Efficacy and Safety Study of TissueGene-C to Degenerative Arthritis

NCT01671072 | Completed Phase 2 DMC

• 1 other identifier: KS-TGC-01-2B
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 3

Brief Summary

The purpose of this study is to determine whether TissueGene-C, an allogeneic human chondrocytes expressing Transforming Growth Factor(TGF)-b1, is effective and safe in patients with degenerative arthritis

Conditions

Degenerative Arthritis

Keywords

Chondrocyte cells; Osteoarthritis; Gene therapy

Outcome Measures

Primary Outcomes (1)

• Changes in IKDC Subjective Score.

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

  Week 0 and 24

Secondary Outcomes (5)

• Changes in WOMAC scores.

  Week 0 and 24

• Changes in KOOS scores.

  Week 0 and 24

• Changes in 100 mm-VAS.

  Week 0 and 24

• MRI scan

  Week 0 and 24

• Proportion of Patients Use of Rescue Medication

  Week 4, 12 and 24

Study Arms (2)

TissueGene-C

EXPERIMENTAL

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

Biological: TissueGene-C

Normal Saline

PLACEBO COMPARATOR

Single intra-articular injection to the damaged knee joint at the same volume

Drug: Normal Saline

Interventions

TissueGene-C BIOLOGICAL

TissueGene-C at 1.8 x 10\^7 cells

TissueGene-C

Normal Saline DRUG

Sodium chloride 0.9%, 3.5ml

Normal Saline

Eligibility Criteria

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

You may qualify if:

• 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 Grade 2 or 3 osteoarthritis as determined by the radiographic criteria of Kellgren and Lawrence
• With a Body Mass Index(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 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

You may not qualify if:

• Showed clinically significant hematology, serum chemistry, and urine test results at the screening visit
• Took glucosamine, chondroitin, or any natural medicine within 14 days before the injection of the investigational product (but if the 14-day washout period had elapsed, the patient can be enrolled in this study)
• Has taken anti-inflammatory drugs (prescribed or over-the-counter) within 14 days before the injection of the investigational product (but if the 14-day washout period had elapsed, the patient can be enrolled in this study)
• Has taken immunosuppressive agents, including antirheumatic drugs (e.g., methotrexate or antimetabolites) within 3 months before enrollment in this study
• With a history of drug abuse within one year prior to enrollment in this study, or showed positive results in the urine drug test or the serum alcohol test at the screening visit
• Received an injection in the target knee within two months before enrollment in this 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 tibia, ochronosis, hemophilic arthropathy, infectious arthritis, Charcot's disease in the knee joint, villonodular synovitis, synovial chondromas)
• With an infectious disease, including HIV or hepatitis
• With any of the following clinically significant diseases:
• heart disease \[e.g., myocardial infarction, arrhythmia, other serious heart diseases, coronary artery bypass graft (CABG)\]
• 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

Sponsors & Collaborators

• Kolon Life Science: lead

Study Sites (3)

Samsung Medical Center

Gangnam-gu, Seoul, 135-710, South Korea

Location

Seoul National Univ. Hospital

Seoul, 110-744, South Korea

Location

Asan Medical Center

Seoul, 138-736, South Korea

Location

MeSH Terms

Conditions

Osteoarthritis

Interventions

Saline Solution

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Chul Won Ha, MD, PhD

  Samsung Medical Center

  PRINCIPAL INVESTIGATOR

• Seong Il Bin, MD, PhD

  Asan Medical Center

  PRINCIPAL INVESTIGATOR

• Myung Chul Lee, MD, PhD

  Seoul National Univ. Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 20, 2012
• First Posted: August 23, 2012
• Study Start: July 1, 2011
• Primary Completion: October 1, 2012
• Study Completion: January 1, 2013
• Last Updated: January 22, 2015

Record last verified: 2015-01

Locations

KR (3)