Defect of Articular CartilageNCT02524509
the Safety and Efficacy Evaluation of Chondron Compared With Mircrofracture of Knee
An observational study of Defect of Articular Cartilage and Articular Cartilage Disorder of Knee, run by Cellontech Co., Ltd. at 1 site in South Korea.
Trial summary
The purpose of this study is to evaluate safety and efficacy of Chondron(autologous cultured Chondrocyte) by comparing between Chondron implantation and Microfracture. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Defect of Articular Cartilage, Articular Cartilage Disorder of Knee, Degeneration; Articular Cartilage, Knee
- How many people
- 21 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jan 2012to Sep 2016
- Phase
- Observational
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Total 50 patients. Patients who received autologous chondrocyte implantation using CHONDRON (autologous cultured chondrocyte) for knee osteoarthritis or patients underwent microfracture. There are total 28 patients who get CHONDRON grafting until now. Considering dropout rate, the selected number of investigational group is total 25, and 25 of equivalent control group is planned.
Who may be able to join
- 1. Patients who underwent autologous chondrocyte implantation using CHONDRON (autologous cultured chondrocyte) or patients underwent microfracture more than 2 years ago.
- 2. Patients who meet the above criteria 1, the patient or a guardian agreed to participate in the clinical trial, and signed a written agreement form
Who cannot join
- 1. Patients with psychological disease or other patients who are determined to be unsuitable to this clinical trial by the investigators conducting the clinical trial.
- 2. Patients who underwent autologous chondrocyte implantation applying CHONDRON (autologous cultured chondrocyte) or microfracture, and the lesion was treated with other procedures subsequently.
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Inha University Medical School Hospital
Incheon, Inchoen
About this study
Official title: An Inverstigational Clinical Trial for the Safety and Efficacy Evaluation of Chondron(Autologous Cultured Chondrocyte)Compared With Mircrofracture Surgery in Subjects With Cartilage Defects of the Knee Joint
The purpose of this study is to evaluate safety and efficacy of Chondron(autologous cultured Chondrocyte) by comparing between Chondron implantation and Microfracture.
Read the detailed description
It is an open clinical trial. Among the patients who received autologous cartilage cell graft using CHONDRON (autologous cartilage cells) in the past (investigational group) or microfracture (control group), the subjects who agreed to participate in the trial voluntarily will undergo the screening process that assesses the suitability of the subjects to the clinical trial and participate in the clinical trial. During the clinical trial period, the subjects should follow the instruction of clinician in charge. Hospital visit is total 2 times* regularly. At the visit, to evaluate the efficacy according to the protocol, the subject will be examined by clinicians, MRI test, and X-ray. If the selection time and the visit time are same, hospital visit will be one time*.
- Conditions
- Defect of Articular Cartilage, Articular Cartilage Disorder of Knee, Degeneration; Articular Cartilage, Knee
- Keywords
- Chonodron, Microfracture, autologous cultured chondrocyte, cartilage defect of knee
- Medical subject headings
- Fractures, Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| CHONDRON | Patients who already received autologous chondrocyte implantation using CHONDRON (Autologous Cultured Chondrocyte) for knee cartilage defects | |
| Microfracture | patients already underwent microfracture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Score change of KOOS(Knee Injury and Osteoarthritis Outcome)
comparison of the difference between a group with Chondron Implantation and a group with Microfracture.
Measured: Screening, post op 2years
Secondary outcomes (4)
Score change of 100 Vas(visual Analog System)
Comparison the difference between a group with Chondron Implantation and a group with Microfracture
Measured: Screening, post op 2years
Score change of IKDC (International Knee Documentation Committee)
comparison the difference between a group with Chondron Implantation and a group with Microfracture
Measured: screening, post op 2 years
Score change of KSS(Knee Society Score)
Comparision the difference between a group with Chondron Implantation and a group with Microfracture.
Measured: Screening, Post op 2 years
Comparing MRI results
Comparison the difference of morphological improvement from MRI image between a group with Chondron Implantation and a group with Microfracture
Measured: Screening, Post op 2years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2015 (estimated)
- Study startJan 2012
- Primary completionSep 2016
- Study completionSep 2016
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
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cellontech Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Myung Goo Kim, MD, Principal investigator, Inha University Medical School Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02524509
- Sponsor's protocol ID
- 07CON
- Status last verified
- Nov 2016
- First submitted
- 13 Aug 2015
- Last updated
- 7 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Inverstigational Clinical Trial for the Safety and Efficacy Evaluation of Chondron(Autologous Cultured Chondrocyte)Compared With Mircrofracture Surgery in Subjects With Cartilage Defects of the Knee Joint
- ClinicalTrials.gov ID
- NCT02524509
- Acronym / sponsor ID
- 07CON
- Conditions
- Defect of Articular Cartilage, Articular Cartilage Disorder of Knee, Degeneration; Articular Cartilage, Knee
- Keywords
- Chonodron, Microfracture, autologous cultured chondrocyte, cartilage defect of knee
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Cellontech Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Jan 2012
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 14 Aug 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 purpose of this study is to evaluate safety and efficacy of Chondron(autologous cultured Chondrocyte) by comparing between Chondron implantation and Microfracture.
Detailed description
It is an open clinical trial. Among the patients who received autologous cartilage cell graft using CHONDRON (autologous cartilage cells) in the past (investigational group) or microfracture (control group), the subjects who agreed to participate in the trial voluntarily will undergo the screening process that assesses the suitability of the subjects to the clinical trial and participate in the clinical trial. During the clinical trial period, the subjects should follow the instruction of clinician in charge. Hospital visit is total 2 times* regularly. At the visit, to evaluate the efficacy according to the protocol, the subject will be examined by clinicians, MRI test, and X-ray. If the selection time and the visit time are same, hospital visit will be one time*.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CHONDRON | – | –Patients who already received autologous chondrocyte implantation using CHONDRON (Autologous Cultured Chondrocyte) for knee cartilage defects |
| Microfracture | – | –patients already underwent microfracture |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Total 50 patients. Patients who received autologous chondrocyte implantation using CHONDRON (autologous cultured chondrocyte) for knee osteoarthritis or patients underwent microfracture. There are total 28 patients who get CHONDRON grafting until now. Considering dropout rate, the selected number of investigational group is total 25, and 25 of equivalent control group is planned.
Key inclusion criteria (2 listed)
- 1. Patients who underwent autologous chondrocyte implantation using CHONDRON (autologous cultured chondrocyte) or patients underwent microfracture more than 2 years ago.
- 2. Patients who meet the above criteria 1, the patient or a guardian agreed to participate in the clinical trial, and signed a written agreement form
Key exclusion criteria (2 listed)
- 1. Patients with psychological disease or other patients who are determined to be unsuitable to this clinical trial by the investigators conducting the clinical trial.
- 2. Patients who underwent autologous chondrocyte implantation applying CHONDRON (autologous cultured chondrocyte) or microfracture, and the lesion was treated with other procedures subsequently.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Score change of KOOS(Knee Injury and Osteoarthritis Outcome)
Time frame: Screening, post op 2years
comparison of the difference between a group with Chondron Implantation and a group with Microfracture.
4 secondary outcomes
Score change of 100 Vas(visual Analog System)
Time frame: Screening, post op 2years
Score change of IKDC (International Knee Documentation Committee)
Time frame: screening, post op 2 years
Score change of KSS(Knee Society Score)
Time frame: Screening, Post op 2 years
Comparing MRI results
Time frame: Screening, Post op 2years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 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.
Myung Goo Kim, MD principal investigator
Inha University Medical School Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Defect of Articular Cartilage and Articular Cartilage Disorder of Knee, run by Cellontech Co., Ltd. at 1 site 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 2 inclusion and 2 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: finished, as of the sponsor's last update on 7 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 1 site 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Score change of KOOS(Knee Injury and Osteoarthritis Outcome) (time frame: Screening, post op 2years). 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 7 Apr 2026.