Articular Cartilage Defects of KneeNCT01056900
Observation of the Result After Chondron (Autologous Chondrocytes) Treatment
An observational study of Articular Cartilage Defects of Knee, run by Cellontech Co., Ltd. at 1 site in South Korea.
Trial summary
This investigator-sponsored trial attempts to evaluate the effectiveness of Chondron transplantation by tracking subjects who had the Chondron implantation to observe effectiveness. Read more about this study
- Who is it for?
- Ages 15 to 65 years
- Conditions the study is for
- Articular Cartilage Defects of Knee
- What is being tested?
- Autologous Chondrocyte Implantation
- Type of treatment
- Surgery or procedure
- How many people
- 127 participants
- Where
- 1 siteSouth Korea
- Study dates
- Dec 2008to Nov 2009
- 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 15 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: In this exploratory clinical trial Chondron (autologous chondrocytes) is transplanted in the cartilaginous defects and the effectiveness is observed through follow-up. Target subjects are about 5% of about 2,000 patients with Chondron implants.
Who may be able to join
- Adult males and females aged between 15 and 65
- Patients with a partial cartilaginous defect in the ankle joint confirmed arthroscopically or visually
- Patients with misalignment between tibia and talus of the ankle joint, lateral ankle instability, and a bony defect in the cartilaginous defect or who had a correction simultaneously or in advance
- Patients whose surrounding cartilage is normal
- Subjects who consented to the clinical trial or on whose behalf a person with parental rights consented to the clinical trial
Who cannot join
- Patients hypersensitive to bovine protein
- Patients hypersensitive to antibiotics like gentamicin
- Patients with inflammatory arthritis, such as rheumatoid arthritis and gouty arthritis
- Patients with arthritis associated with autoimmune diseases
- Patients who are pregnant, nursing a baby or likely to get pregnant
- Patients with other diseases including tumors except for cartilaginous defects of joints
Show all 11Show fewer
- Patients with an anamnesis within the past two years, such as radiation treatment and chemotherapy
- Diabetics (however, patients who were normal in the blood glucose test and have no complication due to diabetes will be excluded if the doctor says Chondron can be administered to them)
- Patients with infections who are taking antibiotics and antimicrobial agents
- Patients who are treated with adrenal cortical hormones
- Patients whom the investigators find to be unfit for this clinical trial, such as mental patients
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Investigator-sponsored Trial for Observation of the Result After Chondron (Autologous Chondrocytes) Treatment
This investigator-sponsored trial attempts to evaluate the effectiveness of Chondron transplantation by tracking subjects who had the Chondron implantation to observe effectiveness.
Read the detailed description
Many treatment cases proved that autologous chondrocyte transplantation is a useful treatment method for patients with damaged articular cartilage.
This investigator-sponsored trial attempts to evaluate the effectiveness of Chondron(autologous chondrocyte) transplantation by tracking subjects who had the Chondron implantation to observe effectiveness.
- Conditions
- Articular Cartilage Defects of Knee
- Being tested
- Autologous Chondrocyte Implantation
- Keywords
- articular cartilage defects, ACI, Autologous Chondrocyte Implantation, Knee joint, chondron
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autologous Chondrocyte ImplantationProcedure or surgery
Also called Chondron(671500010 [ A74600011 ])
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Chondron Implantation | This clinical trial was a follow-up study involving 127 patients from 10 hospitals, for whom autologous chondrocyte transplantation was already performed. All the subjects were investigated as a single group Receives: Procedure: Autologous Chondrocyte Implantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of KSS(Knee Society Score)-A,B
Measured: pre-operation, post -operation 4month, post-operation 12month, over post-operation 24month.
Secondary outcomes (2)
Additional treatment related to autologous chondrocyte implantation
Measured: post -operation 4month, post-operation 12month, over post-operation 24month.
Satisfaction of patients
Measured: post -operation 4month, post-operation 12month, over post-operation 24month.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2010 (estimated)
- Study startDec 2008
- Primary completionAug 2009
- Study completionNov 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Articular Cartilage Defects of KneeStudies 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
- 127 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cellontech Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Nam Yong Choi, Principal investigator, St. Paul Hospital of Catholic Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01056900
- Sponsor's protocol ID
- 05CON
- Status last verified
- Jan 2010
- First submitted
- 21 Jan 2010
- Last updated
- 26 Jan 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Investigator-sponsored Trial for Observation of the Result After Chondron (Autologous Chondrocytes) Treatment
- ClinicalTrials.gov ID
- NCT01056900
- Acronym / sponsor ID
- 05CON
- Conditions
- Articular Cartilage Defects of Knee
- Keywords
- articular cartilage defects, ACI, Autologous Chondrocyte Implantation, Knee joint, chondron
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 127 participants (actual)
- Lead sponsor
- Cellontech Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Dec 2008
- Primary completion
- Aug 2009 (actual)
- Study completion
- Nov 2009 (actual)
- First posted
- 26 Jan 2010 (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.
This investigator-sponsored trial attempts to evaluate the effectiveness of Chondron transplantation by tracking subjects who had the Chondron implantation to observe effectiveness.
Detailed description
Many treatment cases proved that autologous chondrocyte transplantation is a useful treatment method for patients with damaged articular cartilage.
This investigator-sponsored trial attempts to evaluate the effectiveness of Chondron(autologous chondrocyte) transplantation by tracking subjects who had the Chondron implantation to observe effectiveness.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chondron Implantation | – | Procedure: Autologous Chondrocyte ImplantationThis clinical trial was a follow-up study involving 127 patients from 10 hospitals, for whom autologous chondrocyte transplantation was already performed. All the subjects were investigated as a single group |
Who may qualify
- Ages
- 15 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- In this exploratory clinical trial Chondron (autologous chondrocytes) is transplanted in the cartilaginous defects and the effectiveness is observed through follow-up. Target subjects are about 5% of about 2,000 patients with Chondron implants.
Key inclusion criteria (5 listed)
Key exclusion criteria (11 listed)
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 |
|---|---|---|
| Autologous Chondrocyte ImplantationAlso: Chondron(671500010 [ A74600011 ])* 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. | Procedure or surgery | Chondron Implantation |
Primary outcome
Change of KSS(Knee Society Score)-A,B
Time frame: pre-operation, post -operation 4month, post-operation 12month, over post-operation 24month.
2 secondary outcomes
Additional treatment related to autologous chondrocyte implantation
Time frame: post -operation 4month, post-operation 12month, over post-operation 24month.
Satisfaction of patients
Time frame: post -operation 4month, post-operation 12month, over post-operation 24month.
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 26 Jan 2010.
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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.
Nam Yong Choi principal investigator
St. Paul Hospital of Catholic Medical College
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 Articular Cartilage Defects 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 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 26 Jan 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.
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 of KSS(Knee Society Score)-A,B (time frame: pre-operation, post -operation 4month, post-operation 12month, over post-operation 24month.). 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 26 Jan 2010.