Effects of CHONDRON (Autologous Chondrocytes) With Ankle Cartilage Defect

An Investigator Clinical Trial to Observe Effects of CHONDRON (Autologous Chondrocytes) for 12 Months in Patients With Ankle Cartilage Defect

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.

Study Overview

• Status: Completed
• Conditions: Articular Cartilage Defects of Ankle Joint
• Intervention / Treatment: Procedure: Chondron(autologous chondrocyte) Implantation

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.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 3

Contacts and Locations

Study Locations

• Korea, Republic of
  • Sungdong-ku
    • Seoul, Sungdong-ku, Korea, Republic of, 133831
      • Sewon Cellontech

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 65 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Chondron implantation; ankle cartilage defect patients who had CHONDRON transplantation

Procedure: Chondron(autologous chondrocyte) Implantation; Test drug: Chondron (more than 12 million chondrocytes in 0.4ml, i.e. 1 vial); Directions and dosage: Suspend the cells in the vial sufficiently, and implant them in the defective part, making sure that sufficient amounts are injected. *30 subjects participated in this open clinical trial. Those who agreed to participate voluntarily went through screening to confirm the appropriateness for the clinical trial, and then received Gel type CHONDRON (fibrin mixed autologous chondrocytes) transplantation.; Other Names: Chondron

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Average Change From Baseline in American Orthopedic Foot and Ankle Society(AOFAS) at 12 Months Post-surgery	AOFAS scores(best score-100,worst score- 0 ); pain-none:40/Strong and Always present:O; Functionactivities-without support activities:10/need restrain, clutch , walker or wheelchair:0Maximum gait distance- more than 6:5/ less than 1:0gait surface-easy in any surace:5/strong difficult in irregular ground stair or slopes:0Gait abnormality-none:8/marked:0saggital mobidity- normal or minimal restrain:6/strong restraint:0hindfoot mobidity -normal minimal restrain:6/strong restrain:0ankle and hindfoot stability - stable:8/unstable:0; alignment- good:10/bad:0	baseline(preoperative stage),12months post-surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Average Change From Baseline in 100mm Visual Analogue Scale(VAS) at 12months Post-surgery	A VAS is a horizontal line, 100mm in length, anchored by word descriptors about pain at each end.The VAS is measured degree of pain from 0mm to 100mm. Severe pain is represented by 100mm and no pain is represented by 0mm. The VAS score is determined by measuring in millimetres from the left hand end of the line to the point that the patient marks. The difference of secondary evaluation variables VAS at baseline and after the end of the trial were analyzed by using paired t-test. Improvements were compared and analysis by each time point.	baseline(preoperative stage),12months post-surgery
Average Change From Baseline in the Modified Hannover Scoring System at 12 Months Post Surgery	The Modified Hannover Score System contains information about patient's status(pain-36, clinical finding- 4, patient's subjective assessment- 25, statics- 6, fuction- 26, radiology-7;best score-104, worst score-0).The scores of 27 patients in the FAS group were taken in the screening period (Visit S), 12 months after transplantation (Visit 7). The difference of the scores at screening and 12 months after transplantation was compared by using the paired t-test. Improvements were compared and analyzed at each time point.	baseline(preoperative stage),12months post-surgery

Collaborators and Investigators

• Sponsor: Sewon Cellontech Co., Ltd.
• Investigators: Principal Investigator: Gyeung Tea Lee, MD, Eulji General Hospital

Study record dates

Study Major Dates

• Study Start: January 1, 2006
• Primary Completion (Actual): January 1, 2009
• Study Completion (Actual): February 1, 2009

Study Registration Dates

• First Submitted: January 13, 2010
• First Submitted That Met QC Criteria: January 14, 2010
• First Posted (Estimate): January 15, 2010

Study Record Updates

• Last Update Posted (Estimate): May 11, 2010
• Last Update Submitted That Met QC Criteria: May 6, 2010
• Last Verified: May 1, 2010

More Information

Terms related to this study

• Keywords: ACI; articular cartilage defects; chondron; ankle joint
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Connective Tissue Diseases; Cartilage Diseases
• Other Study ID Numbers: 02CON