Degenerative ArthritisPhase 2NCT01825811

Efficacy and Safety Study of TissueGene-C Mixed With Fibrin-glue for the Patients With Degenerative Arthritis

A Phase 2 study testing TissueGene-C (Low dose) and TissueGene-C (High dose) in people with Degenerative Arthritis, run by Kolon Life Science at 6 sites in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to determine whether TissueGene-C, allogeneic human chondrocytes expressing Transforming Growth Factor(TGF)-b1, mixed with fibrin-glue 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 (Low dose) and TissueGene-C (High dose)
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 18 participants
Where: 6 sitesSouth Korea
Study dates: Oct 2012to Jun 2014
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 a 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
With major lesions concentrated in one section of the knee, and with the major lesions considered the main cause of the clinical symptoms

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With major lesions defect size 2 cm2 ~ 10cm2
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
Mechanical axis (HKA) is greater than 5°
Patients receiving injections to the treated knee within 2 months prior to study entry
Patients who are pregnant or currently breast-feeding children
With another joint disease (e.g., inflammatory arthritis, infectious arthritis)
With an infectious disease, including HIV or hepatitis

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With any of the following clinically significant diseases:
heart disease [e.g., myocardial infarction, arrhythmia, other serious heart diseases,
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

6 sites in 1 country.

City, postcode or hospital

6 sites in 1 country

South Korea6 sites

Kyungpook National University Hospital
Daegu, 700-721
Inha University Hospital
Incheon, 400-711
Seoul National University Hospital
Seoul, 110-744
Samsung Medical Center
Seoul, 135-710
Asan Medical Center
Seoul, 138-736
Ewha Womans University Mokdong Hospital
Seoul, 158-710

Other trials in South Korea

About this study

Official title: A Single-blind, Randomized, Parallel-group, Multi-center Phase 2 Study to Determine the Efficacy and Safety of TissueGene-C Mixed With Fibrin-glue in Patients With Degenerative Arthritis

Read the detailed description

TissueGene-C is a biological new drug which consists of non-transduced chondrocytes and transduced chondrocytes that express TGF-b1 to regenerate the damaged cartilage.

During the clinical trial Phase 2, the investigators compare low dose or high dose TissueGene-C in 12 - months trial with 18 outpatients who have degenerative arthritis. The patients are randomized to two dose levels of TissueGene-C by 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 (High dose)
Keywords: Cell mediated gene therapy, Osteoarthritis, Fibrin-glue, Degenerative Arthritis
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
TissueGene-C at 1.0 x 10^6 cells mixed with fibrin-glue
TissueGene-C (High dose)Biological
TissueGene-C at 3.0 x 10^6 cells mixed with fibrin-glue

Study groups in NCT01825811
Study group	Role	What they receive
TissueGene-C (Low dose)	Experimental	TissueGene-C (1.0 x 10^6 cells per cm^2 of the cartilage defect) combined with fibrin-glue Receives: Biological: TissueGene-C (Low dose)
Experimental: TissueGene-C (High dose)	Experimental	TissueGene-C (3.0 x 10^6 cells per cm^2 of the cartilage defect) combined with fibrin-glue Receives: Biological: TissueGene-C (High dose)

What is being measured

The primary outcome is the main question the study is designed to answer.

Changes in IKDC Subjective Knee Evaluation
Symptoms, sports activities, and function of the knee will be measured by the International Knee Documentation Committee (IKDC)
Measured: Week 0 and 48

Secondary outcomes (8)

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, 24 and 48
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, 24 and 48
Changes in 100 mm-VAS
Pain of the knee will be measured by the 100mm Visual Analogue Scale (VAS)
Measured: Week 0, 24 and 48
Comparative Evaluation of Knee Magnetic Resonance Images (MRIs)
Comparison of pre-procedure MRI scans to those obtained at pre-dosing and at months 6 and 12 by an independent radiographic reviewer
Measured: Week 0, 24 and 48
Changes in ICRS Cartilage Repair Assessment
Measured: week 0 and 48
Changes in IKDC Subjective Knee Evaluation
Symptoms, sports activities, and function of the knee will be measured by the International Knee Documentation Committee (IKDC)
Measured: Week 0 and 24
Changes in KOOS QOL Sub-scale scores
Measured: Week 0, 24 and 48
Proportion of Patients Use of Rescue Medication
Measured: Week 12, 24 and 48

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2012Jun 2014

First posted8 Apr 2013 (estimated)
Study startOct 2012
Primary completionApr 2014
Study completionJun 2014

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: 18 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01825811
Sponsor's protocol ID: KS-TGC(S)-01-2
Status last verified: Jan 2015
First submitted: 3 Apr 2013
Last updated: 22 Jan 2015
Results posted: No
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Degenerative Arthritis trials

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 Single-blind, Randomized, Parallel-group, Multi-center Phase 2 Study to Determine the Efficacy and Safety of TissueGene-C Mixed With Fibrin-glue in Patients With Degenerative Arthritis
ClinicalTrials.gov ID: NCT01825811
Acronym / sponsor ID: KS-TGC(S)-01-2
Conditions: Degenerative Arthritis
Keywords: Cell mediated gene therapy, Osteoarthritis, Fibrin-glue, Degenerative Arthritis
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 18 participants (actual)
Lead sponsor: Kolon Life ScienceIndustry (pharma, biotech, devices)
Study start: Oct 2012
Primary completion: Apr 2014 (actual)
Study completion: Jun 2014 (actual)
First posted: 8 Apr 2013 (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.

Detailed description

TissueGene-C is a biological new drug which consists of non-transduced chondrocytes and transduced chondrocytes that express TGF-b1 to regenerate the damaged cartilage.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
TissueGene-C (Low dose)	Experimental	Biological: TissueGene-C (Low dose)TissueGene-C (1.0 x 10^6 cells per cm^2 of the cartilage defect) combined with fibrin-glue
Experimental: TissueGene-C (High dose)	Experimental	Biological: TissueGene-C (High dose)TissueGene-C (3.0 x 10^6 cells per cm^2 of the cartilage defect) combined with fibrin-glue

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 a 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

Key exclusion criteria (18 listed)

Showed clinically significant hematology, serum chemistry, and urine test results at the screening visit
Mechanical axis (HKA) is greater than 5°
Patients receiving injections to the treated knee within 2 months prior to study entry
Patients who are pregnant or currently breast-feeding children
With another joint disease (e.g., inflammatory arthritis, infectious arthritis)

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)TissueGene-C at 1.0 x 10^6 cells mixed with fibrin-glue	Biological	TissueGene-C (Low dose)
TissueGene-C (High dose)TissueGene-C at 3.0 x 10^6 cells mixed with fibrin-glue	Biological	Experimental: TissueGene-C (High dose)

Primary outcome

Changes in IKDC Subjective Knee Evaluation
Time frame: Week 0 and 48
Symptoms, sports activities, and function of the knee will be measured by the International Knee Documentation Committee (IKDC)

8 secondary outcomes

Changes in WOMAC scores
Time frame: Week 0, 24 and 48
Changes in KOOS scores
Time frame: Week 0, 24 and 48
Changes in 100 mm-VAS
Time frame: Week 0, 24 and 48
Comparative Evaluation of Knee Magnetic Resonance Images (MRIs)
Time frame: Week 0, 24 and 48
Changes in ICRS Cartilage Repair Assessment
Time frame: week 0 and 48
Changes in IKDC Subjective Knee Evaluation
Time frame: Week 0 and 24
Changes in KOOS QOL Sub-scale scores
Time frame: Week 0, 24 and 48
Proportion of Patients Use of Rescue Medication
Time frame: Week 12, 24 and 48

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.

Related trials for Degenerative Arthritis

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Holistic Healing for Knee Osteoarthritis
Knee Osteoarthritis (Knee OA)
Active, not recruiting
Effectiveness of Therapeutic Exercises on Spinopelvic Mobility
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Recruiting
Effect of Anti-inflammatory Diet in Osteoarthritis
Osteoarthritis, Knee
Active, not recruitingPhase 2/3
Single vs Triple Hyaluronic Acid in Knee Osteoarthritis
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Not yet recruiting
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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 Chul Lee, MD, PhD principal investigator

Seoul National University Hospital

Chul Won Ha, MD, PhD principal investigator

Samsung Medical Center

Seong Il Bin, MD, PhD principal investigator

Asan Medical Center

6 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 (Low dose) and TissueGene-C (High dose) in people with Degenerative Arthritis, run by Kolon Life Science at 6 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 18 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 6 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.

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 Knee Evaluation (time frame: Week 0 and 48). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01825811.

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.