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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00599248
First Posted: January 23, 2008
Last Update Posted: July 7, 2017
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.
Information provided by (Responsible Party):
TissueGene, Inc.
Results First Submitted: May 23, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Participant);   Primary Purpose: Treatment
Condition: Osteoarthritis, Knee
Interventions: Biological: TissueGene-C
Biological: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Enrollment and assignment of patients in Arms 2 and 3 (dose escalation to sequentially higher doses) was only performed after completion of review of safety data in the previous Arm (lower dose) by the Independent Data Monitoring Committee

Reporting Groups
  Description
Active Treatment (TG-C) 1

TissueGene-C at 3x10e6 cells/joint

TissueGene-C: TissueGene-C at 3x10e6 cells/joint administered by single intra-articular injection

Active Treatment (TG-C) 2

TissueGene-C at 1 x 10e7 cells/joint

TissueGene-C: TissueGene-C at 1x10e7 cells/joint administered by single intra-articular injection

Active Treatment (TG-C) 3

TissueGene-C at 3x10e7 cells/joint

TissueGene-C: TissueGene-C at 3x10e7 cells/joint administered by single intra-articular injection

Placebo Control (DMEM)

Placebo Control (DMEM)

Placebo: Placebo control (DMEM) administered by a single intraarticular injection


Participant Flow:   Overall Study
    Active Treatment (TG-C) 1   Active Treatment (TG-C) 2   Active Treatment (TG-C) 3   Placebo Control (DMEM)
STARTED   3   3   3   3 
COMPLETED   3   3   3   3 
NOT COMPLETED   0   0   0   0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Adults 18 or older with degenerative joint disease of the knee (confirmed by Kellgren and Lawrence criteria) refractory to existing drug therapies who were scheduled for total knee arthroplasty.

Reporting Groups
  Description
Active Treatment (TG-C)

TissueGene-C at 3x10e6, 1x10e7 or, 3x10e7 cells/joint

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

Placebo Control (DMEM)

Placebo control

Placebo: Placebo control (DMEM)

Total Total of all reporting groups

Baseline Measures
   Active Treatment (TG-C)   Placebo Control (DMEM)   Total 
Overall Participants Analyzed 
[Units: Participants]
 9   3   12 
Age 
[Units: Participants]
Count of Participants
     
<=18 years      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      7  77.8%      3 100.0%      10  83.3% 
>=65 years      2  22.2%      0   0.0%      2  16.7% 
Age 
[Units: Years]
Median (Full Range)
 61.0 
 (39 to 67) 
 60.0 
 (36 to 61) 
 60.5 
 (36 to 67) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      8  88.9%      2  66.7%      10  83.3% 
Male      1  11.1%      1  33.3%      2  16.7% 
Region of Enrollment 
[Units: Participants]
     
United States   9   3   12 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Summary of Adverse Events   [ Time Frame: Through 28 days post-dosing ]

2.  Secondary:   Number of Patients Showing Engraftment at the Defect   [ Time Frame: 28 Days ]

3.  Secondary:   Number of Patients With Distribution of hChonJb#7 Cells Detected Outside of the Injection Site   [ Time Frame: 12 Months ]

4.  Secondary:   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 ]

5.  Secondary:   Number of Patients With Tissue Overgrowth or Transformation in the Knee Joint   [ Time Frame: 29 ]

6.  Secondary:   Number of Patients With Improvements in Pain and Function of the Knee Joint   [ Time Frame: 28 Days ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
This study was designed a a preliminary assessment of safety in a limited population (12 subjects: 9 active 3 placebo) therefore statistics are presented descriptively.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: R. Ogden Copeland
Organization: TissueGene, Inc
phone: (301) 921-6000 ext 122
e-mail: ocopeland@tissuegene.com



Responsible Party: TissueGene, Inc.
ClinicalTrials.gov Identifier: NCT00599248     History of Changes
Other Study ID Numbers: TGC-03-01
First Submitted: January 11, 2008
First Posted: January 23, 2008
Results First Submitted: May 23, 2016
Results First Posted: June 30, 2016
Last Update Posted: July 7, 2017