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

NCT02341391 | Completed Phase 1 DMC

• 1 other identifier: TGC-KI-01
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Degenerative Arthritis

Keywords

chondrocyte cells; Osteoarthritis; gene therapy

Outcome Measures

Primary Outcomes (1)

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

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

  6 months

Secondary Outcomes (6)

• Changes in MRI scan

  before and 28 days, 3 months, and 6 months

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

  before and 7 days, 14 days, 21 days, 28 days, 3 months, and 6 months

• Changes in WOMAC scores

  before and 7 days, 14 days, 21 days, 28 days, 3 months, and 6 months

• Changes in 100 mm-VAS

  before and 7 days, 14 days, 21 days, 28 days, 3 months, and 6 months

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

  before and 7 days, 14 days, 21 days, 28 days, 3 months, and 6 months

Study Arms (3)

TissueGene-C(Low dose)

EXPERIMENTAL

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

Biological: TissueGene-C(Low dose)

TissueGene-C(Medium dose)

EXPERIMENTAL

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

Biological: TissueGene-C(Medium dose)

TissueGene-C(High dose)

EXPERIMENTAL

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

Biological: TissueGene-C(High dose)

Interventions

TissueGene-C(Low dose) BIOLOGICAL

3.0 x 10\^6 cells

TissueGene-C(Low dose)

TissueGene-C(Medium dose) BIOLOGICAL

1.0 x 10\^7 cells

TissueGene-C(Medium dose)

TissueGene-C(High dose) BIOLOGICAL

3.0 x 10\^7 cells

TissueGene-C(High dose)

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kolon Life Science: lead

Study Sites (1)

Samsung Medical Center

Seoul, 135-710, South Korea

Location

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Chul Won Ha, MD, PhD

  Samsung Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 8, 2015
• First Posted: January 19, 2015
• Study Start: February 1, 2007
• Primary Completion: August 1, 2008
• Study Completion: September 1, 2008
• Last Updated: July 5, 2018

Record last verified: 2018-07

Locations

KR (1)