Trial Outcomes & Findings for Expression of Angiogenic Biomarkers During Healing of Intra-Oral Soft Tissue Engineered Grafts (NCT NCT01134081)
NCT ID: NCT01134081
Last Updated: 2017-08-21
Results Overview
Within-subject difference between the concentrations at the CelTX and Free Gingival Graft areas
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
44 participants
Primary outcome timeframe
5 time-points: pre-surgical, week(s) 1, 2, 3 and 4
Results posted on
2017-08-21
Participant Flow
44 subjects were enrolled. All 44 subjects participated in both arms/groups for a total of 88 surgical sites. 2 surgical sites of each patient were randomly selected to receive LCC as a donor material in 1 site and a conventional autograft using keratinized tissue from the palate as the donor material at the contralateral site.
Participant milestones
| Measure |
CelTx™ & Free Gingival Grafts
CelTx™: Living bilayered cell therapy product Free Gingival Grafts: Harvested tissue from palate
|
|---|---|
|
Overall Study
STARTED
|
44
|
|
Overall Study
COMPLETED
|
44
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Expression of Angiogenic Biomarkers During Healing of Intra-Oral Soft Tissue Engineered Grafts
Baseline characteristics by cohort
| Measure |
CelTx™ & Free Gingival Grafts
n=88 Surgical sites
CelTx™: Living bilayered cell therapy product Free Gingival Grafts: Harvested tissue from palate
|
|---|---|
|
Age, Continuous
|
47.1 years
STANDARD_DEVIATION 13.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
25 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
44 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 5 time-points: pre-surgical, week(s) 1, 2, 3 and 4Population: 44 subjects were enrolled. All 44 subjects participated in both arms/groups for a total of 88 surgical sites. 2 surgical sites of each patient were randomly selected to receive LCC as a donor material in 1 site and a conventional autograft using keratinized tissue from the palate as the donor material at the contralateral site.
Within-subject difference between the concentrations at the CelTX and Free Gingival Graft areas
Outcome measures
| Measure |
CelTx™
n=44 Surgical sites
Living bilayered cell therapy product
|
Free Gingival Grafts
n=44 Surgical sites
Harvested tissue from palate
|
|---|---|---|
|
Differences in Angiogenic Biomarkers
GM-CSF-week 2
|
93.20 ng/mL
Standard Error 21.38
|
93.81 ng/mL
Standard Error 20.36
|
|
Differences in Angiogenic Biomarkers
VEGF-pre-surgical
|
0.51 ng/mL
Standard Error .07
|
.69 ng/mL
Standard Error .15
|
|
Differences in Angiogenic Biomarkers
VGEF-week 1
|
1.04 ng/mL
Standard Error .24
|
.67 ng/mL
Standard Error .12
|
|
Differences in Angiogenic Biomarkers
VGEF-week 2
|
.28 ng/mL
Standard Error .06
|
.16 ng/mL
Standard Error .04
|
|
Differences in Angiogenic Biomarkers
VGEF-week 3
|
.14 ng/mL
Standard Error .03
|
.11 ng/mL
Standard Error .03
|
|
Differences in Angiogenic Biomarkers
VGEF-week 4
|
.1 ng/mL
Standard Error .02
|
.06 ng/mL
Standard Error .02
|
|
Differences in Angiogenic Biomarkers
Angiogenin (ANG)-pre-surgical
|
6.19 ng/mL
Standard Error .97
|
5.60 ng/mL
Standard Error .82
|
|
Differences in Angiogenic Biomarkers
Angiogenin (ANG)-week 1
|
8.32 ng/mL
Standard Error 1.26
|
7.09 ng/mL
Standard Error 1.24
|
|
Differences in Angiogenic Biomarkers
Angiogenin (ANG)-week 2
|
3.67 ng/mL
Standard Error .65
|
2.56 ng/mL
Standard Error .54
|
|
Differences in Angiogenic Biomarkers
Angiogenin (ANG)-week 3
|
1.92 ng/mL
Standard Error .30
|
1.85 ng/mL
Standard Error .36
|
|
Differences in Angiogenic Biomarkers
Angiogenin (ANG)-week 4
|
1.34 ng/mL
Standard Error .23
|
1.58 ng/mL
Standard Error .38
|
|
Differences in Angiogenic Biomarkers
IL-8-pre-surgical
|
1.29 ng/mL
Standard Error .21
|
1.31 ng/mL
Standard Error .22
|
|
Differences in Angiogenic Biomarkers
IL-8-week 1
|
5.6 ng/mL
Standard Error .76
|
4.44 ng/mL
Standard Error .72
|
|
Differences in Angiogenic Biomarkers
IL-8-week 2
|
.58 ng/mL
Standard Error .15
|
.31 ng/mL
Standard Error .09
|
|
Differences in Angiogenic Biomarkers
IL-8-week 3
|
.19 ng/mL
Standard Error .07
|
.15 ng/mL
Standard Error .06
|
|
Differences in Angiogenic Biomarkers
IL-8-week 4
|
.11 ng/mL
Standard Error .03
|
.11 ng/mL
Standard Error .04
|
|
Differences in Angiogenic Biomarkers
FGF-2-pre-surgical
|
.65 ng/mL
Standard Error .12
|
.72 ng/mL
Standard Error .17
|
|
Differences in Angiogenic Biomarkers
FGF-2-week 1
|
1.36 ng/mL
Standard Error .51
|
.85 ng/mL
Standard Error .17
|
|
Differences in Angiogenic Biomarkers
FGF-2-week 2
|
.4 ng/mL
Standard Error .11
|
.34 ng/mL
Standard Error .11
|
|
Differences in Angiogenic Biomarkers
FGF-2-week 3
|
.20 ng/mL
Standard Error .06
|
.29 ng/mL
Standard Error .08
|
|
Differences in Angiogenic Biomarkers
FGF-2-week 4
|
.18 ng/mL
Standard Error .07
|
.24 ng/mL
Standard Error .08
|
|
Differences in Angiogenic Biomarkers
Angiostatin (ANT)-pre-surgical
|
6728.08 ng/mL
Standard Error 1996.62
|
7931.32 ng/mL
Standard Error 2813.77
|
|
Differences in Angiogenic Biomarkers
Angiostatin (ANT)-week 1
|
12330.29 ng/mL
Standard Error 3523.17
|
3871.60 ng/mL
Standard Error 782.5
|
|
Differences in Angiogenic Biomarkers
Angiostatin (ANT)-week 2
|
3059.87 ng/mL
Standard Error 1037.32
|
1524.59 ng/mL
Standard Error 654.12
|
|
Differences in Angiogenic Biomarkers
Angiostatin (ANT)-week 3
|
1668.22 ng/mL
Standard Error 605.07
|
1682.54 ng/mL
Standard Error 453.33
|
|
Differences in Angiogenic Biomarkers
Angiostatin (ANT)-week 4
|
1527.26 ng/mL
Standard Error 507.75
|
1183.51 ng/mL
Standard Error 441.75
|
|
Differences in Angiogenic Biomarkers
TIMP-1-pre-surgical
|
9.14 ng/mL
Standard Error 1.09
|
8.56 ng/mL
Standard Error 1.25
|
|
Differences in Angiogenic Biomarkers
TIMP-1-week 1
|
16.63 ng/mL
Standard Error 1.68
|
14.68 ng/mL
Standard Error 1.77
|
|
Differences in Angiogenic Biomarkers
TIMP-1-week 2
|
7.81 ng/mL
Standard Error 1.42
|
5.60 ng/mL
Standard Error .93
|
|
Differences in Angiogenic Biomarkers
TIMP-1-week 3
|
4.63 ng/mL
Standard Error .94
|
3.98 ng/mL
Standard Error .77
|
|
Differences in Angiogenic Biomarkers
TIMP-1-week 4
|
3.98 ng/mL
Standard Error .72
|
3.58 ng/mL
Standard Error .73
|
|
Differences in Angiogenic Biomarkers
TIMP-2-pre-surgical
|
6.85 ng/mL
Standard Error 1.51
|
11.11 ng/mL
Standard Error 4.18
|
|
Differences in Angiogenic Biomarkers
TIMP-2-week 1
|
17.13 ng/mL
Standard Error 3.47
|
9.91 ng/mL
Standard Error 2.14
|
|
Differences in Angiogenic Biomarkers
TIMP-2-week 2
|
3.70 ng/mL
Standard Error .95
|
2.41 ng/mL
Standard Error .77
|
|
Differences in Angiogenic Biomarkers
TIMP-2-week 3
|
2.16 ng/mL
Standard Error .70
|
1.43 ng/mL
Standard Error .46
|
|
Differences in Angiogenic Biomarkers
TIMP-2-week 4
|
1.50 ng/mL
Standard Error .52
|
.93 ng/mL
Standard Error .34
|
|
Differences in Angiogenic Biomarkers
GM-CSF-pre-surgical
|
59.48 ng/mL
Standard Error 19.53
|
50.27 ng/mL
Standard Error 13.97
|
|
Differences in Angiogenic Biomarkers
GM-CSF-week 1
|
99.85 ng/mL
Standard Error 21.57
|
102.02 ng/mL
Standard Error 24.65
|
|
Differences in Angiogenic Biomarkers
GM-CSF-week 3
|
91.16 ng/mL
Standard Error 20.76
|
86.16 ng/mL
Standard Error 18.34
|
|
Differences in Angiogenic Biomarkers
GM-CSF-week 4
|
71.81 ng/mL
Standard Error 16.76
|
80.34 ng/mL
Standard Error 16.12
|
|
Differences in Angiogenic Biomarkers
IP-10-pre-surgical
|
.78 ng/mL
Standard Error .36
|
.21 ng/mL
Standard Error .07
|
|
Differences in Angiogenic Biomarkers
IP-10-week 1
|
.03 ng/mL
Standard Error .02
|
.5 ng/mL
Standard Error .45
|
|
Differences in Angiogenic Biomarkers
IP-10-week 2
|
.39 ng/mL
Standard Error .29
|
.08 ng/mL
Standard Error .08
|
|
Differences in Angiogenic Biomarkers
IP-10-week 3
|
.18 ng/mL
Standard Error .12
|
.02 ng/mL
Standard Error .01
|
|
Differences in Angiogenic Biomarkers
IP-10-week 4
|
.01 ng/mL
Standard Error .01
|
.01 ng/mL
Standard Error .01
|
PRIMARY outcome
Timeframe: 5 time-points: pre-surgical, week(s) 1, 2, 3 and 4Population: 44 subjects were enrolled. All 44 subjects participated in both arms/groups for a total of 88 surgical sites. 2 surgical sites of each patient were randomly selected to receive LCC as a donor material in 1 site and a conventional autograft using keratinized tissue from the palate as the donor material at the contralateral site.
Within-subject difference between the concentrations at the CelTX and Free Gingival Graft areas
Outcome measures
| Measure |
CelTx™
n=44 Participants
Living bilayered cell therapy product
|
Free Gingival Grafts
n=44 Participants
Harvested tissue from palate
|
|---|---|---|
|
Differences in Angiogenic Biomarkers: PDGF-BB
Pre-surgical
|
10.59 pg/mL
Standard Error 3.06
|
9.73 pg/mL
Standard Error 3.41
|
|
Differences in Angiogenic Biomarkers: PDGF-BB
Week 1
|
51.82 pg/mL
Standard Error 20.41
|
28.92 pg/mL
Standard Error 13.73
|
|
Differences in Angiogenic Biomarkers: PDGF-BB
Week 2
|
4.50 pg/mL
Standard Error 3.03
|
2.33 pg/mL
Standard Error 1.00
|
|
Differences in Angiogenic Biomarkers: PDGF-BB
Week 3
|
2.15 pg/mL
Standard Error .83
|
1.01 pg/mL
Standard Error .44
|
|
Differences in Angiogenic Biomarkers: PDGF-BB
Week 4
|
.86 pg/mL
Standard Error .43
|
.87 pg/mL
Standard Error .50
|
Adverse Events
CelTx™
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Free Gingival Graft
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place