The Post-marketing Surveillance to Evaluate the Efficacy and Safety of a CHONDRON (Autologous Cultured Chondrocyte)

NCT02539056 | Completed DMC

• 1 other identifier: 08CON
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 2

Brief Summary

A clinical trial to evaluate the long-term efficacy and safety of a CHONDRON (Autologous cultured Chondrocyte) for 48weeks, and additional 96weeks in patients with cartilage defects in their knees.

Conditions

Osteoarthritis; Traumatic Arthritis

Keywords

cartilage defects; Chondron; Autologous cultured Chondrocyte

Outcome Measures

Primary Outcomes (1)

• 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 from that of baseline.

  48 weeks after the surgery

Secondary Outcomes (6)

• change of IKDC (International Knee Documentation Committee)

  baseline and 48 weeks after the surgery and 12, 24 and 96 weeks after the surgery

• Chnage of KSS(Knee Society Score)

  baseline and 48 weeks after the surgery and 12, 24 and 96 weeks after the surgery

• Chnage of ICRS(International Cartilage Repair Society) score

  baseline and 48 weeks after the surgery

• Chnage of KOOS(Knee injury and osteoarthritis outcome) score

  baseline and 48 weeks after the surgery and 12, 24 and 96 weeks after the surgery

• Change of MRI and mMOCART result

  baseline and 48 weeks after the surgery and 12, 24 and 96 weeks after the surgery

Study Arms (1)

Chondron Implantation

EXPERIMENTAL

Chondron Implantation for the subject with cartilage defect

Device: Chondron Implantation

Interventions

Chondron Implantation DEVICE

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.

Chondron Implantation

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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
• Patients which surrounding cartilage are normal
• Patients who were 15 years old or older
• 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

You may not qualify if:

• Patients hypersensitive to bovine protein
• Patients hypersensitive to gentamicin antibiotics
• Patients with inflammatory arthritis such as rheumatoid arthritis, gout arthritis
• Patients with arthritis related to autoimmune disease
• Pregnant, breast-feeding patients or those who have a possibility of pregnancy
• 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).
• 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).
• 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)
• Patients with an infection that required hospitalization for antibiotics or the administration of antiseptic agents
• Patients under adrenocorticoid therapy (Exception: if the possibility of Chondron treatment is confirmed with doctor's clinical decision).
• Patients with psychiatric disorder and those who are considered to be inappropriate for this trial by the judgment of the clinical trial manager
• 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).
• 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.)
• 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.)
• Patients who had participated in another clinical trial (limited to those who participated in other studies on fracture within the last six months.)

Sponsors & Collaborators

• Cellontech Co., Ltd.: lead

Study Sites (2)

Inha Univerisity Hospital

Incheon, Incheon, South Korea

Location

Ewha Womans University Mokdong Hospital

Seoul, Seoul, South Korea

Location

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Myung Ku Kim, MD

  Inha University Hospital

  PRINCIPAL INVESTIGATOR

• Jae Doo Yoo, MD

  Ewha Womans University Mokdong Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 28, 2015
• First Posted: September 2, 2015
• Study Start: October 15, 2012
• Primary Completion: March 18, 2016
• Study Completion: March 18, 2016
• Last Updated: April 8, 2026

Record last verified: 2016-11

Locations

KR (2)