Clinical trial NCT01050816: Effects of CHONDRON (Autologous Chondrocytes) With Ankle Cartilage Defect
Official title: An Investigator Clinical Trial to Observe Effects of CHONDRON (Autologous Chondrocytes) for 12 Months in Patients With Ankle Cartilage Defect
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Articular Cartilage Defects of Ankle Joint
Keywords: articular cartilage defects
ACI
ankle joint
chondron
Lead sponsor: Sewon Cellontech Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2010-01-15
Enrollment: 30
Sex: ALL
Minimum age (years): 15
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: An open clinical trial transplanting CHONDRON (autologous chondrocytes) to ankle cartilage defect patients who are appropriate for the trial, and evaluating the validity and safety for 12 months.

Detailed description: This clinical trial was designed to observe effects of CHONDRON (autologous chondrocytes) for 12 months in patients with ankle cartilage defects. In this clinical trial, 30 subjects were screened- 4 were excluded half way and 26 finished the trial. Full-thickness articular cartilage specimen was obtained from sites that do not have direct articulation within the ankle joint(anterior talus, anterior process of calcaneus, calcaneocuboid joint area.) Gel-type CHONDRON (Fibrin mixed Autologous chondrocytes) was transplanted at the defects. Evaluation variables were AOFAS, 100 mm VAS, HANNOVER score, self-assessment of improvement by the patient, MRI and arthroscopy.

Eligibility criteria: Inclusion Criteria:

1. adult men and women over 15 and less than 65 years of age
2. applied to patients with arthroscopically or grossly confirmed, partial cartilage defect at the ankle joint
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 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: Average Change From Baseline in American Orthopedic Foot and Ankle Society(AOFAS) at 12 Months Post-surgery
timeFrame: baseline(preoperative stage),12months post-surgery
Secondary outcomes:
measure: Average Change From Baseline in 100mm Visual Analogue Scale(VAS) at 12months Post-surgery
timeFrame: baseline(preoperative stage),12months post-surgery
measure: Average Change From Baseline in the Modified Hannover Scoring System at 12 Months Post Surgery
timeFrame: baseline(preoperative stage),12months post-surgery
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Sewon Cellontech
state: Sungdong-ku
Study officials:
affiliation: Eulji General Hospital
name: Gyeung Tea Lee, MD
role: PRINCIPAL_INVESTIGATOR
References: