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

Degenerative Arthritis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01825811
• Other study ID #: KS-TGC(S)-01-2
• Status: Completed
• Phase: Phase 2
• First received: April 3, 2013
• Last updated: January 20, 2015
• Start date: October 2012
• Est. completion date: June 2014

Study information

• Verified date: January 2015
• Source: Kolon Life Science
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: June 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Female or male aged 18 years or more

2. Diagnosed with degenerative arthritis of the knee

3. With an IKDC score of 60 or lower at the screening visit

4. With a BMI of higher than18.5 and lower than 30

5. With an International Cartilage Repair Society(ICRS) Grade IV cartilage damage in the major lesions, as confirmed through an MRI scan

6. With major lesions concentrated in one section of the knee, and with the major lesions considered the main cause of the clinical symptoms

7. With major lesions defect size 2 cm2 ~ 10cm2

8. With no alleviation of the symptoms even after at least three months of non-surgical treatment

9. Healthy, with no major findings from the physical examination, hematology, serum chemistry, and urine tests, and no significant medical history

10. Agreed to use an effective contraceptive method during the study period

11. Voluntarily agreed to participate in this study, and signed the informed consent form

Exclusion Criteria:

1. Showed clinically significant hematology, serum chemistry, and urine test results at the screening visit

2. Mechanical axis (HKA) is greater than 5°

3. Patients receiving injections to the treated knee within 2 months prior to study entry

4. Patients who are pregnant or currently breast-feeding children

5. With another joint disease (e.g., inflammatory arthritis, infectious arthritis)

6. With an infectious disease, including HIV or hepatitis

7. 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)

8. Participated in another clinical trial (using the investigational drug or a medical device) within 30 days before enrollment in this study

9. Considered inappropriate by the investigator for participation in this study

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arthritis
• Degenerative Arthritis
• Osteoarthritis

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Kyungpook National University Hospital	Daegu
Korea, Republic of	Inha University Hospital	Incheon
Korea, Republic of	Asan Medical Center	Seoul
Korea, Republic of	Ewha Womans University Mokdong Hospital	Seoul
Korea, Republic of	Samsung Medical Center	Seoul
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Kolon Life Science

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in IKDC Subjective Knee Evaluation	Symptoms, sports activities, and function of the knee will be measured by the International Knee Documentation Committee (IKDC)	Week 0 and 48	No
Secondary	Changes in WOMAC scores	Pain, stiffness, and physical function of the knee will be measured by the Western Ontario and McMaster Universities (WOMAC)	Week 0, 24 and 48	No
Secondary	Changes in KOOS scores	Symptoms, pain and functionality of the knee joint will be evaluated via the Knee Injury and Osteoarthritis Outcome Score (KOOS)	Week 0, 24 and 48	No
Secondary	Changes in 100 mm-VAS	Pain of the knee will be measured by the 100mm Visual Analogue Scale (VAS)	Week 0, 24 and 48	No
Secondary	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	Week 0, 24 and 48	No
Secondary	Changes in ICRS Cartilage Repair Assessment		week 0 and 48	No
Secondary	Changes in IKDC Subjective Knee Evaluation	Symptoms, sports activities, and function of the knee will be measured by the International Knee Documentation Committee (IKDC)	Week 0 and 24	No
Secondary	Changes in KOOS QOL Sub-scale scores		Week 0, 24 and 48	No
Secondary	Proportion of Patients Use of Rescue Medication		Week 12, 24 and 48	No