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

Osteoarthritis Clinical Trial

Official title:

This Post-marketing Surveillance to Evaluate the Efficacy and Safety of a CHONDRON (Autologous Cultured Chondrocyte) in Patients With Cartilage Defects in Their Knees.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02539056
• Other study ID #: 08CON
• Status: Active, not recruiting
• Phase: Phase 4
• First received: August 28, 2015
• Last updated: September 1, 2015
• Start date: July 2012
• Est. completion date: August 2016

Study information

• Verified date: August 2015
• Source: Sewon Cellontech Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Ministry of Food and Drug Safety
• Study type: Interventional

Clinical Trial 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.

Description:

This is an open trial, involving a total of 24 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 24
• Est. completion date: August 2016
• Est. primary completion date: February 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 15 Years and older

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteoarthritis
• Traumatic Arthritis

Intervention

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.

Locations

Country	Name	City	State
Korea, Republic of	Inha Univerisity Hospital	Incheon
Korea, Republic of	Ewha Womans University Mokdong Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Sewon Cellontech Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	change of IKDC (International Knee Documentation Committee)	The IKDC values of the affected knee at basleine and 48 weeks 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	No
Secondary	Chnage of KSS(Knee Society Score)	The primary endpoint for the analysis is the change in the KSS 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	No
Secondary	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	No
Secondary	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 48 weeks after the surgery and 12, 24 and 96 weeks after the surgery	No
Secondary	Change of MRI and mMOCART result	The morphological improvement of MRI image for the affected knee at baseline will be compared with those at 48 weeks after the surgery (and 12, 24, and 96weeks 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	No
Secondary	change in pain of 100mm Visual Analog Scale	The change in the 100mmVAS will be assessed at baseline and 12, 24 and 96 weeks after the surgery.	baseline, 12, 24 and 96 weeks after the surgery	No