OsteoarthritisNCT02539056
The Post-marketing Surveillance to Evaluate the Efficacy and Safety of a CHONDRON (Autologous Cultured Chondrocyte)
A study testing Chondron Implantation in people with Osteoarthritis and Traumatic Arthritis, run by Cellontech Co., Ltd. at 2 sites in South Korea.
Trial summary
A clinical trial to evaluate the long-term efficacy and safety of a CHONDRON (Autologous cultured Chondrocyte) for 48weeks, and additional 96weeks in patients with cartilage defects in their knees. Read more about this study
- Who is it for?
- Ages 15 years and olderHealthy volunteers can take part
- Conditions the study is for
- Osteoarthritis, Traumatic Arthritis
- What is being tested?
- Chondron Implantation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 2 sitesSouth Korea
- Study dates
- 15 Oct 2012to 18 Mar 2016
- Phase
- Interventional
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Patients with cartilage defects in their knee (Including Knee OA and Knee TA) * For a single lesion, less than 15 cm2 cartilage defects; and for multiple lesions, less than 20 cm2
- Patients with misalignment of their tibia and femur, unstable ligament in their knee, or bony defects in the lesions of their knee, and/or who had been treated for alignment
- Patients which surrounding cartilage are normal
- Patients who were 15 years old or older
- Patients or their representative (for adults), or patients and their parent/guardian (for minors), who agreed to participate in the study and signed the informed consent form
Who cannot join
- 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 (Exception: if the possibility of Chondron treatment is confirmed with doctor's clinical decision).
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- Patients who have a history of receiving radiotherapy, chemotherapy in the last 2 years (Exception: if the possibility of Chondron treatment is confirmed with doctor's clinical decision).
- 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 with an infection that required hospitalization for antibiotics or the administration of antiseptic agents
- Patients under adrenocorticoid therapy (Exception: if the possibility of Chondron treatment is confirmed with doctor's clinical decision).
- Patients with psychiatric disorder and those who are considered to be inappropriate for this trial by the judgment of the clinical trial manager
- Patients with cartilage defects in both knees (If the necessity of other surgery on the opposite side of knee joint using Chondron is confirmed with doctor's clinical decision).
- Patients with liver, heart, or kidney disease (Those who show normal or insignificant test results may be enrolled in this study and receive the Chondron based on the investigator's judgment. Hypertension patients are allowed.)
- Patients who had been infected with a virus (Those who show normal or insignificant test results may be enrolled in this study and receive the Chondron based on the investigator's judgment.)
- Patients who had participated in another clinical trial (limited to those who participated in other studies on fracture within the last six months.)
Trial locations and contacts
2 sites in 1 country.
South Korea2 sites
Inha Univerisity Hospital
Incheon, Incheon
Ewha Womans University Mokdong Hospital
Seoul, Seoul
About this study
Official title: This Post-marketing Surveillance to Evaluate the Efficacy and Safety of a CHONDRON (Autologous Cultured Chondrocyte) in Patients With Cartilage Defects in Their Knees.
A clinical trial to evaluate the long-term efficacy and safety of a CHONDRON (Autologous cultured Chondrocyte) for 48weeks, and additional 96weeks in patients with cartilage defects in their knees.
Read the detailed description
This is an open trial, involving a total of 24 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 8* 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, blood samples, x-ray, MRI tests, observation with the naked eyes and arthroscopy will be performed. *If tissue samples can be collected at screening visit, there will be only 7 visits.
- Conditions
- Osteoarthritis, Traumatic Arthritis
- Being tested
- Chondron Implantation
- Keywords
- cartilage defects, Chondron, Autologous cultured Chondrocyte
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chondron ImplantationDevice
In one vial (0.4 ml), Main ingredient: 1.2 million or more autologous chondrocytes Culture solution: Adequate amount of Dulbecco's modified Eagle medium (DMEM) 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 |
|---|---|---|
| Chondron Implantation | Experimental | Chondron Implantation for the subject with cartilage defect Receives: Device: Chondron Implantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in pain of 100mm Visual Analog Scale
The primary endpoint for the analysis is the change in the 100mmVAS at 48 weeks after the surgery from that of baseline.
Measured: 48 weeks after the surgery
Secondary outcomes (6)
change of IKDC (International Knee Documentation Committee)
The IKDC values of the affected knee at basleine and 48 weeks after the surgery will be primarily compared based on the evaluations by the subjects and the investigators (and 12, 24 and 96 weeks after the surgery).
Measured: baseline and 48 weeks after the surgery and 12, 24 and 96 weeks after the surgery
Chnage of KSS(Knee Society Score)
The primary endpoint for the analysis is the change in the KSS at baseline and 48 weeks after the surgery (and 12, 24 and 96 weeks after the surgery).
Measured: baseline and 48 weeks after the surgery and 12, 24 and 96 weeks after the surgery
Chnage of ICRS(International Cartilage Repair Society) score
The ICRS grades of the affected knee at baseline and 48 weeks after the surgery will be primarily compared
Measured: baseline and 48 weeks after the surgery
Chnage of KOOS(Knee injury and osteoarthritis outcome) score
The primary endpoint for the analysis is the change in the KOOS at baseline and 48 weeks after the surgery (and 12, 24 and 96 weeks after the surgery).
Measured: baseline and 48 weeks after the surgery and 12, 24 and 96 weeks after the surgery
Change of MRI and mMOCART result
The morphological improvement of MRI image for the affected knee at baseline will be compared with those at 48 weeks after the surgery (and 12, 24, and 96weeks after the surgery). The primary endpoint for the analysis is the change in the mMOCART at baseline and 48 weeks after the surgery (and 12, 24 and 96 weeks after the surgery).
Measured: baseline and 48 weeks after the surgery and 12, 24 and 96 weeks after the surgery
change in pain of 100mm Visual Analog Scale
The change in the 100mmVAS will be assessed at baseline and 12, 24 and 96 weeks after the surgery.
Measured: baseline, 12, 24 and 96 weeks 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 posted2 Sep 2015 (estimated)
- Study start15 Oct 2012
- Primary completion18 Mar 2016
- Study completion18 Mar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoarthritisStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cellontech Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Myung Ku Kim, MD, Principal investigator, Inha University HospitalJae Doo Yoo, MD, Principal investigator, Ewha Womans University Mokdong Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02539056
- Sponsor's protocol ID
- 08CON
- Status last verified
- Nov 2016
- First submitted
- 28 Aug 2015
- Last updated
- 8 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
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
- This Post-marketing Surveillance to Evaluate the Efficacy and Safety of a CHONDRON (Autologous Cultured Chondrocyte) in Patients With Cartilage Defects in Their Knees.
- ClinicalTrials.gov ID
- NCT02539056
- Acronym / sponsor ID
- 08CON
- Conditions
- Osteoarthritis, Traumatic Arthritis
- Keywords
- cartilage defects, Chondron, Autologous cultured Chondrocyte
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Cellontech Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 15 Oct 2012 (actual)
- Primary completion
- 18 Mar 2016 (actual)
- Study completion
- 18 Mar 2016 (actual)
- First posted
- 2 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.
A clinical trial to evaluate the long-term efficacy and safety of a CHONDRON (Autologous cultured Chondrocyte) for 48weeks, and additional 96weeks in patients with cartilage defects in their knees.
Detailed description
This is an open trial, involving a total of 24 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 8* 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, blood samples, x-ray, MRI tests, observation with the naked eyes and arthroscopy will be performed. *If tissue samples can be collected at screening visit, there will be only 7 visits.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chondron Implantation | Experimental | Device: Chondron ImplantationChondron Implantation for the subject with cartilage defect |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Patients with cartilage defects in their knee (Including Knee OA and Knee TA) * For a single lesion, less than 15 cm2 cartilage defects; and for multiple lesions, less than 20 cm2
- Patients with misalignment of their tibia and femur, unstable ligament in their knee, or bony defects in the lesions of their knee, and/or who had been treated for alignment
- Patients which surrounding cartilage are normal
- Patients who were 15 years old or older
- Patients or their representative (for adults), or patients and their parent/guardian (for minors), who agreed to participate in the study and signed the informed consent form
Key exclusion criteria (15 listed)
- 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
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 |
|---|---|---|
| Chondron ImplantationIn one vial (0.4 ml), Main ingredient: 1.2 million or more autologous chondrocytes Culture solution: Adequate amount of Dulbecco's modified Eagle medium (DMEM) The cells that fill the vial are sufficiently suspended, and a sufficient amount of suspension is grafted in the defect with fibrin glue. | Device | Chondron Implantation |
Primary outcome
change in pain of 100mm Visual Analog Scale
Time frame: 48 weeks after the surgery
The primary endpoint for the analysis is the change in the 100mmVAS at 48 weeks after the surgery from that of baseline.
6 secondary outcomes
change of IKDC (International Knee Documentation Committee)
Time frame: baseline and 48 weeks after the surgery and 12, 24 and 96 weeks after the surgery
Chnage of KSS(Knee Society Score)
Time frame: baseline and 48 weeks after the surgery and 12, 24 and 96 weeks after the surgery
Chnage of ICRS(International Cartilage Repair Society) score
Time frame: baseline and 48 weeks after the surgery
Chnage of KOOS(Knee injury and osteoarthritis outcome) score
Time frame: baseline and 48 weeks after the surgery and 12, 24 and 96 weeks after the surgery
Change of MRI and mMOCART result
Time frame: baseline and 48 weeks after the surgery and 12, 24 and 96 weeks after the surgery
change in pain of 100mm Visual Analog Scale
Time frame: baseline, 12, 24 and 96 weeks after the surgery
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 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.
Myung Ku Kim, MD principal investigator
Inha University Hospital
Jae Doo Yoo, MD principal investigator
Ewha Womans University Mokdong Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Chondron Implantation in people with Osteoarthritis and Traumatic Arthritis, 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 5 inclusion and 15 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 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.
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?
change in pain of 100mm Visual Analog Scale (time frame: 48 weeks 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.