- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02537067
Efficacy and Safety of Chondron (Autologus Chondrocyte) in Patients With Cartilage Defects in Their Ankle
August 28, 2015 updated by: Sewon Cellontech Co., Ltd.
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
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
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
28
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Seoul, Korea, Republic of
- Eulji General Hospital
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Gyeonggi
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Goyang, Gyeonggi, Korea, Republic of
- Myongji Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
15 years to 65 years (Child, Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Autologous cultured Chondrocyte
Subjects who give consent will be screened and those who meet trial criteria will receive CHONDRON (Autologous cultured Chondrocyte) by transplant.
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Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Grade change of ICRS(International Cartilage Repair Society) by arthroscopy
Time Frame: 12 months after the surgery
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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.
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12 months after the surgery
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Score change of AOFAS(American orthopedic foot & ankle society) Score
Time Frame: baseline and six, 12 and 18 months after the surgery
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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.
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baseline and six, 12 and 18 months after the surgery
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Hannover Score
Time Frame: baseline and six, 12 and 18 months after the surgery
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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.
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baseline and six, 12 and 18 months after the surgery
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Score change of Evaluation by physician in charge
Time Frame: six, 12 and 18 months after the surgery
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The improvement will be evaluated by the physician using a five-level scale six, 12 and 18 months after the Chondron grafting.
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six, 12 and 18 months after the surgery
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Score change of 100mmVAS(visual analogue scale)
Time Frame: baseline and six, 12 and 18 months after the surgery
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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.
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baseline and six, 12 and 18 months after the surgery
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Comparing MRI results
Time Frame: baseline and 18 months after the surgery
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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.
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baseline and 18 months after the surgery
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Jin Su Kim, MD, Eulji General Hospital
- Principal Investigator: Ki Hyuck Sung, MD, Myongji Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2010
Primary Completion (Actual)
May 1, 2015
Study Completion (Anticipated)
December 1, 2015
Study Registration Dates
First Submitted
August 13, 2015
First Submitted That Met QC Criteria
August 28, 2015
First Posted (Estimate)
September 1, 2015
Study Record Updates
Last Update Posted (Estimate)
September 1, 2015
Last Update Submitted That Met QC Criteria
August 28, 2015
Last Verified
August 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 04CON
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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