Degenerative ArthritisPhase 2NCT01671072
Efficacy and Safety Study of TissueGene-C to Degenerative Arthritis
A Phase 2 study testing TissueGene-C and Normal Saline in people with Degenerative Arthritis, run by Kolon Life Science at 3 sites in South Korea.
Trial summary
The purpose of this study is to determine whether TissueGene-C, an allogeneic human chondrocytes expressing Transforming Growth Factor(TGF)-b1, is effective and safe in patients with degenerative arthritis Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Degenerative Arthritis
- What is being tested?
- TissueGene-C and Normal Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 54 participants
- Where
- 3 sitesSouth Korea
- Study dates
- Jul 2011to Jan 2013
- Phase
- Phase 2
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female or male aged 18 years or more
- Diagnosed with degenerative arthritis of the knee
- With an IKDC score of 60 or lower at the screening visit
- With Grade 2 or 3 osteoarthritis as determined by the radiographic criteria of Kellgren and Lawrence
- With a Body Mass Index(BMI) of higher than18.5 and lower than 30
- With an International Cartilage Repair Society(ICRS) Grade IV cartilage damage in the major lesions, as confirmed through an MRI scan
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- With major lesions concentrated in one section of the knee, and with the major lesions considered the main cause of the clinical symptoms
- With no alleviation of the symptoms even after at least three months of non-surgical treatment
- Healthy, with no major findings from the physical examination, hematology, serum chemistry, and urine tests, and no significant medical history
- Agreed to use an effective contraceptive method during the study period
- Voluntarily agreed to participate in this study, and signed the informed consent form
Who cannot join
- Showed clinically significant hematology, serum chemistry, and urine test results at the screening visit
- Falls under Inclusion Criteria 6 but with the damage in the relevant lesion considered ICRS Grade IV sized more than 6 cm2
- Took glucosamine, chondroitin, or any natural medicine within 14 days before the injection of the investigational product (but if the 14-day washout period had elapsed, the patient can be enrolled in this study)
- Has taken anti-inflammatory drugs (prescribed or over-the-counter) within 14 days before the injection of the investigational product (but if the 14-day washout period had elapsed, the patient can be enrolled in this study)
- Has taken immunosuppressive agents, including antirheumatic drugs (e.g., methotrexate or antimetabolites) within 3 months before enrollment in this study
- With a history of drug abuse within one year prior to enrollment in this study, or showed positive results in the urine drug test or the serum alcohol test at the screening visit
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- Received an injection in the target knee within two months before enrollment in this 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 tibia, ochronosis, hemophilic arthropathy, infectious arthritis, Charcot's disease in the knee joint, villonodular synovitis, synovial chondromas)
- With an infectious disease, including HIV or hepatitis
- With any of the following clinically significant diseases:
- heart disease [e.g., myocardial infarction, arrhythmia, other serious heart diseases, 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 past 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
- Considered inappropriate by the investigator for participation in this study
Trial locations and contacts
3 sites in 1 country.
South Korea3 sites
Samsung Medical Center
Gangnam-gu, Seoul, 135-710
Seoul National Univ. Hospital
Seoul, 110-744
Asan Medical Center
Seoul, 138-736
About this study
Official title: A Placebo Controlled, Single-blind, Randomized, Multi-center Phase 2B Study to Determine the Efficacy and Safety of TissueGene-C, an Allogeneic Human Chondrocytes Expressing TGF-b1, in Patients With Degenerative Arthritis
The purpose of this study is to determine whether TissueGene-C, an allogeneic human chondrocytes expressing Transforming Growth Factor(TGF)-b1, is effective and safe in patients with degenerative arthritis
Read the detailed description
TissueGene-C is a biological new drug which consists of normal chondrocytes and transduced chondrocytes that express growth factors to regenerate the damaged cartilage tissues.
In the clinical trial Phase 2b, the investigators compared TissueGene-C to placebo during 6 - months trial with 54 outpatients who have had degenerative arthritis. The outpatients are assigned to TissueGene-C or placebo in 1:1 ratio, and will be monitored and recorded for improving clinical symptoms, sports activities, and function of the knee, and for the presence of adverse events.
- Conditions
- Degenerative Arthritis
- Being tested
- TissueGene-C, Normal Saline
- 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-CBiological
TissueGene-C at 1.8 x 10^7 cells
Normal SalineDrug
Sodium chloride 0.9%, 3.5ml
| Study group | Role | What they receive |
|---|---|---|
| TissueGene-C | Experimental | Single intra-articular injection to the damaged knee joint a dose of 1.8 x 10^7 cells Receives: Biological: TissueGene-C |
| Normal Saline | Placebo comparator | Single intra-articular injection to the damaged knee joint at the same volume Receives: Drug: Normal Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in IKDC Subjective Score.
Symptoms, sports activities, and function of the knee will be measured by the International Knee Documentation Committee (IKDC)
Measured: Week 0 and 24
Secondary outcomes (5)
Changes in WOMAC scores.
Pain, stiffness, and physical function of the knee will be measured by the Western Ontario and McMaster Universities (WOMAC)
Measured: Week 0 and 24
Changes in KOOS scores.
Symptoms, pain and functionality of the knee joint will be evaluated via the Knee Injury and Osteoarthritis Outcome Score (KOOS)
Measured: Week 0 and 24
Changes in 100 mm-VAS.
Pain of the knee will be measured by the 100mm Visual Analogue Scale (VAS)
Measured: Week 0 and 24
MRI scan
Comparison of pre-procedure MRI scans to those obtained at pre-dosing and at months 6 and 12 following dosing by an independent radiographic reviewer.
Measured: Week 0 and 24
Proportion of Patients Use of Rescue Medication
Measured: Week 4, 12 and 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2012 (estimated)
- Study startJul 2011
- Primary completionOct 2012
- Study completionJan 2013
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 54 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 CenterSeong Il Bin, MD, PhD, Principal investigator, Asan Medical CenterMyung Chul Lee, MD, PhD, Principal investigator, Seoul National Univ. Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01671072
- Sponsor's protocol ID
- KS-TGC-01-2B
- Status last verified
- Jan 2015
- First submitted
- 20 Aug 2012
- Last updated
- 22 Jan 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Placebo Controlled, Single-blind, Randomized, Multi-center Phase 2B Study to Determine the Efficacy and Safety of TissueGene-C, an Allogeneic Human Chondrocytes Expressing TGF-b1, in Patients With Degenerative Arthritis
- ClinicalTrials.gov ID
- NCT01671072
- Acronym / sponsor ID
- KS-TGC-01-2B
- Conditions
- Degenerative Arthritis
- Keywords
- Chondrocyte cells, Osteoarthritis, Gene therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Kolon Life ScienceIndustry (pharma, biotech, devices)
- Study start
- Jul 2011
- Primary completion
- Oct 2012 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 23 Aug 2012 (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 determine whether TissueGene-C, an allogeneic human chondrocytes expressing Transforming Growth Factor(TGF)-b1, is effective and safe in patients with degenerative arthritis
Detailed description
TissueGene-C is a biological new drug which consists of normal chondrocytes and transduced chondrocytes that express growth factors to regenerate the damaged cartilage tissues.
In the clinical trial Phase 2b, the investigators compared TissueGene-C to placebo during 6 - months trial with 54 outpatients who have had degenerative arthritis. The outpatients are assigned to TissueGene-C or placebo in 1:1 ratio, and will be monitored and recorded for improving clinical symptoms, sports activities, and function of the knee, and for the presence of adverse events.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TissueGene-C | Experimental | Biological: TissueGene-CSingle intra-articular injection to the damaged knee joint a dose of 1.8 x 10^7 cells |
| Normal Saline | Placebo comparator | Drug: Normal SalineSingle intra-articular injection to the damaged knee joint at the same volume |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Female or male aged 18 years or more
- Diagnosed with degenerative arthritis of the knee
- With an IKDC score of 60 or lower at the screening visit
- With Grade 2 or 3 osteoarthritis as determined by the radiographic criteria of Kellgren and Lawrence
- With a Body Mass Index(BMI) of higher than18.5 and lower than 30
Key exclusion criteria (22 listed)
- Showed clinically significant hematology, serum chemistry, and urine test results at the screening visit
- Falls under Inclusion Criteria 6 but with the damage in the relevant lesion considered ICRS Grade IV sized more than 6 cm2
- Took glucosamine, chondroitin, or any natural medicine within 14 days before the injection of the investigational product (but if the 14-day washout period had elapsed, the patient can be enrolled in this study)
- Has taken anti-inflammatory drugs (prescribed or over-the-counter) within 14 days before the injection of the investigational product (but if the 14-day washout period had elapsed, the patient can be enrolled in this study)
- Has taken immunosuppressive agents, including antirheumatic drugs (e.g., methotrexate or antimetabolites) within 3 months before enrollment in this study
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-CTissueGene-C at 1.8 x 10^7 cells | Biological | TissueGene-C |
| Normal SalineSodium chloride 0.9%, 3.5ml | Drug | Normal Saline |
Primary outcome
Changes in IKDC Subjective Score.
Time frame: Week 0 and 24
Symptoms, sports activities, and function of the knee will be measured by the International Knee Documentation Committee (IKDC)
5 secondary outcomes
Changes in WOMAC scores.
Time frame: Week 0 and 24
Changes in KOOS scores.
Time frame: Week 0 and 24
Changes in 100 mm-VAS.
Time frame: Week 0 and 24
MRI scan
Time frame: Week 0 and 24
Proportion of Patients Use of Rescue Medication
Time frame: Week 4, 12 and 24
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 22 Jan 2015.
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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
Seong Il Bin, MD, PhD principal investigator
Asan Medical Center
Myung Chul Lee, MD, PhD principal investigator
Seoul National Univ. Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing TissueGene-C and Normal Saline in people with Degenerative Arthritis, run by Kolon Life Science at 3 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 11 inclusion and 22 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 22 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Changes in IKDC Subjective Score. (time frame: Week 0 and 24). 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 22 Jan 2015.