Human Fibroblast Growth Factor 2(Massachusetts Eye and Ear Infirmary)(Human Fibroblast Growth Factor 2(Massachusetts Eye and Ear Infirmary))

概要

基本信息

药物类型

生长因子

别名

FGF-2

靶点

FGFR1 x FGFR2

作用方式

刺激剂

作用机制

FGFR1刺激剂(成纤维细胞生长因子受体-1刺激剂)、FGFR2刺激剂(成纤维细胞生长因子受体-2刺激剂)

治疗领域

耳鼻咽喉疾病其他疾病

在研适应症

鼓膜穿孔

非在研适应症

根分叉部缺损牙龈退缩牙周炎

原研机构-

在研机构

NYU Langone Health

非在研机构

SVS Institute of Dental Sciences

Massachusetts Eye & Ear Infirmary, Inc.

最高研发阶段临床2期

首次获批日期-

最高研发阶段(中国)-

特殊审评-

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关联

2

项与 Human Fibroblast Growth Factor 2(Massachusetts Eye and Ear Infirmary) 相关的临床试验

NCT04960384

/ Enrolling by invitation临床2期IIT

Fibroblast Growth Factor Regeneration of Tympanic Membrane Perforations

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.

开始日期2022-05-27

申办/合作机构

NYU Langone Health

NCT02307916

/ Completed临床2期IIT

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.

开始日期2016-10-01

申办/合作机构

Massachusetts Eye & Ear Infirmary, Inc.

[+1]

100 项与 Human Fibroblast Growth Factor 2(Massachusetts Eye and Ear Infirmary) 相关的临床结果

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100 项与 Human Fibroblast Growth Factor 2(Massachusetts Eye and Ear Infirmary) 相关的转化医学

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100 项与 Human Fibroblast Growth Factor 2(Massachusetts Eye and Ear Infirmary) 相关的专利（医药）

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174

项与 Human Fibroblast Growth Factor 2(Massachusetts Eye and Ear Infirmary) 相关的文献（医药）

2024-09-01·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

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

OBJECTIVE:

This 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).

DESIGN:

hPDLSCs 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.

RESULTS:

At 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).

CONCLUSIONS:

FGF-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.

2023-08-01·Journal of periodontal research

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

Review

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

BACKGROUND:

Growth 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.

OBJECTIVE:

To 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 METHODS:

A 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.

RESULTS:

Primary 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.

CONCLUSION:

rhFGF-2 can improve RBF% in the treatment of periodontal defects, especially when it is used in combination with a bone substitute.

2023-06-01·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

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

Introduction:

There 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.

Methods:

One-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.

Results:

For 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.

Conclusion:

This 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 项与 Human Fibroblast Growth Factor 2(Massachusetts Eye and Ear Infirmary) 相关的药物交易

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研发状态

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
鼓膜穿孔	临床2期	美国	Massachusetts Eye & Ear Infirmary, Inc.	2016-10-01
根分叉部缺损	临床1期	印度	SVS Institute of Dental Sciences	2019-05-01
牙龈退缩	临床1期	印度	SVS Institute of Dental Sciences	2019-05-01
牙周炎	临床1期	印度	SVS Institute of Dental Sciences	2019-05-01

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临床结果

适应症

分期

评价

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT02307916 (CTgov)	临床2期	鼓膜穿孔	57	FGF-2 (FGF-2)	憲壓夢願觸觸夢鑰鹽積 = 鹹觸願鹽鹽憲淵鹽齋鑰願夢網餘壓淵淵範鏇簾 (襯艱襯淵襯製齋壓觸顧, 觸餘遞膚遞鏇壓鹽觸憲 ~ 鹽網網蓋壓夢積觸齋遞) 更多	-	2020-06-11
				Placebo (Placebo)	憲壓夢願觸觸夢鑰鹽積 = 網鑰鬱築鏇衊製遞構鬱願夢網餘壓淵淵範鏇簾 (襯艱襯淵襯製齋壓觸顧, 糧糧遞窪蓋獵範範鏇齋 ~ 艱觸繭糧廠醖觸糧構遞) 更多
ARVO2012	N/A	-	-	TGFβ1	艱齋艱獵願構餘襯衊襯(鏇構廠遞餘襯遞築齋網) = 鏇廠製窪鬱鬱醖廠窪鹽遞構憲築鹽製範鏇築鏇 (網鹹餘淵繭構壓網鬱鑰 ) 更多	-	2012-03-01
				FGF2	艱齋艱獵願構餘襯衊襯(鏇構廠遞餘襯遞築齋網) = 鹽顧範壓鑰衊製觸鬱夢遞構憲築鹽製範鏇築鏇 (網鹹餘淵繭構壓網鬱鑰 ) 更多