Articular Cartilage Defects of Ankle JointPhase 3NCT01050816
Effects of CHONDRON (Autologous Chondrocytes) With Ankle Cartilage Defect
A Phase 3 study testing Chondron(autologous chondrocyte) Implantation in people with Articular Cartilage Defects of Ankle Joint, run by Cellontech Co., Ltd. at 1 site in South Korea.
Trial summary
An open clinical trial transplanting CHONDRON (autologous chondrocytes) to ankle cartilage defect patients who are appropriate for the trial, and evaluating the validity and safety for 12 months. Read more about this study
- Who is it for?
- Ages 15 to 65 years
- Conditions the study is for
- Articular Cartilage Defects of Ankle Joint
- What is being tested?
- Chondron(autologous chondrocyte) Implantation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jan 2006to Feb 2009
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- adult men and women over 15 and less than 65 years of age
- applied to patients with arthroscopically or grossly confirmed, partial cartilage defect at the ankle joint
- 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.
- patients which surrounding cartilage are normal
- patients who agreed to clinical trial participation voluntarily or by the will of the person in parental authority, and signed the written 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
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- patients who have a history of receiving radiotherapy, chemotherapy in the last 2 years
- 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 who are administering antibiotics and antimicrobial agents due to infection
- patients who receive steroid hormone therapy
- Patients with psychiatric disorder and those who are considered to be inappropriate for this trial by the judgment of the clinical trial manager
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Investigator Clinical Trial to Observe Effects of CHONDRON (Autologous Chondrocytes) for 12 Months in Patients With Ankle Cartilage Defect
An open clinical trial transplanting CHONDRON (autologous chondrocytes) to ankle cartilage defect patients who are appropriate for the trial, and evaluating the validity and safety for 12 months.
Read the detailed description
This clinical trial was designed to observe effects of CHONDRON (autologous chondrocytes) for 12 months in patients with ankle cartilage defects. In this clinical trial, 30 subjects were screened- 4 were excluded half way and 26 finished the trial. Full-thickness articular cartilage specimen was obtained from sites that do not have direct articulation within the ankle joint(anterior talus, anterior process of calcaneus, calcaneocuboid joint area.) Gel-type CHONDRON (Fibrin mixed Autologous chondrocytes) was transplanted at the defects. Evaluation variables were AOFAS, 100 mm VAS, HANNOVER score, self-assessment of improvement by the patient, MRI and arthroscopy.
- Being tested
- Chondron(autologous chondrocyte) Implantation
- Keywords
- articular cartilage defects, ACI, ankle joint, chondron
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chondron(autologous chondrocyte) ImplantationProcedure or surgery
Also called Chondron
- Test drug: Chondron (more than 12 million chondrocytes in 0.4ml, i.e. 1 vial)
- Directions and dosage:
Suspend the cells in the vial sufficiently, and implant them in the defective part, making sure that sufficient amounts are injected.
*30 subjects participated in this open clinical trial. Those who agreed to participate voluntarily went through screening to confirm the appropriateness for the clinical trial, and then received Gel type CHONDRON (fibrin mixed autologous chondrocytes) transplantation.
| Study group | Role | What they receive |
|---|---|---|
| Chondron implantation | Experimental | ankle cartilage defect patients who had CHONDRON transplantation Receives: Procedure: Chondron(autologous chondrocyte) Implantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average Change From Baseline in American Orthopedic Foot and Ankle Society(AOFAS) at 12 Months Post-surgery
AOFAS scores(best score-100,worst score- 0 )
- pain-none:40/Strong and Always present:O
- Function
- activities-without support activities:10/need restrain, clutch , walker or wheelchair:0
- Maximum gait distance- more than 6:5/ less than 1:0
- gait surface-easy in any surace:5/strong difficult in irregular ground stair or slopes:0
- Gait abnormality-none:8/marked:0
- saggital mobidity- normal or minimal restrain:6/strong restraint:0
- hindfoot mobidity -normal minimal restrain:6/strong restrain:0
- ankle and hindfoot stability - stable:8/unstable:0
- alignment- good:10/bad:0
Measured: baseline(preoperative stage),12months post-surgery
Secondary outcomes (2)
Average Change From Baseline in 100mm Visual Analogue Scale(VAS) at 12months Post-surgery
A VAS is a horizontal line, 100mm in length, anchored by word descriptors about pain at each end.The VAS is measured degree of pain from 0mm to 100mm. Severe pain is represented by 100mm and no pain is represented by 0mm. The VAS score is determined by measuring in millimetres from the left hand end of the line to the point that the patient marks.
The difference of secondary evaluation variables VAS at baseline and after the end of the trial were analyzed by using paired t-test. Improvements were compared and analysis by each time point.
Measured: baseline(preoperative stage),12months post-surgery
Average Change From Baseline in the Modified Hannover Scoring System at 12 Months Post Surgery
The Modified Hannover Score System contains information about patient's status(pain-36, clinical finding- 4, patient's subjective assessment- 25, statics- 6, fuction- 26, radiology-7;best score-104, worst score-0).The scores of 27 patients in the FAS group were taken in the screening period (Visit S), 12 months after transplantation (Visit 7). The difference of the scores at screening and 12 months after transplantation was compared by using the paired t-test. Improvements were compared and analyzed at each time point.
Measured: baseline(preoperative stage),12months post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2010 (estimated)
- Study startJan 2006
- Primary completionJan 2009
- Study completionFeb 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Articular Cartilage Defects of Ankle JointStudies 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
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cellontech Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Gyeung Tea Lee, MD, Principal investigator, Eulji General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01050816
- Sponsor's protocol ID
- 02CON
- Status last verified
- May 2010
- First submitted
- 13 Jan 2010
- Last updated
- 11 May 2010
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Investigator Clinical Trial to Observe Effects of CHONDRON (Autologous Chondrocytes) for 12 Months in Patients With Ankle Cartilage Defect
- ClinicalTrials.gov ID
- NCT01050816
- Acronym / sponsor ID
- 02CON
- Keywords
- articular cartilage defects, ACI, ankle joint, chondron
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Cellontech Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Jan 2006
- Primary completion
- Jan 2009 (actual)
- Study completion
- Feb 2009 (actual)
- First posted
- 15 Jan 2010 (estimated)
- Results
- Posted 7 May 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
An open clinical trial transplanting CHONDRON (autologous chondrocytes) to ankle cartilage defect patients who are appropriate for the trial, and evaluating the validity and safety for 12 months.
Detailed description
This clinical trial was designed to observe effects of CHONDRON (autologous chondrocytes) for 12 months in patients with ankle cartilage defects. In this clinical trial, 30 subjects were screened- 4 were excluded half way and 26 finished the trial. Full-thickness articular cartilage specimen was obtained from sites that do not have direct articulation within the ankle joint(anterior talus, anterior process of calcaneus, calcaneocuboid joint area.) Gel-type CHONDRON (Fibrin mixed Autologous chondrocytes) was transplanted at the defects. Evaluation variables were AOFAS, 100 mm VAS, HANNOVER score, self-assessment of improvement by the patient, MRI and arthroscopy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chondron implantation | Experimental | Procedure: Chondron(autologous chondrocyte) Implantationankle cartilage defect patients who had CHONDRON transplantation |
Who may qualify
- Ages
- 15 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- adult men and women over 15 and less than 65 years of age
- applied to patients with arthroscopically or grossly confirmed, partial cartilage defect at the ankle joint
- 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.
- patients which surrounding cartilage are normal
- patients who agreed to clinical trial participation voluntarily or by the will of the person in parental authority, and signed the written consent form
Key exclusion criteria (11 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(autologous chondrocyte) ImplantationAlso: Chondron* Test drug: Chondron (more than 12 million chondrocytes in 0.4ml, i.e. 1 vial) * Directions and dosage: Suspend the cells in the vial sufficiently, and implant them in the defective part, making sure that sufficient amounts are injected. *30 subjects participated in this open clinical trial. Those who agreed to participate voluntarily went through screening to confirm the appropriateness for the clinical trial, and then received Gel type CHONDRON (fibrin mixed autologous chondrocytes) transplantation. | Procedure or surgery | Chondron implantation |
Primary outcome
Average Change From Baseline in American Orthopedic Foot and Ankle Society(AOFAS) at 12 Months Post-surgery
Time frame: baseline(preoperative stage),12months post-surgery
AOFAS scores(best score-100,worst score- 0 ) 1. pain-none:40/Strong and Always present:O 2. Function * activities-without support activities:10/need restrain, clutch , walker or wheelchair:0 * Maximum gait distance- more than 6:5/ less than 1:0 * gait surface-easy in any surace:5/strong difficult in irregular ground stair or slopes:0 * Gait abnormality-none:8/marked:0 * saggital mobidity- normal or minimal restrain:6/strong restraint:0 * hindfoot mobidity -normal minimal restrain:6/strong restrain:0 * ankle and hindfoot stability - stable:8/unstable:0 3. alignment- good:10/bad:0
2 secondary outcomes
Average Change From Baseline in 100mm Visual Analogue Scale(VAS) at 12months Post-surgery
Time frame: baseline(preoperative stage),12months post-surgery
Average Change From Baseline in the Modified Hannover Scoring System at 12 Months Post Surgery
Time frame: baseline(preoperative stage),12months post-surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2010.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Gyeung Tea Lee, MD principal investigator
Eulji General Hospital
1 site 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(autologous chondrocyte) Implantation in people with Articular Cartilage Defects of Ankle Joint, 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 5 inclusion and 11 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 11 May 2010. 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.
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?
Yes. Results are posted in the registry (first posted 7 May 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Average Change From Baseline in American Orthopedic Foot and Ankle Society(AOFAS) at 12 Months Post-surgery (time frame: baseline(preoperative stage),12months post-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 11 May 2010.