Trial Outcomes & Findings for Study of PVS-10200 for the Treatment of Restenosis in Patients With Peripheral Artery Disease (TRIUMPH) (NCT NCT01099215)
NCT ID: NCT01099215
Last Updated: 2021-06-28
Results Overview
Major Adverse Events are: - Death - Major amputation - Procedural related serious adverse events - Investigational product related serious adverse events
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
21 participants
Primary outcome timeframe
within 4 weeks after study procedure
Results posted on
2021-06-28
Participant Flow
The study period was from 30 March 2010 (first patient's screening visit) to 19 June 2012 (last patient's Week 48 visit). A total of 30 subjects were screened for study eligibility, of whom a total of 21 subjects were registered (i.e., enrolled) and treated with PVS-10200. The study was conducted at 3 study centers in France
Participant milestones
| Measure |
Low Dose PVS-10200 (Cohort A)
Low dose PVS-10200 (6×10\^5 cells/cm lesion)
|
High Dose PVS-10200 (Cohort B)
High dose PVS-10200 (15×10\^5 cells/cm lesion)
|
|---|---|---|
|
Overall Study
STARTED
|
11
|
10
|
|
Overall Study
COMPLETED
|
10
|
9
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
| Measure |
Low Dose PVS-10200 (Cohort A)
Low dose PVS-10200 (6×10\^5 cells/cm lesion)
|
High Dose PVS-10200 (Cohort B)
High dose PVS-10200 (15×10\^5 cells/cm lesion)
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
|
Overall Study
Adverse Event
|
0
|
1
|
Baseline Characteristics
Study of PVS-10200 for the Treatment of Restenosis in Patients With Peripheral Artery Disease (TRIUMPH)
Baseline characteristics by cohort
| Measure |
Cohort A
n=11 Participants
Low dose PVS-10200 (6×10\^5 cells/cm lesion)
|
Cohort B
n=10 Participants
High dose PVS-10200 (15×10\^5 cells/cm lesion)
|
Total
n=21 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
61.6 Years
STANDARD_DEVIATION 10.11 • n=5 Participants
|
70.7 Years
STANDARD_DEVIATION 7.67 • n=7 Participants
|
66.0 Years
STANDARD_DEVIATION 9.96 • n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Region of Enrollment
France
|
11 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Resting Ankle Brachial Index, Leg with Target Lesion
|
0.954 ratio
STANDARD_DEVIATION 0.164 • n=5 Participants
|
0.851 ratio
STANDARD_DEVIATION 0.258 • n=7 Participants
|
0.902 ratio
STANDARD_DEVIATION 0.217 • n=5 Participants
|
|
Fontaine Classification
STAGE IIB-MODERATE TO SEVERE CLAUDICATION(<200M)
|
10 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Fontaine Classification
STAGE IV - ULCERATION OR GANGRENE
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: within 4 weeks after study procedurePopulation: Intention-to-Treat Population Analysis
Major Adverse Events are: - Death - Major amputation - Procedural related serious adverse events - Investigational product related serious adverse events
Outcome measures
| Measure |
Cohort A
n=11 Participants
Low dose PVS-10200 (6×10\^5 cells/cm lesion)
|
Cohort B
n=10 Participants
High dose PVS-10200 (15×10\^5 cells/cm lesion)
|
|---|---|---|
|
Incidence of Major Adverse Events (MAEs)
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: within 24 and 48 weeks from study procedurePopulation: Intention-to-Treat Population Analysis
Major Adverse Events are: - Death - Major amputation - Procedural related serious adverse events - Investigational product related serious adverse events
Outcome measures
| Measure |
Cohort A
n=11 Participants
Low dose PVS-10200 (6×10\^5 cells/cm lesion)
|
Cohort B
n=10 Participants
High dose PVS-10200 (15×10\^5 cells/cm lesion)
|
|---|---|---|
|
Incidence of Major Adverse Events (MAEs)
Week 24
|
0 participants
|
0 participants
|
|
Incidence of Major Adverse Events (MAEs)
Week 48
|
0 participants
|
1 participants
|
SECONDARY outcome
Timeframe: Up to 48 weeks from study procedurePopulation: Intention-to-Treat Population Analysis
Outcome measures
| Measure |
Cohort A
n=11 Participants
Low dose PVS-10200 (6×10\^5 cells/cm lesion)
|
Cohort B
n=10 Participants
High dose PVS-10200 (15×10\^5 cells/cm lesion)
|
|---|---|---|
|
Incidence of Serious Adverse Events
|
7 participants
|
7 participants
|
SECONDARY outcome
Timeframe: Up to 48 weeks from study procedurePopulation: Safety Population Analysis
Outcome measures
| Measure |
Cohort A
n=11 Participants
Low dose PVS-10200 (6×10\^5 cells/cm lesion)
|
Cohort B
n=10 Participants
High dose PVS-10200 (15×10\^5 cells/cm lesion)
|
|---|---|---|
|
Incidence of Adverse Events, Laboratory Abnormalities
Clinically Significant Laboratory
|
1 participants
|
5 participants
|
|
Incidence of Adverse Events, Laboratory Abnormalities
Treatment Emergent Adverse Events
|
11 participants
|
10 participants
|
SECONDARY outcome
Timeframe: within 4 weeks from study procedurePopulation: Intention-to-Treat Population Analysis (Data was not available for all 21 subjects because it includes only ultrasound data obtained that was considered diagnostic and evaluable by the core lab)
Primary patency was defined as duplex ultrasound peak systolic velocity \[PSV\] ratio ≤2.4.Ultrasound data was obtained for each patient at each time point and had to be considered diagnostic and evaluable by the core lab; if it was not, then this analysis could not be done for that particular subject.
Outcome measures
| Measure |
Cohort A
n=11 Participants
Low dose PVS-10200 (6×10\^5 cells/cm lesion)
|
Cohort B
n=10 Participants
High dose PVS-10200 (15×10\^5 cells/cm lesion)
|
|---|---|---|
|
Maintenance of Primary Patency of Superficial Femoral Artery (SFA)
NO
|
0 participants
|
0 participants
|
|
Maintenance of Primary Patency of Superficial Femoral Artery (SFA)
YES
|
9 participants
|
9 participants
|
SECONDARY outcome
Timeframe: within 24 weeks from study procedurePopulation: Intention-to-Treat Population Analysis (Data was not available for all 21 subjects because it includes only ultrasound data obtained that was considered diagnostic and evaluable by the core lab)
Primary patency was defined as duplex ultrasound peak systolic velocity \[PSV\] ratio ≤2.4.Ultrasound data was obtained for each patient at each time point and had to be considered diagnostic and evaluable by the core lab; if it was not, then this analysis could not be done for that particular subject.
Outcome measures
| Measure |
Cohort A
n=11 Participants
Low dose PVS-10200 (6×10\^5 cells/cm lesion)
|
Cohort B
n=10 Participants
High dose PVS-10200 (15×10\^5 cells/cm lesion)
|
|---|---|---|
|
Maintenance of Primary Patency of Superficial Femoral Artery (SFA)
YES
|
5 participants
|
4 participants
|
|
Maintenance of Primary Patency of Superficial Femoral Artery (SFA)
NO
|
4 participants
|
4 participants
|
SECONDARY outcome
Timeframe: within 48 weeks from study procedurePopulation: Intention-to-Treat Population Analysis (Data was not available for all 21 subjects because it includes only ultrasound data obtained that was considered diagnostic and evaluable by the core lab)
Primary patency was defined as duplex ultrasound peak systolic velocity \[PSV\] ratio ≤2.4.Ultrasound data was obtained for each patient at each time point and had to be considered diagnostic and evaluable by the core lab; if it was not, then this analysis could not be done for that particular subject.
Outcome measures
| Measure |
Cohort A
n=11 Participants
Low dose PVS-10200 (6×10\^5 cells/cm lesion)
|
Cohort B
n=10 Participants
High dose PVS-10200 (15×10\^5 cells/cm lesion)
|
|---|---|---|
|
Maintenance of Primary Patency of Superficial Femoral Artery (SFA)
NO
|
3 participants
|
3 participants
|
|
Maintenance of Primary Patency of Superficial Femoral Artery (SFA)
YES
|
4 participants
|
3 participants
|
SECONDARY outcome
Timeframe: within 4 weeks from study procedurePopulation: Intention-to-Treat Population Analysis (Data was not available for all 21 subjects because it includes only ultrasound data obtained that was considered diagnostic and evaluable by the core lab)
Binary restenosis relied on duplex ultrasound data with a Yes/No assessment with 0-49% being No (peak systolic velocity \[PSV\] ratio ≤2.4) and Yes being 50-99% (PSV ratio \>2.4), with the PSV ratio calculated as PSV from stenosis divided by the PSV from a normal segment of artery proximal to the stenosis. Ultrasound data was obtained for each patient at each time point and had to be considered diagnostic and evaluable by the core lab; if it was not, then this analysis could not be done for that particular subject.
Outcome measures
| Measure |
Cohort A
n=11 Participants
Low dose PVS-10200 (6×10\^5 cells/cm lesion)
|
Cohort B
n=10 Participants
High dose PVS-10200 (15×10\^5 cells/cm lesion)
|
|---|---|---|
|
Rate of Binary In-stent Restenosis
NO
|
9 participants
|
9 participants
|
|
Rate of Binary In-stent Restenosis
YES
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: within 24 weeks from study procedurePopulation: Intention-to-Treat Population Analysis (Data was not available for all 21 subjects because it includes only ultrasound data obtained that was considered diagnostic and evaluable by the core lab)
Binary restenosis relied on duplex ultrasound data with a Yes/No assessment with 0-49% being No (peak systolic velocity \[PSV\] ratio ≤2.4) and Yes being 50-99% (PSV ratio \>2.4), with the PSV ratio calculated as PSV from stenosis divided by the PSV from a normal segment of artery proximal to the stenosis. Ultrasound data was obtained for each patient at each time point and had to be considered diagnostic and evaluable by the core lab; if it was not, then this analysis could not be done for that particular subject.
Outcome measures
| Measure |
Cohort A
n=11 Participants
Low dose PVS-10200 (6×10\^5 cells/cm lesion)
|
Cohort B
n=10 Participants
High dose PVS-10200 (15×10\^5 cells/cm lesion)
|
|---|---|---|
|
Rate of Binary In-stent Restenosis
NO
|
9 participants
|
8 participants
|
|
Rate of Binary In-stent Restenosis
YES
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: within 48 weeks from study procedurePopulation: Intention-to-Treat Population Analysis (Data was not available for all 21 subjects because it includes only ultrasound data obtained that was considered diagnostic and evaluable by the core lab)
Binary restenosis relied on duplex ultrasound data with a Yes/No assessment with 0-49% being No (peak systolic velocity \[PSV\] ratio ≤2.4) and Yes being 50-99% (PSV ratio \>2.4), with the PSV ratio calculated as PSV from stenosis divided by the PSV from a normal segment of artery proximal to the stenosis. Ultrasound data was obtained for each patient at each time point and had to be considered diagnostic and evaluable by the core lab; if it was not, then this analysis could not be done for that particular subject.
Outcome measures
| Measure |
Cohort A
n=11 Participants
Low dose PVS-10200 (6×10\^5 cells/cm lesion)
|
Cohort B
n=10 Participants
High dose PVS-10200 (15×10\^5 cells/cm lesion)
|
|---|---|---|
|
Rate of Binary In-stent Restenosis
NO
|
8 participants
|
7 participants
|
|
Rate of Binary In-stent Restenosis
YES
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: up to 48 Weeks from study procedurePopulation: Intention-to-Treat Population Analysis
Survival analysis - outcome reported as patients requiring reintervention of the target lesion / vessel
Outcome measures
| Measure |
Cohort A
n=11 Participants
Low dose PVS-10200 (6×10\^5 cells/cm lesion)
|
Cohort B
n=10 Participants
High dose PVS-10200 (15×10\^5 cells/cm lesion)
|
|---|---|---|
|
Number of Patients Requiring Reintervention of Target Lesion / Target Vessel
|
4 participants
15.4% • Interval 29.0 to
|
2 participants
12.6% • Interval 52.86 to 65.43
|
SECONDARY outcome
Timeframe: within 4, 24 and 48 weeks from study procedurePopulation: Intention-to-Treat Population Analysis
ABI was calculated by dividing the systolic blood pressure at the ankle by the systolic blood pressures in the arm. This test is used to predict the severity of PAD.
Outcome measures
| Measure |
Cohort A
n=11 Participants
Low dose PVS-10200 (6×10\^5 cells/cm lesion)
|
Cohort B
n=10 Participants
High dose PVS-10200 (15×10\^5 cells/cm lesion)
|
|---|---|---|
|
Resting Ankle-brachial Index
Week 48
|
0.931 ratio
Standard Deviation 0.193
|
0.857 ratio
Standard Deviation 0.226
|
|
Resting Ankle-brachial Index
Week 4
|
0.984 ratio
Standard Deviation 0.128
|
0.887 ratio
Standard Deviation 0.237
|
|
Resting Ankle-brachial Index
Week 24
|
0.948 ratio
Standard Deviation 0.172
|
0.842 ratio
Standard Deviation 0.204
|
SECONDARY outcome
Timeframe: within 4, 24 and 48 weeks from baselinePopulation: Safety Population Analysis
Changes in physical examination were compared to baseline: numbers of subjects presenting any new finding or worsening of abnormal findings compared to the screening examination are reported
Outcome measures
| Measure |
Cohort A
n=11 Participants
Low dose PVS-10200 (6×10\^5 cells/cm lesion)
|
Cohort B
n=10 Participants
High dose PVS-10200 (15×10\^5 cells/cm lesion)
|
|---|---|---|
|
Changes in Physical Exam
Week 4
|
0 participants
|
3 participants
|
|
Changes in Physical Exam
Week 24
|
5 participants
|
1 participants
|
|
Changes in Physical Exam
Week 48
|
3 participants
|
3 participants
|
SECONDARY outcome
Timeframe: change from baseline to 4 weeksPopulation: Intention-to-Treat Population Analysis
CLASSIFICATION OF PERIPHERAL ATERIAL DISEASE ACCORDING TO FONTAINE Stage Clinical description I Asymptomatic IIA Mild claudication IIB Moderate -severe claudication III Ischemic rest pain IV Ulceration or gangrene
Outcome measures
| Measure |
Cohort A
n=11 Participants
Low dose PVS-10200 (6×10\^5 cells/cm lesion)
|
Cohort B
n=10 Participants
High dose PVS-10200 (15×10\^5 cells/cm lesion)
|
|---|---|---|
|
The Fontaine Class of Peripheral Artery Disease
STAGE IIB (Baseline) to STAGE I (Week 4)
|
9 participants
|
5 participants
|
|
The Fontaine Class of Peripheral Artery Disease
STAGE IIB (Baseline) to STAGE IIA (Week 4)
|
1 participants
|
1 participants
|
|
The Fontaine Class of Peripheral Artery Disease
STAGE IV (Baseline) to STAGE I (Week 4)
|
1 participants
|
0 participants
|
|
The Fontaine Class of Peripheral Artery Disease
STAGE IV (Baseline) to STAGE IV (Week 4)
|
0 participants
|
4 participants
|
SECONDARY outcome
Timeframe: change from baseline to 24 weeksPopulation: Intention-to-Treat Population Analysis
CLASSIFICATION OF PERIPHERAL ATERIAL DISEASE ACCORDING TO FONTAINE Stage Clinical description I Asymptomatic IIA Mild claudication IIB Moderate -severe claudication III Ischemic rest pain IV Ulceration or gangrene
Outcome measures
| Measure |
Cohort A
n=11 Participants
Low dose PVS-10200 (6×10\^5 cells/cm lesion)
|
Cohort B
n=10 Participants
High dose PVS-10200 (15×10\^5 cells/cm lesion)
|
|---|---|---|
|
The Fontaine Class of Peripheral Artery Disease
STAGE IIB (Baseline) to STAGE I (Week 24)
|
4 participants
|
3 participants
|
|
The Fontaine Class of Peripheral Artery Disease
STAGE IIB (Baseline) to STAGE IIA (Week 24)
|
4 participants
|
1 participants
|
|
The Fontaine Class of Peripheral Artery Disease
STAGE IIB (Baseline) to STAGE IIB (Week 24)
|
2 participants
|
1 participants
|
|
The Fontaine Class of Peripheral Artery Disease
STAGE IV (Baseline) to STAGE I (Week 24)
|
0 participants
|
1 participants
|
|
The Fontaine Class of Peripheral Artery Disease
STAGE IV (Baseline) to STAGE IV (Week 24)
|
0 participants
|
2 participants
|
|
The Fontaine Class of Peripheral Artery Disease
Missing
|
1 participants
|
2 participants
|
SECONDARY outcome
Timeframe: change from baseline to 48 weeksPopulation: Intention-to-Treat Population Analysis
CLASSIFICATION OF PERIPHERAL ATERIAL DISEASE ACCORDING TO FONTAINE Stage Clinical description I Asymptomatic IIA Mild claudication IIB Moderate -severe claudication III Ischemic rest pain IV Ulceration or gangrene
Outcome measures
| Measure |
Cohort A
n=11 Participants
Low dose PVS-10200 (6×10\^5 cells/cm lesion)
|
Cohort B
n=10 Participants
High dose PVS-10200 (15×10\^5 cells/cm lesion)
|
|---|---|---|
|
The Fontaine Class of Peripheral Artery Disease
STAGE IV (Baseline) to STAGE I (Week 48)
|
0 participants
|
1 participants
|
|
The Fontaine Class of Peripheral Artery Disease
STAGE IV (Baseline) to STAGE IIB (Week 48)
|
0 participants
|
1 participants
|
|
The Fontaine Class of Peripheral Artery Disease
STAGE IV (Baseline) to STAGE IV (Week 48)
|
0 participants
|
1 participants
|
|
The Fontaine Class of Peripheral Artery Disease
Missing
|
1 participants
|
1 participants
|
|
The Fontaine Class of Peripheral Artery Disease
STAGE IIB (Baseline) to STAGE I (Week 48)
|
6 participants
|
4 participants
|
|
The Fontaine Class of Peripheral Artery Disease
STAGE IIB (Baseline) to STAGE IIA (Week 48)
|
1 participants
|
1 participants
|
|
The Fontaine Class of Peripheral Artery Disease
STAGE IIB (Baseline) to STAGE IIB (Week 48)
|
3 participants
|
1 participants
|
Adverse Events
Cohort A
Serious events: 7 serious events
Other events: 11 other events
Deaths: 0 deaths
Cohort B
Serious events: 7 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cohort A
n=11 participants at risk
Low dose PVS-10200 (6×10\^5 cells/cm lesion)
|
Cohort B
n=10 participants at risk
High dose PVS-10200 (15×10\^5 cells/cm lesion)
|
|---|---|---|
|
Surgical and medical procedures
ANGIOPLASTY
|
9.1%
1/11 • 30 March 2010 (first patient's screening visit) to 19 June 2012 (last patient's Week 48 visit)
No increase in humoral sensitization seen after PVS-10200 treatment. Positive panel-reactive antibodies (PRA) findings seen at Wk 48 only in 2 subjects who also had positive PRA findings at Screening (i.e., sensitized prior to PVS 10-200 exposure). No treatment-emergent Adverse Events associated with humoral sensitization seen in either subject.
|
0.00%
0/10 • 30 March 2010 (first patient's screening visit) to 19 June 2012 (last patient's Week 48 visit)
No increase in humoral sensitization seen after PVS-10200 treatment. Positive panel-reactive antibodies (PRA) findings seen at Wk 48 only in 2 subjects who also had positive PRA findings at Screening (i.e., sensitized prior to PVS 10-200 exposure). No treatment-emergent Adverse Events associated with humoral sensitization seen in either subject.
|
|
Injury, poisoning and procedural complications
ARTERIAL RESTENOSIS
|
18.2%
2/11 • 30 March 2010 (first patient's screening visit) to 19 June 2012 (last patient's Week 48 visit)
No increase in humoral sensitization seen after PVS-10200 treatment. Positive panel-reactive antibodies (PRA) findings seen at Wk 48 only in 2 subjects who also had positive PRA findings at Screening (i.e., sensitized prior to PVS 10-200 exposure). No treatment-emergent Adverse Events associated with humoral sensitization seen in either subject.
|
0.00%
0/10 • 30 March 2010 (first patient's screening visit) to 19 June 2012 (last patient's Week 48 visit)
No increase in humoral sensitization seen after PVS-10200 treatment. Positive panel-reactive antibodies (PRA) findings seen at Wk 48 only in 2 subjects who also had positive PRA findings at Screening (i.e., sensitized prior to PVS 10-200 exposure). No treatment-emergent Adverse Events associated with humoral sensitization seen in either subject.
|
|
Vascular disorders
ARTERIAL STENOSIS
|
9.1%
1/11 • 30 March 2010 (first patient's screening visit) to 19 June 2012 (last patient's Week 48 visit)
No increase in humoral sensitization seen after PVS-10200 treatment. Positive panel-reactive antibodies (PRA) findings seen at Wk 48 only in 2 subjects who also had positive PRA findings at Screening (i.e., sensitized prior to PVS 10-200 exposure). No treatment-emergent Adverse Events associated with humoral sensitization seen in either subject.
|
0.00%
0/10 • 30 March 2010 (first patient's screening visit) to 19 June 2012 (last patient's Week 48 visit)
No increase in humoral sensitization seen after PVS-10200 treatment. Positive panel-reactive antibodies (PRA) findings seen at Wk 48 only in 2 subjects who also had positive PRA findings at Screening (i.e., sensitized prior to PVS 10-200 exposure). No treatment-emergent Adverse Events associated with humoral sensitization seen in either subject.
|
|
Infections and infestations
ERYSIPELAS
|
0.00%
0/11 • 30 March 2010 (first patient's screening visit) to 19 June 2012 (last patient's Week 48 visit)
No increase in humoral sensitization seen after PVS-10200 treatment. Positive panel-reactive antibodies (PRA) findings seen at Wk 48 only in 2 subjects who also had positive PRA findings at Screening (i.e., sensitized prior to PVS 10-200 exposure). No treatment-emergent Adverse Events associated with humoral sensitization seen in either subject.
|
10.0%
1/10 • 30 March 2010 (first patient's screening visit) to 19 June 2012 (last patient's Week 48 visit)
No increase in humoral sensitization seen after PVS-10200 treatment. Positive panel-reactive antibodies (PRA) findings seen at Wk 48 only in 2 subjects who also had positive PRA findings at Screening (i.e., sensitized prior to PVS 10-200 exposure). No treatment-emergent Adverse Events associated with humoral sensitization seen in either subject.
|
|
Vascular disorders
FEMORAL ARTERY OCCLUSION
|
0.00%
0/11 • 30 March 2010 (first patient's screening visit) to 19 June 2012 (last patient's Week 48 visit)
No increase in humoral sensitization seen after PVS-10200 treatment. Positive panel-reactive antibodies (PRA) findings seen at Wk 48 only in 2 subjects who also had positive PRA findings at Screening (i.e., sensitized prior to PVS 10-200 exposure). No treatment-emergent Adverse Events associated with humoral sensitization seen in either subject.
|
10.0%
1/10 • 30 March 2010 (first patient's screening visit) to 19 June 2012 (last patient's Week 48 visit)
No increase in humoral sensitization seen after PVS-10200 treatment. Positive panel-reactive antibodies (PRA) findings seen at Wk 48 only in 2 subjects who also had positive PRA findings at Screening (i.e., sensitized prior to PVS 10-200 exposure). No treatment-emergent Adverse Events associated with humoral sensitization seen in either subject.
|
|
Injury, poisoning and procedural complications
IN-STENT ARTERIAL RESTENOSIS
|
27.3%
3/11 • 30 March 2010 (first patient's screening visit) to 19 June 2012 (last patient's Week 48 visit)
No increase in humoral sensitization seen after PVS-10200 treatment. Positive panel-reactive antibodies (PRA) findings seen at Wk 48 only in 2 subjects who also had positive PRA findings at Screening (i.e., sensitized prior to PVS 10-200 exposure). No treatment-emergent Adverse Events associated with humoral sensitization seen in either subject.
|
30.0%
3/10 • 30 March 2010 (first patient's screening visit) to 19 June 2012 (last patient's Week 48 visit)
No increase in humoral sensitization seen after PVS-10200 treatment. Positive panel-reactive antibodies (PRA) findings seen at Wk 48 only in 2 subjects who also had positive PRA findings at Screening (i.e., sensitized prior to PVS 10-200 exposure). No treatment-emergent Adverse Events associated with humoral sensitization seen in either subject.
|
|
Vascular disorders
INTERMITTENT CLAUDICATION
|
54.5%
6/11 • 30 March 2010 (first patient's screening visit) to 19 June 2012 (last patient's Week 48 visit)
No increase in humoral sensitization seen after PVS-10200 treatment. Positive panel-reactive antibodies (PRA) findings seen at Wk 48 only in 2 subjects who also had positive PRA findings at Screening (i.e., sensitized prior to PVS 10-200 exposure). No treatment-emergent Adverse Events associated with humoral sensitization seen in either subject.
|
20.0%
2/10 • 30 March 2010 (first patient's screening visit) to 19 June 2012 (last patient's Week 48 visit)
No increase in humoral sensitization seen after PVS-10200 treatment. Positive panel-reactive antibodies (PRA) findings seen at Wk 48 only in 2 subjects who also had positive PRA findings at Screening (i.e., sensitized prior to PVS 10-200 exposure). No treatment-emergent Adverse Events associated with humoral sensitization seen in either subject.
|
|
Surgical and medical procedures
LEG AMPUTATION
|
0.00%
0/11 • 30 March 2010 (first patient's screening visit) to 19 June 2012 (last patient's Week 48 visit)
No increase in humoral sensitization seen after PVS-10200 treatment. Positive panel-reactive antibodies (PRA) findings seen at Wk 48 only in 2 subjects who also had positive PRA findings at Screening (i.e., sensitized prior to PVS 10-200 exposure). No treatment-emergent Adverse Events associated with humoral sensitization seen in either subject.
|
10.0%
1/10 • 30 March 2010 (first patient's screening visit) to 19 June 2012 (last patient's Week 48 visit)
No increase in humoral sensitization seen after PVS-10200 treatment. Positive panel-reactive antibodies (PRA) findings seen at Wk 48 only in 2 subjects who also had positive PRA findings at Screening (i.e., sensitized prior to PVS 10-200 exposure). No treatment-emergent Adverse Events associated with humoral sensitization seen in either subject.
|
|
Gastrointestinal disorders
PANCREATITIS ACUTE
|
9.1%
1/11 • 30 March 2010 (first patient's screening visit) to 19 June 2012 (last patient's Week 48 visit)
No increase in humoral sensitization seen after PVS-10200 treatment. Positive panel-reactive antibodies (PRA) findings seen at Wk 48 only in 2 subjects who also had positive PRA findings at Screening (i.e., sensitized prior to PVS 10-200 exposure). No treatment-emergent Adverse Events associated with humoral sensitization seen in either subject.
|
0.00%
0/10 • 30 March 2010 (first patient's screening visit) to 19 June 2012 (last patient's Week 48 visit)
No increase in humoral sensitization seen after PVS-10200 treatment. Positive panel-reactive antibodies (PRA) findings seen at Wk 48 only in 2 subjects who also had positive PRA findings at Screening (i.e., sensitized prior to PVS 10-200 exposure). No treatment-emergent Adverse Events associated with humoral sensitization seen in either subject.
|
|
Surgical and medical procedures
PERIPHERAL ARTERY ANGIOPLASTY
|
9.1%
1/11 • 30 March 2010 (first patient's screening visit) to 19 June 2012 (last patient's Week 48 visit)
No increase in humoral sensitization seen after PVS-10200 treatment. Positive panel-reactive antibodies (PRA) findings seen at Wk 48 only in 2 subjects who also had positive PRA findings at Screening (i.e., sensitized prior to PVS 10-200 exposure). No treatment-emergent Adverse Events associated with humoral sensitization seen in either subject.
|
0.00%
0/10 • 30 March 2010 (first patient's screening visit) to 19 June 2012 (last patient's Week 48 visit)
No increase in humoral sensitization seen after PVS-10200 treatment. Positive panel-reactive antibodies (PRA) findings seen at Wk 48 only in 2 subjects who also had positive PRA findings at Screening (i.e., sensitized prior to PVS 10-200 exposure). No treatment-emergent Adverse Events associated with humoral sensitization seen in either subject.
|
|
Infections and infestations
PYELONEPHRITIS
|
0.00%
0/11 • 30 March 2010 (first patient's screening visit) to 19 June 2012 (last patient's Week 48 visit)
No increase in humoral sensitization seen after PVS-10200 treatment. Positive panel-reactive antibodies (PRA) findings seen at Wk 48 only in 2 subjects who also had positive PRA findings at Screening (i.e., sensitized prior to PVS 10-200 exposure). No treatment-emergent Adverse Events associated with humoral sensitization seen in either subject.
|
10.0%
1/10 • 30 March 2010 (first patient's screening visit) to 19 June 2012 (last patient's Week 48 visit)
No increase in humoral sensitization seen after PVS-10200 treatment. Positive panel-reactive antibodies (PRA) findings seen at Wk 48 only in 2 subjects who also had positive PRA findings at Screening (i.e., sensitized prior to PVS 10-200 exposure). No treatment-emergent Adverse Events associated with humoral sensitization seen in either subject.
|
|
Surgical and medical procedures
TOE AMPUTATION
|
0.00%
0/11 • 30 March 2010 (first patient's screening visit) to 19 June 2012 (last patient's Week 48 visit)
No increase in humoral sensitization seen after PVS-10200 treatment. Positive panel-reactive antibodies (PRA) findings seen at Wk 48 only in 2 subjects who also had positive PRA findings at Screening (i.e., sensitized prior to PVS 10-200 exposure). No treatment-emergent Adverse Events associated with humoral sensitization seen in either subject.
|
20.0%
2/10 • 30 March 2010 (first patient's screening visit) to 19 June 2012 (last patient's Week 48 visit)
No increase in humoral sensitization seen after PVS-10200 treatment. Positive panel-reactive antibodies (PRA) findings seen at Wk 48 only in 2 subjects who also had positive PRA findings at Screening (i.e., sensitized prior to PVS 10-200 exposure). No treatment-emergent Adverse Events associated with humoral sensitization seen in either subject.
|
|
General disorders
WOUND NECROSIS
|
0.00%
0/11 • 30 March 2010 (first patient's screening visit) to 19 June 2012 (last patient's Week 48 visit)
No increase in humoral sensitization seen after PVS-10200 treatment. Positive panel-reactive antibodies (PRA) findings seen at Wk 48 only in 2 subjects who also had positive PRA findings at Screening (i.e., sensitized prior to PVS 10-200 exposure). No treatment-emergent Adverse Events associated with humoral sensitization seen in either subject.
|
10.0%
1/10 • 30 March 2010 (first patient's screening visit) to 19 June 2012 (last patient's Week 48 visit)
No increase in humoral sensitization seen after PVS-10200 treatment. Positive panel-reactive antibodies (PRA) findings seen at Wk 48 only in 2 subjects who also had positive PRA findings at Screening (i.e., sensitized prior to PVS 10-200 exposure). No treatment-emergent Adverse Events associated with humoral sensitization seen in either subject.
|
Other adverse events
| Measure |
Cohort A
n=11 participants at risk
Low dose PVS-10200 (6×10\^5 cells/cm lesion)
|
Cohort B
n=10 participants at risk
High dose PVS-10200 (15×10\^5 cells/cm lesion)
|
|---|---|---|
|
Injury, poisoning and procedural complications
Arterial Restenosis
|
18.2%
2/11 • 30 March 2010 (first patient's screening visit) to 19 June 2012 (last patient's Week 48 visit)
No increase in humoral sensitization seen after PVS-10200 treatment. Positive panel-reactive antibodies (PRA) findings seen at Wk 48 only in 2 subjects who also had positive PRA findings at Screening (i.e., sensitized prior to PVS 10-200 exposure). No treatment-emergent Adverse Events associated with humoral sensitization seen in either subject.
|
0.00%
0/10 • 30 March 2010 (first patient's screening visit) to 19 June 2012 (last patient's Week 48 visit)
No increase in humoral sensitization seen after PVS-10200 treatment. Positive panel-reactive antibodies (PRA) findings seen at Wk 48 only in 2 subjects who also had positive PRA findings at Screening (i.e., sensitized prior to PVS 10-200 exposure). No treatment-emergent Adverse Events associated with humoral sensitization seen in either subject.
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
9.1%
1/11 • 30 March 2010 (first patient's screening visit) to 19 June 2012 (last patient's Week 48 visit)
No increase in humoral sensitization seen after PVS-10200 treatment. Positive panel-reactive antibodies (PRA) findings seen at Wk 48 only in 2 subjects who also had positive PRA findings at Screening (i.e., sensitized prior to PVS 10-200 exposure). No treatment-emergent Adverse Events associated with humoral sensitization seen in either subject.
|
30.0%
3/10 • 30 March 2010 (first patient's screening visit) to 19 June 2012 (last patient's Week 48 visit)
No increase in humoral sensitization seen after PVS-10200 treatment. Positive panel-reactive antibodies (PRA) findings seen at Wk 48 only in 2 subjects who also had positive PRA findings at Screening (i.e., sensitized prior to PVS 10-200 exposure). No treatment-emergent Adverse Events associated with humoral sensitization seen in either subject.
|
|
Vascular disorders
Hypertension
|
36.4%
4/11 • 30 March 2010 (first patient's screening visit) to 19 June 2012 (last patient's Week 48 visit)
No increase in humoral sensitization seen after PVS-10200 treatment. Positive panel-reactive antibodies (PRA) findings seen at Wk 48 only in 2 subjects who also had positive PRA findings at Screening (i.e., sensitized prior to PVS 10-200 exposure). No treatment-emergent Adverse Events associated with humoral sensitization seen in either subject.
|
0.00%
0/10 • 30 March 2010 (first patient's screening visit) to 19 June 2012 (last patient's Week 48 visit)
No increase in humoral sensitization seen after PVS-10200 treatment. Positive panel-reactive antibodies (PRA) findings seen at Wk 48 only in 2 subjects who also had positive PRA findings at Screening (i.e., sensitized prior to PVS 10-200 exposure). No treatment-emergent Adverse Events associated with humoral sensitization seen in either subject.
|
|
Injury, poisoning and procedural complications
In-Stent Arterial Restenosis
|
27.3%
3/11 • 30 March 2010 (first patient's screening visit) to 19 June 2012 (last patient's Week 48 visit)
No increase in humoral sensitization seen after PVS-10200 treatment. Positive panel-reactive antibodies (PRA) findings seen at Wk 48 only in 2 subjects who also had positive PRA findings at Screening (i.e., sensitized prior to PVS 10-200 exposure). No treatment-emergent Adverse Events associated with humoral sensitization seen in either subject.
|
30.0%
3/10 • 30 March 2010 (first patient's screening visit) to 19 June 2012 (last patient's Week 48 visit)
No increase in humoral sensitization seen after PVS-10200 treatment. Positive panel-reactive antibodies (PRA) findings seen at Wk 48 only in 2 subjects who also had positive PRA findings at Screening (i.e., sensitized prior to PVS 10-200 exposure). No treatment-emergent Adverse Events associated with humoral sensitization seen in either subject.
|
|
General disorders
Injection Site Haemorrhage
|
18.2%
2/11 • 30 March 2010 (first patient's screening visit) to 19 June 2012 (last patient's Week 48 visit)
No increase in humoral sensitization seen after PVS-10200 treatment. Positive panel-reactive antibodies (PRA) findings seen at Wk 48 only in 2 subjects who also had positive PRA findings at Screening (i.e., sensitized prior to PVS 10-200 exposure). No treatment-emergent Adverse Events associated with humoral sensitization seen in either subject.
|
0.00%
0/10 • 30 March 2010 (first patient's screening visit) to 19 June 2012 (last patient's Week 48 visit)
No increase in humoral sensitization seen after PVS-10200 treatment. Positive panel-reactive antibodies (PRA) findings seen at Wk 48 only in 2 subjects who also had positive PRA findings at Screening (i.e., sensitized prior to PVS 10-200 exposure). No treatment-emergent Adverse Events associated with humoral sensitization seen in either subject.
|
|
Vascular disorders
Intermittent Claudication
|
54.5%
6/11 • 30 March 2010 (first patient's screening visit) to 19 June 2012 (last patient's Week 48 visit)
No increase in humoral sensitization seen after PVS-10200 treatment. Positive panel-reactive antibodies (PRA) findings seen at Wk 48 only in 2 subjects who also had positive PRA findings at Screening (i.e., sensitized prior to PVS 10-200 exposure). No treatment-emergent Adverse Events associated with humoral sensitization seen in either subject.
|
20.0%
2/10 • 30 March 2010 (first patient's screening visit) to 19 June 2012 (last patient's Week 48 visit)
No increase in humoral sensitization seen after PVS-10200 treatment. Positive panel-reactive antibodies (PRA) findings seen at Wk 48 only in 2 subjects who also had positive PRA findings at Screening (i.e., sensitized prior to PVS 10-200 exposure). No treatment-emergent Adverse Events associated with humoral sensitization seen in either subject.
|
|
Surgical and medical procedures
Toe Amputation
|
0.00%
0/11 • 30 March 2010 (first patient's screening visit) to 19 June 2012 (last patient's Week 48 visit)
No increase in humoral sensitization seen after PVS-10200 treatment. Positive panel-reactive antibodies (PRA) findings seen at Wk 48 only in 2 subjects who also had positive PRA findings at Screening (i.e., sensitized prior to PVS 10-200 exposure). No treatment-emergent Adverse Events associated with humoral sensitization seen in either subject.
|
20.0%
2/10 • 30 March 2010 (first patient's screening visit) to 19 June 2012 (last patient's Week 48 visit)
No increase in humoral sensitization seen after PVS-10200 treatment. Positive panel-reactive antibodies (PRA) findings seen at Wk 48 only in 2 subjects who also had positive PRA findings at Screening (i.e., sensitized prior to PVS 10-200 exposure). No treatment-emergent Adverse Events associated with humoral sensitization seen in either subject.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Company-specific confidentiality agreement
- Publication restrictions are in place
Restriction type: OTHER