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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:
Information provided by (Responsible Party):
TissueGene, Inc.
ClinicalTrials.gov Identifier:
NCT00599248
First received: January 11, 2008
Last updated: May 23, 2016
Last verified: May 2016
Results First Received: May 23, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Subject);   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
No text entered.

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

Plcebo Control (DMEM)

Placebo control

Placebo: Placebo control (DMEM)


Participant Flow:   Overall Study
    Active Treatment (TG-C)   Plcebo Control (DMEM)
STARTED   9   3 
COMPLETED   9   3 
NOT COMPLETED   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]
     
<=18 years   0   0   0 
Between 18 and 65 years   7   3   10 
>=65 years   2   0   2 
Age 
[Units: Years]
Median (Full Range)
 61.0 
 (39 to 67) 
 60.0 
 (36 to 61) 
 60.5 
 (36 to 67) 
Gender 
[Units: Participants]
     
Female   8   2   10 
Male   1   1   2 
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:   Cartilage Regeneration by Histology and Observation   [ 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 ]


  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 statistical analysis is limited.


  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
Study First Received: January 11, 2008
Results First Received: May 23, 2016
Last Updated: May 23, 2016
Health Authority: United States: Food and Drug Administration