Fibrin Sealant (Spinal Restoration)(Fibrin Sealant (Spinal Restoration))

概要

基本信息

药物类型

血液提取物

别名

BIOSTAT BIOLOGX

靶点

fibrin

作用机制

fibrin调节剂(纤维蛋白调节剂)

治疗领域

神经系统疾病皮肤和肌肉骨骼疾病

在研适应症-

非在研适应症

椎间盘退化腰痛

原研机构

Spinal Restoration, Inc.

在研机构-

非在研机构

Spinal Restoration, Inc.

最高研发阶段终止临床3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

8

项与 Fibrin Sealant (Spinal Restoration) 相关的临床试验

ChiCTR1900023323 / Suspended早期临床1期IIT

A Multi-centerClinical Trial for Fibrin Sealant Used in EVAR as Filling Technique Treating Abdominal Aortic Aneurysm

开始日期2019-06-03

申办/合作机构-

RBR-9j7qqr / Not yet recruiting临床1/2期

Fibrin sealant derived from snake venom for the treatment of venous ulcers: non controlled phase I / II to evaluate the safety, efficacy and confirm the lowest dose clinical trial - study selante II

开始日期2015-08-01

申办/合作机构-

RBR-9mbdj3 / Active, not recruiting临床1/2期IIT

Clinical trial phase I / II to evaluate the safety and best dose of the new fibrin sealant derived from snake venom in the treatment of venous ulcers - Study SELANTE I.

开始日期2014-03-10

申办/合作机构-

100 项与 Fibrin Sealant (Spinal Restoration) 相关的临床结果

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100 项与 Fibrin Sealant (Spinal Restoration) 相关的转化医学

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100 项与 Fibrin Sealant (Spinal Restoration) 相关的专利（医药）

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883

项与 Fibrin Sealant (Spinal Restoration) 相关的文献（医药）

2024-09-01·International journal of oral and maxillofacial surgery

Efficacy of hydroxyapatite and fibrin sealant as carriers for bone morphogenetic protein-2 in maxillary sinus floor augmentation: a retrospective study

Article

作者: Nam, J W

The aim of this retrospective study was to assess the efficacy of recombinant human bone morphogenetic protein-2 (rhBMP-2) with hydroxyapatite (HA) granules and fibrin sealant (FS) in maxillary sinus floor augmentation (MSFA), with a focus on the volume change. Fifty-two of 137 patients who underwent MSFA with rhBMP-2/HA grafting between June 2016 and December 2022 met the study inclusion criteria; 25 had received rhBMP-2/HA without FS and 27 had received rhBMP-2/HA with FS. Computed tomography (CT) images were obtained preoperatively, immediately following the operation, and at 6 months postoperative. These images were three-dimensionally reconstructed to measure the volumetric and height changes following MSFA. The mean ± standard deviation percentage of volumetric change at 6 months was 48.75 ± 37.44% in the group with FS and 29.77 ± 13.42% in the group without FS (P = 0.019). The vertical height measured at a specific site of the grafted area showed a mean percentage change at 6 months of 4.05 ± 12.08% in the group with FS and 6.07 ± 10.15% in the group without FS (P = 0.518). The additional use of FS as a carrier for rhBMP-2/HA in MSFA was found to improve surgical convenience and bone regeneration ability.

2024-09-01·Journal of glaucoma

The Efficacy of Fibrin Sealant in Sutureless Deep Sclerectomy—Preliminary Outcomes

Article

作者: Netukova, Magdalena ; Rosina, Jozef ; Pluhovsky, Patrik ; Holubova, Lucie ; Studeny, Pavel ; Vranova, Jana ; Urbaniova, Katarina ; Pencak, Martin ; Baxant, Alina-Dana

Précis::

Deep sclerectomy (DS) with fibrin adhesive can constitute a safe alternative to the classic procedure using sutures, providing nonallergenic, nontoxic, and secure adhesion with no sign of aqueous humor outflow obstruction postoperatively.

Objective::

To evaluate short and medium-term postoperative results of DS with a fibrin sealant.

Patients and Methods::

This prospective, noncomparative, interventional case series involves 12 eyes of 12 patients with uncontrolled open angle glaucoma who underwent DS with Esnoper (Clip or V2000) implant between February 2021 and March 2022. A novel method of wound closure (sclera, Tenon fascia, and conjunctiva) employing fibrin glue was used instead of classic sutures. Surgical outcomes assessed include: intraocular pressure and glaucoma therapy reduction, best-corrected visual acuity changes, and number of complications registered peri and postoperatively. All measurements were performed preoperatively, as well as at 1 day, at 1 and 2 weeks, and at 1, 2, 3, 6, 9, and 12 months after surgery.

Results::

The mean intraocular pressure decreased from 24.0 ± 9.1 mm Hg to 13.8 ± 6.3 mm Hg at 1 year postoperatively (P < 0.001). Kaplan-Meier survival analysis revealed complete and qualified success rates of 83.3% and 91.7%. The mean glaucoma therapy decreased from 3.2 ± 1.1 to 0.8 ± 1.3 drugs 12 months after surgery (P < 0.001). Nd:YAG goniopunture was performed in 2 eyes at 1 and 12 months postoperatively. No significant best-corrected visual acuity changes were registered. Perioperatively, we noted a trabeculo-descemet microperforation in 1 eye, transient hypotony in 5 eyes, and mild hyphema in 2 eyes.

Conclusions::

Fibrin adhesive provided an effective closure in sutureless DS in the patients included in our study. This modification of classical DS may simplify the surgical technique, ensure secure wound adaptation, optimize healing, and lower the risk of inflammation and fibrosis postoperatively.

2024-08-01·Journal of neurosurgery

Leukocyte- and platelet-rich fibrin in cranial surgery: a single-blinded, prospective, randomized controlled noninferiority trial

Article

作者: Van Calenbergh, Frank ; Van Hoylandt, Anaïs ; Coucke, Birgit ; van Loon, Johannes ; De Vleeschouwer, Steven ; Van Gerven, Laura ; Theys, Tom

OBJECTIVE:

CSF leakage is a major complication after cranial surgery, and although fibrin sealants are widely used for reinforcing dural closure, concerns exist regarding their safety, efficacy, and cost. Leukocyte- and platelet-rich fibrin (L-PRF), an autologous platelet concentrate, is readily available and inexpensive, making it a cost-effective alternative for commercially available fibrin sealants. This study aimed to demonstrate the noninferiority of L-PRF compared with commercially available fibrin sealants in preventing postoperative CSF leakage in supra- and infratentorial cranial surgery, with secondary outcomes focused on CSF leakage risk factors and adverse events.

METHODS:

In a single-blinded, prospective, randomized controlled interventional trial conducted at a neurosurgery department of a tertiary care center (UZ Leuven, Belgium), patients undergoing elective cranial neurosurgery were randomly assigned to receive either L-PRF (active treatment) or commercially available fibrin sealants (control) for dural closure in a 1:1 ratio.

RESULTS:

Among 350 included patients, 328 were analyzed for the primary endpoint (44.5% male, mean age 52.3 ± 15.1 years). Six patients (5 in the control group, 1 in the L-PRF group) presented with CSF leakage requiring any intervention (relative risk [RR] 0.20, one-sided 95% CI −∞ to 1.02, p = 0.11), confirming noninferiority. Of these 6 patients, 1 (in the control group) presented with CSF leakage requiring revision surgery. No risk factors for reconstruction failure in combination with L-PRF were identified. RRs for adverse events such as infection (0.72, 95% CI −∞ to 1.96) and meningitis (0.36, 95% CI −∞ to 1.25) favored L-PRF treatment, although L-PRF treatment showed slightly more bleeding events (1.44, 95% CI −∞ to 4.66).

CONCLUSIONS:

Dural reinforcement with L-PRF proved noninferior to commercially available fibrin sealants, with no safety issues. Introducing L-PRF to standard clinical practice could result in important cost savings due to accessibility and lower cost.Clinical trial registration no.: NCT03812120 (ClinicalTrials.gov).

100 项与 Fibrin Sealant (Spinal Restoration) 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
椎间盘退化	临床3期	美国	Spinal Restoration, Inc.	2009-11-11
腰痛	临床3期	美国	Spinal Restoration, Inc.	2009-11-11

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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


NCT01011816 (CTgov)	临床3期	椎间盘退化 \| 腰痛	220	BIOSTAT BIOLOGX (BIOSTAT BIOLOGX)	鹹選顧襯積艱遞鬱糧壓(築鹹鹹積鬱糧糧壓夢範) = 觸艱餘築網積膚窪簾艱獵繭築築夢築鑰蓋鹹憲 (鏇鹽繭衊鏇簾積醖糧觸, 鹹積簾鹹鏇鏇鏇夢醖壓 ~ 襯遞鏇淵鏇觸蓋選襯窪) 更多	-	2014-05-05
				Saline (Saline)	鹹選顧襯積艱遞鬱糧壓(築鹹鹹積鬱糧糧壓夢範) = 鬱廠蓋鏇襯艱顧願淵範獵繭築築夢築鑰蓋鹹憲 (鏇鹽繭衊鏇簾積醖糧觸, 夢遞範淵鹹淵積淵積艱 ~ 蓋顧簾築襯膚齋鬱積獵) 更多
NCT01649505 (CTgov)	N/A	术后并发症 \| 浆液肿 \| 乳腺癌	2	breast reconstruction+fibrin sealant (Beriplast P, TISSEEL VH) (Arm I (Fibrin Sealant))	衊鏇鏇築淵鏇鏇窪鏇製(築鹹壓構簾製齋網窪範) = 顧選夢積淵鹹淵繭網繭選齋遞餘簾蓋壓餘膚艱 (鏇願築鏇鬱鏇憲淵願繭, 獵鑰簾範遞繭構艱選衊 ~ 積糧鹽窪憲積餘製齋鏇) 更多	-	2013-03-15
				breast reconstruction (Arm II (Standard Electrocoagulation))	衊鏇鏇築淵鏇鏇窪鏇製(築鹹壓構簾製齋網窪範) = 積齋遞齋遞糧獵鑰齋襯選齋遞餘簾蓋壓餘膚艱 (鏇願築鏇鬱鏇憲淵願繭, 醖繭構獵壓製鑰齋夢衊 ~ 艱遞顧艱簾膚鏇壓繭鏇) 更多
AHNS2012	N/A	-	120	Saline control	網簾窪鬱繭簾選選構鏇(壓窪顧膚網餘鹽範網範) = 積齋襯窪遞襯觸繭鬱廠構齋鏇膚鏇簾製膚憲願 (顧鏇簾繭鏇構獵鹽願願 )	积极	2012-07-22
ARVO2008	N/A	-	114	Fibrin Sealant (Suture)	獵鑰範蓋壓願構鬱淵鹽(鏇壓觸鑰積襯餘膚襯繭) = 築齋憲膚淵簾積築鹹觸夢顧鬱艱膚憲選製築壓 (衊鬱夢鬱齋膚繭蓋網積 ) 更多	积极	2008-05-01
Pubmed \| J Burn Care Res	临床3期	烧伤	138	Fibrin Sealant containing 4 IU/ml thrombin (FS 4IU VH S/D)	簾憲艱鹹襯廠顧鹹繭糧(遞膚艱顧廠憲齋積鬱構) = 艱鑰憲膚壓選獵醖膚繭衊鹽鑰積遞選選鹽繭鑰 (遞艱艱網膚艱醖遞憲築 ) 更多	积极	2008-03-01
				Fibrin Sealant	簾憲艱鹹襯廠顧鹹繭糧(遞膚艱顧廠憲齋積鬱構) = 獵鏇獵艱壓築窪積齋齋衊鹽鑰積遞選選鹽繭鑰 (遞艱艱網膚艱醖遞憲築 ) 更多