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Trial Outcomes & Findings for Controlled Study to Evaluate the Safety and Efficacy of Azficel-T for Vocal Fold Scarring and Age-Related Dysphonia (NCT NCT02120781)

NCT ID: NCT02120781

Last Updated: 2021-06-03

Results Overview

Any improvement from baseline in mucosal wave grade using videostrobscopy to assess the pliability of vocal folds which is visualized as mucosal waves on the vocal fold surface while a participant is phonating a sustained vowel sound.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

21 participants

Primary outcome timeframe

Four months after final treatment, or up to a total of 25 weeks from baseline with unilateral treatment and 27 weeks from baseline for bilateral treatment

Results posted on

2021-06-03

Participant Flow

Participant milestones

Participant milestones
Measure
Azficel-T (Autologous Fibroblasts)
Azficel-T will be injected into the vocal fold(s) three times at two week intervals. Azficel-T (autologous fibroblasts): Autologous fibroblasts will be cultured from three 3-mm post auricular punch biopsies. Biopsies will be shipped from the clinical sites to the Fibrocell manufacturing site where the cells will be harvested, tested for sterility, endotoxin level, cell identity, viability and concentration. When the desired cell number is reached, cells will be transported to the investigative site as a suspension in shipping media. Depending upon the clinical circumstances for each subject, the vocal fold(s) will be injected transorally or percutaneously in order to deposit 1.0 mL of study drug into the lamina propria layer of each vocal fold. The injection process will be visualized via a flexible fiberoptic laryngoscope inserted through the nostril.
Control
Sterile saline will be injected into the vocal fold(s) three times at two week intervals. Placebo: Subjects randomized to placebo will receive injections of sterile saline into the vocal fold(s).
Overall Study
STARTED
15
6
Overall Study
COMPLETED
11
5
Overall Study
NOT COMPLETED
4
1

Reasons for withdrawal

Reasons for withdrawal
Measure
Azficel-T (Autologous Fibroblasts)
Azficel-T will be injected into the vocal fold(s) three times at two week intervals. Azficel-T (autologous fibroblasts): Autologous fibroblasts will be cultured from three 3-mm post auricular punch biopsies. Biopsies will be shipped from the clinical sites to the Fibrocell manufacturing site where the cells will be harvested, tested for sterility, endotoxin level, cell identity, viability and concentration. When the desired cell number is reached, cells will be transported to the investigative site as a suspension in shipping media. Depending upon the clinical circumstances for each subject, the vocal fold(s) will be injected transorally or percutaneously in order to deposit 1.0 mL of study drug into the lamina propria layer of each vocal fold. The injection process will be visualized via a flexible fiberoptic laryngoscope inserted through the nostril.
Control
Sterile saline will be injected into the vocal fold(s) three times at two week intervals. Placebo: Subjects randomized to placebo will receive injections of sterile saline into the vocal fold(s).
Overall Study
Physician Decision
2
0
Overall Study
Completion not documented
2
1

Baseline Characteristics

Controlled Study to Evaluate the Safety and Efficacy of Azficel-T for Vocal Fold Scarring and Age-Related Dysphonia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Azficel-T (Autologous Fibroblasts)
n=15 Participants
Azficel-T will be injected into the vocal fold(s) three times at two week intervals. Azficel-T (autologous fibroblasts): Autologous fibroblasts will be cultured from three 3-mm post auricular punch biopsies. Biopsies will be shipped from the clinical sites to the Fibrocell manufacturing site where the cells will be harvested, tested for sterility, endotoxin level, cell identity, viability and concentration. When the desired cell number is reached, cells will be transported to the investigative site as a suspension in shipping media. Depending upon the clinical circumstances for each subject, the vocal fold(s) will be injected transorally or percutaneously in order to deposit 1.0 mL of study drug into the lamina propria layer of each vocal fold. The injection process will be visualized via a flexible fiberoptic laryngoscope inserted through the nostril.
Control
n=6 Participants
Sterile saline will be injected into the vocal fold(s) three times at two week intervals. Placebo: Subjects randomized to placebo will receive injections of sterile saline into the vocal fold(s).
Total
n=21 Participants
Total of all reporting groups
Age, Continuous
61.8 years
STANDARD_DEVIATION 13.95 • n=99 Participants
68.3 years
STANDARD_DEVIATION 19.37 • n=107 Participants
63.7 years
STANDARD_DEVIATION 15.46 • n=206 Participants
Sex: Female, Male
Female
5 Participants
n=99 Participants
1 Participants
n=107 Participants
6 Participants
n=206 Participants
Sex: Female, Male
Male
10 Participants
n=99 Participants
5 Participants
n=107 Participants
15 Participants
n=206 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
1 Participants
n=99 Participants
1 Participants
n=107 Participants
2 Participants
n=206 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
13 Participants
n=99 Participants
5 Participants
n=107 Participants
18 Participants
n=206 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
1 Participants
n=99 Participants
0 Participants
n=107 Participants
1 Participants
n=206 Participants
Race (NIH/OMB)
American Indian or Alaska Native
1 Participants
n=99 Participants
0 Participants
n=107 Participants
1 Participants
n=206 Participants
Race (NIH/OMB)
Asian
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
Race (NIH/OMB)
Black or African American
2 Participants
n=99 Participants
0 Participants
n=107 Participants
2 Participants
n=206 Participants
Race (NIH/OMB)
White
11 Participants
n=99 Participants
6 Participants
n=107 Participants
17 Participants
n=206 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
Race (NIH/OMB)
Unknown or Not Reported
1 Participants
n=99 Participants
0 Participants
n=107 Participants
1 Participants
n=206 Participants
Region of Enrollment
United States
15 participants
n=99 Participants
6 participants
n=107 Participants
21 participants
n=206 Participants

PRIMARY outcome

Timeframe: Four months after final treatment, or up to a total of 25 weeks from baseline with unilateral treatment and 27 weeks from baseline for bilateral treatment

Any improvement from baseline in mucosal wave grade using videostrobscopy to assess the pliability of vocal folds which is visualized as mucosal waves on the vocal fold surface while a participant is phonating a sustained vowel sound.

Outcome measures

Outcome measures
Measure
Azficel-T (Autologous Fibroblasts)
n=15 Participants
Azficel-T will be injected into the vocal fold(s) three times at two week intervals. Azficel-T (autologous fibroblasts): Autologous fibroblasts will be cultured from three 3-mm post auricular punch biopsies. Biopsies will be shipped from the clinical sites to the Fibrocell manufacturing site where the cells will be harvested, tested for sterility, endotoxin level, cell identity, viability and concentration. When the desired cell number is reached, cells will be transported to the investigative site as a suspension in shipping media. Depending upon the clinical circumstances for each subject, the vocal fold(s) will be injected transorally or percutaneously in order to deposit 1.0 mL of study drug into the lamina propria layer of each vocal fold. The injection process will be visualized via a flexible fiberoptic laryngoscope inserted through the nostril.
Control
n=6 Participants
Sterile saline will be injected into the vocal fold(s) three times at two week intervals. Placebo: Subjects randomized to placebo will receive injections of sterile saline into the vocal fold(s).
Number of Participants With Any Improvement From Baseline in Mucosal Wave Grade
14 Participants
5 Participants

PRIMARY outcome

Timeframe: Four months after final treatment, or up to a total of 25 weeks from baseline with unilateral treatment and 27 weeks from baseline for bilateral treatment

Absolute change (decrease by 18 or more points) from baseline in the Voice Handicap Index (VHI) score 4 months after the final treatment. The VHI is a 30-item test with 10 items in 3 subscales: emotional, physical, and functional. Each item is scored on a 5-point scale: "0" indicating the subject never felt this about the voice problem and "4" indicating the subject always felt this to be the case. An 8-point difference on any subscale (sub-scale range 0-40, higher values represent worse outcomes) has been found to be significant, as was an 18-point difference in the total VHI score (Total scale range 0-120, higher values represent worse outcomes).

Outcome measures

Outcome measures
Measure
Azficel-T (Autologous Fibroblasts)
n=15 Participants
Azficel-T will be injected into the vocal fold(s) three times at two week intervals. Azficel-T (autologous fibroblasts): Autologous fibroblasts will be cultured from three 3-mm post auricular punch biopsies. Biopsies will be shipped from the clinical sites to the Fibrocell manufacturing site where the cells will be harvested, tested for sterility, endotoxin level, cell identity, viability and concentration. When the desired cell number is reached, cells will be transported to the investigative site as a suspension in shipping media. Depending upon the clinical circumstances for each subject, the vocal fold(s) will be injected transorally or percutaneously in order to deposit 1.0 mL of study drug into the lamina propria layer of each vocal fold. The injection process will be visualized via a flexible fiberoptic laryngoscope inserted through the nostril.
Control
n=6 Participants
Sterile saline will be injected into the vocal fold(s) three times at two week intervals. Placebo: Subjects randomized to placebo will receive injections of sterile saline into the vocal fold(s).
Number of Participants With an Absolute Change in Voice Handicap Index Score (Decrease of 18 or More Points) From Baseline
4 Participants
3 Participants

PRIMARY outcome

Timeframe: Four months after final treatment, or up to a total of 25 weeks from baseline with unilateral treatment and 27 weeks from baseline for bilateral treatment

Mean percentage change from baseline in the Voice Handicap Index (VHI) score 4 months after the final treatment. The VHI is a 30-item test with 10 items in 3 subscales: emotional, physical, and functional. Each item is scored on a 5-point scale: "0" indicating the subject never felt this about the voice problem and "4" indicating the subject always felt this to be the case. An 8-point difference on any subscale (sub-scale range 0-40, higher values represent worse outcomes) has been found to be significant, as was an 18-point difference in the total VHI score (Total scale range 0-120, higher values represent worse outcomes).

Outcome measures

Outcome measures
Measure
Azficel-T (Autologous Fibroblasts)
n=15 Participants
Azficel-T will be injected into the vocal fold(s) three times at two week intervals. Azficel-T (autologous fibroblasts): Autologous fibroblasts will be cultured from three 3-mm post auricular punch biopsies. Biopsies will be shipped from the clinical sites to the Fibrocell manufacturing site where the cells will be harvested, tested for sterility, endotoxin level, cell identity, viability and concentration. When the desired cell number is reached, cells will be transported to the investigative site as a suspension in shipping media. Depending upon the clinical circumstances for each subject, the vocal fold(s) will be injected transorally or percutaneously in order to deposit 1.0 mL of study drug into the lamina propria layer of each vocal fold. The injection process will be visualized via a flexible fiberoptic laryngoscope inserted through the nostril.
Control
n=6 Participants
Sterile saline will be injected into the vocal fold(s) three times at two week intervals. Placebo: Subjects randomized to placebo will receive injections of sterile saline into the vocal fold(s).
Mean Percentage Change From Baseline in Voice Handicap Index Score
-10.00 percentage of change
Standard Deviation 57.074
-28.86 percentage of change
Standard Deviation 51.949

PRIMARY outcome

Timeframe: Four months after final treatment, or up to a total of 25 weeks from baseline with unilateral treatment and 27 weeks from baseline for bilateral treatment

Perceptual analysis of dysphonia using the Grade of Dysphonia, Roughness, Breathiness, Asthenia, Strain (GRBAS) scale is assessed by a blinded voice clinician 4 months after the final treatment. The voice clinician considers pre- and post-treatment voice recordings, and categorizes the individual parameters on the GRBAS scale (absent, mild, moderate, and severe). Scores of mild, moderate, or severe represent increasingly worse outcomes than a score of absent.

Outcome measures

Outcome measures
Measure
Azficel-T (Autologous Fibroblasts)
n=15 Participants
Azficel-T will be injected into the vocal fold(s) three times at two week intervals. Azficel-T (autologous fibroblasts): Autologous fibroblasts will be cultured from three 3-mm post auricular punch biopsies. Biopsies will be shipped from the clinical sites to the Fibrocell manufacturing site where the cells will be harvested, tested for sterility, endotoxin level, cell identity, viability and concentration. When the desired cell number is reached, cells will be transported to the investigative site as a suspension in shipping media. Depending upon the clinical circumstances for each subject, the vocal fold(s) will be injected transorally or percutaneously in order to deposit 1.0 mL of study drug into the lamina propria layer of each vocal fold. The injection process will be visualized via a flexible fiberoptic laryngoscope inserted through the nostril.
Control
n=6 Participants
Sterile saline will be injected into the vocal fold(s) three times at two week intervals. Placebo: Subjects randomized to placebo will receive injections of sterile saline into the vocal fold(s).
Number of Participants With at Least One Level of Improvement in Perceptual Analysis of Dysphonia Using GRBAS Scale.
4 Participants
2 Participants

PRIMARY outcome

Timeframe: Four months after final treatment, or up to a total of 25 weeks from baseline with unilateral treatment and 27 weeks from baseline for bilateral treatment

Perceptual analysis of roughness using the Grade of Dysphonia, Roughness, Breathiness, Asthenia, Strain (GRBAS) scale is assessed by a blinded voice clinician 4 months after the final treatment. The voice clinician considers pre- and post-treatment voice recordings, and categorizes the individual parameters on the GRBAS scale (absent, mild, moderate, and severe). Scores of mild, moderate, or severe represent increasingly worse outcomes than a score of absent.

Outcome measures

Outcome measures
Measure
Azficel-T (Autologous Fibroblasts)
n=15 Participants
Azficel-T will be injected into the vocal fold(s) three times at two week intervals. Azficel-T (autologous fibroblasts): Autologous fibroblasts will be cultured from three 3-mm post auricular punch biopsies. Biopsies will be shipped from the clinical sites to the Fibrocell manufacturing site where the cells will be harvested, tested for sterility, endotoxin level, cell identity, viability and concentration. When the desired cell number is reached, cells will be transported to the investigative site as a suspension in shipping media. Depending upon the clinical circumstances for each subject, the vocal fold(s) will be injected transorally or percutaneously in order to deposit 1.0 mL of study drug into the lamina propria layer of each vocal fold. The injection process will be visualized via a flexible fiberoptic laryngoscope inserted through the nostril.
Control
n=6 Participants
Sterile saline will be injected into the vocal fold(s) three times at two week intervals. Placebo: Subjects randomized to placebo will receive injections of sterile saline into the vocal fold(s).
Number of Participants With at Least One Level of Improvement in Perceptual Analysis of Roughness Using GRBAS Scale.
1 Participants
2 Participants

PRIMARY outcome

Timeframe: Four months after final treatment, or up to a total of 25 weeks from baseline with unilateral treatment and 27 weeks from baseline for bilateral treatment

Perceptual analysis of breathiness using the Grade of Dysphonia, Roughness, Breathiness, Asthenia, Strain (GRBAS) scale is assessed by a blinded voice clinician 4 months after the final treatment. The voice clinician considers pre- and post-treatment voice recordings, and categorizes the individual parameters on the GRBAS scale (absent, mild, moderate, and severe). Scores of mild, moderate, or severe represent increasingly worse outcomes than a score of absent.

Outcome measures

Outcome measures
Measure
Azficel-T (Autologous Fibroblasts)
n=15 Participants
Azficel-T will be injected into the vocal fold(s) three times at two week intervals. Azficel-T (autologous fibroblasts): Autologous fibroblasts will be cultured from three 3-mm post auricular punch biopsies. Biopsies will be shipped from the clinical sites to the Fibrocell manufacturing site where the cells will be harvested, tested for sterility, endotoxin level, cell identity, viability and concentration. When the desired cell number is reached, cells will be transported to the investigative site as a suspension in shipping media. Depending upon the clinical circumstances for each subject, the vocal fold(s) will be injected transorally or percutaneously in order to deposit 1.0 mL of study drug into the lamina propria layer of each vocal fold. The injection process will be visualized via a flexible fiberoptic laryngoscope inserted through the nostril.
Control
n=6 Participants
Sterile saline will be injected into the vocal fold(s) three times at two week intervals. Placebo: Subjects randomized to placebo will receive injections of sterile saline into the vocal fold(s).
Number of Participants With at Least One Level of Improvement in Perceptual Analysis of Breathiness Using GRBAS Scale.
5 Participants
0 Participants

PRIMARY outcome

Timeframe: Four months after final treatment, or up to a total of 25 weeks from baseline with unilateral treatment and 27 weeks from baseline for bilateral treatment

Perceptual analysis of asthenia using the Grade of Dysphonia, Roughness, Breathiness, Asthenia, Strain (GRBAS) scale is assessed by a blinded voice clinician 4 months after the final treatment. The voice clinician considers pre- and post-treatment voice recordings, and categorizes the individual parameters on the GRBAS scale (absent, mild, moderate, and severe). Scores of mild, moderate, or severe represent increasingly worse outcomes than a score of absent.

Outcome measures

Outcome measures
Measure
Azficel-T (Autologous Fibroblasts)
n=15 Participants
Azficel-T will be injected into the vocal fold(s) three times at two week intervals. Azficel-T (autologous fibroblasts): Autologous fibroblasts will be cultured from three 3-mm post auricular punch biopsies. Biopsies will be shipped from the clinical sites to the Fibrocell manufacturing site where the cells will be harvested, tested for sterility, endotoxin level, cell identity, viability and concentration. When the desired cell number is reached, cells will be transported to the investigative site as a suspension in shipping media. Depending upon the clinical circumstances for each subject, the vocal fold(s) will be injected transorally or percutaneously in order to deposit 1.0 mL of study drug into the lamina propria layer of each vocal fold. The injection process will be visualized via a flexible fiberoptic laryngoscope inserted through the nostril.
Control
n=6 Participants
Sterile saline will be injected into the vocal fold(s) three times at two week intervals. Placebo: Subjects randomized to placebo will receive injections of sterile saline into the vocal fold(s).
Number of Participants With at Least One Level of Improvement in Perceptual Analysis of Asthenia Using GRBAS Scale.
4 Participants
3 Participants

PRIMARY outcome

Timeframe: Four months after final treatment, or up to a total of 25 weeks from baseline with unilateral treatment and 27 weeks from baseline for bilateral treatment

Perceptual analysis of strain using the Grade of Dysphonia, Roughness, Breathiness, Asthenia, Strain (GRBAS) scale is assessed by a blinded voice clinician 4 months after the final treatment. The voice clinician considers pre- and post-treatment voice recordings, and categorizes the individual parameters on the GRBAS scale (absent, mild, moderate, and severe). Scores of mild, moderate, or severe represent increasingly worse outcomes than a score of absent.

Outcome measures

Outcome measures
Measure
Azficel-T (Autologous Fibroblasts)
n=15 Participants
Azficel-T will be injected into the vocal fold(s) three times at two week intervals. Azficel-T (autologous fibroblasts): Autologous fibroblasts will be cultured from three 3-mm post auricular punch biopsies. Biopsies will be shipped from the clinical sites to the Fibrocell manufacturing site where the cells will be harvested, tested for sterility, endotoxin level, cell identity, viability and concentration. When the desired cell number is reached, cells will be transported to the investigative site as a suspension in shipping media. Depending upon the clinical circumstances for each subject, the vocal fold(s) will be injected transorally or percutaneously in order to deposit 1.0 mL of study drug into the lamina propria layer of each vocal fold. The injection process will be visualized via a flexible fiberoptic laryngoscope inserted through the nostril.
Control
n=6 Participants
Sterile saline will be injected into the vocal fold(s) three times at two week intervals. Placebo: Subjects randomized to placebo will receive injections of sterile saline into the vocal fold(s).
Number of Participants With at Least One Level of Improvement in Perceptual Analysis of Strain Using GRBAS Scale.
2 Participants
1 Participants

Adverse Events

Azficel-T (Autologous Fibroblasts)

Serious events: 3 serious events
Other events: 13 other events
Deaths: 0 deaths

Control

Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure
Azficel-T (Autologous Fibroblasts)
n=15 participants at risk
Azficel-T will be injected into the vocal fold(s) three times at two week intervals. Azficel-T (autologous fibroblasts): Autologous fibroblasts will be cultured from three 3-mm post auricular punch biopsies. Biopsies will be shipped from the clinical sites to the Fibrocell manufacturing site where the cells will be harvested, tested for sterility, endotoxin level, cell identity, viability and concentration. When the desired cell number is reached, cells will be transported to the investigative site as a suspension in shipping media. Depending upon the clinical circumstances for each subject, the vocal fold(s) will be injected transorally or percutaneously in order to deposit 1.0 mL of study drug into the lamina propria layer of each vocal fold. The injection process will be visualized via a flexible fiberoptic laryngoscope inserted through the nostril.
Control
n=6 participants at risk
Sterile saline will be injected into the vocal fold(s) three times at two week intervals. Placebo: Subjects randomized to placebo will receive injections of sterile saline into the vocal fold(s).
Gastrointestinal disorders
intestinal obstruction
6.7%
1/15 • Number of events 1 • Adverse event data were collected for 12 months after the first study treatment.
0.00%
0/6 • Adverse event data were collected for 12 months after the first study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
breast cancer
6.7%
1/15 • Number of events 1 • Adverse event data were collected for 12 months after the first study treatment.
0.00%
0/6 • Adverse event data were collected for 12 months after the first study treatment.
Musculoskeletal and connective tissue disorders
arthralgia
6.7%
1/15 • Number of events 1 • Adverse event data were collected for 12 months after the first study treatment.
0.00%
0/6 • Adverse event data were collected for 12 months after the first study treatment.

Other adverse events

Other adverse events
Measure
Azficel-T (Autologous Fibroblasts)
n=15 participants at risk
Azficel-T will be injected into the vocal fold(s) three times at two week intervals. Azficel-T (autologous fibroblasts): Autologous fibroblasts will be cultured from three 3-mm post auricular punch biopsies. Biopsies will be shipped from the clinical sites to the Fibrocell manufacturing site where the cells will be harvested, tested for sterility, endotoxin level, cell identity, viability and concentration. When the desired cell number is reached, cells will be transported to the investigative site as a suspension in shipping media. Depending upon the clinical circumstances for each subject, the vocal fold(s) will be injected transorally or percutaneously in order to deposit 1.0 mL of study drug into the lamina propria layer of each vocal fold. The injection process will be visualized via a flexible fiberoptic laryngoscope inserted through the nostril.
Control
n=6 participants at risk
Sterile saline will be injected into the vocal fold(s) three times at two week intervals. Placebo: Subjects randomized to placebo will receive injections of sterile saline into the vocal fold(s).
Respiratory, thoracic and mediastinal disorders
oropharyngeal pain
20.0%
3/15 • Number of events 3 • Adverse event data were collected for 12 months after the first study treatment.
16.7%
1/6 • Number of events 2 • Adverse event data were collected for 12 months after the first study treatment.
Respiratory, thoracic and mediastinal disorders
cough
6.7%
1/15 • Number of events 2 • Adverse event data were collected for 12 months after the first study treatment.
16.7%
1/6 • Number of events 1 • Adverse event data were collected for 12 months after the first study treatment.
Respiratory, thoracic and mediastinal disorders
dysphonia
6.7%
1/15 • Number of events 3 • Adverse event data were collected for 12 months after the first study treatment.
0.00%
0/6 • Adverse event data were collected for 12 months after the first study treatment.
Respiratory, thoracic and mediastinal disorders
increased upper airway secretion
6.7%
1/15 • Number of events 1 • Adverse event data were collected for 12 months after the first study treatment.
0.00%
0/6 • Adverse event data were collected for 12 months after the first study treatment.
Respiratory, thoracic and mediastinal disorders
laryngeal erythema
6.7%
1/15 • Number of events 1 • Adverse event data were collected for 12 months after the first study treatment.
0.00%
0/6 • Adverse event data were collected for 12 months after the first study treatment.
Respiratory, thoracic and mediastinal disorders
laryngeal haematoma
6.7%
1/15 • Number of events 1 • Adverse event data were collected for 12 months after the first study treatment.
0.00%
0/6 • Adverse event data were collected for 12 months after the first study treatment.
Respiratory, thoracic and mediastinal disorders
pharyngeal oedema
6.7%
1/15 • Number of events 1 • Adverse event data were collected for 12 months after the first study treatment.
0.00%
0/6 • Adverse event data were collected for 12 months after the first study treatment.
Respiratory, thoracic and mediastinal disorders
sneezing
6.7%
1/15 • Number of events 1 • Adverse event data were collected for 12 months after the first study treatment.
0.00%
0/6 • Adverse event data were collected for 12 months after the first study treatment.
Infections and infestations
laryngitis
6.7%
1/15 • Number of events 1 • Adverse event data were collected for 12 months after the first study treatment.
16.7%
1/6 • Number of events 1 • Adverse event data were collected for 12 months after the first study treatment.
Infections and infestations
bronchitis
0.00%
0/15 • Adverse event data were collected for 12 months after the first study treatment.
16.7%
1/6 • Number of events 1 • Adverse event data were collected for 12 months after the first study treatment.
Infections and infestations
nasopharyngitis
0.00%
0/15 • Adverse event data were collected for 12 months after the first study treatment.
16.7%
1/6 • Number of events 1 • Adverse event data were collected for 12 months after the first study treatment.
Infections and infestations
hordeolum
6.7%
1/15 • Number of events 2 • Adverse event data were collected for 12 months after the first study treatment.
0.00%
0/6 • Adverse event data were collected for 12 months after the first study treatment.
Infections and infestations
post procedural infection
6.7%
1/15 • Number of events 1 • Adverse event data were collected for 12 months after the first study treatment.
0.00%
0/6 • Adverse event data were collected for 12 months after the first study treatment.
Infections and infestations
sinusitis
0.00%
0/15 • Adverse event data were collected for 12 months after the first study treatment.
16.7%
1/6 • Number of events 1 • Adverse event data were collected for 12 months after the first study treatment.
Gastrointestinal disorders
dyspepsia
0.00%
0/15 • Adverse event data were collected for 12 months after the first study treatment.
16.7%
1/6 • Number of events 1 • Adverse event data were collected for 12 months after the first study treatment.
General disorders
injection site pain
0.00%
0/15 • Adverse event data were collected for 12 months after the first study treatment.
16.7%
1/6 • Number of events 1 • Adverse event data were collected for 12 months after the first study treatment.
General disorders
injection site paraesthesia
6.7%
1/15 • Number of events 1 • Adverse event data were collected for 12 months after the first study treatment.
0.00%
0/6 • Adverse event data were collected for 12 months after the first study treatment.
Injury, poisoning and procedural complications
procedural anxiety
6.7%
1/15 • Number of events 1 • Adverse event data were collected for 12 months after the first study treatment.
16.7%
1/6 • Number of events 1 • Adverse event data were collected for 12 months after the first study treatment.
Injury, poisoning and procedural complications
animal bite
6.7%
1/15 • Number of events 1 • Adverse event data were collected for 12 months after the first study treatment.
0.00%
0/6 • Adverse event data were collected for 12 months after the first study treatment.
Musculoskeletal and connective tissue disorders
neck pain
6.7%
1/15 • Number of events 1 • Adverse event data were collected for 12 months after the first study treatment.
0.00%
0/6 • Adverse event data were collected for 12 months after the first study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
squamous cell carcinoma
0.00%
0/15 • Adverse event data were collected for 12 months after the first study treatment.
16.7%
1/6 • Number of events 1 • Adverse event data were collected for 12 months after the first study treatment.
Ear and labyrinth disorders
ear pain
6.7%
1/15 • Number of events 1 • Adverse event data were collected for 12 months after the first study treatment.
0.00%
0/6 • Adverse event data were collected for 12 months after the first study treatment.
Immune system disorders
hypersensitivity
6.7%
1/15 • Number of events 1 • Adverse event data were collected for 12 months after the first study treatment.
0.00%
0/6 • Adverse event data were collected for 12 months after the first study treatment.
Investigations
blood urine present
6.7%
1/15 • Number of events 1 • Adverse event data were collected for 12 months after the first study treatment.
0.00%
0/6 • Adverse event data were collected for 12 months after the first study treatment.
Metabolism and nutrition disorders
hypercholesterolemia
0.00%
0/15 • Adverse event data were collected for 12 months after the first study treatment.
16.7%
1/6 • Number of events 2 • Adverse event data were collected for 12 months after the first study treatment.
Nervous system disorders
restless leg syndrome
6.7%
1/15 • Number of events 1 • Adverse event data were collected for 12 months after the first study treatment.
0.00%
0/6 • Adverse event data were collected for 12 months after the first study treatment.

Additional Information

Head, Research and Development

Castle Creek Biosciences

Phone: 13128471291

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place