Phase 1 N=12 Randomized Single-blind Treatment

Safety Study of TissueGene-C in Degenerative Joint Disease of the Knee

Osteoarthritis, Knee

Bottom Line

View on ClinicalTrials.gov: NCT00599248 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jun 2016

Primary outcome: Primary: Summary of Adverse Events — 2; 2; 3; 2 Adverse events

Study Design & Population

Study type: Interventional
Phase: Phase 1
Interventions: TissueGene-C (Biological); Placebo (Biological)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Kolon TissueGene, Inc.
Primary completion: May 2009

Outcome Measures

Outcome	Result	p-value
PRIMARY Summary of Adverse Events	2; 2; 3; 2	—
SECONDARY Number of Patients Showing Engraftment at the Defect	0; 0; 0; 0	—
SECONDARY Number of Patients With Distribution of hChonJb#7 Cells Detected Outside of the Injection Site	0; 0; 0; 0	—
SECONDARY Number of Participants With Observable Evidence of Cartilage Regeneration	0; 0; 0; 0	—
SECONDARY Number of Patients With Tissue Overgrowth or Transformation in the Knee Joint	0; 0; 0; 0	—
SECONDARY Number of Patients With Improvements in Pain and Function of the Knee Joint	3; 3; 3; 3	—

Summary

The study is being conducted to investigate the safety and activity of TissueGene-C injected into the knee joint of patients with chronic degenerative joint disease (DJD) who will be undergoing total knee replacement.

Eligibility Criteria

Inclusion Criteria

Male or Female subjects
Age 18 years and older
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.
Patients with Degenerative Joint Disease (DJD) of the knee that is refractory to existing drug therapies and who are scheduled for Total Knee Arthroplasty.
Based on Radiographic findings, defect should be more than 2 cm.
Patients providing written informed consent, after the nature of the study, are fully explained.
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 (SBP) should be between 90-160mm. Hg, and Diastolic Blood Pressure (DBP) between 50-90mm.Hg,
Osteoarthritis confirmed by the Radiographic Criteria of Kellgren and Lawrence
Symptom of pain for more than four (4) consecutive months and intensity greater than Grade 4 on the 11-point numeric scale.

Exclusion Criteria

Patients with abnormal hematology, serum chemistry, or urinalysis screening laboratory results
Patients taking anti-inflammatory medications (prescription or over-the-counter), including herbal therapies, within 14 days of baseline visit
Patients with a recent (within 1 year) history of drug abuse and/or a positive urine drug/alcohol test at the time of screening
Patients receiving injections to the treated knee within 2 months prior to study entry
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, and synovial chondromatosis.
Patients with ongoing infectious disease, including HIV and hepatitis
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.
Positive drug screen at screening visit

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00599248). 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.