Efficacy and Safety Study of TissueGene-C to Degenerative Arthritis

NCT02072070 | Completed Phase 3 DMC

• 1 other identifier: KS-TGC-01-3
• Study Type: interventional
• Target: 163
• Locations: 1 country
• Sites: 12

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 (2)

• Changes in IKDC scores

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

  Week 0 and 52

• Changes in 100 mm VAS scores

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

  Week 0 and 52

Secondary Outcomes (8)

• Changes in WOMAC scores

  Wekk 0, 26, 39 and 52

• Changes in KOOS scores

  Week 0, 26, 39 and 52

• Changes in MRI scan

  Week 0, 26 and 52

• Changes in Joint Space Width by an independent radiographic reviewer.

  Week 0, 26 and 52

• Level of Biomarkers in blood and urine.

  Week 0, 26, 39 and 52

Study Arms (2)

TissueGene-C

EXPERIMENTAL

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

Biological: TissueGene-C

Placebo

PLACEBO COMPARATOR

Single intra-articular injection to the damaged knee joint

Drug: Placebo

Interventions

TissueGene-C BIOLOGICAL

TissueGene-C at 1.8 x 10\^7 cells

TissueGene-C

Placebo DRUG

Placebo control(Normal Saline)

Placebo

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female patients at least 19 years of age
• Patients diagnosed with degenerative arthritis
• Patients with IKDC(Knee Documentation Committee subjective score) score of 60 or below
• Patients with 100 mm VAS(Visual Analog Scale) score of 40 or above
• With Grade 3 osteoarthritis as determined by the radiographic criteria of Kellgren and Lawrence
• With an International Cartilage Repair Society(ICRS) Grade III or IV cartilage damage in the major lesions, as confirmed through an MRI scan
• With a Body Mass Index(BMI) of higher than18.5 and lower than 30
• Patients who satisfies the clinical/radiational criteria by the American College of Rheumatology (ACR) guidelines, and applies to one of the following.
• Older than 50
• Morning stiffness for less than 30 minutes
• Crepitus and Osteophytes
• 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

You may not qualify if:

• Showed clinically significant hematology, serum chemistry, and urine test results at the screening visit
• patients with a major lesion of ICRS grade 4 which is larger than 6cm2(for patient with ICRS grade 4)
• patients with a major lesion of ICRS grade 3 which is larger than 6cm2(for patient without a ICRS grade 4),
• Patient who had skin disease around target knee
• patients who have a positive skin reaction to CS-10
• Patients who had been administered with drugs such as oriental medicine, glucosamine and chondroitin within 14 days of baseline visit
• Patients taking steroidal anti-inflammatory medications within 14 days of baseline visit
• Patients with severe pain in other areas that could effect the diagnosis of the symptoms of the
• History of surgery like arthroendoscopy within the past 6 months on the target knee
• Patients who had been administered with immunosuppressants, including antirheumatic drugs (including methotrexate or antimetabolite), within the past 3 months
• Patients who had been treated with physical therapy or herbal remedy (acupuncture, heat etc.) within 2 weeks of baseline visit
• History of injection within the past 3 months on the target knee
• 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

Sponsors & Collaborators

• Kolon Life Science: lead

Study Sites (12)

Chungbuk National University Hospital

Cheongju-si, 361-711, South Korea

Location

Kyungpook National Univ. Hospital

Daegu, 700-721, South Korea

Location

Inha University Hospital

Incheon, 400-711, South Korea

Location

Chonbuk National University Hospital

Jeonju, 561-712, South Korea

Location

Inje University Seoul Paik Hospital

Seoul, 100-032, South Korea

Location

Seoul National University Hospital

Seoul, 110-744, South Korea

Location

Hanyang University Medical Center

Seoul, 133-791, South Korea

Location

Samsung Medical Center

Seoul, 135-710, South Korea

Location

The Catholic University of Korea Seoul St. Mary's Hospital

Seoul, 137-701, South Korea

Location

ASAN Medical Center

Seoul, 138-736, South Korea

Location

Ewha Womans University Mokdong Hospital

Seoul, 158-710, South Korea

Location

Ulsan University Hospital

Ulsan, 682-714, South Korea

Location

Related Publications (2)

• Chen L, Huang FL, Tang Q, Zhao ZK, Ye ZY, Liang JH. Targeted therapy for knee osteoarthritis: From basic to clinics. Medicine (Baltimore). 2025 Aug 15;104(33):e43686. doi: 10.1097/MD.0000000000043686.

  PMID: 40826764 DERIVED

• Kim MK, Ha CW, In Y, Cho SD, Choi ES, Ha JK, Lee JH, Yoo JD, Bin SI, Choi CH, Kyung HS, Lee MC. A Multicenter, Double-Blind, Phase III Clinical Trial to Evaluate the Efficacy and Safety of a Cell and Gene Therapy in Knee Osteoarthritis Patients. Hum Gene Ther Clin Dev. 2018 Mar;29(1):48-59. doi: 10.1089/humc.2017.249.

  PMID: 29641281 DERIVED

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Jin Gu Kim, MD, PhD

  Inje University

  PRINCIPAL INVESTIGATOR

• Su Hee Kyung, MD, PhD

  Kyungpook National University Hospital

  PRINCIPAL INVESTIGATOR

• Chul Won Ha, MD, PhD

  Samsung Medical Center

  PRINCIPAL INVESTIGATOR

• Myung Chul Lee, MD, PhD

  Seoul National University Hospital

  STUDY CHAIR

• Yong In, MD, PhD

  The Catholic University of Korea Seoul ST. Mary's Hospita

  PRINCIPAL INVESTIGATOR

• Seong Il Bin, MD, PhD

  Asan Medical Center

  PRINCIPAL INVESTIGATOR

• Seong Do Cho, MD, PhD

  Ulsan University Hospital

  PRINCIPAL INVESTIGATOR

• Jae Doo Yoo, MD, PhD

  Ewha Womans University Mokdong

  PRINCIPAL INVESTIGATOR

• Myung Gu Kim, MD, PhD

  Inha University Hospital

  PRINCIPAL INVESTIGATOR

• Ju Hong Lee, MD, PhD

  Chonbuk National University Hospital

  PRINCIPAL INVESTIGATOR

• Ui Seong Choi, MD, PhD

  Chungbuk National University Hospital

  PRINCIPAL INVESTIGATOR

• Chung Hyeok Choi, MD, PhD

  Hanyang University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 17, 2014
• First Posted: February 26, 2014
• Study Start: November 1, 2013
• Primary Completion: August 1, 2015
• Study Completion: August 1, 2015
• Last Updated: November 17, 2017

Record last verified: 2017-11

Locations

KR (12)