A Study to Determine the Safety and Efficacy of TG-C in Subjects with Symptomatic Early Hip Osteoarthritis

NCT05276011 | Not Yet Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: TGC-OAH-201
• Study Type: interventional
• Target: 255
• Locations: 0 countries
• Sites: N/A

Brief Summary

A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study to Determine the Efficacy, Safety, and Dosing of TG-C in Adult Subjects with Symptomatic Early Hip Osteoarthritis. TG-C will be administered to the target hip by a single ultrasound (or fluoroscopy)-guided, intra-articular injection with image capture showing correct injection of study drug into the femoroacetabular joint. Patients will be followed for 12 months for safety and efficacy.

Conditions

Degenerative Osteoarthritis

Keywords

hip

Outcome Measures

Primary Outcomes (1)

• Change in Hip Pain as Assessed by VAS

  Assessment of change from baseline in target hip pain using the Visual Analog Scale (VAS). The VAS is a method for the assessment of the intensity of pain. The VAS is a horizontal line, 100 mm in length and anchored by word descriptors at each end (no pain, very severe pain). The patient marks on the line at the point that represents their current state. The VAS score is determined by measuring in millimeters from the left hand end to the point of the mark. The score ranges from "0" or no pain to "100" very severe pain.

  Baseline to Month 12

Secondary Outcomes (5)

• Hip Disability and Osteoarthritis Outcome Score (HOOS)

  Baseline to Month 12

• Timed Up and Go Test (TUG)

  Baseline to Months 1, 3, 6, 9, and 12

• UCLA Activity Score

  Baseline to Months 1, 3, 6, 9, and 12

• Joint Space Width (JSW) on standing X-ray

  Baseline to Month 12

• WOMAC® (Western Ontario and McMaster Universities Osteoarthritis Index) total score

  Baseline to Month 12

Other Outcomes (5)

• Physical Component Score (PCS) of the Short Form 12-Item Health Survey (SF-12 Questionnaire)

  12 months

• Clinician Global Impression of Change (CGI-C)

  Week 1 and Months 1, 3, 6, 9, and 12

• Clinician Global Impression of Severity (CGI-S)

  Baseline and at Months 1, 3, 6, 9, and 12

Study Arms (3)

Active Treatment (TG-C)

ACTIVE COMPARATOR

TG-C at 1.0 x 10e7 cells per single 2 mL intraarticular injection

Biological: TG-C

Active Treatment 2 (TG-C)

ACTIVE COMPARATOR

TG-C at 3.0 x 10e6 cells per single 2 mL intraarticular injection

Biological: TG-C

Placebo Control (Normal Saline)

PLACEBO COMPARATOR

Normal saline, single 2 mL intraarticular injection

Biological: Placebo Control

Interventions

TG-C BIOLOGICAL

2 mL injection of non-transduced human chondrocytes and irradiated transduced human GP2-293 cells expressing TGF-B1.

Also known as: TissueGene-C

Active Treatment (TG-C); Active Treatment 2 (TG-C)

Placebo Control BIOLOGICAL

2 mL normal saline injection

Also known as: Normal Saline

Placebo Control (Normal Saline)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 18 to 80 years old
• The subject has a diagnosis of Grade ≤2 primary OA of the target hip
• Pain ≥ 40 on VAS scale
• The subject has groin pain that is elicited by hip rotation on physical examination
• No history of significant organ system disorders.
• Body mass index (BMI) \<40 kg/m2
• Systolic blood pressure of 100 to 160 mmHg and diastolic blood pressure of 60 to 90 mmHg.
• Using birth control
• Written informed consent

You may not qualify if:

• The subject exhibits severe symptoms in the target hip that result in difficulty or an inability to walk.
• The subject has severe hip OA ipsilateral to the target hip.
• Previous cartilage transplantation procedure to the injured cartilage surface.
• Major injury to the target hip within 12 months of screening.
• Active dermal ulcer or infection in the proximity of the target hip within 1 month before screening.
• The subject has had surgery on the target hip within the last 6 months.
• Total hip replacement surgery or other surgery on the target hip in the next 12 months.
• MRI indicates bone marrow infiltration, fracture, osteonecrosis/bone infarct, osteochondritis dissecans, tumor, moderate to severe dysplasia, avascular necrosis, post-traumatic arthritis, transient osteoporosis, slipped-cap femoral epiphysis, juvenile idiopathic arthritis, or axial juvenile spondyloarthritis.
• Hip conditions including but not limited to any autoimmune or infectious cause for arthritis; metabolic joint disease; neuropathic disorders, groin pain from non-orthopedic sources, or tumors, congestive heart failure, or chronic kidney disease.
• Uncontrolled diabetes based on a hemoglobin A1c (HbA1c) value \>8% at the screening Visit.
• Increased risk for post-procedure bleeding or post-procedure infection.
• Ongoing infectious disease, including, but not limited to, HIV, hepatitis C, or current or prior hepatitis B.
• Cognitive impairment that would limit his/her ability to provide informed consent or to complete assessments and questionnaires.
• year history of drug or alcohol abuse.
• Contraindication to or cannot undergo MRI.

Sponsors & Collaborators

• Kolon TissueGene, Inc.: lead

MeSH Terms

Conditions

Joint Diseases

Interventions

Saline Solution

Condition Hierarchy (Ancestors)

Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Moon Jong Noh, PhD

  Kolon TissueGene, Inc.

  STUDY CHAIR

Central Study Contacts

Diana Halim, MS

CONTACT

(301) 921-6000; dhalim@tissuegene.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double-blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 2, 2022
• First Posted: March 11, 2022
• Study Start: October 1, 2025
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: December 11, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share