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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00599248
Recruitment Status : Completed
First Posted : January 23, 2008
Results First Posted : June 30, 2016
Last Update Posted : July 7, 2017
Sponsor:
Information provided by (Responsible Party):
Kolon TissueGene, Inc.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Osteoarthritis, Knee Biological: TissueGene-C Biological: Placebo Phase 1

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
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: A Phase 1 Study to Determine the Safety and Biological Activity of Cell-Mediated Gene Therapy Using TissueGene-C in Patients With Degenerative Joint Disease Prior to Total Knee Arthroplasty
Study Start Date : January 2007
Actual Primary Completion Date : May 2009
Actual Study Completion Date : May 2010

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: 1
TissueGene-C single intraarticular injection of 3x10e6 cells/joint
 Biological: TissueGene-C
TissueGene-C at 3x10e6, 1x10e7 or 3x10e7 cells/joint to be administered by intra-articular injection
Experimental: 2
TissueGene-C single intraarticular injection of 1x10e7 cells/joint
 Biological: TissueGene-C
TissueGene-C at 3x10e6, 1x10e7 or 3x10e7 cells/joint to be administered by intra-articular injection
Experimental: 3
TissueGene-C single intraarticular injection of 3x10e7 cells/joint
 Biological: TissueGene-C
TissueGene-C at 3x10e6, 1x10e7 or 3x10e7 cells/joint to be administered by intra-articular injection
Placebo Comparator: 4
Placebo control single intraarticular injection
 Biological: Placebo
Placebo control (DMEM)


Outcome Measures
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Primary Outcome Measures :
  1. Summary of Adverse Events [ Time Frame: Through 28 days post-dosing ]
    The incidence of observations at the site of administration and the incidence adverse events assessed through 28 days after treatment.


Secondary Outcome Measures :
  1. Number of Patients Showing Engraftment at the Defect [ Time Frame: 28 Days ]
    Dose Response of the TG-C in Engrafting at the Defect as Compared to Placebo Control

  2. Number of Patients With Distribution of hChonJb#7 Cells Detected Outside of the Injection Site [ Time Frame: 12 Months ]
    Number of Patients with Distribution of hChonJb#7 Cells Detected Outside of the Injection Site as determined by PCR analysis for vector DNA.

  3. Number of Participants With Observable Evidence of Cartilage Regeneration [ Time Frame: Days 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 ]
    The evaluation of regeneration of hyaline cartilage as determined by histological analysis of resected knee tissue and observation for engraftment and cartilage production.

  4. Number of Patients With Tissue Overgrowth or Transformation in the Knee Joint [ Time Frame: 29 ]
    Visual and histological analysis of knee joint tissues to determine the number of patients with tissue overgrowth or transformation

  5. Number of Patients With Improvements in Pain and Function of the Knee Joint [ Time Frame: 28 Days ]
    Assessment of the number of patients with improvement in pain and function of the knee joint


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00599248


Locations
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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
Kolon TissueGene, Inc.
Investigators
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Principal Investigator: Michael Mont, MD Sinai Hospital of Baltimore
Principal Investigator: David Romness, MD Commonwealth Orthopedics, Virginia Hospital Center
More Information
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Responsible Party: Kolon TissueGene, Inc.
ClinicalTrials.gov Identifier: NCT00599248    
Other Study ID Numbers: TGC-03-01
First Posted: January 23, 2008    Key Record Dates
Results First Posted: June 30, 2016
Last Update Posted: July 7, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Kolon TissueGene, Inc.:
osteoarthritis, knee
Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Joint Diseases
 Arthritis
Musculoskeletal Diseases
Rheumatic Diseases