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

NCT ID: NCT00599248

Last Updated: 2017-07-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-01-31
• Study Completion Date: 2010-05-31

Brief 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.

Detailed Description

The purpose of this first human study is to investigate the safety and biological activity of intra-articularly applied TissueGene-C in patients with chronic degenerative joint disease (DJD) who will be undergoing total knee replacement. In addition, data on joint pain, range of motion, and functionality will be obtained in this patient population prior to total knee replacement.

The primary objective of this study is to evaluate the safety and biological activity of intra-articularly administered TissueGene-C as evidenced by observation of the injection site for irritation or other abnormalities affecting the incidence and severity of adverse events, and the changes in physical examination findings and laboratory tests as compared to the placebo control.

The secondary objectives of this study are to:

1. Evaluate the dose response of the hChonJb#7 cells in grafting at the defect as compared to the placebo control.

2. Evaluate distribution of hChonJb#7 cells out of the injection site.

3. Evaluate the regeneration of hyaline cartilage as determined by the histological analysis of the resected knee tissue.

4. Evaluate the joint for evidence of tissue overgrowth or transformation.

5. Evaluate the biological activity of TissueGene-C on joint pain, range of motion and functionality as compared to the placebo control

Conditions

Osteoarthritis, Knee

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

1

TissueGene-C single intraarticular injection of 3x10e6 cells/joint

Group Type: EXPERIMENTAL

TissueGene-C

Intervention Type: BIOLOGICAL

TissueGene-C at 3x10e6, 1x10e7 or 3x10e7 cells/joint to be administered by intra-articular injection

2

TissueGene-C single intraarticular injection of 1x10e7 cells/joint

Group Type: EXPERIMENTAL

TissueGene-C

Intervention Type: BIOLOGICAL

TissueGene-C at 3x10e6, 1x10e7 or 3x10e7 cells/joint to be administered by intra-articular injection

3

TissueGene-C single intraarticular injection of 3x10e7 cells/joint

Group Type: EXPERIMENTAL

TissueGene-C

Intervention Type: BIOLOGICAL

TissueGene-C at 3x10e6, 1x10e7 or 3x10e7 cells/joint to be administered by intra-articular injection

4

Placebo control single intraarticular injection

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: BIOLOGICAL

Placebo control (DMEM)

Interventions

TissueGene-C

TissueGene-C at 3x10e6, 1x10e7 or 3x10e7 cells/joint to be administered by intra-articular injection

Intervention Type: BIOLOGICAL

Placebo

Placebo control (DMEM)

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

1. Male or Female subjects

2. Age 18 years and older

3. 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.

4. Patients with Degenerative Joint Disease (DJD) of the knee that is refractory to existing drug therapies and who are scheduled for Total Knee Arthroplasty.

5. Based on Radiographic findings, defect should be more than 2 cm.

6. Patients providing written informed consent, after the nature of the study, are fully explained.

7. Body Mass Index (BMI) should be between '18.5 - 45.5'. The applied scale is the same for both men and women.

8. Blood Pressure measurements - Systolic Blood Pressure (SBP) should be between 90-160mm. Hg, and Diastolic Blood Pressure (DBP) between 50-90mm.Hg,

9. Osteoarthritis confirmed by the Radiographic Criteria of Kellgren and Lawrence

10. Symptom of pain for more than four (4) consecutive months and intensity greater than Grade 4 on the 11-point numeric scale.

Exclusion Criteria

1. Patients with abnormal hematology, serum chemistry, or urinalysis screening laboratory results

2. Patients taking anti-inflammatory medications (prescription or over-the-counter), including herbal therapies, within 14 days of baseline visit

3. Patients with a recent (within 1 year) history of drug abuse and/or a positive urine drug/alcohol test at the time of screening

4. Patients receiving injections to the treated knee within 2 months prior to study entry

5. Patients who are pregnant or currently breast-feeding children

6. 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.

7. Patients with ongoing infectious disease, including HIV and hepatitis

8. Patients with clinically significant cardiovascular, renal, hepatic, endocrine disease, cancer, or Type I diabetes

9. Patients participating in a study of an experimental drug or medical device within 30 days of study entry.

10. Positive drug screen at screening visit

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kolon TissueGene, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michael Mont, MD

Role: PRINCIPAL_INVESTIGATOR

Sinai Hospital of Baltimore

David Romness, MD

Role: PRINCIPAL_INVESTIGATOR

Commonwealth Orthopedics, Virginia Hospital Center

Locations

Sinai Hospital of Baltimore

Baltimore, Maryland, United States

Commonwealth Orthopedics

Arlington, Virginia, United States

Countries

United States

Other Identifiers

TGC-03-01

Identifier Type: -

Identifier Source: org_study_id