Status:
COMPLETED
Study of TG-C in Patients With Grade 3 Degenerative Joint Disease of the Knee
Lead Sponsor:
Kolon TissueGene, Inc.
Conditions:
Osteoarthritis, Knee
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to see if we can safely regenerate cartilage without invasive surgery using a biologic product called TissueGene-C.
Detailed Description
Protocol TGC09201 is a multi-center, double-blind, placebo-controlled, randomized study. A total of one hundred (100) adults with grade 3 chronic degenerative joint disease (DJD) of the knee joint (as...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
May 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2014
Estimated Enrollment :
102 Patients enrolled
Trial Details
Trial ID
NCT01221441
Start Date
May 1 2011
End Date
October 1 2014
Last Update
February 15 2016
Active Locations (5)
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1
Advent Clinical Research
Pinellas Park, Florida, United States, 33781
2
Sinai Hospital of Baltimore
Baltimore, Maryland, United States, 21215
3
Rothman Institute
Philadelphia, Pennsylvania, United States, 19107
4
University Orthopedics
State College, Pennsylvania, United States, 16801