Phase 2
N=102
Study of TG-C in Patients With Grade 3 Degenerative Joint Disease of the Knee
Osteoarthritis, Knee
Bottom Line
View on ClinicalTrials.gov: NCT01221441 ↗Enrolled (actual)
102
Serious AEs
10.8%
Results posted
Feb 2016
Primary outcome: Primary: Change From Baseline in the International Knee Documentation Committee (IKDC) Subjective Knee Evaluation Score at 1 Year — 23.3; 9.9 scores on a scale — p=<0.01
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- TissueGene-C (Biological); Normal Saline (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Kolon TissueGene, Inc.
- Primary completion
- Oct 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in the International Knee Documentation Committee (IKDC) Subjective Knee Evaluation Score at 1 Year |
23.3; 9.9 | <0.01 sig |
| PRIMARY Change From Baseline in Visual Analog Scale (VAS) Score at 1 Year |
-39.7; -24.3 | <0.01 sig |
| SECONDARY Change From Baseline in Knee Injury and Osteoarthritis Outcome Score (KOOS) at 2 Years |
10.0; 10.5 | <0.01 sig |
| SECONDARY Change From Baseline in Articular Cartilage Damage in the Knee as Determined by the Lysholm Knee Score at 2 Years |
20.1; 11.4 | <0.01 sig |
| SECONDARY Comparative Evaluation of Knee Magnetic Resonance Images (MRIs) From Baseline to 1 Year |
0.03; -0.49 | — |
| SECONDARY Change in Pain Severity From Baseline to 2 Years as Assessed by Questionnaire |
-0.87; -0.30 | — |
| SECONDARY Number of Participants With Change in Pain Severity Measured by Incidence and Dose of Analgesia |
37; 20 | — |
| SECONDARY Change From Baseline in Knee Function as Determined by the Lower Extremity Functional Scale at 2 Years |
16.7; 13.8 | — |
| SECONDARY The Incidence of Total Knee Arthroplasty |
1; 1 | — |
| SECONDARY The Number of Patients Experiencing Injection Site Reactions Related to Treatment |
35; 5 | — |
| SECONDARY The Incidence and Severity of Adverse Events in Treated Patients |
12; 7; 41; 18; 8; 4 | — |
| SECONDARY Number of Participants With Adverse Events Due to Clinically Significant Changes in Hematology and Urinalysis Tests |
17; 5 | — |
| SECONDARY Change in SF-36 General Health Assessment Questionnaire (Overall Score) From Baseline to 2 Years |
7.6; 6.7 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT01221441). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.