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

NCT03203330

Active Not RecruitingPhase 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 safety and efficacy 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 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 (44)

Birmingham, Alabama, United States
Birmingham, Alabama, United States
Phoenix, Arizona, United States
Tucson, Arizona, United States
Apple Valley, California, United States
Covina, California, United States
La Mesa, California, United States
Napa, California, United States
San Diego, California, United States
Santa Monica, California, United States
Whittier, California, United States
Washington D.C., District of Columbia, United States
Daytona Beach, Florida, United States
Miami, Florida, United States
Miami, Florida, United States
Miami, Florida, United States
New Port Richey, Florida, United States
Oldsmar, Florida, United States
Sunrise, Florida, United States
Winter Park, Florida, United States
Newnan, Georgia, United States
Chicago, Illinois, United States
Chicago, Illinois, United States
Oak Brook, Illinois, United States
Marrero, Louisiana, United States
Baltimore, Maryland, United States
Lincoln, Nebraska, United States
New York, New York, United States
Durham, North Carolina, United States
Wilmington, North Carolina, United States
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