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Trial record 5 of 10 for:    tissuegene

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 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
Enrollment 12
Recruitment Details  
Pre-assignment Details 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
Arm/Group Title Active Treatment (TG-C) 1 Active Treatment (TG-C) 2 Active Treatment (TG-C) 3 Placebo Control (DMEM)
Hide Arm/Group Description

TissueGene-C at 3x10e6 cells/joint

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

TissueGene-C at 1 x 10e7 cells/joint

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

TissueGene-C at 3x10e7 cells/joint

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

Placebo Control (DMEM)

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

Period Title: Overall Study
Started 3 3 3 3
Completed 3 3 3 3
Not Completed 0 0 0 0
Arm/Group Title Active Treatment (TG-C) Placebo Control (DMEM) Total
Hide Arm/Group Description

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

Placebo: Placebo control (DMEM)

Total of all reporting groups
Overall Number of Baseline Participants 9 3 12
Hide Baseline Analysis Population Description
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.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants 3 participants 12 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, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 9 participants 3 participants 12 participants
61.0
(39 to 67)
60.0
(36 to 61)
60.5
(36 to 67)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants 3 participants 12 participants
Female
8
  88.9%
2
  66.7%
10
  83.3%
Male
1
  11.1%
1
  33.3%
2
  16.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 9 participants 3 participants 12 participants
9 3 12
1.Primary Outcome
Title Summary of Adverse Events
Hide Description The incidence of observations at the site of administration and the incidence adverse events assessed through 28 days after treatment.
Time Frame Through 28 days post-dosing
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-to-treat
Arm/Group Title Active Treatment (TG-C) 1 Active Treatment (TG-C) 2 Active Treatment (TG-C) 3 Placebo Control (DMEM)
Hide Arm/Group Description:

TissueGene-C at 3x10e6 cells/joint

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

TissueGene-C at 1x10e7 cells/joint

TissueGene-C: TissueGene-C at 1x107 cells/joint to be administered by a single intra-articular injection

TissueGene-C at 3x10e7 cells/joint

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

Placebo control

Placebo: Placebo control (DMEM)

Overall Number of Participants Analyzed 3 3 3 3
Measure Type: Number
Unit of Measure: Adverse events
2 2 3 2
2.Secondary Outcome
Title Number of Patients Showing Engraftment at the Defect
Hide Description Dose Response of the TG-C in Engrafting at the Defect as Compared to Placebo Control
Time Frame 28 Days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Active Treatment (TG-C) 1 Active Treatment (TG-C) 2 Active Treatment (TG-C) 3 Placebo Control (DMEM)
Hide Arm/Group Description:

TissueGene-C at 3x10e6 cells/joint

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

TissueGene-C at 1x10e7 cells/joint

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

TissueGene-C at 3x10e7 cells/joint

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

Placebo control

Placebo: Placebo control (DMEM)

Overall Number of Participants Analyzed 3 3 3 3
Measure Type: Number
Unit of Measure: participants
0 0 0 0
3.Secondary Outcome
Title Number of Patients With Distribution of hChonJb#7 Cells Detected Outside of the Injection Site
Hide Description Number of Patients with Distribution of hChonJb#7 Cells Detected Outside of the Injection Site as determined by PCR analysis for vector DNA.
Time Frame 12 Months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Active Treatment (TG-C) 1 Active Treatment (TG-C) 2 Active Treatment (TG-C) 3 Placebo Control (DMEM)
Hide Arm/Group Description:

TissueGene-C at 3x10e6 cells/joint

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

TissueGene-C at 1x10e7 cells/joint

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

TissueGene-C at 3x10e7 cells/joint

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

Placebo control

Placebo: Placebo control (DMEM)

Overall Number of Participants Analyzed 3 3 3 3
Measure Type: Number
Unit of Measure: participants
0 0 0 0
4.Secondary Outcome
Title Number of Participants With Observable Evidence of Cartilage Regeneration
Hide Description 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 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
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-to-treat
Arm/Group Title Active Treatment (TG-C) 1 Active Treatment (TG-C) 2 Active Treatment (TG-C) 3 Placebo Control (DMEM)
Hide Arm/Group Description:

TissueGene-C at 3x10e6 cells/joint

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

TissueGene-C at 1x10e7 cells/joint

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

TissueGene-C at 3x10e7 cells/joint

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

Placebo control

Placebo: Placebo control (DMEM)

Overall Number of Participants Analyzed 3 3 3 3
Measure Type: Number
Unit of Measure: participants
0 0 0 0
5.Secondary Outcome
Title Number of Patients With Tissue Overgrowth or Transformation in the Knee Joint
Hide Description Visual and histological analysis of knee joint tissues to determine the number of patients with tissue overgrowth or transformation
Time Frame 29
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Active Treatment (TG-C) 1 Active Treatment (TG-C) 2 Active Treatment (TG-C) 3 Placebo Control (DMEM)
Hide Arm/Group Description:

TissueGene-C at 3x10e6 cells/joint

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

TissueGene-C at 1x10e7 cells/joint

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

TissueGene-C at 3x10e7 cells/joint

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

Placebo control

Placebo: Placebo control (DMEM)

Overall Number of Participants Analyzed 3 3 3 3
Measure Type: Number
Unit of Measure: participants
0 0 0 0
6.Secondary Outcome
Title Number of Patients With Improvements in Pain and Function of the Knee Joint
Hide Description Assessment of the number of patients with improvement in pain and function of the knee joint
Time Frame 28 Days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Active Treatment (TG-C) 1 Active Treatment (TG-C) 2 Active Treatment (TG-C) 3 Placebo Control (DMEM)
Hide Arm/Group Description:

TissueGene-C at 3x10e6 cells/joint

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

TissueGene-C at 1x10e7 cells/joint

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

TissueGene-C at 3x10e7 cells/joint

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

Placebo control

Placebo: Placebo control (DMEM)

Overall Number of Participants Analyzed 3 3 3 3
Measure Type: Number
Unit of Measure: participants
3 3 3 3
Time Frame 1 Year
Adverse Event Reporting Description Treatment emergent adverse events
 
Arm/Group Title Active Treatment (TG-C) Placebo Control (DMEM)
Hide Arm/Group Description

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

Placebo: Placebo control (DMEM)

All-Cause Mortality
Active Treatment (TG-C) Placebo Control (DMEM)
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
Active Treatment (TG-C) Placebo Control (DMEM)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/9 (0.00%)      0/3 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Active Treatment (TG-C) Placebo Control (DMEM)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   7/9 (77.78%)      2/3 (66.67%)    
Gastrointestinal disorders     
Diarrhea * 1  2/9 (22.22%)  2 1/3 (33.33%)  1
Gingival bleeding * 1  1/9 (11.11%)  1 0/3 (0.00%)  0
Abdominal pain * 1  1/9 (11.11%)  1 0/3 (0.00%)  0
General disorders     
Pyrexia * 1  1/9 (11.11%)  1 0/3 (0.00%)  0
Fatigue * 1  1/9 (11.11%)  1 0/3 (0.00%)  0
Infections and infestations     
Gastroenteritis * 1  2/9 (22.22%)  2 0/3 (0.00%)  0
Investigations     
Activated PTT prolonged * 1  2/9 (22.22%)  2 1/3 (33.33%)  1
PT Prolonged * 1  1/9 (11.11%)  1 1/3 (33.33%)  1
Blood test abnormal * 1  0/9 (0.00%)  0 1/3 (33.33%)  1
Musculoskeletal and connective tissue disorders     
Arthralgia * 1  2/9 (22.22%)  2 0/3 (0.00%)  0
Muscle spasms * 1  0/9 (0.00%)  0 1/3 (33.33%)  1
Pain in extremity * 1  1/9 (11.11%)  1 0/3 (0.00%)  0
Joint range of motion decreased * 1  1/9 (11.11%)  1 0/3 (0.00%)  0
Joint effusion * 1  1/9 (11.11%)  1 0/3 (0.00%)  0
Lower extremity mass * 1  1/9 (11.11%)  1 0/3 (0.00%)  0
Nervous system disorders     
Headache * 1  3/9 (33.33%)  3 0/3 (0.00%)  0
Paresthesia * 1  0/9 (0.00%)  0 1/3 (33.33%)  1
Sinus headache * 1  0/9 (0.00%)  0 1/3 (33.33%)  1
Respiratory, thoracic and mediastinal disorders     
Rhinitis allgergic * 1  1/9 (11.11%)  1 0/3 (0.00%)  0
Oropharyngeal pain * 1  1/9 (11.11%)  1 0/3 (0.00%)  0
Nasal congestion * 1  1/9 (11.11%)  1 0/3 (0.00%)  0
Skin and subcutaneous tissue disorders     
Pruritis generalized * 1  1/9 (11.11%)  1 0/3 (0.00%)  0
Urticaria * 1  1/9 (11.11%)  1 0/3 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (12.0)
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.
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: R. Ogden Copeland
Organization: TissueGene, Inc
Phone: (301) 921-6000 ext 122
EMail: ocopeland@tissuegene.com
Layout table for additonal information
Responsible Party: Kolon TissueGene, Inc.
ClinicalTrials.gov Identifier: NCT00599248    
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