Delving into the Latest Updates on Human Fibroblast Growth Factor 2(Massachusetts Eye and Ear Infirmary) with Synapse

Overview

Basic Info

Drug Type

Growth factors

Synonyms

FGF-2

Target

FGFR1 x FGFR2

Action

stimulants

Mechanism

FGFR1 stimulants(Fibroblast growth factor receptor 1 stimulants), FGFR2 stimulants(Fibroblast growth factor receptor 2 stimulants)

Therapeutic Areas

Otorhinolaryngologic DiseasesOther Diseases

Active Indication

Tympanic Membrane Perforation

Inactive Indication

Furcation DefectsGingival RecessionPeriodontitis

Originator Organization-

Active Organization

NYU Langone Health

Inactive Organization

SVS Institute of Dental Sciences

Massachusetts Eye & Ear Infirmary, Inc.

License Organization-

Drug Highest PhasePhase 2

First Approval Date-

Regulation-

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This study is a double blinded, placebo-controlled phase II study evaluating the efficacy of FGF-2 for the treatment of chronic non-healing tympanic membrane perforations (TMP). The documentation of TM closure will be the main efficacy outcome measure. Pretreatment photographs will document the area of the TM perforation and allow measurement of surface areas of the TMP for comparison of pre- and post-treatment. The study will be divided into two phases, the Randomized Treatment phase (part A), and the Unblinded Crossover phase (part B). In part A of the study, subjects will be randomized 1:1 (using simple randomization) to receive FGF-2 or placebo treatment up to 3 treatments. Subjects that fail three study treatments will move on to part B of the study. Subjects who received placebo in part A and failed three placebo treatments will crossover to receive unblinded FGF-2 for up to 3 treatments. Subjects who received FGF-2 in part A and failed three experimental treatments will not have additional FGF-2 treatment, and will move on to study follow up.

Start Date27 May 2022

Sponsor / Collaborator

NYU Langone Health

NCT02307916

/ CompletedPhase 2IIT

Fibroblast Growth Factor Regeneration of Tympanic Membrane Perforations

A Phase II randomized trial will be initiated to evaluate closure of the perforated tympanic membrane as the primary measureable outcome. The goal is to determine the safety and efficacy of Fibroblast Growth Factor-2 (FGF-2) in the closure of chronic tympanic membrane perforations (TMP). If FGF-2 is topically applied for the treatment of chronic TMP in humans, it is hypothesized it will be safe, tolerable and effective for use as treatment for tympanic membrane perforation. A total of 60 subjects will be recruited.

Start Date01 Oct 2016

Sponsor / Collaborator

Massachusetts Eye & Ear Infirmary, Inc.

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100 Clinical Results associated with Human Fibroblast Growth Factor 2(Massachusetts Eye and Ear Infirmary)

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100 Translational Medicine associated with Human Fibroblast Growth Factor 2(Massachusetts Eye and Ear Infirmary)

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100 Patents (Medical) associated with Human Fibroblast Growth Factor 2(Massachusetts Eye and Ear Infirmary)

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177

Literatures (Medical) associated with Human Fibroblast Growth Factor 2(Massachusetts Eye and Ear Infirmary)

01 Sep 2024·Archives of Oral Biology

The role of fibroblast growth factor-2 in modulating the differentiation of periodontal ligament and alveolar bone-derived stem cells

Article

Author: Kaigler, Darnell ; Sexton, Benjamin ; Dal-Fabbro, Renan ; Bottino, Marco C ; Han, Yuanyuan ; Xu, Jinping

OBJECTIVEThis study examined how range concentrations of Fibroblast Growth Factor-2 (FGF-2) influence the differentiation and activity of human-derived periodontal ligament (hPDLSCs) and alveolar bone-derived stem cells (haBMSCs).DESIGNhPDLSCs and haBMSCs were cultured with varying concentrations of FGF-2 (0, 1, 2.5, 5, 10, 20 ng/mL) and monitored for osteogenic differentiation through alkaline phosphatase (ALP) activity and quantification of gene expression (qRT-PCR) for osteogenesis markers. Additionally, alizarin red staining and a hydroxyproline colorimetric assay evaluated and quantified osteogenic matrix mineralization and collagen deposition. Statistical analyses were performed using one-way ANOVA or two-way ANOVA for multiple comparisons between groups.RESULTSAt low FGF-2 concentrations, hPDLSCs differentiated toward an osteogenic lineage, whereas higher concentrations of FGF-2 inhibited osteogenesis and promoted fibroblastic differentiation. The effect of FGF-2 at the lowest concentration tested (1 ng/mL) led to significantly higher ALP activity than osteogenically induced positive controls at early time points and equivalent RUNX2 expression at early and later time points. FGF-2 supplementation of haBMSC cultures was sufficient, at all concentrations, to increase ALP activity at an earlier time point. Mineralization of haBMSC cultures increased significantly within 5-20 ng/mL FGF-2 concentrations under basal growth media conditions (α-minimal essential medium supplemented with 15 % fetal bovine serum and 1 % penicillin/streptomycin).CONCLUSIONSFGF-2 has a dual capacity in promoting osteogenic and fibroblastic differentiation within hPDLSCs contingent upon the dosage and timing of administration, alongside supporting osteogenic differentiation in haBMSCs. These findings underscore the need for precision growth factors dosing when considering the design of biomaterials for periodontal regeneration.

01 Aug 2023·Journal of periodontal research

The role of rhFGF-2 in periodontal defect bone fill: A systematic review of the literature.

Review

Author: Doufexi, Aikaterini-Elisavet ; Pouliou, Maria-Myrsini ; Fragkioudakis, Ioannis ; Batas, Leonidas

BACKGROUNDGrowth factors have been used with success in periodontal regeneration, especially in intrabony defects. Among those, the recombined form of fibroblast growth factor-2 (rhFGF-2) has been also examined.OBJECTIVETo address the outcomes of periodontal regeneration using rhFGF-2 alone or in combination with bone substitutes primarily in terms of Radiographic Bone Fill (RBF%) and secondary Probing Pocket Depth (PPD), and Probing Attachment Levels (PAL).MATERIAL AND METHODSA search in MEDLINE and EMBASE using the Ovid interface was conducted from 2000 up to and including the 12th of November 2022. Starting from the initially identified 1289 articles, 34 studies were selected for further analysis. Following the full-text screening, 7 of the 34 studies met the inclusion criteria and thus were included in the systematic review after assessing their quality according to the Newcastle-Ottawa scale (NOS). Clinical and radiographic results (bone gain, pocket depth, and clinical attachment level) after the application of FGF-2 alone or in combination with different carriers were studied in patients with intrabony defects of at least one wall and pocket depth greater than 4 mm.RESULTSPrimary outcomes: RBF% was higher in studies using a combination of rhFGF-2 and bone substitutes (74.6 ± 20.0%) compared to others using the specific growth factor alone or negative controls (22.7 ± 20.7%). In terms of secondary outcomes, the analysis failed to show an additional benefit from the use of the rhFGF-2 alone or in combination with bone substitutes.CONCLUSIONrhFGF-2 can improve RBF% in the treatment of periodontal defects, especially when it is used in combination with a bone substitute.

01 Jun 2023·Regenerative therapy

Effects of combined application of fibroblast growth factor (FGF)-2 and carbonate apatite for tissue regeneration in a beagle dog model of one-wall periodontal defect.

Article

Author: Takedachi, Masahide ; Murakami, Shinya ; Kitamura, Masahiro ; Nagayasu-Tanaka, Toshie ; Harada, Tatsuhiro ; Anzai, Jun

IntroductionThere has been an increasing desire for the development of predictive periodontal regenerative therapy for severe periodontitis. In this study, we investigated the effect of the combined use of fibroblast growth factor-2 (FGF-2), a drug for periodontal regeneration approved in Japan, and carbonated apatite (CO₃Ap), bioresorbable and osteoconductive scaffold, on periodontal regeneration in beagle dog model of one-wall periodontal defect (severe intraosseous defect) for 24 weeks in comparison with CO₃Ap or vehicle alone.MethodsOne-wall periodontal defects were created (mesiodistal width × depth: 4 × 4 mm) on the mesial portion of the mandibular first molar (M1) of beagle dogs on both side. Mixture of FGF-2 and CO₃Ap, vehicle and CO₃Ap, or vehicle alone were administered to the defects and designated as groups FGF-2+CO₃Ap, CO₃Ap, and control, respectively. To assess the periodontal regeneration, radiographic analysis over time for 24 weeks, and micro computed tomography (μCT) and histological evaluation at 6 and 24 weeks were performed.ResultsFor the regenerated tissue in the defect site, the mineral content of the FGF-2+CO₃Ap group was higher than that of the CO₃Ap group in the radiographic analysis at 6-24 weeks. In the context of new bone formation and replacement, the FGF-2+CO₃Ap group exhibited significantly greater new bone volume and smaller CO₃Ap volume than the CO₃Ap group in the μCT analysis at 6 and 24 weeks. Furthermore, the density of the new bone in the FGF-2+CO₃Ap group at 24 weeks was similar to those in the control and CO₃Ap groups. Histological evaluation revealed that the length of the new periodontal ligament and cementum in the FGF-2+CO₃Ap group was greater than that in the CO₃Ap group at 6 weeks. We also examined the effect of the combined use of the FGF-2 and CO₃Ap on the existing bone adjacent to the defect and demonstrated that the existing bone height and volume in the FGF-2+CO₃Ap group remained significantly greater than those in the CO₃Ap group.ConclusionThis study demonstrated that the combination of FGF-2 and CO₃Ap was effective not only in enhancing new bone formation and replacing scaffold but also in maintaining the existing bone adjacent to the defect site in a beagle dog model of one-wall periodontal defect. Additionally, new periodontal tissues induced by FGF-2 and CO₃Ap may follow a maturation process similar to that formed by spontaneous healing. This suggests that the combined use of FGF-2 and CO₃Ap would promote periodontal regeneration in severe bony defects of periodontitis patient.

100 Deals associated with Human Fibroblast Growth Factor 2(Massachusetts Eye and Ear Infirmary)

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Furcation Defects	Preclinical	India	SVS Institute of Dental Sciences	01 May 2019
Gingival Recession	Preclinical	India	SVS Institute of Dental Sciences	01 May 2019
Periodontitis	Preclinical	India	SVS Institute of Dental Sciences	01 May 2019
Tympanic Membrane Perforation	Preclinical	United States	Massachusetts Eye & Ear Infirmary, Inc.	01 Oct 2016

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02307916 (CTgov)	Phase 2	Tympanic Membrane Perforation	57	FGF-2 (FGF-2)	rpkkufkjgt(ffdallwtck) = myhlospcxd vhyxzusflg (cunaisctqs, atjyutbgsd - ysarvbbvtg) View more	-	11 Jun 2020
				Placebo (Placebo)	rpkkufkjgt(ffdallwtck) = ysdysjdrur vhyxzusflg (cunaisctqs, lswzqceerp - pxfljpittn) View more
ARVO2012	Not Applicable	-	-	TGFβ1	avocbxlzko(gzjmqcdugn) = rxtdmwyubs bxhwhsiepp (qiycghnzvw ) View more	-	01 Mar 2012
				FGF2	avocbxlzko(gzjmqcdugn) = kmipfpbozc bxhwhsiepp (qiycghnzvw ) View more

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