Clinical trial NCT02537067: Efficacy and Safety of Chondron (Autologus Chondrocyte) in Patients With Cartilage Defects in Their Ankle
Official title: A Phase III Clinical Trial to Evaluate the Efficacy and Safety of Chondron (Autologus Chondrocyte) in Patients With Cartilage Defects in Their Ankle for 18 Months
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Defect of Articular Cartilage
Degenerative Joint Disease of Ankle and/or Foot
Ankle (Ligaments); Instability, Familial
Keywords: a partial cartilage defect of ankle
Chondron
Autologus Chondrocyte
Lead sponsor: Sewon Cellontech Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2015-09-01
Enrollment: 28
Sex: ALL
Minimum age (years): 15
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The objective of this study is to evaluate the efficacy and safety of Chondron (Autologus Chondrocyte) in patients with cartilage defects in their ankle for 18 months

Detailed description: This is an open label trial, involving a total of 28 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 6\* 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, x-ray, MRI tests and arthroscopy will be performed. \*If tissue samples can be collected at screening visit, there will be only 5 visits.

Eligibility criteria: Inclusion Criteria:

* 1. Adult men and women over 15 and less than 65 years of age 2. Applicable to patients who have a partial cartilage defect in their ankle based on an MRI (defect size: for a single lesion, less than 15 cm2; and for multiple lesions, less than 20 cm2) 3. Patients with ankle-tibia malalignment of the ankle joint, unstable ankle ligaments, bone defects at the cartilage defect area or patients who received correction in advance 4. Patients which surrounding cartilage are normal 5.Patients with a Grade III or IV cartilage defect size on the ICRS (International Cartilage Repair Society) 6. Patients who agreed to clinical trial participation voluntarily or by the will of the person in parental authority, and signed the written 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 7. Patients who have a history of receiving radiotherapy, chemotherapy in the last 2 years 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 who are administering antibiotics and antimicrobial agents due to infection 10. Patients who receive steroid hormone therapy 11. Patients with psychiatric disorder and those who are considered to be inappropriate for this trial by the judgment of the clinical trial manager

Primary outcomes:
measure: Grade change of ICRS(International Cartilage Repair Society) by arthroscopy
timeFrame: 12 months after the surgery
Secondary outcomes:
measure: Score change of AOFAS(American orthopedic foot & ankle society) Score
timeFrame: baseline and six, 12 and 18 months after the surgery
measure: Hannover Score
timeFrame: baseline and six, 12 and 18 months after the surgery
measure: Score change of Evaluation by physician in charge
timeFrame: six, 12 and 18 months after the surgery
measure: Score change of 100mmVAS(visual analogue scale)
timeFrame: baseline and six, 12 and 18 months after the surgery
measure: Comparing MRI results
timeFrame: baseline and 18 months after the surgery
Other outcomes:
Locations:
city: Goyang
country: Korea, Republic of
facility: Myongji Hospital
state: Gyeonggi
city: Seoul
country: Korea, Republic of
facility: Eulji General Hospital
Study officials:
affiliation: Eulji General Hospital
name: Jin Su Kim, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Myongji Hospital
name: Ki Hyuck Sung, MD
role: PRINCIPAL_INVESTIGATOR
References: