Trial Outcomes & Findings for Safety Follow-Up to HP 802-247-09-015 (NCT NCT00900029)
NCT ID: NCT00900029
Last Updated: 2017-08-02
Results Overview
At each visit the status of closed target ulcers was evaluated as remained closed or re-opened.
Recruitment status
COMPLETED
Target enrollment
206 participants
Primary outcome timeframe
Over the 24-week study period, at each of the bi-monthly visits
Results posted on
2017-08-02
Participant Flow
Eligible subjects were those who completed study 802-247-09-015. Of the 228 subjects who completed 802-247-09-015, 206 consented to enter this safety follow up study, between June 1, 2009 and October, 20, 2011.
Both PIs and subjects remained blinded to the therapy each subject received in 802-247-09-015. No test article was administered during this study and any therapy was at the discretion of the PI, with no restrictions.
Participant milestones
| Measure |
LD-Q14D
LD-Q14D: 0.5 x 106 cell/mL applied to wound surface every 2 weeks
|
LD-Q7D
LD-Q7D: 0.5 x 106 cell/mL applied to wound surface every week
|
HD-Q14D
HD-Q14D: 5.0 x 106 cell/mL applied to wound surface every 2 weeks
|
HD-Q7D
HD-Q7D: 5.0 x 106 cell/mL applied to wound surface every week
|
HP802-247 Vehicle
Acellular vehicle applied weekly applied to wound surface every week
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
38
|
41
|
41
|
42
|
44
|
|
Overall Study
COMPLETED
|
35
|
37
|
38
|
35
|
38
|
|
Overall Study
NOT COMPLETED
|
3
|
4
|
3
|
7
|
6
|
Reasons for withdrawal
| Measure |
LD-Q14D
LD-Q14D: 0.5 x 106 cell/mL applied to wound surface every 2 weeks
|
LD-Q7D
LD-Q7D: 0.5 x 106 cell/mL applied to wound surface every week
|
HD-Q14D
HD-Q14D: 5.0 x 106 cell/mL applied to wound surface every 2 weeks
|
HD-Q7D
HD-Q7D: 5.0 x 106 cell/mL applied to wound surface every week
|
HP802-247 Vehicle
Acellular vehicle applied weekly applied to wound surface every week
|
|---|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
2
|
1
|
4
|
4
|
|
Overall Study
Withdrawal by Subject
|
2
|
2
|
1
|
1
|
1
|
|
Overall Study
Adverse Event
|
0
|
0
|
1
|
1
|
1
|
|
Overall Study
Death
|
1
|
0
|
0
|
1
|
0
|
Baseline Characteristics
Safety Follow-Up to HP 802-247-09-015
Baseline characteristics by cohort
| Measure |
HP802-247 Vehicle
n=44 Participants
Acellular vehicle applied weekly
|
LD-Q14D
n=38 Participants
LD-Q14D: 0.5 x 106 cell/mL applied to wound surface every 2 weeks
|
LD-Q7D
n=41 Participants
LD-Q7D: 0.5 x 106 cell/mL applied to wound surface every week
|
HD-Q14D
n=41 Participants
HD-Q14D: 5.0 x 106 cell/mL applied to wound surface every 2 weeks
|
HD-Q7D
n=42 Participants
HD-Q7D: 5.0 x 106 cell/mL applied to wound surface every week
|
Total
n=206 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Customized
18-39 years
|
1 participants
n=5 Participants
|
4 participants
n=7 Participants
|
3 participants
n=5 Participants
|
3 participants
n=4 Participants
|
4 participants
n=21 Participants
|
15 participants
n=8 Participants
|
|
Age, Customized
40-49 years
|
8 participants
n=5 Participants
|
6 participants
n=7 Participants
|
4 participants
n=5 Participants
|
6 participants
n=4 Participants
|
6 participants
n=21 Participants
|
30 participants
n=8 Participants
|
|
Age, Customized
50-59 years
|
11 participants
n=5 Participants
|
7 participants
n=7 Participants
|
10 participants
n=5 Participants
|
8 participants
n=4 Participants
|
6 participants
n=21 Participants
|
42 participants
n=8 Participants
|
|
Age, Customized
60+ years
|
24 participants
n=5 Participants
|
21 participants
n=7 Participants
|
24 participants
n=5 Participants
|
24 participants
n=4 Participants
|
26 participants
n=21 Participants
|
119 participants
n=8 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
20 Participants
n=21 Participants
|
84 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
29 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
22 Participants
n=4 Participants
|
22 Participants
n=21 Participants
|
122 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
9 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
12 Participants
n=21 Participants
|
48 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
35 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
35 Participants
n=4 Participants
|
30 Participants
n=21 Participants
|
158 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Black or African American
|
9 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
45 Participants
n=8 Participants
|
|
Race (NIH/OMB)
White
|
31 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
29 Participants
n=4 Participants
|
30 Participants
n=21 Participants
|
147 Participants
n=8 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
12 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: Over the 24-week study period, at each of the bi-monthly visitsPopulation: Subjects who completed the 802-247-09-015 study with a closed target wound attended three bimonthly visits.
At each visit the status of closed target ulcers was evaluated as remained closed or re-opened.
Outcome measures
| Measure |
LD-Q14D
n=27 Participants
LD-Q14D: 0.5 x 106 cell/mL applied to wound surface every 2 weeks
|
LD-Q7D
n=21 Participants
LD-Q7D: 0.5 x 106 cell/mL applied to wound surface every week
|
HD-Q14D
n=25 Participants
HD-Q14D: 5.0 x 106 cell/mL applied to wound surface every 2 weeks
|
HD-Q7D
n=23 Participants
HD-Q7D: 5.0 x 106 cell/mL applied to wound surface every week
|
HP802-247 Vehicle
n=18 Participants
Acellular vehicle applied weekly
|
|---|---|---|---|---|---|
|
The Number of Participants With Closed Target Ulcers at Each Visit
Month 2 (Visit 1)
|
22 participants
|
19 participants
|
24 participants
|
20 participants
|
17 participants
|
|
The Number of Participants With Closed Target Ulcers at Each Visit
Month 4 (Visit 2)
|
25 participants
|
19 participants
|
22 participants
|
21 participants
|
16 participants
|
|
The Number of Participants With Closed Target Ulcers at Each Visit
Month 6 (Visit 3)
|
25 participants
|
19 participants
|
21 participants
|
20 participants
|
15 participants
|
|
The Number of Participants With Closed Target Ulcers at Each Visit
Enrollment
|
27 participants
|
21 participants
|
25 participants
|
23 participants
|
18 participants
|
PRIMARY outcome
Timeframe: Over the 24-week study period, at each of the bi-monthly visitsPopulation: Subjects who completed the 802-247-09-015 study with open target wound attended three bimonthly visits over the duration of the study.
At each visit the status of open target ulcers was evaluated as "remained open" or "closed".
Outcome measures
| Measure |
LD-Q14D
n=8 Participants
LD-Q14D: 0.5 x 106 cell/mL applied to wound surface every 2 weeks
|
LD-Q7D
n=16 Participants
LD-Q7D: 0.5 x 106 cell/mL applied to wound surface every week
|
HD-Q14D
n=13 Participants
HD-Q14D: 5.0 x 106 cell/mL applied to wound surface every 2 weeks
|
HD-Q7D
n=12 Participants
HD-Q7D: 5.0 x 106 cell/mL applied to wound surface every week
|
HP802-247 Vehicle
n=20 Participants
Acellular vehicle applied weekly
|
|---|---|---|---|---|---|
|
Number of Subjects With Target Wound Closed for the First Time During the Study Period.
Month 2 (Visit 1)
|
3 participants
|
1 participants
|
4 participants
|
2 participants
|
4 participants
|
|
Number of Subjects With Target Wound Closed for the First Time During the Study Period.
Month 4 (Visit 2)
|
5 participants
|
3 participants
|
4 participants
|
5 participants
|
8 participants
|
|
Number of Subjects With Target Wound Closed for the First Time During the Study Period.
Month 6 (Visit 3)
|
4 participants
|
4 participants
|
7 participants
|
6 participants
|
7 participants
|
Adverse Events
LD-Q14D
Serious events: 3 serious events
Other events: 10 other events
Deaths: 0 deaths
LD-Q7D
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
HD-Q14D
Serious events: 4 serious events
Other events: 5 other events
Deaths: 0 deaths
HD-Q7D
Serious events: 5 serious events
Other events: 11 other events
Deaths: 0 deaths
HP802-247 Vehicle
Serious events: 4 serious events
Other events: 14 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
LD-Q14D
n=38 participants at risk
LD-Q14D: 0.5 x 106 cell/mL applied to wound surface every 2 weeks
|
LD-Q7D
n=41 participants at risk
LD-Q7D: 0.5 x 106 cell/mL applied to wound surface every week
|
HD-Q14D
n=41 participants at risk
HD-Q14D: 5.0 x 106 cell/mL applied to wound surface every 2 weeks
|
HD-Q7D
n=42 participants at risk
HD-Q7D: 5.0 x 106 cell/mL applied to wound surface every week
|
HP802-247 Vehicle
n=44 participants at risk
|
|---|---|---|---|---|---|
|
Cardiac disorders
Acute coronary syndrome
|
0.00%
0/38 • The duration of the 24-week study period
All subjects with at least one study visit were questioned about adverse events and were included in the number of participants assessed for safety. The first assessments at each visit were about changes in general health and concomitant medications and the occurrence of adverse events.
|
0.00%
0/41 • The duration of the 24-week study period
All subjects with at least one study visit were questioned about adverse events and were included in the number of participants assessed for safety. The first assessments at each visit were about changes in general health and concomitant medications and the occurrence of adverse events.
|
0.00%
0/41 • The duration of the 24-week study period
All subjects with at least one study visit were questioned about adverse events and were included in the number of participants assessed for safety. The first assessments at each visit were about changes in general health and concomitant medications and the occurrence of adverse events.
|
2.4%
1/42 • Number of events 1 • The duration of the 24-week study period
All subjects with at least one study visit were questioned about adverse events and were included in the number of participants assessed for safety. The first assessments at each visit were about changes in general health and concomitant medications and the occurrence of adverse events.
|
0.00%
0/44 • The duration of the 24-week study period
All subjects with at least one study visit were questioned about adverse events and were included in the number of participants assessed for safety. The first assessments at each visit were about changes in general health and concomitant medications and the occurrence of adverse events.
|
|
Cardiac disorders
Arrhythmia
|
2.6%
1/38 • Number of events 1 • The duration of the 24-week study period
All subjects with at least one study visit were questioned about adverse events and were included in the number of participants assessed for safety. The first assessments at each visit were about changes in general health and concomitant medications and the occurrence of adverse events.
|
0.00%
0/41 • The duration of the 24-week study period
All subjects with at least one study visit were questioned about adverse events and were included in the number of participants assessed for safety. The first assessments at each visit were about changes in general health and concomitant medications and the occurrence of adverse events.
|
0.00%
0/41 • The duration of the 24-week study period
All subjects with at least one study visit were questioned about adverse events and were included in the number of participants assessed for safety. The first assessments at each visit were about changes in general health and concomitant medications and the occurrence of adverse events.
|
0.00%
0/42 • The duration of the 24-week study period
All subjects with at least one study visit were questioned about adverse events and were included in the number of participants assessed for safety. The first assessments at each visit were about changes in general health and concomitant medications and the occurrence of adverse events.
|
0.00%
0/44 • The duration of the 24-week study period
All subjects with at least one study visit were questioned about adverse events and were included in the number of participants assessed for safety. The first assessments at each visit were about changes in general health and concomitant medications and the occurrence of adverse events.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/38 • The duration of the 24-week study period
All subjects with at least one study visit were questioned about adverse events and were included in the number of participants assessed for safety. The first assessments at each visit were about changes in general health and concomitant medications and the occurrence of adverse events.
|
0.00%
0/41 • The duration of the 24-week study period
All subjects with at least one study visit were questioned about adverse events and were included in the number of participants assessed for safety. The first assessments at each visit were about changes in general health and concomitant medications and the occurrence of adverse events.
|
0.00%
0/41 • The duration of the 24-week study period
All subjects with at least one study visit were questioned about adverse events and were included in the number of participants assessed for safety. The first assessments at each visit were about changes in general health and concomitant medications and the occurrence of adverse events.
|
2.4%
1/42 • Number of events 1 • The duration of the 24-week study period
All subjects with at least one study visit were questioned about adverse events and were included in the number of participants assessed for safety. The first assessments at each visit were about changes in general health and concomitant medications and the occurrence of adverse events.
|
0.00%
0/44 • The duration of the 24-week study period
All subjects with at least one study visit were questioned about adverse events and were included in the number of participants assessed for safety. The first assessments at each visit were about changes in general health and concomitant medications and the occurrence of adverse events.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/38 • The duration of the 24-week study period
All subjects with at least one study visit were questioned about adverse events and were included in the number of participants assessed for safety. The first assessments at each visit were about changes in general health and concomitant medications and the occurrence of adverse events.
|
0.00%
0/41 • The duration of the 24-week study period
All subjects with at least one study visit were questioned about adverse events and were included in the number of participants assessed for safety. The first assessments at each visit were about changes in general health and concomitant medications and the occurrence of adverse events.
|
0.00%
0/41 • The duration of the 24-week study period
All subjects with at least one study visit were questioned about adverse events and were included in the number of participants assessed for safety. The first assessments at each visit were about changes in general health and concomitant medications and the occurrence of adverse events.
|
4.8%
2/42 • Number of events 2 • The duration of the 24-week study period
All subjects with at least one study visit were questioned about adverse events and were included in the number of participants assessed for safety. The first assessments at each visit were about changes in general health and concomitant medications and the occurrence of adverse events.
|
0.00%
0/44 • The duration of the 24-week study period
All subjects with at least one study visit were questioned about adverse events and were included in the number of participants assessed for safety. The first assessments at each visit were about changes in general health and concomitant medications and the occurrence of adverse events.
|
|
Cardiac disorders
Cardiac valve disease
|
0.00%
0/38 • The duration of the 24-week study period
All subjects with at least one study visit were questioned about adverse events and were included in the number of participants assessed for safety. The first assessments at each visit were about changes in general health and concomitant medications and the occurrence of adverse events.
|
0.00%
0/41 • The duration of the 24-week study period
All subjects with at least one study visit were questioned about adverse events and were included in the number of participants assessed for safety. The first assessments at each visit were about changes in general health and concomitant medications and the occurrence of adverse events.
|
0.00%
0/41 • The duration of the 24-week study period
All subjects with at least one study visit were questioned about adverse events and were included in the number of participants assessed for safety. The first assessments at each visit were about changes in general health and concomitant medications and the occurrence of adverse events.
|
2.4%
1/42 • Number of events 1 • The duration of the 24-week study period
All subjects with at least one study visit were questioned about adverse events and were included in the number of participants assessed for safety. The first assessments at each visit were about changes in general health and concomitant medications and the occurrence of adverse events.
|
0.00%
0/44 • The duration of the 24-week study period
All subjects with at least one study visit were questioned about adverse events and were included in the number of participants assessed for safety. The first assessments at each visit were about changes in general health and concomitant medications and the occurrence of adverse events.
|
|
Cardiac disorders
Supraventricular tachycardia
|
2.6%
1/38 • Number of events 1 • The duration of the 24-week study period
All subjects with at least one study visit were questioned about adverse events and were included in the number of participants assessed for safety. The first assessments at each visit were about changes in general health and concomitant medications and the occurrence of adverse events.
|
0.00%
0/41 • The duration of the 24-week study period
All subjects with at least one study visit were questioned about adverse events and were included in the number of participants assessed for safety. The first assessments at each visit were about changes in general health and concomitant medications and the occurrence of adverse events.
|
0.00%
0/41 • The duration of the 24-week study period
All subjects with at least one study visit were questioned about adverse events and were included in the number of participants assessed for safety. The first assessments at each visit were about changes in general health and concomitant medications and the occurrence of adverse events.
|
0.00%
0/42 • The duration of the 24-week study period
All subjects with at least one study visit were questioned about adverse events and were included in the number of participants assessed for safety. The first assessments at each visit were about changes in general health and concomitant medications and the occurrence of adverse events.
|
4.5%
2/44 • Number of events 2 • The duration of the 24-week study period
All subjects with at least one study visit were questioned about adverse events and were included in the number of participants assessed for safety. The first assessments at each visit were about changes in general health and concomitant medications and the occurrence of adverse events.
|
|
Infections and infestations
Cellulitis
|
2.6%
1/38 • Number of events 1 • The duration of the 24-week study period
All subjects with at least one study visit were questioned about adverse events and were included in the number of participants assessed for safety. The first assessments at each visit were about changes in general health and concomitant medications and the occurrence of adverse events.
|
0.00%
0/41 • The duration of the 24-week study period
All subjects with at least one study visit were questioned about adverse events and were included in the number of participants assessed for safety. The first assessments at each visit were about changes in general health and concomitant medications and the occurrence of adverse events.
|
2.4%
1/41 • Number of events 1 • The duration of the 24-week study period
All subjects with at least one study visit were questioned about adverse events and were included in the number of participants assessed for safety. The first assessments at each visit were about changes in general health and concomitant medications and the occurrence of adverse events.
|
0.00%
0/42 • The duration of the 24-week study period
All subjects with at least one study visit were questioned about adverse events and were included in the number of participants assessed for safety. The first assessments at each visit were about changes in general health and concomitant medications and the occurrence of adverse events.
|
0.00%
0/44 • The duration of the 24-week study period
All subjects with at least one study visit were questioned about adverse events and were included in the number of participants assessed for safety. The first assessments at each visit were about changes in general health and concomitant medications and the occurrence of adverse events.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/38 • The duration of the 24-week study period
All subjects with at least one study visit were questioned about adverse events and were included in the number of participants assessed for safety. The first assessments at each visit were about changes in general health and concomitant medications and the occurrence of adverse events.
|
0.00%
0/41 • The duration of the 24-week study period
All subjects with at least one study visit were questioned about adverse events and were included in the number of participants assessed for safety. The first assessments at each visit were about changes in general health and concomitant medications and the occurrence of adverse events.
|
2.4%
1/41 • Number of events 1 • The duration of the 24-week study period
All subjects with at least one study visit were questioned about adverse events and were included in the number of participants assessed for safety. The first assessments at each visit were about changes in general health and concomitant medications and the occurrence of adverse events.
|
0.00%
0/42 • The duration of the 24-week study period
All subjects with at least one study visit were questioned about adverse events and were included in the number of participants assessed for safety. The first assessments at each visit were about changes in general health and concomitant medications and the occurrence of adverse events.
|
2.3%
1/44 • Number of events 1 • The duration of the 24-week study period
All subjects with at least one study visit were questioned about adverse events and were included in the number of participants assessed for safety. The first assessments at each visit were about changes in general health and concomitant medications and the occurrence of adverse events.
|
|
Infections and infestations
Wound infection
|
0.00%
0/38 • The duration of the 24-week study period
All subjects with at least one study visit were questioned about adverse events and were included in the number of participants assessed for safety. The first assessments at each visit were about changes in general health and concomitant medications and the occurrence of adverse events.
|
0.00%
0/41 • The duration of the 24-week study period
All subjects with at least one study visit were questioned about adverse events and were included in the number of participants assessed for safety. The first assessments at each visit were about changes in general health and concomitant medications and the occurrence of adverse events.
|
0.00%
0/41 • The duration of the 24-week study period
All subjects with at least one study visit were questioned about adverse events and were included in the number of participants assessed for safety. The first assessments at each visit were about changes in general health and concomitant medications and the occurrence of adverse events.
|
0.00%
0/42 • The duration of the 24-week study period
All subjects with at least one study visit were questioned about adverse events and were included in the number of participants assessed for safety. The first assessments at each visit were about changes in general health and concomitant medications and the occurrence of adverse events.
|
2.3%
1/44 • Number of events 1 • The duration of the 24-week study period
All subjects with at least one study visit were questioned about adverse events and were included in the number of participants assessed for safety. The first assessments at each visit were about changes in general health and concomitant medications and the occurrence of adverse events.
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.00%
0/38 • The duration of the 24-week study period
All subjects with at least one study visit were questioned about adverse events and were included in the number of participants assessed for safety. The first assessments at each visit were about changes in general health and concomitant medications and the occurrence of adverse events.
|
0.00%
0/41 • The duration of the 24-week study period
All subjects with at least one study visit were questioned about adverse events and were included in the number of participants assessed for safety. The first assessments at each visit were about changes in general health and concomitant medications and the occurrence of adverse events.
|
2.4%
1/41 • Number of events 1 • The duration of the 24-week study period
All subjects with at least one study visit were questioned about adverse events and were included in the number of participants assessed for safety. The first assessments at each visit were about changes in general health and concomitant medications and the occurrence of adverse events.
|
0.00%
0/42 • The duration of the 24-week study period
All subjects with at least one study visit were questioned about adverse events and were included in the number of participants assessed for safety. The first assessments at each visit were about changes in general health and concomitant medications and the occurrence of adverse events.
|
2.3%
1/44 • Number of events 1 • The duration of the 24-week study period
All subjects with at least one study visit were questioned about adverse events and were included in the number of participants assessed for safety. The first assessments at each visit were about changes in general health and concomitant medications and the occurrence of adverse events.
|
|
Injury, poisoning and procedural complications
Injury, poisoning and procedural complications
|
0.00%
0/38 • The duration of the 24-week study period
All subjects with at least one study visit were questioned about adverse events and were included in the number of participants assessed for safety. The first assessments at each visit were about changes in general health and concomitant medications and the occurrence of adverse events.
|
0.00%
0/41 • The duration of the 24-week study period
All subjects with at least one study visit were questioned about adverse events and were included in the number of participants assessed for safety. The first assessments at each visit were about changes in general health and concomitant medications and the occurrence of adverse events.
|
2.4%
1/41 • Number of events 1 • The duration of the 24-week study period
All subjects with at least one study visit were questioned about adverse events and were included in the number of participants assessed for safety. The first assessments at each visit were about changes in general health and concomitant medications and the occurrence of adverse events.
|
0.00%
0/42 • The duration of the 24-week study period
All subjects with at least one study visit were questioned about adverse events and were included in the number of participants assessed for safety. The first assessments at each visit were about changes in general health and concomitant medications and the occurrence of adverse events.
|
0.00%
0/44 • The duration of the 24-week study period
All subjects with at least one study visit were questioned about adverse events and were included in the number of participants assessed for safety. The first assessments at each visit were about changes in general health and concomitant medications and the occurrence of adverse events.
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.00%
0/38 • The duration of the 24-week study period
All subjects with at least one study visit were questioned about adverse events and were included in the number of participants assessed for safety. The first assessments at each visit were about changes in general health and concomitant medications and the occurrence of adverse events.
|
0.00%
0/41 • The duration of the 24-week study period
All subjects with at least one study visit were questioned about adverse events and were included in the number of participants assessed for safety. The first assessments at each visit were about changes in general health and concomitant medications and the occurrence of adverse events.
|
0.00%
0/41 • The duration of the 24-week study period
All subjects with at least one study visit were questioned about adverse events and were included in the number of participants assessed for safety. The first assessments at each visit were about changes in general health and concomitant medications and the occurrence of adverse events.
|
2.4%
1/42 • Number of events 1 • The duration of the 24-week study period
All subjects with at least one study visit were questioned about adverse events and were included in the number of participants assessed for safety. The first assessments at each visit were about changes in general health and concomitant medications and the occurrence of adverse events.
|
0.00%
0/44 • The duration of the 24-week study period
All subjects with at least one study visit were questioned about adverse events and were included in the number of participants assessed for safety. The first assessments at each visit were about changes in general health and concomitant medications and the occurrence of adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant soft tissue neoplasm
|
0.00%
0/38 • The duration of the 24-week study period
All subjects with at least one study visit were questioned about adverse events and were included in the number of participants assessed for safety. The first assessments at each visit were about changes in general health and concomitant medications and the occurrence of adverse events.
|
0.00%
0/41 • The duration of the 24-week study period
All subjects with at least one study visit were questioned about adverse events and were included in the number of participants assessed for safety. The first assessments at each visit were about changes in general health and concomitant medications and the occurrence of adverse events.
|
2.4%
1/41 • Number of events 1 • The duration of the 24-week study period
All subjects with at least one study visit were questioned about adverse events and were included in the number of participants assessed for safety. The first assessments at each visit were about changes in general health and concomitant medications and the occurrence of adverse events.
|
0.00%
0/42 • The duration of the 24-week study period
All subjects with at least one study visit were questioned about adverse events and were included in the number of participants assessed for safety. The first assessments at each visit were about changes in general health and concomitant medications and the occurrence of adverse events.
|
0.00%
0/44 • The duration of the 24-week study period
All subjects with at least one study visit were questioned about adverse events and were included in the number of participants assessed for safety. The first assessments at each visit were about changes in general health and concomitant medications and the occurrence of adverse events.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/38 • The duration of the 24-week study period
All subjects with at least one study visit were questioned about adverse events and were included in the number of participants assessed for safety. The first assessments at each visit were about changes in general health and concomitant medications and the occurrence of adverse events.
|
0.00%
0/41 • The duration of the 24-week study period
All subjects with at least one study visit were questioned about adverse events and were included in the number of participants assessed for safety. The first assessments at each visit were about changes in general health and concomitant medications and the occurrence of adverse events.
|
0.00%
0/41 • The duration of the 24-week study period
All subjects with at least one study visit were questioned about adverse events and were included in the number of participants assessed for safety. The first assessments at each visit were about changes in general health and concomitant medications and the occurrence of adverse events.
|
2.4%
1/42 • Number of events 1 • The duration of the 24-week study period
All subjects with at least one study visit were questioned about adverse events and were included in the number of participants assessed for safety. The first assessments at each visit were about changes in general health and concomitant medications and the occurrence of adverse events.
|
0.00%
0/44 • The duration of the 24-week study period
All subjects with at least one study visit were questioned about adverse events and were included in the number of participants assessed for safety. The first assessments at each visit were about changes in general health and concomitant medications and the occurrence of adverse events.
|
|
Surgical and medical procedures
Alcohol detoxification
|
0.00%
0/38 • The duration of the 24-week study period
All subjects with at least one study visit were questioned about adverse events and were included in the number of participants assessed for safety. The first assessments at each visit were about changes in general health and concomitant medications and the occurrence of adverse events.
|
0.00%
0/41 • The duration of the 24-week study period
All subjects with at least one study visit were questioned about adverse events and were included in the number of participants assessed for safety. The first assessments at each visit were about changes in general health and concomitant medications and the occurrence of adverse events.
|
0.00%
0/41 • The duration of the 24-week study period
All subjects with at least one study visit were questioned about adverse events and were included in the number of participants assessed for safety. The first assessments at each visit were about changes in general health and concomitant medications and the occurrence of adverse events.
|
2.4%
1/42 • Number of events 1 • The duration of the 24-week study period
All subjects with at least one study visit were questioned about adverse events and were included in the number of participants assessed for safety. The first assessments at each visit were about changes in general health and concomitant medications and the occurrence of adverse events.
|
0.00%
0/44 • The duration of the 24-week study period
All subjects with at least one study visit were questioned about adverse events and were included in the number of participants assessed for safety. The first assessments at each visit were about changes in general health and concomitant medications and the occurrence of adverse events.
|
|
Vascular disorders
Aneurysm ruptured
|
0.00%
0/38 • The duration of the 24-week study period
All subjects with at least one study visit were questioned about adverse events and were included in the number of participants assessed for safety. The first assessments at each visit were about changes in general health and concomitant medications and the occurrence of adverse events.
|
0.00%
0/41 • The duration of the 24-week study period
All subjects with at least one study visit were questioned about adverse events and were included in the number of participants assessed for safety. The first assessments at each visit were about changes in general health and concomitant medications and the occurrence of adverse events.
|
0.00%
0/41 • The duration of the 24-week study period
All subjects with at least one study visit were questioned about adverse events and were included in the number of participants assessed for safety. The first assessments at each visit were about changes in general health and concomitant medications and the occurrence of adverse events.
|
0.00%
0/42 • The duration of the 24-week study period
All subjects with at least one study visit were questioned about adverse events and were included in the number of participants assessed for safety. The first assessments at each visit were about changes in general health and concomitant medications and the occurrence of adverse events.
|
2.3%
1/44 • Number of events 1 • The duration of the 24-week study period
All subjects with at least one study visit were questioned about adverse events and were included in the number of participants assessed for safety. The first assessments at each visit were about changes in general health and concomitant medications and the occurrence of adverse events.
|
|
Vascular disorders
Deep vein thrombosis
|
2.6%
1/38 • Number of events 1 • The duration of the 24-week study period
All subjects with at least one study visit were questioned about adverse events and were included in the number of participants assessed for safety. The first assessments at each visit were about changes in general health and concomitant medications and the occurrence of adverse events.
|
0.00%
0/41 • The duration of the 24-week study period
All subjects with at least one study visit were questioned about adverse events and were included in the number of participants assessed for safety. The first assessments at each visit were about changes in general health and concomitant medications and the occurrence of adverse events.
|
0.00%
0/41 • The duration of the 24-week study period
All subjects with at least one study visit were questioned about adverse events and were included in the number of participants assessed for safety. The first assessments at each visit were about changes in general health and concomitant medications and the occurrence of adverse events.
|
0.00%
0/42 • The duration of the 24-week study period
All subjects with at least one study visit were questioned about adverse events and were included in the number of participants assessed for safety. The first assessments at each visit were about changes in general health and concomitant medications and the occurrence of adverse events.
|
0.00%
0/44 • The duration of the 24-week study period
All subjects with at least one study visit were questioned about adverse events and were included in the number of participants assessed for safety. The first assessments at each visit were about changes in general health and concomitant medications and the occurrence of adverse events.
|
|
Vascular disorders
Venous insufficiency
|
0.00%
0/38 • The duration of the 24-week study period
All subjects with at least one study visit were questioned about adverse events and were included in the number of participants assessed for safety. The first assessments at each visit were about changes in general health and concomitant medications and the occurrence of adverse events.
|
0.00%
0/41 • The duration of the 24-week study period
All subjects with at least one study visit were questioned about adverse events and were included in the number of participants assessed for safety. The first assessments at each visit were about changes in general health and concomitant medications and the occurrence of adverse events.
|
0.00%
0/41 • The duration of the 24-week study period
All subjects with at least one study visit were questioned about adverse events and were included in the number of participants assessed for safety. The first assessments at each visit were about changes in general health and concomitant medications and the occurrence of adverse events.
|
0.00%
0/42 • The duration of the 24-week study period
All subjects with at least one study visit were questioned about adverse events and were included in the number of participants assessed for safety. The first assessments at each visit were about changes in general health and concomitant medications and the occurrence of adverse events.
|
2.3%
1/44 • Number of events 1 • The duration of the 24-week study period
All subjects with at least one study visit were questioned about adverse events and were included in the number of participants assessed for safety. The first assessments at each visit were about changes in general health and concomitant medications and the occurrence of adverse events.
|
Other adverse events
| Measure |
LD-Q14D
n=38 participants at risk
LD-Q14D: 0.5 x 106 cell/mL applied to wound surface every 2 weeks
|
LD-Q7D
n=41 participants at risk
LD-Q7D: 0.5 x 106 cell/mL applied to wound surface every week
|
HD-Q14D
n=41 participants at risk
HD-Q14D: 5.0 x 106 cell/mL applied to wound surface every 2 weeks
|
HD-Q7D
n=42 participants at risk
HD-Q7D: 5.0 x 106 cell/mL applied to wound surface every week
|
HP802-247 Vehicle
n=44 participants at risk
|
|---|---|---|---|---|---|
|
Infections and infestations
Cellulitis
|
5.3%
2/38 • Number of events 2 • The duration of the 24-week study period
All subjects with at least one study visit were questioned about adverse events and were included in the number of participants assessed for safety. The first assessments at each visit were about changes in general health and concomitant medications and the occurrence of adverse events.
|
0.00%
0/41 • The duration of the 24-week study period
All subjects with at least one study visit were questioned about adverse events and were included in the number of participants assessed for safety. The first assessments at each visit were about changes in general health and concomitant medications and the occurrence of adverse events.
|
0.00%
0/41 • The duration of the 24-week study period
All subjects with at least one study visit were questioned about adverse events and were included in the number of participants assessed for safety. The first assessments at each visit were about changes in general health and concomitant medications and the occurrence of adverse events.
|
4.8%
2/42 • Number of events 2 • The duration of the 24-week study period
All subjects with at least one study visit were questioned about adverse events and were included in the number of participants assessed for safety. The first assessments at each visit were about changes in general health and concomitant medications and the occurrence of adverse events.
|
4.5%
2/44 • Number of events 3 • The duration of the 24-week study period
All subjects with at least one study visit were questioned about adverse events and were included in the number of participants assessed for safety. The first assessments at each visit were about changes in general health and concomitant medications and the occurrence of adverse events.
|
|
Infections and infestations
Wound infection
|
2.6%
1/38 • Number of events 1 • The duration of the 24-week study period
All subjects with at least one study visit were questioned about adverse events and were included in the number of participants assessed for safety. The first assessments at each visit were about changes in general health and concomitant medications and the occurrence of adverse events.
|
2.4%
1/41 • Number of events 1 • The duration of the 24-week study period
All subjects with at least one study visit were questioned about adverse events and were included in the number of participants assessed for safety. The first assessments at each visit were about changes in general health and concomitant medications and the occurrence of adverse events.
|
2.4%
1/41 • Number of events 2 • The duration of the 24-week study period
All subjects with at least one study visit were questioned about adverse events and were included in the number of participants assessed for safety. The first assessments at each visit were about changes in general health and concomitant medications and the occurrence of adverse events.
|
4.8%
2/42 • Number of events 3 • The duration of the 24-week study period
All subjects with at least one study visit were questioned about adverse events and were included in the number of participants assessed for safety. The first assessments at each visit were about changes in general health and concomitant medications and the occurrence of adverse events.
|
4.5%
2/44 • Number of events 4 • The duration of the 24-week study period
All subjects with at least one study visit were questioned about adverse events and were included in the number of participants assessed for safety. The first assessments at each visit were about changes in general health and concomitant medications and the occurrence of adverse events.
|
|
Injury, poisoning and procedural complications
Injury, poisoning and procedural complications
|
2.6%
1/38 • Number of events 1 • The duration of the 24-week study period
All subjects with at least one study visit were questioned about adverse events and were included in the number of participants assessed for safety. The first assessments at each visit were about changes in general health and concomitant medications and the occurrence of adverse events.
|
0.00%
0/41 • The duration of the 24-week study period
All subjects with at least one study visit were questioned about adverse events and were included in the number of participants assessed for safety. The first assessments at each visit were about changes in general health and concomitant medications and the occurrence of adverse events.
|
4.9%
2/41 • Number of events 3 • The duration of the 24-week study period
All subjects with at least one study visit were questioned about adverse events and were included in the number of participants assessed for safety. The first assessments at each visit were about changes in general health and concomitant medications and the occurrence of adverse events.
|
0.00%
0/42 • The duration of the 24-week study period
All subjects with at least one study visit were questioned about adverse events and were included in the number of participants assessed for safety. The first assessments at each visit were about changes in general health and concomitant medications and the occurrence of adverse events.
|
2.3%
1/44 • Number of events 1 • The duration of the 24-week study period
All subjects with at least one study visit were questioned about adverse events and were included in the number of participants assessed for safety. The first assessments at each visit were about changes in general health and concomitant medications and the occurrence of adverse events.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/38 • The duration of the 24-week study period
All subjects with at least one study visit were questioned about adverse events and were included in the number of participants assessed for safety. The first assessments at each visit were about changes in general health and concomitant medications and the occurrence of adverse events.
|
0.00%
0/41 • The duration of the 24-week study period
All subjects with at least one study visit were questioned about adverse events and were included in the number of participants assessed for safety. The first assessments at each visit were about changes in general health and concomitant medications and the occurrence of adverse events.
|
2.4%
1/41 • Number of events 1 • The duration of the 24-week study period
All subjects with at least one study visit were questioned about adverse events and were included in the number of participants assessed for safety. The first assessments at each visit were about changes in general health and concomitant medications and the occurrence of adverse events.
|
0.00%
0/42 • The duration of the 24-week study period
All subjects with at least one study visit were questioned about adverse events and were included in the number of participants assessed for safety. The first assessments at each visit were about changes in general health and concomitant medications and the occurrence of adverse events.
|
4.5%
2/44 • Number of events 2 • The duration of the 24-week study period
All subjects with at least one study visit were questioned about adverse events and were included in the number of participants assessed for safety. The first assessments at each visit were about changes in general health and concomitant medications and the occurrence of adverse events.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
10.5%
4/38 • Number of events 5 • The duration of the 24-week study period
All subjects with at least one study visit were questioned about adverse events and were included in the number of participants assessed for safety. The first assessments at each visit were about changes in general health and concomitant medications and the occurrence of adverse events.
|
4.9%
2/41 • Number of events 2 • The duration of the 24-week study period
All subjects with at least one study visit were questioned about adverse events and were included in the number of participants assessed for safety. The first assessments at each visit were about changes in general health and concomitant medications and the occurrence of adverse events.
|
0.00%
0/41 • The duration of the 24-week study period
All subjects with at least one study visit were questioned about adverse events and were included in the number of participants assessed for safety. The first assessments at each visit were about changes in general health and concomitant medications and the occurrence of adverse events.
|
7.1%
3/42 • Number of events 4 • The duration of the 24-week study period
All subjects with at least one study visit were questioned about adverse events and were included in the number of participants assessed for safety. The first assessments at each visit were about changes in general health and concomitant medications and the occurrence of adverse events.
|
13.6%
6/44 • Number of events 9 • The duration of the 24-week study period
All subjects with at least one study visit were questioned about adverse events and were included in the number of participants assessed for safety. The first assessments at each visit were about changes in general health and concomitant medications and the occurrence of adverse events.
|
|
Infections and infestations
Infections and infestations
|
13.2%
5/38 • Number of events 6 • The duration of the 24-week study period
All subjects with at least one study visit were questioned about adverse events and were included in the number of participants assessed for safety. The first assessments at each visit were about changes in general health and concomitant medications and the occurrence of adverse events.
|
4.9%
2/41 • Number of events 2 • The duration of the 24-week study period
All subjects with at least one study visit were questioned about adverse events and were included in the number of participants assessed for safety. The first assessments at each visit were about changes in general health and concomitant medications and the occurrence of adverse events.
|
2.4%
1/41 • Number of events 2 • The duration of the 24-week study period
All subjects with at least one study visit were questioned about adverse events and were included in the number of participants assessed for safety. The first assessments at each visit were about changes in general health and concomitant medications and the occurrence of adverse events.
|
11.9%
5/42 • Number of events 7 • The duration of the 24-week study period
All subjects with at least one study visit were questioned about adverse events and were included in the number of participants assessed for safety. The first assessments at each visit were about changes in general health and concomitant medications and the occurrence of adverse events.
|
15.9%
7/44 • Number of events 10 • The duration of the 24-week study period
All subjects with at least one study visit were questioned about adverse events and were included in the number of participants assessed for safety. The first assessments at each visit were about changes in general health and concomitant medications and the occurrence of adverse events.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders
|
10.5%
4/38 • Number of events 6 • The duration of the 24-week study period
All subjects with at least one study visit were questioned about adverse events and were included in the number of participants assessed for safety. The first assessments at each visit were about changes in general health and concomitant medications and the occurrence of adverse events.
|
7.3%
3/41 • Number of events 3 • The duration of the 24-week study period
All subjects with at least one study visit were questioned about adverse events and were included in the number of participants assessed for safety. The first assessments at each visit were about changes in general health and concomitant medications and the occurrence of adverse events.
|
4.9%
2/41 • Number of events 4 • The duration of the 24-week study period
All subjects with at least one study visit were questioned about adverse events and were included in the number of participants assessed for safety. The first assessments at each visit were about changes in general health and concomitant medications and the occurrence of adverse events.
|
9.5%
4/42 • Number of events 5 • The duration of the 24-week study period
All subjects with at least one study visit were questioned about adverse events and were included in the number of participants assessed for safety. The first assessments at each visit were about changes in general health and concomitant medications and the occurrence of adverse events.
|
20.5%
9/44 • Number of events 14 • The duration of the 24-week study period
All subjects with at least one study visit were questioned about adverse events and were included in the number of participants assessed for safety. The first assessments at each visit were about changes in general health and concomitant medications and the occurrence of adverse events.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60