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Effects of CHONDRON (Autologous Chondrocytes) With Ankle Cartilage Defect

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ClinicalTrials.gov Identifier: NCT01050816
Recruitment Status : Completed
First Posted : January 15, 2010
Results First Posted : May 7, 2010
Last Update Posted : May 11, 2010
Sponsor:
Information provided by:
Sewon Cellontech Co., Ltd.

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Articular Cartilage Defects of Ankle Joint
Intervention Procedure: Chondron(autologous chondrocyte) Implantation
Enrollment 30
Recruitment Details 30 subjects who have ankle cartilage defects
Pre-assignment Details  
Arm/Group Title Chondron Implantation
Hide Arm/Group Description Those who agreed to participate voluntarily went through screening to confirm the appropriateness for the clinical trial, and then received appropriate amounts(by size, but mean:4vail(1.6ml)) of CHONDRON (autologous chondrocytes) transplantation.
Period Title: Overall Study
Started 30
Completed 26
Not Completed 4
Reason Not Completed
Lost to Follow-up             2
patient's refusal             2
Arm/Group Title Chondron Implantation
Hide Arm/Group Description Those who agreed to participate voluntarily went through screening to confirm the appropriateness for the clinical trial, and then received appropriate amounts(by size, but mean:4vail(1.6ml)) of CHONDRON (autologous chondrocytes) transplantation.
Overall Number of Baseline Participants 30
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants
<=18 years
0
   0.0%
Between 18 and 65 years
30
 100.0%
>=65 years
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 30 participants
36.67  (11.44)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants
Female
4
  13.3%
Male
26
  86.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Korea, Republic of Number Analyzed 30 participants
30
1.Primary Outcome
Title Average Change From Baseline in American Orthopedic Foot and Ankle Society(AOFAS) at 12 Months Post-surgery
Hide Description

AOFAS scores(best score-100,worst score- 0 )

  1. pain-none:40/Strong and Always present:O
  2. Function

    • activities-without support activities:10/need restrain, clutch , walker or wheelchair:0
    • Maximum gait distance- more than 6:5/ less than 1:0
    • gait surface-easy in any surace:5/strong difficult in irregular ground stair or slopes:0
    • Gait abnormality-none:8/marked:0
    • saggital mobidity- normal or minimal restrain:6/strong restraint:0
    • hindfoot mobidity -normal minimal restrain:6/strong restrain:0
    • ankle and hindfoot stability - stable:8/unstable:0
  3. alignment- good:10/bad:0
Time Frame baseline(preoperative stage),12months post-surgery
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Among the 30 patients, 27 who received CHONDRON transplantation became subjects for Full Analysis Set(FAS) analysis, as validity evaluation analysis subjects. The remaining 3 patients were omitted, being excluded from the FAS analysis. (1 subject refused to participate, 2 were unable to do follow-up.)
Arm/Group Title Chondron Implantation
Hide Arm/Group Description:
Those who agreed to participate voluntarily went through screening to confirm the appropriateness for the clinical trial, and then received appropriate amounts(by size, but mean:4vail(1.6ml)) of CHONDRON (autologous chondrocytes) transplantation.
Overall Number of Participants Analyzed 27
Mean (Standard Deviation)
Unit of Measure: scores
16.93  (13.04)
2.Secondary Outcome
Title Average Change From Baseline in 100mm Visual Analogue Scale(VAS) at 12months Post-surgery
Hide Description

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.

Time Frame baseline(preoperative stage),12months post-surgery
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Among the 30 patients, 27 who received CHONDRON transplantation became subjects for FAS analysis, as validity evaluation analysis subjects. The remaining 3 patients were omitted, being excluded from the FAS analysis. (1 subject refused to participate, 2 were unable to do follow-up.)
Arm/Group Title Chondron Implantation
Hide Arm/Group Description:
Those who agreed to participate voluntarily went through screening to confirm the appropriateness for the clinical trial, and then received appropriate amounts(by size, but mean:4vail(1.6ml)) of CHONDRON (autologous chondrocytes) transplantation.
Overall Number of Participants Analyzed 27
Mean (Standard Deviation)
Unit of Measure: mm
-27.19  (31.33)
3.Secondary Outcome
Title Average Change From Baseline in the Modified Hannover Scoring System at 12 Months Post Surgery
Hide Description 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.
Time Frame baseline(preoperative stage),12months post-surgery
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Among the 30 patients, 27 who received CHONDRON transplantation became subjects for FAS analysis, as validity evaluation analysis subjects. The remaining 3 patients were omitted, being excluded from the FAS analysis. (1 subject refused to participate, 2 were unable to do follow-up.)
Arm/Group Title Chondron Implantation
Hide Arm/Group Description:
Those who agreed to participate voluntarily went through screening to confirm the appropriateness for the clinical trial, and then received appropriate amounts(by size, but mean:4vail(1.6ml)) of CHONDRON (autologous chondrocytes) transplantation.
Overall Number of Participants Analyzed 27
Mean (Standard Deviation)
Unit of Measure: scores
26.26  (18.07)
Time Frame Observations are done during the screening period, on the day of cartilage sampling, CHONDRON transplantation, and 1 week, 6 week, 3 months, 6 months, and 12 months after surgery.
Adverse Event Reporting Description Vital signs (blood pressure, pulse rate, body temperature) were measured on the day of sampling, transplantation, and 1 week after surgery and were recorded in the case record. Clinicopathologic tests were done in the screening period (Screening), on the days of tissue sampling and of transplantation. Results were written in the case record.
 
Arm/Group Title Chondron Implantation
Hide Arm/Group Description Those who agreed to participate voluntarily went through screening to confirm the appropriateness for the clinical trial, and then received appropriate amounts(by size, but mean:4vail(1.6ml)) of CHONDRON (autologous chondrocytes) transplantation.
All-Cause Mortality
Chondron Implantation
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Chondron Implantation
Affected / at Risk (%) # Events
Total   2/30 (6.67%)    
Musculoskeletal and connective tissue disorders   
malleolar ostoeotomy nonunion *  2/30 (6.67%)  3
*
Indicates events were collected by non-systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
Chondron Implantation
Affected / at Risk (%) # Events
Total   25/30 (83.33%)    
Gastrointestinal disorders   
nausea *  8/30 (26.67%)  8
dyspepsia *  2/30 (6.67%)  4
vomiting *  2/30 (6.67%)  2
epigastric soreness’ *  3/30 (10.00%)  3
abdominal pain *  2/30 (6.67%)  2
gastritis *  1/30 (3.33%)  1
polyp *  1/30 (3.33%)  1
constipation *  1/30 (3.33%)  1
diarrhea *  1/30 (3.33%)  1
defecation disorder’ *  1/30 (3.33%)  1
General disorders   
edema *  2/30 (6.67%)  5
headache *  4/30 (13.33%)  6
Fever *  2/30 (6.67%)  2
Musculoskeletal and connective tissue disorders   
pain *  10/30 (33.33%)  19
malleolar osteotomy site pain *  1/30 (3.33%)  1
lower extremities numbness *  2/30 (6.67%)  2
sholuder pain *  1/30 (3.33%)  1
lower extremities pain *  1/30 (3.33%)  1
Nervous system disorders   
vertigo *  1/30 (3.33%)  1
Psychiatric disorders   
insomnia *  1/30 (3.33%)  1
Renal and urinary disorders   
dysuria *  2/30 (6.67%)  2
testicular pain *  1/30 (3.33%)  1
proteinuria *  1/30 (3.33%)  1
Respiratory, thoracic and mediastinal disorders   
upper respiratory infection *  2/30 (6.67%)  3
Skin and subcutaneous tissue disorders   
eczema *  2/30 (6.67%)  2
*
Indicates events were collected by non-systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Lee Gyeong Tae
Organization: Eulji General Hospital
Phone: +82-11-214-3323
Responsible Party: Gyeong Tea , Lee, Eulji General Hospital
ClinicalTrials.gov Identifier: NCT01050816     History of Changes
Other Study ID Numbers: 02CON
First Submitted: January 13, 2010
First Posted: January 15, 2010
Results First Submitted: January 21, 2010
Results First Posted: May 7, 2010
Last Update Posted: May 11, 2010