Phase 3
N=30
Effects of CHONDRON (Autologous Chondrocytes) With Ankle Cartilage Defect
Articular Cartilage Defects of Ankle Joint
Bottom Line
View on ClinicalTrials.gov: NCT01050816 ↗Enrolled (actual)
30
Serious AEs
6.7%
Results posted
May 2010
Primary outcome: Primary: Average Change From Baseline in American Orthopedic Foot and Ankle Society(AOFAS) at 12 Months Post-surgery — 16.93 scores
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Chondron(autologous chondrocyte) Implantation (Procedure)
- Age
- Pediatric, Adult, Older Adult · 15+ yrs
- Sex
- All
- Sponsor
- Cellontech Co., Ltd.
- Primary completion
- Jan 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Average Change From Baseline in American Orthopedic Foot and Ankle Society(AOFAS) at 12 Months Post-surgery |
16.93 | — |
| SECONDARY Average Change From Baseline in 100mm Visual Analogue Scale(VAS) at 12months Post-surgery |
-27.19 | — |
| SECONDARY Average Change From Baseline in the Modified Hannover Scoring System at 12 Months Post Surgery |
26.26 | — |
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.
Eligibility Criteria
Inclusion Criteria
- adult men and women over 15 and less than 65 years of age
- applied to patients with arthroscopically or grossly confirmed, partial cartilage defect at the ankle joint
- 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.
- patients which surrounding cartilage are normal
- 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
- 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
- patients who have a history of receiving radiotherapy, chemotherapy in the last 2 years
- 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 who are administering antibiotics and antimicrobial agents due to infection
- patients who receive steroid hormone therapy
- Patients with psychiatric disorder and those who are considered to be inappropriate for this trial by the judgment of the clinical trial manager
Data sourced from ClinicalTrials.gov (NCT01050816). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.