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Effects of CHONDRON (Autologous Chondrocytes) With Ankle Cartilage Defect

Primary Purpose

Articular Cartilage Defects of Ankle Joint

Status
Completed
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Chondron(autologous chondrocyte) Implantation
Sponsored by
Sewon Cellontech Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Articular Cartilage Defects of Ankle Joint focused on measuring articular cartilage defects, ACI, ankle joint, chondron

Eligibility Criteria

15 Years - 65 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Sewon Cellontech

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Chondron implantation

Arm Description

ankle cartilage defect patients who had CHONDRON transplantation

Outcomes

Primary Outcome Measures

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 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 alignment- good:10/bad:0

Secondary Outcome Measures

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.
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.

Full Information

First Posted
January 13, 2010
Last Updated
May 6, 2010
Sponsor
Sewon Cellontech Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT01050816
Brief Title
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

2. Study Status

Record Verification Date
May 2010
Overall Recruitment Status
Completed
Study Start Date
January 2006 (undefined)
Primary Completion Date
January 2009 (Actual)
Study Completion Date
February 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Sewon Cellontech Co., Ltd.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Articular Cartilage Defects of Ankle Joint
Keywords
articular cartilage defects, ACI, ankle joint, chondron

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Chondron implantation
Arm Type
Experimental
Arm Description
ankle cartilage defect patients who had CHONDRON transplantation
Intervention Type
Procedure
Intervention Name(s)
Chondron(autologous chondrocyte) Implantation
Other Intervention Name(s)
Chondron
Intervention Description
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.
Primary Outcome Measure Information:
Title
Average Change From Baseline in American Orthopedic Foot and Ankle Society(AOFAS) at 12 Months Post-surgery
Description
AOFAS scores(best score-100,worst score- 0 ) pain-none:40/Strong and Always present:O 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 alignment- good:10/bad:0
Time Frame
baseline(preoperative stage),12months post-surgery
Secondary Outcome Measure Information:
Title
Average Change From Baseline in 100mm Visual Analogue Scale(VAS) at 12months Post-surgery
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
Title
Average Change From Baseline in the Modified Hannover Scoring System at 12 Months Post Surgery
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gyeung Tea Lee, MD
Organizational Affiliation
Eulji General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sewon Cellontech
City
Seoul
State/Province
Sungdong-ku
ZIP/Postal Code
133831
Country
Korea, Republic of

12. IPD Sharing Statement

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Effects of CHONDRON (Autologous Chondrocytes) With Ankle Cartilage Defect

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