Degenerative ArthritisPhase 1NCT02341391
Safety and Biological Efficacy Study of TisssueGene-C to Degenerative Arthritis
A Phase 1 study testing TissueGene-C(Low dose), TissueGene-C(Medium dose) and TissueGene-C(High dose) in people with Degenerative Arthritis, run by Kolon Life Science at 1 site in South Korea.
Trial summary
The primary purpose of the this study is to evaluate the safety of TissueGene-C, a gene therapy product that uses allogenic human chondrocytes expressing Transforming Growth Factor(TGF)-β1 by assessing the inflammation at the injection site, the incidence and severity of the adverse events, the physical examination… Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Degenerative Arthritis
- What is being tested?
- TissueGene-C(Low dose), TissueGene-C(Medium dose) and TissueGene-C(High dose)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteSouth Korea
- Study dates
- Feb 2007to Sep 2008
- Phase
- Phase 1
- 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 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female patients
- Patients aged 45 years or more with Grade IV [based on the International Cartilage Repair Society(ICRS) evaluation criteria from the MRI scan results] degenerative arthritis of the knee, whose symptoms had not been relieved by the conventional symptomatic treatment
- Healthy, with no major physical examination, hematology, serum chemistry, and urine test findings and no significant medical history
- Patients with cartilage damage sized 2-6 cm2 (based on the ICRS evaluation criteria from the MRI scan results)
- Voluntarily agreed to participate in this study and signed the informed consent form
Who cannot join
- Showed clinically significant hematology, serum chemistry, or urine test results at the screening visit
- Took an anti-inflammatory medication (prescribed or over-the-counter), including natural medicine, within 14 days from the administration of the investigational product
- Has a history of drug abuse within one year from the enrollment, or the urine test or blood alcohol test result was positive at the screening visit
- Received any injection in the target knee within two months before the initiation of the study
- Pregnant or breastfeeding female
- With another joint disease apart from degenerative arthritis (e.g., systemic rheumatic inflammatory disease associated with the knee or chondrocalcinosis, hemachromatosis, inflammatory arthritis, necrosis of the trochanter, Paget's disease adjacent to a joint in the femur or the tibia, ochronosis, hemophilic arthropathy, infectious arthritis, Charcot's disease in the knee joint, villonodular synovitis, and synovial chondromas)
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- With an infectious disease, including HIV or hepatitis (HBV/HCV)
- With a history any of the following clinically significant diseases:
- heart disease [e.g., myocardial infarction, arrhythmia, other serious heart disease, coronary artery bypass graft (CABG)]
- kidney disease (e.g., chronic renal failure, glomerulonephritis)
- liver disease (e.g., liver cirrhosis, fatty liver, acute or chronic liver disease)
- endocrine disease (e.g., hyperthyroidism, hypothyroidism, thyroiditis, diabetes insipidus, Cushing's disease)
- insulin-dependent diabetes mellitus
- medical history of or current malignant tumor In particular, the tumors that TissueGene-C may aggravate can be screened using the following tests
- Leukemia : White Blood Cell level in the hematology
- Osteochondroma, Chondromas, Chondroblastoma, Chondromyxoid fibroma, Chondrosarcoma : Alkaline phosphatase level in the hematology
- Participated in another clinical trial (using the investigational drug or a medical device) within 30 days before enrollment in this study
- Showed positive drug test results at the screening visit
- Did not agree to use a contraceptive method (male and female)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Dose-escalating, Single-center, Phase I Clinical Trial to Investigate the Safety and Biological Efficacy of TissueGene-C in Degenerative Arthritis Patients.
The primary purpose of the this study is to evaluate the safety of TissueGene-C, a gene therapy product that uses allogenic human chondrocytes expressing Transforming Growth Factor(TGF)-β1 by assessing the inflammation at the injection site, the incidence and severity of the adverse events, the physical examination findings, and the laboratory test results after the intra-articular injection of TissueGene-C.
And Secondary purpose is to evaluate the biological efficacy (knee pain, range of motion, functional tests, and MRI) of TissueGene-C and the distribution of TissueGene-C outside the injection site.
Read the detailed description
TissueGene-C is a biological new drug which consists of normal chondrocyte cells and transduced chondrocyte cells that express growth factor to modify osteoarthritis symptom for long term period.
During clinical trial Phase 1, we compare three different dose levels of TisssueGene-C in 6 months with 12 outpatients with degenerative arthritis. The patients are randomized by three different dose levels of TisssueGene-C in 1:1:1 ratio, and they are monitored and recorded for alleviating symptoms, sports activities, function of the knee, and the presence of adverse events.
- Conditions
- Degenerative Arthritis
- Being tested
- TissueGene-C(Low dose), TissueGene-C(Medium dose), TissueGene-C(High dose)
- Keywords
- chondrocyte cells, Osteoarthritis, gene therapy
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TissueGene-C(Low dose)Biological
3.0 x 10^6 cells
TissueGene-C(Medium dose)Biological
1.0 x 10^7 cells
TissueGene-C(High dose)Biological
3.0 x 10^7 cells
| Study group | Role | What they receive |
|---|---|---|
| TissueGene-C(Low dose) | Experimental | Single intra-articular injection to the damaged knee joint at doses of 3.0 x 10^6 cells Receives: Biological: TissueGene-C(Low dose) |
| TissueGene-C(Medium dose) | Experimental | Single intra-articular injection to the damaged knee joint at doses of 1.0 x 10^7 cells Receives: Biological: TissueGene-C(Medium dose) |
| TissueGene-C(High dose) | Experimental | Single intra-articular injection to the damaged knee joint at doses of 3.0 x 10^7 cells Receives: Biological: TissueGene-C(High dose) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Adverse Events after the administration of TissueGene-C
Number of Participants with Adverse Events after the administration of TissueGene-C
Measured: 6 months
Secondary outcomes (6)
Changes in MRI scan
Change in the MRI scan results after the administration of TissueGene-C
Measured: before and 28 days, 3 months, and 6 months
Change in the Knee Society Clinical Rating System(KSCRS) test results
Comparative Evaluation of knee exam
Measured: before and 7 days, 14 days, 21 days, 28 days, 3 months, and 6 months
Changes in WOMAC scores
Pain, stiffness, and physical function of the knee will be measured by the Western Ontario and McMaster Universities(WOMAC)
Measured: before and 7 days, 14 days, 21 days, 28 days, 3 months, and 6 months
Changes in 100 mm-VAS
Pain of the knee will be measured by the 100mm Visual Analogue Scale (VAS)
Measured: before and 7 days, 14 days, 21 days, 28 days, 3 months, and 6 months
Analysis of the TGF-β1 expression using Enzyme-linked Immunosorbent Assay(ELISA) and Polymerase Chain Reaction(PCR)
Analysis of the TGF-β1 expression using Enzyme-linked Immunosorbent Assay(ELISA) and Polymerase Chain Reaction(PCR)
Measured: before and 7 days, 14 days, 21 days, 28 days, 3 months, and 6 months
Replication-competent retrovirus test (RCR test)
Replication-competent retrovirus test (RCR test)
Measured: before and 7 days, 14 days, 21 days, 28 days, 3 months, and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2015 (estimated)
- Study startFeb 2007
- Primary completionAug 2008
- Study completionSep 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Degenerative ArthritisStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kolon Life Science
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Chul Won Ha, MD, PhD, Principal investigator, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02341391
- Sponsor's protocol ID
- TGC-KI-01
- Status last verified
- Jul 2018
- First submitted
- 8 Jan 2015
- Last updated
- 5 Jul 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Dose-escalating, Single-center, Phase I Clinical Trial to Investigate the Safety and Biological Efficacy of TissueGene-C in Degenerative Arthritis Patients.
- ClinicalTrials.gov ID
- NCT02341391
- Acronym / sponsor ID
- TGC-KI-01
- Conditions
- Degenerative Arthritis
- Keywords
- chondrocyte cells, Osteoarthritis, gene therapy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Kolon Life ScienceIndustry (pharma, biotech, devices)
- Study start
- Feb 2007
- Primary completion
- Aug 2008 (actual)
- Study completion
- Sep 2008 (actual)
- First posted
- 19 Jan 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 primary purpose of the this study is to evaluate the safety of TissueGene-C, a gene therapy product that uses allogenic human chondrocytes expressing Transforming Growth Factor(TGF)-β1 by assessing the inflammation at the injection site, the incidence and severity of the adverse events, the physical examination findings, and the laboratory test results after the intra-articular injection of TissueGene-C.
And Secondary purpose is to evaluate the biological efficacy (knee pain, range of motion, functional tests, and MRI) of TissueGene-C and the distribution of TissueGene-C outside the injection site.
Detailed description
TissueGene-C is a biological new drug which consists of normal chondrocyte cells and transduced chondrocyte cells that express growth factor to modify osteoarthritis symptom for long term period.
During clinical trial Phase 1, we compare three different dose levels of TisssueGene-C in 6 months with 12 outpatients with degenerative arthritis. The patients are randomized by three different dose levels of TisssueGene-C in 1:1:1 ratio, and they are monitored and recorded for alleviating symptoms, sports activities, function of the knee, and the presence of adverse events.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| TissueGene-C(Low dose) | Experimental | Biological: TissueGene-C(Low dose)Single intra-articular injection to the damaged knee joint at doses of 3.0 x 10^6 cells |
| TissueGene-C(Medium dose) | Experimental | Biological: TissueGene-C(Medium dose)Single intra-articular injection to the damaged knee joint at doses of 1.0 x 10^7 cells |
| TissueGene-C(High dose) | Experimental | Biological: TissueGene-C(High dose)Single intra-articular injection to the damaged knee joint at doses of 3.0 x 10^7 cells |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female patients
- Patients aged 45 years or more with Grade IV [based on the International Cartilage Repair Society(ICRS) evaluation criteria from the MRI scan results] degenerative arthritis of the knee, whose symptoms had not been relieved by the conventional symptomatic treatment
- Healthy, with no major physical examination, hematology, serum chemistry, and urine test findings and no significant medical history
- Patients with cartilage damage sized 2-6 cm2 (based on the ICRS evaluation criteria from the MRI scan results)
- Voluntarily agreed to participate in this study and signed the informed consent form
Key exclusion criteria (19 listed)
- Showed clinically significant hematology, serum chemistry, or urine test results at the screening visit
- Took an anti-inflammatory medication (prescribed or over-the-counter), including natural medicine, within 14 days from the administration of the investigational product
- Has a history of drug abuse within one year from the enrollment, or the urine test or blood alcohol test result was positive at the screening visit
- Received any injection in the target knee within two months before the initiation of the study
- Pregnant or breastfeeding female
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 |
|---|---|---|
| TissueGene-C(Low dose)3.0 x 10^6 cells | Biological | TissueGene-C(Low dose) |
| TissueGene-C(Medium dose)1.0 x 10^7 cells | Biological | TissueGene-C(Medium dose) |
| TissueGene-C(High dose)3.0 x 10^7 cells | Biological | TissueGene-C(High dose) |
Primary outcome
Number of Participants with Adverse Events after the administration of TissueGene-C
Time frame: 6 months
Number of Participants with Adverse Events after the administration of TissueGene-C
6 secondary outcomes
Changes in MRI scan
Time frame: before and 28 days, 3 months, and 6 months
Change in the Knee Society Clinical Rating System(KSCRS) test results
Time frame: before and 7 days, 14 days, 21 days, 28 days, 3 months, and 6 months
Changes in WOMAC scores
Time frame: before and 7 days, 14 days, 21 days, 28 days, 3 months, and 6 months
Changes in 100 mm-VAS
Time frame: before and 7 days, 14 days, 21 days, 28 days, 3 months, and 6 months
Analysis of the TGF-β1 expression using Enzyme-linked Immunosorbent Assay(ELISA) and Polymerase Chain Reaction(PCR)
Time frame: before and 7 days, 14 days, 21 days, 28 days, 3 months, and 6 months
Replication-competent retrovirus test (RCR test)
Time frame: before and 7 days, 14 days, 21 days, 28 days, 3 months, and 6 months
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 5 Jul 2018.
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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.
Chul Won Ha, MD, PhD principal investigator
Samsung Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing TissueGene-C(Low dose), TissueGene-C(Medium dose) and TissueGene-C(High dose) in people with Degenerative Arthritis, run by Kolon Life Science 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 19 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 5 Jul 2018. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 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?
Number of Participants with Adverse Events after the administration of TissueGene-C (time frame: 6 months). 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 5 Jul 2018.