Safety Study of TissueGene-C in Degenerative Joint Disease of the Knee (TGC-03-01)

This study has been completed.
Sponsor:
Information provided by:
TissueGene, Inc.
ClinicalTrials.gov Identifier:
NCT00599248
First received: January 11, 2008
Last updated: October 13, 2010
Last verified: October 2010
  Purpose

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.


Condition Intervention Phase
Osteoarthritis, Knee
Biological: TissueGene-C
Biological: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: A Phase 1 Study to Determin the Safety and Biological Activity of Cell-Mediated Gene Therapy Using TissueGene-C in Patients With Degenerative Joint Disease Prior to Total Knee Arthroplasty

Resource links provided by NLM:


Further study details as provided by TissueGene, Inc.:

Primary Outcome Measures:
  • The incidence and severity of observations at the site of administration, the incidence and severity of adverse events assessed through 28 days after treatment and changes in clinical lab measurements [ Time Frame: Days 0, 3, 7, 11, 28, 29 and at 3, 6, 9, and 12 months following dosing ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • The evaluation of regeneration of hyaline cartilage as determined by histological analysis of resected knee tissue and observation for engraftment and cartilage production. [ Time Frame: 0, 3, 7, 11, 28 (prior to surgery), and day 29 (one day post-surgery) following dosing. Follow-up patient monitoring will be performed at 3, 6, 9, and 12 months following dosing ] [ Designated as safety issue: No ]

Estimated Enrollment: 12
Study Start Date: January 2007
Study Completion Date: May 2010
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
TissueGene-C at 3x10e6, 1x10e7 or, 3x10e7 cells/joint
Biological: TissueGene-C
TissueGene-C at 3x10e6, 1x10e7 or 3x10e7 cells/joint to be administered by intra-articular injection
Placebo Comparator: 2
Placebo control
Biological: Placebo
Placebo control (DMEM)

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
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00599248

Locations
United States, Maryland
Sinai Hospital of Baltimore
Baltimore, Maryland, United States, 21215
United States, Virginia
Commonwealth Orthopedics
Arlington, Virginia, United States, 22205
Sponsors and Collaborators
TissueGene, Inc.
Investigators
Principal Investigator: Michael Mont, MD Sinai Hospital of Baltimore
Principal Investigator: David Romness, MD Commonwealth Orthopedics, Virginia Hospital Center
  More Information

No publications provided

Responsible Party: R. Ogden Copeland/Director, Regulatory Affairs, TissueGene, Inc.
ClinicalTrials.gov Identifier: NCT00599248     History of Changes
Other Study ID Numbers: TGC-03-01
Study First Received: January 11, 2008
Last Updated: October 13, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by TissueGene, Inc.:
osteoarthritis, knee

Additional relevant MeSH terms:
Joint Diseases
Osteoarthritis
Osteoarthritis, Knee
Musculoskeletal Diseases
Arthritis
Rheumatic Diseases

ClinicalTrials.gov processed this record on August 01, 2014