (Estimated): September 2, 2015

Study Record Updates

• Last Update Posted (Actual): April 8, 2026
• Last Update Submitted That Met QC Criteria: April 2, 2026
• Last Verified: November 1, 2016

More Information

Terms related to this study

• Keywords: arthroscopy; cartilage defects; Chondron; Autologous cultured Chondrocyte
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Arthritis; Joint Diseases; Rheumatic Diseases; Osteoarthritis
• Other Study ID Numbers: 09CON