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

Primary Purpose

Degenerative Arthritis

Status

Completed

Phase

Phase 2

Locations

Korea, Republic of

Study Type

Interventional

Intervention

TissueGene-C (Low dose)

TissueGene-C (High dose)

About this trial

This is an interventional treatment trial for Degenerative Arthritis focused on measuring Cell mediated gene therapy, Osteoarthritis, Fibrin-glue, Degenerative Arthritis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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
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

Exclusion Criteria:

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
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

Sites / Locations

Kyungpook National University Hospital
Inha University Hospital
Seoul National University Hospital
Samsung Medical Center
Asan Medical Center
Ewha Womans University Mokdong Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

TissueGene-C (Low dose)

Experimental: TissueGene-C (High dose)

Arm Description

TissueGene-C (1.0 x 10^6 cells per cm^2 of the cartilage defect) combined with fibrin-glue

TissueGene-C (3.0 x 10^6 cells per cm^2 of the cartilage defect) combined with fibrin-glue

Outcomes

Primary Outcome Measures

Changes in IKDC Subjective Knee Evaluation

Symptoms, sports activities, and function of the knee will be measured by the International Knee Documentation Committee (IKDC)

Secondary Outcome Measures

Changes in WOMAC scores

Pain, stiffness, and physical function of the knee will be measured by the Western Ontario and McMaster Universities (WOMAC)

Changes in KOOS scores

Symptoms, pain and functionality of the knee joint will be evaluated via the Knee Injury and Osteoarthritis Outcome Score (KOOS)

Changes in 100 mm-VAS

Pain of the knee will be measured by the 100mm Visual Analogue Scale (VAS)

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

Changes in ICRS Cartilage Repair Assessment

Changes in IKDC Subjective Knee Evaluation

Symptoms, sports activities, and function of the knee will be measured by the International Knee Documentation Committee (IKDC)

Changes in KOOS QOL Sub-scale scores

Proportion of Patients Use of Rescue Medication

Full Information

NCT ID

NCT01825811

First Posted

April 3, 2013

Last Updated

January 20, 2015

Sponsor

Kolon Life Science

1. Study Identification

Unique Protocol Identification Number

NCT01825811

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2015

Overall Recruitment Status

Completed

Study Start Date

October 2012 (undefined)

Primary Completion Date

April 2014 (Actual)

Study Completion Date

June 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Kolon Life Science

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Degenerative Arthritis

Keywords

Cell mediated gene therapy, Osteoarthritis, Fibrin-glue, Degenerative Arthritis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

18 (Actual)

8. Arms, Groups, and Interventions

Arm Title

TissueGene-C (Low dose)

Arm Type

Experimental

Arm Description

TissueGene-C (1.0 x 10^6 cells per cm^2 of the cartilage defect) combined with fibrin-glue

Arm Title

Experimental: TissueGene-C (High dose)

Arm Type

Experimental

Arm Description

TissueGene-C (3.0 x 10^6 cells per cm^2 of the cartilage defect) combined with fibrin-glue

Intervention Type

Biological

Intervention Name(s)

TissueGene-C (Low dose)

Intervention Description

TissueGene-C at 1.0 x 10^6 cells mixed with fibrin-glue

Intervention Type

Biological

Intervention Name(s)

TissueGene-C (High dose)

Intervention Description

TissueGene-C at 3.0 x 10^6 cells mixed with fibrin-glue

Primary Outcome Measure Information:

Title

Changes in IKDC Subjective Knee Evaluation

Description

Symptoms, sports activities, and function of the knee will be measured by the International Knee Documentation Committee (IKDC)

Time Frame

Week 0 and 48

Secondary Outcome Measure Information:

Title

Changes in WOMAC scores

Description

Pain, stiffness, and physical function of the knee will be measured by the Western Ontario and McMaster Universities (WOMAC)

Time Frame

Week 0, 24 and 48

Title

Changes in KOOS scores

Description

Symptoms, pain and functionality of the knee joint will be evaluated via the Knee Injury and Osteoarthritis Outcome Score (KOOS)

Time Frame

Week 0, 24 and 48

Title

Changes in 100 mm-VAS

Description

Pain of the knee will be measured by the 100mm Visual Analogue Scale (VAS)

Time Frame

Week 0, 24 and 48

Title

Comparative Evaluation of Knee Magnetic Resonance Images (MRIs)

Description

Comparison of pre-procedure MRI scans to those obtained at pre-dosing and at months 6 and 12 by an independent radiographic reviewer

Time Frame

Week 0, 24 and 48

Title

Changes in ICRS Cartilage Repair Assessment

Time Frame

week 0 and 48

Title

Changes in IKDC Subjective Knee Evaluation

Description

Symptoms, sports activities, and function of the knee will be measured by the International Knee Documentation Committee (IKDC)

Time Frame

Week 0 and 24

Title

Changes in KOOS QOL Sub-scale scores

Time Frame

Week 0, 24 and 48

Title

Proportion of Patients Use of Rescue Medication

Time Frame

Week 12, 24 and 48

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 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 Exclusion Criteria: 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 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

Overall Study Officials: