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Efficacy and Safety of Chondron (Autologus Chondrocyte) in Patients With Cartilage Defects in Their Ankle

Primary Purpose

Defect of Articular Cartilage, Degenerative Joint Disease of Ankle and/or Foot, Ankle (Ligaments); Instability, Familial

Status
Unknown status
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
CHONDRON
Sponsored by
Sewon Cellontech Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Defect of Articular Cartilage focused on measuring a partial cartilage defect of ankle, Chondron, Autologus Chondrocyte

Eligibility Criteria

15 Years - 65 Years (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 1. Adult men and women over 15 and less than 65 years of age 2. Applicable to patients who have a partial cartilage defect in their ankle based on an MRI (defect size: for a single lesion, less than 15 cm2; and for multiple lesions, less than 20 cm2) 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 with a Grade III or IV cartilage defect size on the ICRS (International Cartilage Repair Society) 6. 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

  • Myongji Hospital
  • Eulji General Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Autologous cultured Chondrocyte

Arm Description

Subjects who give consent will be screened and those who meet trial criteria will receive CHONDRON (Autologous cultured Chondrocyte) by transplant.

Outcomes

Primary Outcome Measures

Grade change of ICRS(International Cartilage Repair Society) by arthroscopy
The change of ICRS grade of the affected ankle shall be assessed at 12 months after the surgery. The results on the surgery date shall be considered the baseline data and shall be compared with those at 12 months after the surgery based on arthroscopy. For the final efficacy evaluation, the percentage of the patients (success rate) who showed Grade III or IV ICRS before the surgery and improved to Grade 0 or I after the surgery will be calculated.

Secondary Outcome Measures

Score change of AOFAS(American orthopedic foot & ankle society) Score
The improvements in the AOFAS in the affected ankle at baseline and six, 12 and 18 months after the surgery will be compared. The final efficacy evaluation shall be done by calculating the difference between the AOFAS at the baseline and that 18 months after the surgery.
Hannover Score
The improvements in the Hannover score in the affected ankle at baseline and six, 12 and 18 months after the surgery will be compared. The final efficacy evaluation shall be done by calculating the difference between the Hannover score at the baseline and that 18 months after the surgery.
Score change of Evaluation by physician in charge
The improvement will be evaluated by the physician using a five-level scale six, 12 and 18 months after the Chondron grafting.
Score change of 100mmVAS(visual analogue scale)
The improvements of pain in the 100mmVAS in the affected ankle at baseline and six, 12 and 18 months after the surgery will be compared. The final efficacy evaluation shall be done by calculating the difference between the 100mmVAS at the baseline and that 18 months after the surgery.
Comparing MRI results
The morphological improvement from MRI image of the affected ankle will be assessed at 18 months after the surgery from those at baseline. For MRI image at baseline, the MRI should be performed within two weeks from the Chondron grafting for the efficacy evaluation.

Full Information

First Posted
August 13, 2015
Last Updated
August 28, 2015
Sponsor
Sewon Cellontech Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT02537067
Brief Title
Efficacy and Safety of Chondron (Autologus Chondrocyte) in Patients With Cartilage Defects in Their Ankle
Official Title
A Phase III Clinical Trial to Evaluate the Efficacy and Safety of Chondron (Autologus Chondrocyte) in Patients With Cartilage Defects in Their Ankle for 18 Months
Study Type
Interventional

2. Study Status

Record Verification Date
August 2015
Overall Recruitment Status
Unknown status
Study Start Date
January 2010 (undefined)
Primary Completion Date
May 2015 (Actual)
Study Completion Date
December 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sewon Cellontech Co., Ltd.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The objective of this study is to evaluate the efficacy and safety of Chondron (Autologus Chondrocyte) in patients with cartilage defects in their ankle for 18 months
Detailed Description
This is an open label trial, involving a total of 28 subjects. Subjects who give consent will be screened and those who meet trial criteria will receive CHONDRON (Autologous cultured Chondrocyte) by transplant. During the trial period, subjects must follow the instructions given by principal investigator. Subjects will make 6* hospital visits on a regular basis inclusive of hospitalization. During these visits subjects will be examined. For the evaluation of safety and efficacy of CHONDRON, examination with doctors, x-ray, MRI tests and arthroscopy will be performed. *If tissue samples can be collected at screening visit, there will be only 5 visits.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Defect of Articular Cartilage, Degenerative Joint Disease of Ankle and/or Foot, Ankle (Ligaments); Instability, Familial
Keywords
a partial cartilage defect of ankle, Chondron, Autologus Chondrocyte

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Autologous cultured Chondrocyte
Arm Type
Experimental
Arm Description
Subjects who give consent will be screened and those who meet trial criteria will receive CHONDRON (Autologous cultured Chondrocyte) by transplant.
Intervention Type
Drug
Intervention Name(s)
CHONDRON
Other Intervention Name(s)
Autologous cultured Chondrocyte
Intervention Description
Harvesting of ankle or knee cartilage The cells that fill the vial are sufficiently suspended, and a sufficient amount of suspension is grafted in the defect with fibrin glue.
Primary Outcome Measure Information:
Title
Grade change of ICRS(International Cartilage Repair Society) by arthroscopy
Description
The change of ICRS grade of the affected ankle shall be assessed at 12 months after the surgery. The results on the surgery date shall be considered the baseline data and shall be compared with those at 12 months after the surgery based on arthroscopy. For the final efficacy evaluation, the percentage of the patients (success rate) who showed Grade III or IV ICRS before the surgery and improved to Grade 0 or I after the surgery will be calculated.
Time Frame
12 months after the surgery
Secondary Outcome Measure Information:
Title
Score change of AOFAS(American orthopedic foot & ankle society) Score
Description
The improvements in the AOFAS in the affected ankle at baseline and six, 12 and 18 months after the surgery will be compared. The final efficacy evaluation shall be done by calculating the difference between the AOFAS at the baseline and that 18 months after the surgery.
Time Frame
baseline and six, 12 and 18 months after the surgery
Title
Hannover Score
Description
The improvements in the Hannover score in the affected ankle at baseline and six, 12 and 18 months after the surgery will be compared. The final efficacy evaluation shall be done by calculating the difference between the Hannover score at the baseline and that 18 months after the surgery.
Time Frame
baseline and six, 12 and 18 months after the surgery
Title
Score change of Evaluation by physician in charge
Description
The improvement will be evaluated by the physician using a five-level scale six, 12 and 18 months after the Chondron grafting.
Time Frame
six, 12 and 18 months after the surgery
Title
Score change of 100mmVAS(visual analogue scale)
Description
The improvements of pain in the 100mmVAS in the affected ankle at baseline and six, 12 and 18 months after the surgery will be compared. The final efficacy evaluation shall be done by calculating the difference between the 100mmVAS at the baseline and that 18 months after the surgery.
Time Frame
baseline and six, 12 and 18 months after the surgery
Title
Comparing MRI results
Description
The morphological improvement from MRI image of the affected ankle will be assessed at 18 months after the surgery from those at baseline. For MRI image at baseline, the MRI should be performed within two weeks from the Chondron grafting for the efficacy evaluation.
Time Frame
baseline and 18 months after the surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 1. Adult men and women over 15 and less than 65 years of age 2. Applicable to patients who have a partial cartilage defect in their ankle based on an MRI (defect size: for a single lesion, less than 15 cm2; and for multiple lesions, less than 20 cm2) 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 with a Grade III or IV cartilage defect size on the ICRS (International Cartilage Repair Society) 6. 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jin Su Kim, MD
Organizational Affiliation
Eulji General Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ki Hyuck Sung, MD
Organizational Affiliation
Myongji Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Myongji Hospital
City
Goyang
State/Province
Gyeonggi
Country
Korea, Republic of
Facility Name
Eulji General Hospital
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

Efficacy and Safety of Chondron (Autologus Chondrocyte) in Patients With Cartilage Defects in Their Ankle

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