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Study to Determine the Efficacy and Safety of TG-C in Subjects With Kellgren/Lawrence Grade 2 or 3 OA of the Knee
Study to Determine the Efficacy and Safety of TG-C in Subjects With Kellgren/Lawrence Grade 2 or 3 OA of the Knee

NCT03291470

CompletedPhase 3

Sponsor: Kolon TissueGene, Inc.

Conditions: Degenerative Osteoarthritis

Interventions: TG-C, Placebo Control

Countries: United States

A randomized, double-blind, placebo-controlled, multi-center, phase 3 study to determine the efficacy and safety of TG-C in subjects with Kellgren and Lawrence Grade 2 or 3 Osteoarthritis of the Knee, Osteoarthritis Research Society International (OARSI) medial joint space narrowing (JSN) Grade 1 or 2 of the knee joint. TG-C is to be administered by a single intra-articular injection to the damaged joint area via ultrasound guidance. Patients will be followed for 24 months for safety and efficacy.

Eligibility overview

Sex: ALL

Age: 40 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
Inclusion Criteria:

* Aged 40 or older
* BMI between 18.5 and 40
* KL Grade 2 or 3 knee OA
* OARSI Grade 1 or 2 medial JSN
* Pain \>= 40 on VAS scale
* Written informed consent
* Using birth control

Exclusion Criteria:

* Knee symptoms that result in difficulty or inability to walk
* Knee effusion \>2+
* Has Grade 3 OARSI JSN
* Has a score of 0 or \>=5 on the cartilage feature of the WORMS at Screening
* MRI exam indicates fracture or tumor
* Has a positive result on RCR testing at screening
* Has taken NSAIDS with 14 days of baseline
* Has taken steroidal anti-inflammatory or biologic therapy medication within 2 months of baseline
* Chronic (\>21 days) narcotic use
* Recent history (within 1 year) of drug or alcohol abuse
* Pregnant or lactating
* Has received injection to target knee within 2 months prior to study entry
* History of various disorders of the knee including but not limited to rheumatoid arthritis, psoriatic arthritis, autoimmune disorder, chondrocalcinosis, gout, hemochromatosis, villonodular synovitis, or synovial chondromatosis
* Severe hip osteoarthritis ipsilateral to the target knee
* Ongoing infectious disease including but not limited to HIV, HTLV-1, VSV-G, HBV, or HCV.
* Clinically significant congestive heart failure, hepatic disease, kidney disease, adrenal insufficiency, acromegaly, uncontrolled hyper- or hypothyroidism, or non-specified uncontrolled endocrine disorder.
* Uncontrolled diabetes based on a HbA1c \> 8% at screening.
* Documented active malignancy within the last 5 years except for basal cell carcinoma, squamous cell carcinoma, and benign pigmented nevi.
Locations (27)
  • Tucson, Arizona, United States
  • Anaheim, California, United States
  • Beverly Hills, California, United States
  • Covina, California, United States
  • Huntington Beach, California, United States
  • La Mesa, California, United States
  • San Diego, California, United States
  • Clearwater, Florida, United States
  • Doral, Florida, United States
  • West Palm Beach, Florida, United States
  • Boise, Idaho, United States
  • Chicago, Illinois, United States
  • Rochester Hills, Michigan, United States
  • St Louis, Missouri, United States
  • Las Vegas, Nevada, United States
  • Brooklyn, New York, United States
  • New York, New York, United States
  • Durham, North Carolina, United States
  • Wilmington, North Carolina, United States
  • Dayton, Ohio, United States
  • Charleston, South Carolina, United States
  • Dallas, Texas, United States
  • Lewisville, Texas, United States
  • Red Oak, Texas, United States
  • San Antonio, Texas, United States
  • San Antonio, Texas, United States
  • Spokane, Washington, United States