scholarly journals Characterization and first‐in‐human clinical dose‐escalation safety evaluation of a next‐gen human freeze‐dried plasma

Transfusion ◽  
2021 ◽  
Author(s):  
Jose A. Cancelas ◽  
Shawnagay Nestheide ◽  
Neeta Rugg ◽  
Anna Eckerman ◽  
Victor W. Macdonald ◽  
...  
Keyword(s):  
Dose Escalation ◽  
Safety Evaluation ◽  
Clinical Dose ◽  
Freeze Dried

scholarly journals A Preliminary Preparation of Endophytic Bacteria CE3 Wettable Powder for Biological Control of Postharvest Diseases

2015 ◽  
Vol 43 (1) ◽  
pp. 159-164 ◽  
Author(s):  
Hua CHENG ◽  
Linling LI ◽  
Juan HUA ◽  
Honghui YUAN ◽  
Shuiyuan CHENG
Keyword(s):  
Biological Control ◽  
Synergistic Effects ◽  
Lethal Dose ◽  
Safety Evaluation ◽  
Field Application ◽  
Fruit Rot ◽  
Postharvest Diseases ◽  
Freeze Dried ◽  
Wettable Powder ◽  
Endothia Parasitica

Recently, there has been an increasing interest among researchers in using combinations of biological control agents to exploit potential synergistic effects among them. In the present study, there were investigated commercially acceptable formulations of Bacillus cereus CE3 wetting powder with long storage life and retained efficacy to control chestnut and other fruit rot caused by Endothia parasitica (Murr) and Fusarium solani. The study sought to develop a new B. cereus formulation that would be more effective and better suited to the conditions of field application. By a series of experiments, the formulation was confirmed as follows: 60% B. cereus freeze-dried powder, 28.9% diatomite as carrier, 4% sodium lignin sulfonate as disperser, 6% alkyl naphthalene sulfonate as wetting agent, 1% K2HPO4 as stabilizer, 0.1% β-cyclodextrin as ultraviolet protectant. The controlling experiments showed that the diluted 100 times of 60% B. cereus wetting powder had 79.47% corrosion rate to chestnut pathogens; and this result is comparable to the diluted 1,000 times of 70% thiophanate-methyl. Safety evaluation results showed that rats acute oral lethal dose 50% was 5,000.35, therefore application of B. cereus wettable powder could not cause a person or animal poisoning. This work illustrated that 60% B. cereus wetting powder had commercial potential; however, to apply this formulation as a biological pesticide in the field, masses production processes need to be further studied.

scholarly journals Pre-Clinical Dose Escalation Studies Establish a Therapeutic Range for U7snRNA-Mediated DMD Exon 2 Skipping

2021 ◽  
Author(s):  
Tabatha Simmons ◽  
Tatyana A. Vetter ◽  
Nianyuan Huang ◽  
Adeline Vulin-Chaffiol ◽  
Nicolas Wein ◽  
...  
Keyword(s):  
Therapeutic Range ◽  
Dose Escalation ◽  
Exon 2 ◽  
Clinical Dose

scholarly journals Canine Mesenchymal Cell Lyosecretome Production and Safety Evaluation after Allogenic Intraarticular Injection in Osteoarthritic Dogs

Animals ◽  
2021 ◽  
Vol 11 (11) ◽  
pp. 3271
Author(s):  
Michela Mocchi ◽  
Elia Bari ◽  
Silvia Dotti ◽  
Riccardo Villa ◽  
Priscilla Berni ◽  
...  
Keyword(s):  
Hyaluronic Acid ◽  
Functional Disability ◽  
Musculoskeletal Diseases ◽  
Safety Evaluation ◽  
Mesenchymal Cell ◽  
Intraarticular Injection ◽  
Dependent Manner ◽  
Current Standard ◽  
Disability Score ◽  
Freeze Dried

In recent years, mesenchymal stromal cells (MSCs) have shown promise as a therapy in treating musculoskeletal diseases, and it is currently believed that their therapeutic effect is mainly related to the release of proteins and extracellular vesicles (EVs), known as secretome. In this work, three batches of canine MSC-secretome were prepared by standardized processes according to the current standard ISO9001 and formulated as a freeze-dried powder named Lyosecretome. The final products were characterized in protein and lipid content, EV size distribution and tested to ensure the microbiological safety required for intraarticular injection. Lyosecretome induced the proliferation of adipose tissue-derived canine MSCs, tenocytes, and chondrocytes in a dose-dependent manner and showed anti-elastase activity, reaching 85% of inhibitory activity at a 20 mg/mL concentration. Finally, to evaluate the safety of the preparation, three patients affected by bilateral knee or elbow osteoarthritis were treated with two intra-articular injections (t = 0 and t = 40 days) of the allogeneic Lyosecretome (20 mg corresponding 2 × 106 cell equivalents) resuspended in hyaluronic acid in one joint and placebo (mannitol resuspended in hyaluronic acid) in the other joint. To establish the safety of the treatment, the follow-up included a questionnaire addressed to the owner and orthopaedic examinations to assess lameness grade, pain score, functional disability score and range of motion up to day 80 post-treatment. Overall, the collected data suggest that intra-articular injection of allogeneic Lyosecretome is safe and does not induce a clinically significant local or systemic adverse response.

scholarly journals Intraarterial Infusion of Lipiodol CDDP Suspension into the Internal Iliac Artery-Pre Clinical Dose Escalation Study Using Canine Model-

2003 ◽  
Vol 53 (3) ◽  
pp. 275-279
Author(s):  
Hiroshi Okazaki ◽  
Kohei Kurokawa ◽  
Kazuhiro Suzuki ◽  
Yuka Matsumura ◽  
Shigeru Honda ◽  
...  
Keyword(s):  
Dose Escalation ◽  
Iliac Artery ◽  
Internal Iliac Artery ◽  
Canine Model ◽  
Dose Escalation Study ◽  
Intraarterial Infusion ◽  
Clinical Dose ◽  
Internal Iliac

scholarly journals Safety evaluation of enzalutamide dose-escalation strategy in patients with castration-resistant prostate cancer

2020 ◽  
Author(s):  
Rieko Miura ◽  
Masaki Hirabatake ◽  
Kei Irie ◽  
Hiroaki Ikesue ◽  
Nobuyuki Muroi ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Dose Escalation ◽  
Safety Evaluation ◽  
Castration Resistant Prostate Cancer ◽  
Castration Resistant

scholarly journals Toxicological safety evaluation of freeze-dried Protaetia brevitarsis larva powder

2018 ◽  
Vol 5 ◽  
pp. 695-703 ◽  
Author(s):  
Jung-Ho Noh ◽  
Ji-Seong Jeong ◽  
Sang-Jin Park ◽  
Eun-Young Yun ◽  
Jae Sam Hwang ◽  
...  
Keyword(s):  
Safety Evaluation ◽  
Freeze Dried

Three-Dimensional Reconstruction Using Stereo Pairs from Serial Thick Sections

1977 ◽  
Vol 35 ◽  
pp. 562-563
Author(s):  
Robert Glaeser ◽  
Thomas Bauer ◽  
David Grano
Keyword(s):  
Three Dimensional ◽  
Dimensional Structure ◽  
Serial Sections ◽  
Thin Sections ◽  
3 Dimensional ◽  
Transmission Electron ◽  
Freeze Dried ◽  
Dimensional Reconstruction ◽  
Stereo Imagery ◽  
Whole Mounts

In transmission electron microscopy, the 3-dimensional structure of an object is usually obtained in one of two ways. For objects which can be included in one specimen, as for example with elements included in freeze- dried whole mounts and examined with a high voltage microscope, stereo pairs can be obtained which exhibit the 3-D structure of the element. For objects which can not be included in one specimen, the 3-D shape is obtained by reconstruction from serial sections. However, without stereo imagery, only detail which remains constant within the thickness of the section can be used in the reconstruction; consequently, the choice is between a low resolution reconstruction using a few thick sections and a better resolution reconstruction using many thin sections, generally a tedious chore. This paper describes an approach to 3-D reconstruction which uses stereo images of serial thick sections to reconstruct an object including detail which changes within the depth of an individual thick section.

Scanning and Transmission Microscopy of Nematocyst Batteries in Epitheliomuscular Cells of Hydra

1971 ◽  
Vol 29 ◽  
pp. 410-411 ◽  
Author(s):  
Jane A. Westfall ◽  
S. Yamataka ◽  
Paul D. Enos
Keyword(s):  
Electron Microscopy ◽  
Scanning Electron Microscopy ◽  
Osmium Tetroxide ◽  
External Surface ◽  
Three Dimensional ◽  
Surface Structures ◽  
Transmission Microscopy ◽  
Transmission Electron ◽  
Freeze Dried ◽  
Scanning Electron

Scanning electron microscopy (SEM) provides three dimensional details of external surface structures and supplements ultrastructural information provided by transmission electron microscopy (TEM). Animals composed of watery jellylike tissues such as hydras and other coelenterates have not been considered suitable for SEM studies because of the difficulty in preserving such organisms in a normal state. This study demonstrates 1) the successful use of SEM on such tissue, and 2) the unique arrangement of batteries of nematocysts within large epitheliomuscular cells on tentacles of Hydra littoralis.Whole specimens of Hydra were prepared for SEM (Figs. 1 and 2) by the fix, freeze-dry, coat technique of Small and Màrszalek. The specimens were fixed in osmium tetroxide and mercuric chloride, freeze-dried in vacuo on a prechilled 1 Kg brass block, and coated with gold-palladium. Tissues for TEM (Figs. 3 and 4) were fixed in glutaraldehyde followed by osmium tetroxide. Scanning micrographs were taken on a Cambridge Stereoscan Mark II A microscope at 10 KV and transmission micrographs were taken on an RCA EMU 3G microscope (Fig. 3) or on a Hitachi HU 11B microscope (Fig. 4).

Characterization of microtubules by dark-field STEM and replication

1991 ◽  
Vol 49 ◽  
pp. 152-153
Author(s):  
S.B. Andrews ◽  
R.D. Leapman ◽  
P.E. Gallant ◽  
T.S. Reese
Keyword(s):  
Protein Interactions ◽  
Low Dose ◽  
Unit Length ◽  
Dark Field ◽  
Carbon Films ◽  
Microtubule Associated Proteins ◽  
Molecular Weights ◽  
Freeze Dried ◽  
Protein Motors ◽  
Associated Proteins

As part of a study on protein interactions involved in microtubule (MT)-based transport, we used the VG HB501 field-emission STEM to obtain low-dose dark-field mass maps of isolated, taxol-stabilized MTs and correlated these micrographs with detailed stereo images from replicas of the same MTs. This approach promises to be useful for determining how protein motors interact with MTs. MTs prepared from bovine and squid brain tubulin were purified and free from microtubule-associated proteins (MAPs). These MTs (0.1-1 mg/ml tubulin) were adsorbed to 3-nm evaporated carbon films supported over Formvar nets on 600-m copper grids. Following adsorption, the grids were washed twice in buffer and then in either distilled water or in isotonic or hypotonic ammonium acetate, blotted, and plunge-frozen in ethane/propane cryogen (ca. -185 C). After cryotransfer into the STEM, specimens were freeze-dried and recooled to ca.-160 C for low-dose (<3000 e/nm2) dark-field mapping. The molecular weights per unit length of MT were determined relative to tobacco mosaic virus standards from elastic scattering intensities. Parallel grids were freeze-dried and rotary shadowed with Pt/C at 14°.

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