FindTrial
Sign In

Expression of Angiogenic Biomarkers During Healing of Intra-Oral Soft Tissue Engineered Grafts

Expression of Angiogenic Biomarkers During Healing of Intra-Oral Soft Tissue Engineered Grafts

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01134081
Enrollment
44
Registered
2010-05-31
Start date
2008-01-31
Completion date
2008-12-31
Last updated
2017-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gingival Recession

Keywords

gum, recession

Brief summary

The purpose of this observational research study is to understand more about wound healing of gum tissue. This study was the biomarker study of a small cohort of study participants derived from NCT01547962 (completed). Two surgical sites of each patient were randomly selected to receive CelTx™ as a donor material in one site and conventional autograft using keratinized tissue from the palate as the donor material at the contralateral (opposite side) site. Fluids collected from between a tooth and the gum and directly from wounds contain proteins that occur in different levels as the wound healing process proceeds. In this research study wound fluid will be collected from the donor palate site (roof of your mouth) and the treated sites on your gum before and after placement of CelTx and conventional treatment (tissue from the roof of your mouth) to measure which proteins and how much of each are present during the first 4 weeks of wound healing.

Detailed description

In a clinical trial designed to evaluate the safety and effectiveness of rhPDGF-BB to promote soft and hard tissue engineering of the periodontium, the subjects provided gingival crevicular fluid (GCF) or periodontal wound fluid (WF) and the results demonstrated contrasting inducible expression patterns of PDGF-AB, VEGF, and ICTP during periodontal healing \[17, 24, 25\]. However, little is known regarding the release of these molecules into local periodontal wound fluid during tissue-engineered grafts. The aim of this study is to determine the presence and influence of angiogenic biomarkers, such as PDGF, VEGF, and FGF, involved in the wound healing process of tissue engineered grafts in the treatment of subjects (with recession-type defects) who have an insufficient zone of attached gingival associated with at least two nonadjacent teeth. STUDY OBJECTIVES The purpose of this pilot study is to compare the expression of angiogenic biomarkers involved in the wound healing process of 2 different periodontal surgical approaches: 1) CelTx™ (living bilayered cell therapy product) and 2) free gingival grafts

Interventions

BIOLOGICALCelTx™

CelTx™ is a living bilayered cell therapy product. CelTx™ is constructed of Type I bovine collagen (extracted from bovine tendons and subsequently purified) and viable allogeneic human fibroblasts and keratinocytes isolated from human neonatal foreskin. This is applied once in the oral cavity.

PROCEDUREFree Gingival Graft

Harvested tissue from palate

Sponsors

Organogenesis
CollaboratorINDUSTRY
University of Michigan
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Subject has signed informed consent to participate in Organogenesis Clinical Protocol 06-PER-002-CTX. * Subject has signed informed consent to participate in this adjunct bio-marker study. * Subject is willing to comply with the additional study visits at weeks 2 and 3 as required by this study.

Exclusion criteria

\- Subject requires antibiotic prophylaxis for routine dental procedures.

Design outcomes

Primary

MeasureTime frameDescription
Differences in Angiogenic Biomarkers5 time-points: pre-surgical, week(s) 1, 2, 3 and 4Within-subject difference between the concentrations at the CelTX and Free Gingival Graft areas
Differences in Angiogenic Biomarkers: PDGF-BB5 time-points: pre-surgical, week(s) 1, 2, 3 and 4Within-subject difference between the concentrations at the CelTX and Free Gingival Graft areas

Countries

United States

Participant flow

Recruitment details

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.

Participants by arm

ArmCount
CelTx™ & Free Gingival Grafts
CelTx™: Living bilayered cell therapy product Free Gingival Grafts: Harvested tissue from palate
44
CelTx™ & Free Gingival Grafts
CelTx™: Living bilayered cell therapy product Free Gingival Grafts: Harvested tissue from palate
88
Total132

Baseline characteristics

CharacteristicCelTx™ & Free Gingival Grafts
Age, Continuous47.1 years
STANDARD_DEVIATION 13.1
Region of Enrollment
United States
44 Participants
Sex: Female, Male
Female
19 Participants
Sex: Female, Male
Male
25 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
0 / 440 / 44
serious
Total, serious adverse events
0 / 440 / 44

Outcome results

Primary

Differences in Angiogenic Biomarkers

Within-subject difference between the concentrations at the CelTX and Free Gingival Graft areas

Time frame: 5 time-points: pre-surgical, week(s) 1, 2, 3 and 4

Population: 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.

ArmMeasureGroupValue (MEAN)Dispersion
CelTx™Differences in Angiogenic BiomarkersVEGF-pre-surgical0.51 ng/mLStandard Error 0.07
CelTx™Differences in Angiogenic BiomarkersVGEF-week 11.04 ng/mLStandard Error 0.24
CelTx™Differences in Angiogenic BiomarkersVGEF-week 2.28 ng/mLStandard Error 0.06
CelTx™Differences in Angiogenic BiomarkersVGEF-week 3.14 ng/mLStandard Error 0.03
CelTx™Differences in Angiogenic BiomarkersVGEF-week 4.1 ng/mLStandard Error 0.02
CelTx™Differences in Angiogenic BiomarkersAngiogenin (ANG)-pre-surgical6.19 ng/mLStandard Error 0.97
CelTx™Differences in Angiogenic BiomarkersAngiogenin (ANG)-week 18.32 ng/mLStandard Error 1.26
CelTx™Differences in Angiogenic BiomarkersAngiogenin (ANG)-week 23.67 ng/mLStandard Error 0.65
CelTx™Differences in Angiogenic BiomarkersAngiogenin (ANG)-week 31.92 ng/mLStandard Error 0.3
CelTx™Differences in Angiogenic BiomarkersAngiogenin (ANG)-week 41.34 ng/mLStandard Error 0.23
CelTx™Differences in Angiogenic BiomarkersIL-8-pre-surgical1.29 ng/mLStandard Error 0.21
CelTx™Differences in Angiogenic BiomarkersIL-8-week 15.6 ng/mLStandard Error 0.76
CelTx™Differences in Angiogenic BiomarkersIL-8-week 2.58 ng/mLStandard Error 0.15
CelTx™Differences in Angiogenic BiomarkersIL-8-week 3.19 ng/mLStandard Error 0.07
CelTx™Differences in Angiogenic BiomarkersIL-8-week 4.11 ng/mLStandard Error 0.03
CelTx™Differences in Angiogenic BiomarkersFGF-2-pre-surgical.65 ng/mLStandard Error 0.12
CelTx™Differences in Angiogenic BiomarkersFGF-2-week 11.36 ng/mLStandard Error 0.51
CelTx™Differences in Angiogenic BiomarkersFGF-2-week 2.4 ng/mLStandard Error 0.11
CelTx™Differences in Angiogenic BiomarkersFGF-2-week 3.20 ng/mLStandard Error 0.06
CelTx™Differences in Angiogenic BiomarkersFGF-2-week 4.18 ng/mLStandard Error 0.07
CelTx™Differences in Angiogenic BiomarkersAngiostatin (ANT)-pre-surgical6728.08 ng/mLStandard Error 1996.62
CelTx™Differences in Angiogenic BiomarkersAngiostatin (ANT)-week 112330.29 ng/mLStandard Error 3523.17
CelTx™Differences in Angiogenic BiomarkersAngiostatin (ANT)-week 23059.87 ng/mLStandard Error 1037.32
CelTx™Differences in Angiogenic BiomarkersAngiostatin (ANT)-week 31668.22 ng/mLStandard Error 605.07
CelTx™Differences in Angiogenic BiomarkersAngiostatin (ANT)-week 41527.26 ng/mLStandard Error 507.75
CelTx™Differences in Angiogenic BiomarkersTIMP-1-pre-surgical9.14 ng/mLStandard Error 1.09
CelTx™Differences in Angiogenic BiomarkersTIMP-1-week 116.63 ng/mLStandard Error 1.68
CelTx™Differences in Angiogenic BiomarkersTIMP-1-week 27.81 ng/mLStandard Error 1.42
CelTx™Differences in Angiogenic BiomarkersTIMP-1-week 34.63 ng/mLStandard Error 0.94
CelTx™Differences in Angiogenic BiomarkersTIMP-1-week 43.98 ng/mLStandard Error 0.72
CelTx™Differences in Angiogenic BiomarkersTIMP-2-pre-surgical6.85 ng/mLStandard Error 1.51
CelTx™Differences in Angiogenic BiomarkersTIMP-2-week 117.13 ng/mLStandard Error 3.47
CelTx™Differences in Angiogenic BiomarkersTIMP-2-week 23.70 ng/mLStandard Error 0.95
CelTx™Differences in Angiogenic BiomarkersTIMP-2-week 32.16 ng/mLStandard Error 0.7
CelTx™Differences in Angiogenic BiomarkersTIMP-2-week 41.50 ng/mLStandard Error 0.52
CelTx™Differences in Angiogenic BiomarkersGM-CSF-pre-surgical59.48 ng/mLStandard Error 19.53
CelTx™Differences in Angiogenic BiomarkersGM-CSF-week 199.85 ng/mLStandard Error 21.57
CelTx™Differences in Angiogenic BiomarkersGM-CSF-week 293.20 ng/mLStandard Error 21.38
CelTx™Differences in Angiogenic BiomarkersGM-CSF-week 391.16 ng/mLStandard Error 20.76
CelTx™Differences in Angiogenic BiomarkersGM-CSF-week 471.81 ng/mLStandard Error 16.76
CelTx™Differences in Angiogenic BiomarkersIP-10-pre-surgical.78 ng/mLStandard Error 0.36
CelTx™Differences in Angiogenic BiomarkersIP-10-week 1.03 ng/mLStandard Error 0.02
CelTx™Differences in Angiogenic BiomarkersIP-10-week 2.39 ng/mLStandard Error 0.29
CelTx™Differences in Angiogenic BiomarkersIP-10-week 3.18 ng/mLStandard Error 0.12
CelTx™Differences in Angiogenic BiomarkersIP-10-week 4.01 ng/mLStandard Error 0.01
Free Gingival GraftsDifferences in Angiogenic BiomarkersAngiostatin (ANT)-week 21524.59 ng/mLStandard Error 654.12
Free Gingival GraftsDifferences in Angiogenic BiomarkersVEGF-pre-surgical.69 ng/mLStandard Error 0.15
Free Gingival GraftsDifferences in Angiogenic BiomarkersGM-CSF-week 480.34 ng/mLStandard Error 16.12
Free Gingival GraftsDifferences in Angiogenic BiomarkersVGEF-week 1.67 ng/mLStandard Error 0.12
Free Gingival GraftsDifferences in Angiogenic BiomarkersAngiostatin (ANT)-week 31682.54 ng/mLStandard Error 453.33
Free Gingival GraftsDifferences in Angiogenic BiomarkersVGEF-week 2.16 ng/mLStandard Error 0.04
Free Gingival GraftsDifferences in Angiogenic BiomarkersTIMP-2-week 4.93 ng/mLStandard Error 0.34
Free Gingival GraftsDifferences in Angiogenic BiomarkersVGEF-week 3.11 ng/mLStandard Error 0.03
Free Gingival GraftsDifferences in Angiogenic BiomarkersAngiostatin (ANT)-week 41183.51 ng/mLStandard Error 441.75
Free Gingival GraftsDifferences in Angiogenic BiomarkersVGEF-week 4.06 ng/mLStandard Error 0.02
Free Gingival GraftsDifferences in Angiogenic BiomarkersIP-10-week 2.08 ng/mLStandard Error 0.08
Free Gingival GraftsDifferences in Angiogenic BiomarkersAngiogenin (ANG)-pre-surgical5.60 ng/mLStandard Error 0.82
Free Gingival GraftsDifferences in Angiogenic BiomarkersTIMP-1-pre-surgical8.56 ng/mLStandard Error 1.25
Free Gingival GraftsDifferences in Angiogenic BiomarkersAngiogenin (ANG)-week 17.09 ng/mLStandard Error 1.24
Free Gingival GraftsDifferences in Angiogenic BiomarkersGM-CSF-pre-surgical50.27 ng/mLStandard Error 13.97
Free Gingival GraftsDifferences in Angiogenic BiomarkersAngiogenin (ANG)-week 22.56 ng/mLStandard Error 0.54
Free Gingival GraftsDifferences in Angiogenic BiomarkersTIMP-1-week 114.68 ng/mLStandard Error 1.77
Free Gingival GraftsDifferences in Angiogenic BiomarkersAngiogenin (ANG)-week 31.85 ng/mLStandard Error 0.36
Free Gingival GraftsDifferences in Angiogenic BiomarkersIP-10-pre-surgical.21 ng/mLStandard Error 0.07
Free Gingival GraftsDifferences in Angiogenic BiomarkersAngiogenin (ANG)-week 41.58 ng/mLStandard Error 0.38
Free Gingival GraftsDifferences in Angiogenic BiomarkersTIMP-1-week 25.60 ng/mLStandard Error 0.93
Free Gingival GraftsDifferences in Angiogenic BiomarkersIL-8-pre-surgical1.31 ng/mLStandard Error 0.22
Free Gingival GraftsDifferences in Angiogenic BiomarkersGM-CSF-week 1102.02 ng/mLStandard Error 24.65
Free Gingival GraftsDifferences in Angiogenic BiomarkersIL-8-week 14.44 ng/mLStandard Error 0.72
Free Gingival GraftsDifferences in Angiogenic BiomarkersTIMP-1-week 33.98 ng/mLStandard Error 0.77
Free Gingival GraftsDifferences in Angiogenic BiomarkersIL-8-week 2.31 ng/mLStandard Error 0.09
Free Gingival GraftsDifferences in Angiogenic BiomarkersIP-10-week 4.01 ng/mLStandard Error 0.01
Free Gingival GraftsDifferences in Angiogenic BiomarkersIL-8-week 3.15 ng/mLStandard Error 0.06
Free Gingival GraftsDifferences in Angiogenic BiomarkersTIMP-1-week 43.58 ng/mLStandard Error 0.73
Free Gingival GraftsDifferences in Angiogenic BiomarkersIL-8-week 4.11 ng/mLStandard Error 0.04
Free Gingival GraftsDifferences in Angiogenic BiomarkersGM-CSF-week 293.81 ng/mLStandard Error 20.36
Free Gingival GraftsDifferences in Angiogenic BiomarkersFGF-2-pre-surgical.72 ng/mLStandard Error 0.17
Free Gingival GraftsDifferences in Angiogenic BiomarkersTIMP-2-pre-surgical11.11 ng/mLStandard Error 4.18
Free Gingival GraftsDifferences in Angiogenic BiomarkersFGF-2-week 1.85 ng/mLStandard Error 0.17
Free Gingival GraftsDifferences in Angiogenic BiomarkersIP-10-week 1.5 ng/mLStandard Error 0.45
Free Gingival GraftsDifferences in Angiogenic BiomarkersFGF-2-week 2.34 ng/mLStandard Error 0.11
Free Gingival GraftsDifferences in Angiogenic BiomarkersTIMP-2-week 19.91 ng/mLStandard Error 2.14
Free Gingival GraftsDifferences in Angiogenic BiomarkersFGF-2-week 3.29 ng/mLStandard Error 0.08
Free Gingival GraftsDifferences in Angiogenic BiomarkersGM-CSF-week 386.16 ng/mLStandard Error 18.34
Free Gingival GraftsDifferences in Angiogenic BiomarkersFGF-2-week 4.24 ng/mLStandard Error 0.08
Free Gingival GraftsDifferences in Angiogenic BiomarkersTIMP-2-week 22.41 ng/mLStandard Error 0.77
Free Gingival GraftsDifferences in Angiogenic BiomarkersAngiostatin (ANT)-pre-surgical7931.32 ng/mLStandard Error 2813.77
Free Gingival GraftsDifferences in Angiogenic BiomarkersIP-10-week 3.02 ng/mLStandard Error 0.01
Free Gingival GraftsDifferences in Angiogenic BiomarkersAngiostatin (ANT)-week 13871.60 ng/mLStandard Error 782.5
Free Gingival GraftsDifferences in Angiogenic BiomarkersTIMP-2-week 31.43 ng/mLStandard Error 0.46
Primary

Differences in Angiogenic Biomarkers: PDGF-BB

Within-subject difference between the concentrations at the CelTX and Free Gingival Graft areas

Time frame: 5 time-points: pre-surgical, week(s) 1, 2, 3 and 4

Population: 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.

ArmMeasureGroupValue (MEAN)Dispersion
CelTx™Differences in Angiogenic Biomarkers: PDGF-BBPre-surgical10.59 pg/mLStandard Error 3.06
CelTx™Differences in Angiogenic Biomarkers: PDGF-BBWeek 24.50 pg/mLStandard Error 3.03
CelTx™Differences in Angiogenic Biomarkers: PDGF-BBWeek 32.15 pg/mLStandard Error 0.83
CelTx™Differences in Angiogenic Biomarkers: PDGF-BBWeek 151.82 pg/mLStandard Error 20.41
CelTx™Differences in Angiogenic Biomarkers: PDGF-BBWeek 4.86 pg/mLStandard Error 0.43
Free Gingival GraftsDifferences in Angiogenic Biomarkers: PDGF-BBWeek 128.92 pg/mLStandard Error 13.73
Free Gingival GraftsDifferences in Angiogenic Biomarkers: PDGF-BBWeek 22.33 pg/mLStandard Error 1
Free Gingival GraftsDifferences in Angiogenic Biomarkers: PDGF-BBPre-surgical9.73 pg/mLStandard Error 3.41
Free Gingival GraftsDifferences in Angiogenic Biomarkers: PDGF-BBWeek 4.87 pg/mLStandard Error 0.5
Free Gingival GraftsDifferences in Angiogenic Biomarkers: PDGF-BBWeek 31.01 pg/mLStandard Error 0.44

Source: ClinicalTrials.gov · Data processed: Mar 29, 2026