Long-term in vivo evaluation of the safety and efficacy of a new porcine collagen dermal filler cross-linked with ribose

2008 ◽  
Vol 58 (2) ◽  
pp. AB63
Keyword(s):  
Dermal Filler ◽  
In Vivo Evaluation ◽  
Safety And Efficacy ◽  
Porcine Collagen

scholarly journals Long-Acting Risperidone Dual Control System: Preparation, Characterization and Evaluation In Vitro and In Vivo

Pharmaceutics ◽  
2021 ◽  
Vol 13 (8) ◽  
pp. 1210
Author(s):  
Xieguo Yan ◽  
Shiqiang Wang ◽  
Kaoxiang Sun
Keyword(s):  
Drug Loading ◽  
Entrapment Efficiency ◽  
In Vitro Dissolution ◽  
Dissolution Behavior ◽  
In Vivo Evaluation ◽  
Long Term Treatment ◽  
Long Acting

Schizophrenia, a psychiatric disorder, requires long-term treatment; however, large fluctuations in blood drug concentration increase the risk of adverse reactions. We prepared a long-term risperidone (RIS) implantation system that can stabilize RIS release and established in-vitro and in-vivo evaluation systems. Cumulative release, drug loading, and entrapment efficiency were used as evaluation indicators to evaluate the effects of different pore formers, polymer ratios, porogen concentrations, and oil–water ratios on a RIS implant (RIS-IM). We also built a mathematical model to identify the optimized formulation by stepwise regression. We also assessed the crystalline changes, residual solvents, solubility and stability after sterilization, in-vivo polymer degradation, pharmacokinetics, and tissue inflammation in the case of the optimized formulation. The surface of the optimized RIS microspheres was small and hollow with 134.4 ± 3.5 µm particle size, 1.60 SPAN, 46.7% ± 2.3% implant drug loading, and 93.4% entrapment efficiency. The in-vitro dissolution behavior of RIS-IM had zero-order kinetics and stable blood concentration; no lag time was released for over three months. Furthermore, the RIS-IM was not only non-irritating to tissues but also had good biocompatibility and product stability. Long-acting RIS-IMs with microspheres and film coatings can provide a new avenue for treating schizophrenia.

scholarly journals LONG-TERM IN VIVO EVALUATION OF CENTRIFUGAL BLOOD PUMPS WITH A SELF WASH-OUT STRUCTURE

ASAIO Journal ◽  
1996 ◽  
Vol 42 (2) ◽  
pp. 38
Author(s):  
Y. Wakisaka ◽  
Y. Taenaka ◽  
E. Tatsumi ◽  
T. Nishimura ◽  
T. Masuzawa ◽  
...  
Keyword(s):  
In Vivo Evaluation ◽  
Blood Pumps

scholarly journals Rationale and Design of the Lead EvaluAtion for Defibrillation and Reliability (LEADR) Study: Safety and Efficacy of a Novel ICD Lead Design

2021 ◽  
Author(s):  
George Crossley ◽  
Prashanthan Sanders ◽  
Paolo De Filippo ◽  
Khaldoun Tarakji ◽  
Bert Hansky ◽  
...  
Keyword(s):  
Clinical Study ◽  
Adaptive Design ◽  
De Novo ◽  
Small Diameter ◽  
Virtual Patient ◽  
Implantable Cardioverter Defibrillators ◽  
Safety And Efficacy ◽  
Icd Leads

Background: Implantable cardioverter defibrillators (ICD) are indicated for primary and secondary prevention of sudden cardiac arrest. Despite enhancements in design and technologies, the ICD lead is the most vulnerable component of the ICD system and failure of ICD leads remains a significant clinical problem. A novel, small diameter, lumenless, catheter delivered, defibrillator lead was developed with the aim to improve long term reliability. Methods and Results: The Lead Evaluation for Defibrillation and Reliability (LEADR) study is a multi-center, single-arm, Bayesian, adaptive design, pre-market interventional pivotal clinical study. Up to 60 study sites from around the world will participate in the study. Patients indicated for a de novo ICD will undergo defibrillation testing at implantation and clinical assessments at baseline, implant, pre-hospital discharge, 3 months, 6 months, and every 6 months thereafter until official study closure. Patients will participate for a minimum of 18 months to approximately 3 years. Fracture-free survival will be evaluated using a Bayesian statistical method that incorporates both virtual patient data (combination of bench testing to failure with in-vivo use condition data) with clinical patients. The clinical subject sample size will be determined using decision rules for number of subject enrollments and follow-up time based upon the observed number of fractures at certain time points in the study. The adaptive study design will therefore result in a minimum of 500 and a maximum of 900 patients enrolled. Conclusion: The LEADR Clinical Study was designed to efficiently provide evidence for short- and long-term safety and efficacy of a novel lead design using Bayesian methods including a novel virtual patient approach.

scholarly journals Bioluminescent Ross River Virus Allows Live Monitoring of Acute and Long-Term Alphaviral Infection by In Vivo Imaging

Viruses ◽  
2019 ◽  
Vol 11 (7) ◽  
pp. 584 ◽  
Author(s):  
Essia Belarbi ◽  
Vincent Legros ◽  
Justine Basset ◽  
Philippe Desprès ◽  
Pierre Roques ◽  
...  
Keyword(s):  
Immunosuppressive Treatment ◽  
Treatment Strategies ◽  
Chronic Phase ◽  
Therapeutic Interventions ◽  
In Vivo Evaluation ◽  
Viral Spread ◽  
Bioluminescent Signal

Arboviruses like chikungunya and Ross River (RRV) are responsible for massive outbreaks of viral polyarthritis. There is no effective treatment or vaccine available against these viruses that induce prolonged and disabling arthritis. To explore the physiopathological mechanisms of alphaviral arthritis, we engineered a recombinant RRV expressing a NanoLuc reporter (RRV-NLuc), which exhibited high stability, near native replication kinetics and allowed real time monitoring of viral spread in an albino mouse strain. During the acute phase of the disease, we observed a high bioluminescent signal reflecting viral replication and dissemination in the infected mice. Using Bindarit, an anti-inflammatory drug that inhibits monocyte recruitment, we observed a reduction in viral dissemination demonstrating the important role of monocytes in the propagation of the virus and the adaptation of this model to the in vivo evaluation of treatment strategies. After resolution of the acute symptoms, we observed an increase in the bioluminescent signal in mice subjected to an immunosuppressive treatment 30 days post infection, thus showing active in vivo replication of remnant virus. We show here that this novel reporter virus is suitable to study the alphaviral disease up to the chronic phase, opening new perspectives for the evaluation of therapeutic interventions.

LONG-TERM IN VIVO EVALUATION OF CENTRIFUGAL BLOOD PUMPS WITH A SELF WASH-OUT STRUCTURE

ASAIO Journal ◽  
1996 ◽  
Vol 42 (2) ◽  
pp. 38
Author(s):  
Y. Wakisaka ◽  
Y. Taenaka ◽  
E. Tatsumi ◽  
T. Nishimura ◽  
T. Masuzawa ◽  
...  
Keyword(s):  
In Vivo Evaluation ◽  
Blood Pumps

scholarly journals Long-term In-vivo Evaluation Of A Resorbable PLLA Scaffold For Regeneration Of The ACL

2015 ◽  
Vol 3 (7_suppl2) ◽  
pp. 2325967115S0003 ◽  
Author(s):  
William Robert Walsh ◽  
Nicky Bertollo ◽  
Robert A. Arciero ◽  
Robert A. Stanton ◽  
Robert A. Poggie
Keyword(s):  
In Vivo Evaluation ◽  
Plla Scaffold

scholarly journals Long-Term In Vivo Evaluation of Chitosan Nerve Guide Properties with respect to Two Different Sterilization Methods

2018 ◽  
Vol 2018 ◽  
pp. 1-11 ◽  
Author(s):  
Maria Stößel ◽  
Jennifer Metzen ◽  
Vivien M. Wildhagen ◽  
Olaf Helmecke ◽  
Lena Rehra ◽  
...  
Keyword(s):  
Peripheral Nerve Injuries ◽  
In Vivo Evaluation ◽  
Medical Products ◽  
Nerve Grafts ◽  
Nerve Guides ◽  
Surrounding Connective Tissue ◽  
Term Evaluation ◽  
Distal Nerve

Severe peripheral nerve injuries are reconstructed either with autologous nerve grafts (gold standard) or alternatively with clinically approved artificial nerve guides. The most common method used to sterilize these medical products is ethylene oxide gassing (EO). However, this method has several disadvantages. An alternative, which has been barely studied so far, represents beta irradiation (β). In previous studies, we developed an artificial nerve guide made of chitosan (chitosan nerve guide, CNG), a biomaterial that is known to potentially retain toxic residues upon EO sterilization. Therefore, we analyzed the long-term regeneration-supporting and mechanical properties of CNGs upon their sterilization with EO or β and their following application in unilateral repair of 12 mm gaps of the rat sciatic nerve. Over a period of 76 weeks, we serially evaluated the recovery of motor functions, the possible emergence of an inflammation in the surrounding connective tissue, the regrowth of axons into the distal nerve, and possible changes in the material properties. Our first long-term evaluation did not reveal significant differences between both sterilization methods. Thus, β is as appropriate as commonly used EO for sterilization of CNGs; however, it may slightly increase the stiffness of the biomaterial over time.

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