Study of TG-C in Patients With Grade 3 Degenerative Joint Disease of the Knee

Completed · Phase 2 · Has a placebo group

Conditions studied: Osteoarthritis, Knee

In brief

The purpose of this study is to see if we can safely regenerate cartilage without invasive surgery using a biologic product called TissueGene-C.

Key facts

Study ID

NCT01221441

Run by

Kolon TissueGene, Inc.

People needed

102

Starts

2011-05-01

Expected to finish

2014-10-01

Last updated by the study team

2016-02-15

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or Female subject
• Age 18 to 70 years
• In general good health as evidenced by physical examination, normal hematology, serum chemistry, and urinalysis screening laboratory results, and a negative history of significant organ system disorders. All laboratory values must be within 20% of normal ranges.
• Body Mass Index (BMI) should be between '18.5 - 45.5'. The applied scale is the same for both men and women.
• Blood Pressure measurements - Systolic Blood Pressure should be between 90-160mm. Hg, and Diastolic Blood Pressure between 50-90mm.Hg,
• Patients with Grade 3 chronic osteoarthritis of the knee as determined by the Radiographic Criteria of Kellgren and Lawrence.
• Symptom of pain for more than four (4) consecutive months and intensity of ≥ 40 and ≤ 90 on the 100-mm scale.
• Patients should be cleared to use protocol specified equipment: 3T MRI.
• Patients providing written informed consent after the nature of the study is fully explained and understood by the patient.

You may not qualify if…

• Age 71 or older
• Patients with abnormal hematology, serum chemistry, or urinalysis screening laboratory results.
• Patients taking non-steroidal anti-inflammatory medications within 14 days of baseline visit unless washed out as per section 3.6.4 above.
• Patients taking steroidal anti-inflammatory medications within 2 months of baseline visit.
• Patients with a recent (within 1 year) history of drug abuse and/or a positive urine drug test at the time of screening.
• Patients receiving injections to the treated knee within 2 months prior to study entry
• Patients who are contraindicated for 3T MRI.
• Patients who are pregnant or currently breast-feeding children.
• Patients with systemic, rheumatic or inflammatory disease of the knee or chondrocalcinosis, hemochromatosis, inflammatory arthritis, necrosis of the femoral condyle, arthropathy of the knee associated with juxta-articular Paget's disease of the femur or tibia, ochronosis, hemophilic arthropathy, infectious arthritis, Charcot's knee joint, villonodular synovitis, synovial chondromatosis, and/or history of inflammatory arthropathy.
• Patients with ongoing infectious disease, including HIV and hepatitis B or C.
• Patients with clinically significant cardiovascular, renal, hepatic, endocrine disease, cancer, or Type I diabetes.
• Patients participating in a study of an experimental drug or medical device within 30 days of study entry.
• Patients that will be unable to comply with the requisite study follow-up and are not able to complete all of the follow-up office visits and 3T MRI exams.

Where it is running

• Advent Clinical Research — Pinellas Park, Florida, United States
• Sinai Hospital of Baltimore — Baltimore, Maryland, United States
• Rothman Institute — Philadelphia, Pennsylvania, United States
• University Orthopedics — State College, Pennsylvania, United States
• Commonwealth Orthopedics — Arlington, Virginia, United States

Full record on ClinicalTrials.gov

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