Clinical trial NCT02539056: The Post-marketing Surveillance to Evaluate the Efficacy and Safety of a CHONDRON (Autologous Cultured Chondrocyte)
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.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Osteoarthritis
Traumatic Arthritis
Keywords: cartilage defects
Chondron
Autologous cultured Chondrocyte
Lead sponsor: Sewon Cellontech Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2015-09-02
Enrollment: 24
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Detailed 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.

Eligibility criteria: 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.)

Primary outcomes:
measure: change in pain of 100mm Visual Analog Scale
timeFrame: 48 weeks after the surgery
Secondary outcomes:
measure: change of IKDC (International Knee Documentation Committee)
timeFrame: baseline and 48 weeks after the surgery and 12, 24 and 96 weeks after the surgery
measure: Chnage of KSS(Knee Society Score)
timeFrame: baseline and 48 weeks after the surgery and 12, 24 and 96 weeks after the surgery
measure: Chnage of ICRS(International Cartilage Repair Society) score
timeFrame: baseline and 48 weeks after the surgery
measure: Chnage of KOOS(Knee injury and osteoarthritis outcome) score
timeFrame: baseline and 48 weeks after the surgery and 12, 24 and 96 weeks after the surgery
measure: Change of MRI and mMOCART result
timeFrame: baseline and 48 weeks after the surgery and 12, 24 and 96 weeks after the surgery
measure: change in pain of 100mm Visual Analog Scale
timeFrame: baseline, 12, 24 and 96 weeks after the surgery
Other outcomes:
Locations:
city: Incheon
country: Korea, Republic of
facility: Inha Univerisity Hospital
city: Seoul
country: Korea, Republic of
facility: Ewha Womans University Mokdong Hospital
Study officials:
affiliation: Inha University Hospital
name: Myung Ku Kim, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Ewha Womans University Mokdong Hospital
name: Jae Doo Yoo, MD
role: PRINCIPAL_INVESTIGATOR
References: