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Safety and Biological Efficacy Study of TisssueGene-C to Degenerative Arthritis

Primary Purpose

Degenerative Arthritis

Status

Completed

Phase

Phase 1

Locations

Korea, Republic of

Study Type

Interventional

Intervention

TissueGene-C(Low dose)

TissueGene-C(Medium dose)

TissueGene-C(High dose)

About this trial

This is an interventional treatment trial for Degenerative Arthritis focused on measuring chondrocyte cells, Osteoarthritis, gene therapy

Eligibility Criteria

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

Inclusion Criteria:

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

Exclusion Criteria:

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)
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)

Sites / Locations

Samsung Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

TissueGene-C(Low dose)

TissueGene-C(Medium dose)

TissueGene-C(High dose)

Arm Description

Single intra-articular injection to the damaged knee joint at doses of 3.0 x 10^6 cells

Single intra-articular injection to the damaged knee joint at doses of 1.0 x 10^7 cells

Single intra-articular injection to the damaged knee joint at doses of 3.0 x 10^7 cells

Outcomes

Primary Outcome Measures

Number of Participants with Adverse Events after the administration of TissueGene-C

Secondary Outcome Measures

Changes in MRI scan

Change in the MRI scan results after the administration of TissueGene-C

Change in the Knee Society Clinical Rating System(KSCRS) test results

Comparative Evaluation of knee exam

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 100 mm-VAS

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

Analysis of the TGF-β1 expression using Enzyme-linked Immunosorbent Assay(ELISA) and Polymerase Chain Reaction(PCR)

Replication-competent retrovirus test (RCR test)

Full Information

NCT ID

NCT02341391

First Posted

January 8, 2015

Last Updated

July 2, 2018

Sponsor

Kolon Life Science

1. Study Identification

Unique Protocol Identification Number

NCT02341391

Brief Title

Safety and Biological Efficacy Study of TisssueGene-C to Degenerative Arthritis

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.

Study Type

Interventional

2. Study Status

Record Verification Date

July 2018

Overall Recruitment Status

Completed

Study Start Date

February 2007 (undefined)

Primary Completion Date

August 2008 (Actual)

Study Completion Date

September 2008 (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 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.

6. Conditions and Keywords

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

Degenerative Arthritis

Keywords

chondrocyte cells, Osteoarthritis, gene therapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

12 (Actual)

8. Arms, Groups, and Interventions

Arm Title

TissueGene-C(Low dose)

Arm Type

Experimental

Arm Description

Single intra-articular injection to the damaged knee joint at doses of 3.0 x 10^6 cells

Arm Title

TissueGene-C(Medium dose)

Arm Type

Experimental

Arm Description

Single intra-articular injection to the damaged knee joint at doses of 1.0 x 10^7 cells

Arm Title

TissueGene-C(High dose)

Arm Type

Experimental

Arm Description

Single intra-articular injection to the damaged knee joint at doses of 3.0 x 10^7 cells

Intervention Type

Biological

Intervention Name(s)

TissueGene-C(Low dose)

Intervention Description

3.0 x 10^6 cells

Intervention Type

Biological

Intervention Name(s)

TissueGene-C(Medium dose)

Intervention Description

1.0 x 10^7 cells

Intervention Type

Biological

Intervention Name(s)

TissueGene-C(High dose)

Intervention Description

3.0 x 10^7 cells

Primary Outcome Measure Information:

Title

Number of Participants with Adverse Events after the administration of TissueGene-C

Description

Number of Participants with Adverse Events after the administration of TissueGene-C

Time Frame

6 months

Secondary Outcome Measure Information:

Title

Changes in MRI scan

Description

Change in the MRI scan results after the administration of TissueGene-C

Time Frame

before and 28 days, 3 months, and 6 months

Title

Change in the Knee Society Clinical Rating System(KSCRS) test results

Description

Comparative Evaluation of knee exam

Time Frame