Defect of Articular CartilagePhase 3NCT02537067
Efficacy and Safety of Chondron (Autologus Chondrocyte) in Patients With Cartilage Defects in Their Ankle
A Phase 3 study testing CHONDRON in people with Defect of Articular Cartilage and Degenerative Joint Disease of Ankle and/or Foot, run by Cellontech Co., Ltd. at 2 sites in South Korea.
Trial 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 Read more about this study
- Who is it for?
- Ages 15 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Defect of Articular Cartilage, Degenerative Joint Disease of Ankle and/or Foot, Ankle (Ligaments); Instability, Familial
- What is being tested?
- CHONDRON
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 2 sitesSouth Korea
- Study dates
- Jan 2010to Nov 2015
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 65 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Male or female subjects aged 15 to 65 years
- Patients with MRI-confirmed partial cartilage defects of the ankle (≤15 cm² single lesion, ≤20 cm² multiple lesions)
- Patients who have undergone correction for malalignment, ligament instability, or bone defects (if applicable)
- Patients with normal surrounding cartilage
- Patients with ICRS Grade III or IV cartilage defects
- Subjects who provide written informed consent
Who cannot join
- Hypersensitivity to bovine protein or gentamicin
- Inflammatory or autoimmune arthritis (e.g., rheumatoid arthritis, gout)
- Pregnant, breastfeeding, or planning pregnancy
- Tumors or serious comorbid conditions
- History of radiotherapy or chemotherapy within 2 years
- Uncontrolled diabetes or diabetes with complications
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- Active infection requiring antibiotics
- Current corticosteroid therapy
- Patients with mental illness or other conditions deemed unsuitable for this study by the clinical trial manager
Trial locations and contacts
2 sites in 1 country.
South Korea2 sites
Myongji Hospital
Goyang-si, Gyeonggi-do
Eulji General Hospital
Seoul, Seoul
About this study
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
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
Read the 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.
- Conditions
- Defect of Articular Cartilage, Degenerative Joint Disease of Ankle and/or Foot, Ankle (Ligaments); Instability, Familial
- Being tested
- CHONDRON
- Keywords
- a partial cartilage defect of ankle, Chondron, Autologus Chondrocyte
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CHONDRONDrug
Also called Autologous cultured Chondrocyte
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Autologous cultured Chondrocyte | Experimental | Subjects who give consent will be screened and those who meet trial criteria will receive CHONDRON (Autologous cultured Chondrocyte) by transplant. Receives: Drug: CHONDRON |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months after the surgery
Secondary outcomes (5)
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.
Measured: baseline and six, 12 and 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.
Measured: baseline and six, 12 and 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.
Measured: six, 12 and 18 months after the surgery
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.
Measured: baseline and six, 12 and 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.
Measured: baseline and 18 months after the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2015 (estimated)
- Study startJan 2010
- Primary completionMay 2015
- Study completionNov 2015
Why it stopped: The study was terminated early due to company reasons.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Defect of Articular CartilageStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cellontech Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jin Su Kim, MD, Principal investigator, Eulji General HospitalKi Hyuck Sung, MD, Principal investigator, Myongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02537067
- Sponsor's protocol ID
- 04CON
- Status last verified
- Nov 2016
- First submitted
- 13 Aug 2015
- Last updated
- 8 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02537067
- Acronym / sponsor ID
- 04CON
- Conditions
- 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
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was terminated early due to company reasons.
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Cellontech Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Jan 2010
- Primary completion
- May 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 1 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Autologous cultured Chondrocyte | Experimental | Drug: CHONDRONSubjects who give consent will be screened and those who meet trial criteria will receive CHONDRON (Autologous cultured Chondrocyte) by transplant. |
Who may qualify
- Ages
- 15 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Male or female subjects aged 15 to 65 years
- Patients with MRI-confirmed partial cartilage defects of the ankle (≤15 cm² single lesion, ≤20 cm² multiple lesions)
- Patients who have undergone correction for malalignment, ligament instability, or bone defects (if applicable)
- Patients with normal surrounding cartilage
- Patients with ICRS Grade III or IV cartilage defects
Key exclusion criteria (9 listed)
- Hypersensitivity to bovine protein or gentamicin
- Inflammatory or autoimmune arthritis (e.g., rheumatoid arthritis, gout)
- Pregnant, breastfeeding, or planning pregnancy
- Tumors or serious comorbid conditions
- History of radiotherapy or chemotherapy within 2 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CHONDRONAlso: Autologous cultured Chondrocyte1. Harvesting of ankle or knee cartilage 2. The cells that fill the vial are sufficiently suspended, and a sufficient amount of suspension is grafted in the defect with fibrin glue. | Drug | Autologous cultured Chondrocyte |
Primary outcome
Grade change of ICRS(International Cartilage Repair Society) by arthroscopy
Time frame: 12 months after the surgery
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.
5 secondary outcomes
Score change of AOFAS(American orthopedic foot & ankle society) Score
Time frame: baseline and six, 12 and 18 months after the surgery
Hannover Score
Time frame: baseline and six, 12 and 18 months after the surgery
Score change of Evaluation by physician in charge
Time frame: six, 12 and 18 months after the surgery
Score change of 100mmVAS(visual analogue scale)
Time frame: baseline and six, 12 and 18 months after the surgery
Comparing MRI results
Time frame: baseline and 18 months after the surgery
Results and safety
The study was stopped early (reason given: The study was terminated early due to company reasons.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jin Su Kim, MD principal investigator
Eulji General Hospital
Ki Hyuck Sung, MD principal investigator
Myongji Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing CHONDRON in people with Defect of Articular Cartilage and Degenerative Joint Disease of Ankle and/or Foot, run by Cellontech Co., Ltd. at 2 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 8 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: The study was terminated early due to company reasons.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Grade change of ICRS(International Cartilage Repair Society) by arthroscopy (time frame: 12 months after the surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2026.