Efficacy and Safety Study of TissueGene-C to Degenerative Arthritis

NCT ID: NCT02341378

Last Updated: 2015-01-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-08-31
• Study Completion Date: 2010-10-31

Brief Summary

To assess the efficacy and safety of the intra-articular injection of TissueGene-C in patients with degenerative arthritis of the knee

Detailed Description

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

During the clinical trial Phase 2A, we compare low dose or high dose TissueGene-C in 6 months trial with 28 outpatients who have degenerative arthritis. The patients are randomized to two dose levels of TisssueGene-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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

TissueGene-C (Low dose)

Single intra-articular injection to the damaged knee joint at a dose of 6.0 x 10\^6 cells

Group Type: EXPERIMENTAL

TissueGene-C(Low dose)

Intervention Type: BIOLOGICAL

TissueGene-C at 6.0x10\^6 cells

TissueGene-C (High dose)

Single intra-articular injection to the damaged knee joint at a dose of 1.8 x 10\^7 cells

Group Type: EXPERIMENTAL

TissueGene-C(High dose)

Intervention Type: BIOLOGICAL

TissueGene-C at 1.8x10\^7 cells

Interventions

TissueGene-C(Low dose)

TissueGene-C at 6.0x10\^6 cells

Intervention Type: BIOLOGICAL

TissueGene-C(High dose)

TissueGene-C at 1.8x10\^7 cells

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

1. Male or female, aged 45 years or more

2. With grade 4 degenerative arthritis of the knee [based on the International Cartilage Repair Society(ICRS) evaluation criteria from the MRI results]

3. With less than 6 cm2major lesions

4. With major lesions (grade 4) concentrated in only one section of the knee and considered the main cause of the clinical symptoms

5. Unresponsive to conventional symptomatic treatment

6. Healthy and with no major physical examination, hematology, serum chemistry, and urine test findings and no significant medical history

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

8. Voluntarily agreed to participate in this study and signed the Informed Consent Form

Exclusion Criteria

1. Abnormal screening laboratory test (hematology, serum, and urine test) findings

2. Took anti-inflammatory medications (prescribed or over-the-counter), including natural medicines, within 14 days before the injection of the investigational product

3. Took antirheumatic drugs (e.g., methotrexate or antimetabolites) within three months before enrollment in this study

4. Has a history of drug abuse within one year from the enrolment, or has positive results in the urine drug test or serum alcohol test at the screening visit

5. Received an injection in the target knee within two months before enrollment in this study

6. Pregnant or breastfeeding female

7. 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, and synovial chondromas)

8. With a current infectious disease, including HIV or hepatitis

9. Has 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

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

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

• Minimum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kolon Life Science

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Chul-won Ha, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Samsung Medical Center

Myung-chul Lee, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Hospital

Locations

Samsung Medical Center

Gangnam-gu, Seoul, South Korea

Seoul National Univ. Hospital

Seoul, , South Korea

Asan Medical Center

Seoul, , South Korea

Countries

South Korea

References

Ha CW, Cho JJ, Elmallah RK, Cherian JJ, Kim TW, Lee MC, Mont MA. A Multicenter, Single-Blind, Phase IIa Clinical Trial to Evaluate the Efficacy and Safety of a Cell-Mediated Gene Therapy in Degenerative Knee Arthritis Patients. Hum Gene Ther Clin Dev. 2015 Jun;26(2):125-30. doi: 10.1089/humc.2014.145. Epub 2015 Apr 17.

Reference Type: DERIVED

PMID: 25760423 (View on PubMed)

Other Identifiers

TCG-K1-02

Identifier Type: -

Identifier Source: org_study_id