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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Chondron implantation | Experimental | ankle cartilage defect patients who had CHONDRON transplantation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Chondron(autologous chondrocyte) Implantation | Procedure |
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. |
| 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 )
| baseline(preoperative stage),12months post-surgery |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gyeung Tea Lee, MD | Eulji General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sewon Cellontech | Seoul | Sungdong-ku | 133831 | South Korea |
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30 subjects who have ankle cartilage defects
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| ID | Title | Description |
|---|---|---|
| FG000 | Chondron Implantation | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Chondron Implantation | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 )
| 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.) | Posted | Mean | Standard Deviation | scores | baseline(preoperative stage),12months post-surgery |
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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.
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Chondron Implantation | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| malleolar ostoeotomy nonunion | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| nausea | Gastrointestinal disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Lee Gyeong Tae | Eulji General Hospital | +82-11-214-3323 | lkt2408@hanmail.net |
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| ID | Term |
|---|---|
| D004343 | Drug Implants |
| ID | Term |
|---|---|
| D003692 | Delayed-Action Preparations |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
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| 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 |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG000 | Chondron Implantation | 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. |
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| Secondary | 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. | 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.) | Posted | Mean | Standard Deviation | mm | baseline(preoperative stage),12months post-surgery |
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| Secondary | 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. | 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.) | Posted | Mean | Standard Deviation | scores | baseline(preoperative stage),12months post-surgery |
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| 2 |
| 30 |
| 25 |
| 30 |
| dyspepsia | Gastrointestinal disorders | Non-systematic Assessment |
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| vomiting | Gastrointestinal disorders | Non-systematic Assessment |
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| epigastric soreness' | Gastrointestinal disorders | Non-systematic Assessment |
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| abdominal pain | Gastrointestinal disorders | Non-systematic Assessment |
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| gastritis | Gastrointestinal disorders | Non-systematic Assessment |
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| polyp | Gastrointestinal disorders | Non-systematic Assessment |
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| constipation | Gastrointestinal disorders | Non-systematic Assessment |
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| diarrhea | Gastrointestinal disorders | Non-systematic Assessment |
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| defecation disorder' | Gastrointestinal disorders | Non-systematic Assessment |
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| pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| malleolar osteotomy site pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| lower extremities numbness | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| sholuder pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| lower extremities pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| dysuria | Renal and urinary disorders | Non-systematic Assessment |
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| testicular pain | Renal and urinary disorders | Non-systematic Assessment |
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| proteinuria | Renal and urinary disorders | Non-systematic Assessment |
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| edema | General disorders | Non-systematic Assessment |
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| headache | General disorders | Non-systematic Assessment |
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| Fever | General disorders | Non-systematic Assessment |
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| insomnia | Psychiatric disorders | Non-systematic Assessment |
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| vertigo | Nervous system disorders | Non-systematic Assessment |
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| eczema | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| upper respiratory infection | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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