Research2019-07-19T11:20:01+00:00

Publications

Elephant disease causes death by hemorrhage… Lyophilized platelets may help!

Authors: Jennifer C. Kishbaugh, DVM, Marc T. Valitutto, VMD, Janelle E. Over, MS, Dawn M. Zimmerman, DVM, MS, Lauren L. Howard, DVM, Dennis L. Schmitt, DCM, PhD, Carlos R. Sanchez, DVM, Suzan Murray, DVM.

The in-human care population of elephants is plagued by an endotheliotropic herpes virus that attacks young elephants and causes an acute loss of platelets with associated bleeding. BodeVet, Inc. working with the Smithsonian Institute has begun the process of producing lyophilized platelets for zoos to have available when bleeding occurs. A clinical trial is proposed to determine if platelet transfusion improves outcome, saving these magnificent animals from death.

Click here to read the full article!

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By |May 8th, 2019|Categories: Publications|0 Comments

Wound-healing properties of trehalose-stabilized freeze-dried outdated platelets

Authors: Ruth Sum,* Sarah Hager,* Giorgio Pietramaggiori, Dennis P. Orgill, Josh Dee, Alan Rudolph, Cindy Orser, G. Michael Fitzpatrick, and David Ho

Project Overview:

Wounds treated with multiple doses of VEGF and a single dose of freeze-dried platelets reached 90% closure faster than wounds left untreated. A single administration of trehalose lyophilized and reconstituted platelet preparations enhanced diabetic wound healing, therefore representing a promising strategy for the treatment of non-healing wounds.

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By |May 8th, 2019|Categories: Publications|0 Comments

Assessment of platelet growth factors in supernatants from rehydrated freeze-dried equine platelets and their effects on fibroblasts in vitro

Authors: Fern Tablin, VMD, PhD; Naomi J. Walker, BA; Sara E. Hogle, DVM; Suzanne M. Pratt, DVM; Jeffrey W. Norris, PhD

Objective:

To determine whether platelet growth factors are preserved in supernatants obtained from rehydrated trehalose-stabilized, freeze-dried (lyophilized) equine latelets and whether those growth factors stimulate fibroblast proliferation and migration and enhance fibroblast-associated contraction in a collagen gel assay.

By |May 8th, 2019|Categories: Publications|0 Comments

Research

Safety Evaluation of Lyophilized Canine Platelets in a Model of CABG

Authors: Todd M. Getz, PhD, Anne S.Hale, DVM, Arthur P. Bode, PhD, Mark D. Johnson, MS, G. Michael Fitzpatrick, PhD

Project Overview: Cellphire evaluated the safety of Lyophilized Canine Platelets (LCP) in comparison to Liquid Stored Canine Platelets following intravenous administration in a model of on-pump coronary artery bypass graft (CABG) in the canine.

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By |May 8th, 2019|Categories: Research|0 Comments

Loading Platelets with Biological Agents for Enhanced Local Delivery

Authors: Dr. Cindy Orser, Dr. Keith Moskowitz, Richard Cliff, Dr. Alan Rudolph, Josh Dee, Nannette Mittereder

Project Overview:

Use Platelets to engineer uptake and delivery of therapeutic compounds to specific sites

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By |May 8th, 2019|Categories: Research|0 Comments

Trehalose Stabilized Freeze Dried Human Platelets, Thrombosomes®, Persist in Circulation 24 Hours After Infusion and Are Non-Immunogenic In New Zealand White Rabbits

Authors: Vibhudutta Awasthi, Josh Dee, Mike Fitzpatrick, Anna Koh, Richard Cliff, Giora Feuerstein

Project Overview:

Thrombosomes®, a human platelet derived hemostatic agent, (PDHA) is being developed to meet a critical unmet medical need, e.g. a safe PDHA that restores hemostasis in patients with a coagulopathy that does not respond to standard treatment

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By |May 8th, 2019|Categories: Research|0 Comments

Trehalose Stabilized Freeze Dried Human Platelets, Thrombosomes®, Reduce Blood Loss in Thromboctopenic Rabbit Ear Bleed Model By As Much As 89.5%

Authors: Vibhudutta Awasthi, Josh Dee, Mike Fitzpatrick, Anna Koh, Richard Cliff, Giora Feuerstein

Project Overview:

Thrombosomes®, are lyophilized derivative of human platelets, is being developed for treatment of civilian or military combat related trauma and shock conditions associated with life-threatening bleeding

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By |May 8th, 2019|Categories: Research|0 Comments

Trehalose Stabilized Freeze Dried Human Platelets, Thrombosomes®, Express Surface Markers, Thromboelastogram (TEG) Values and Size Distribution Similar To Two To Three Day Old Stored Platelets

Authors: Josh Dee, Mike Fitzpatrick, Anna Koh, Richard Cliff, Giora Feuerstein

Project Overview:

Thrombosomes® is lyophilized derivative of human platelets developed as a hemostatic product for treatment of civilian as well as combat related trauma and shock conditions associated with life-threatening bleeding. Thrombosomes is produced by a proprietary process that includes Trehalose, other carbohydrates, and a custom lyophilization process.

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By |May 8th, 2019|Categories: Research|0 Comments

Wound Healing Properties Of Reconstituted Freeze-Dried Platelets

Authors: D. Ho, G. Pietramaggiori, K. Moskowitz, R. Sum, J. Dee, A. Rudolph, C. Burch, W. Pebley, D. Orgill, C. Orser

Project Overview:

The use of fresh platelets has gained value in medicine as an essential part of wound treatments. This is not surprising since platelets contain a number of bioactive factors that contribute to the process of wound healing such as: platelet derived platelet-derived growth factor (PDGF) and transforming growth factor (TGF). Fresh platelets’ short shelf life limits platelet based therapies. If platelets can be stabilized in a freeze-dried form (FDP) then long-term storage and pathogen inactivation methods become possible.

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By |May 8th, 2019|Categories: Research|0 Comments

Temporal Growth Factor Release from Platelet-Rich Plasma, Trehalose Lyophilized Platelets, and Bone Marrow Aspirate and Their Effect on Tendon and Ligament Gene Expression

Authors: Taralyn McCarrel and Lisa Fortier

Abstract:

Platelet-rich plasma (PRP) has generated substantial interest for tendon and ligament regeneration because of the high concentrations of growth factors in platelet a-granules. This study compared the temporal release of growth factors from bone marrowaspirate (BMA), PRP, and lyophilized platelet product (PP), and measured their effects on tendon and ligament gene expression. Blood and BMA were collected and processed to yield PRP and plasma. Flexor digitorum superficialis tendon (FDS) and suspensory ligament (SL) explants were cultured in 10%plasma inDMEM(control), BMA,PRP, or PP. TGF-b1 and PDGF-BBconcentrations were determined at 0, 24, and 96 h of culture using ELISA. Quantitative RT-PCR for collagen types I and III (COL1A1, COL3A1), cartilage oligomeric matrix protein (COMP), decorin, and matrix metalloproteinases-3 and 13 (MMP-3, MMP-13) was performed. TGF-b1 and PDGF-BB concentrations were highest in PRP and PP. Growth factor quantity was unchanged in BMA, increased in PRP, and decreased in PP over 4 days. TGF-b1 and platelet concentrations were positively correlated. Lyophilized PP and PRP resulted in increased COL1A1:COL3A1 ratio, increased COMP, and decreased MMP-13 expression. BMA resulted in decreased COMP and increased MMP-3 and MMP-13 gene expression. Platelet concentration was positively correlated with COL1A1, ratio of COL1A1:COL3A1, and COMP, and negatively correlated with COL3A1, MMP-13,and MMP-3.White blood cell concentration was positively correlated withCOL3A1,MMP3,andMMP13,and negatively correlated with a ratio of COL1A1:COL3A1, COMP, and decorin. These findings support further in vivo investigation of PRP and PP for treatment of tendonitis and desmitis.

By |May 8th, 2019|Categories: Research|0 Comments

Trehalose lyophilized platelets for wound healing

Authors: Giorgio Pietramaggiori, MD; Arja Kaipainen, MD, PhD; David Ho, PhD; Cindy Orser, PhD; Walter Pebley, PE; Alan Rudolph, PhD, MBA; Dennis P. Orgill, MD, PhD

Abstract:

Fresh platelet preparations are utilized to treat a wide variety of wounds, although storage limitations and mixed results have hampered their clinical use. We hypothesized that concentrated lyophilized and reconstituted platelet preparations, preserved with trehalose, maintain and possibly enhance fresh platelets’ ability to improve wound healing. We studied the ability of a single dose of trehalose lyophilized and reconstituted platelets to enhance wound healing when topically applied on full-thickness wounds in the genetically diabetic mouse. We compared these results with the application of multiple doses of fresh platelet preparations and trehalose lyophilized and reconstituted platelets as well as multiple doses of vascular endothelial growth factor (VEGF) and wounds left untreated. Trehalose lyophilized and reconstituted platelets, in single and multiple applications, multiple applications of fresh platelets and multiple applications of VEGF increased granulation tissue deposition, vascularity, and proliferation when compared with untreated wounds, as assessed by histology and immunohistochemistry. Wounds treated with multiple doses of VEGF and a single dose of freeze-dried platelets reached 90% closure faster than wounds left untreated. A single administration of trehalose lyophilized and reconstituted platelet preparations enhanced diabetic wound healing, therefore representing a promising strategy for the treatment of nonhealing wounds.

By |May 8th, 2019|Categories: Research|0 Comments

Single Dose Toxicity Study Of Canine Thrombosomes™ In Dogs Followed By A 14-Day Observation Period

Study Director: Jonathan C. White, M.S.A.

Abstract:

This study was conducted for Cellphire, Inc., to evaluate the safety of the test article, Canine Thrombosomes™, following a single infusion dose of 10x the native platelet protein per animal (10x) or 3 doses of 1x the native platelet protein per animal (3x). Two treatment groups of six male and six female beagle dogs were to be administered the test article at respective doses of 1x or 10x, with half the animals necropsied on each Day 2 and 15. Animals receiving the 1x dose were to receive doses three times on Day 1, approximately 2 hours between doses, followed by one administration of Fresh Canine Platelets (100 mL). Due to a shortage of test article, three animals/sex were administered the 1x or 10x dose then scheduled for necropsy on Day 15 and two animals/sex were dosed for the scheduled Day 2 necropsy. Due to a dosing error, the two animals/sex scheduled for the Day 2 necropsy, were actually administered a single dose of approximately 2.4x followed by the fresh canine platelets. Animals in the 10x dose group received a single administration of the test article followed by a single dose of fresh canine platelets. One additional group of six animals/sex served as the control and received a single dose of the vehicle, Thrombosomes™ Buffer at a fixed volume of 105 mL, the mean dose volume administered to the 10x dose group animals. The test article or vehicle was administered to all groups via intravenous infusion.

Based on the results of this study, canine thrombosomes administered as a single dose of 10x, a single dose of 2.4x (misdosed group) or 3 doses of 1x administered approximately 2 hours apart were considered non-adverse.

By |May 8th, 2019|Categories: Research|0 Comments

Clinical Development of Stabilized Platelets for In-fusible Clinical Applications

Investigator: William T. Phillips, MD

Co-Investigators: Vibhudutta Awasthi, PhD and Beth Goins, PhD

Abstract:

To study the circulation kinetics of freeze-dried platelets (FDP) in normal rabbits and to investigate the effect of re-injection of human freeze-dried platelets (thrombosomes).

There were no observed differences in accumulation of endogenous platelets and FDPs in other tissues. It is clear that accumulation in blood, liver and spleen were substantial among endogenous fresh platelets and various FDPs. The pattern was identical when the data was registered in per organ basis. It is important to note that the regardless of the source of freeze-dried platelets, biodistribution of various FDPs in rabbits was remarkably similar.

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By |May 8th, 2019|Categories: Research|0 Comments

News

Elephant disease causes death by hemorrhage… Lyophilized platelets may help.

The in-human care population of elephants is plagued by an endotheliotropic herpes virus that attacks young elephants and causes an acute loss of platelets with associated bleeding.  BodeVet, Inc. working with the Smithsonian Institute has begun the process of producing lyophilized platelets for zoos to have available when bleeding occurs.  A clinical trial is proposed to determine if platelet transfusion improves outcome, saving these magnificent animals from death.

Click here to read the full article!

JAVMA – Vol 252 – No. 2 – Januar 15, 2018

By |February 1st, 2018|Categories: News|0 Comments

BodeVet CTO to Present at IVECCS 2017

BodeVet Chief Technical officer, Anne Hale, DVM, will advise on controversies in blood banking at the International Veterinary Emergency and Critical Care Symposium (IVECCS) 2017. As a recognized world leader in veterinary blood banking, Anne Hale joins a selection of other experts for a panel discussion. This discussion is open to all IVECCS attendees and takes place at 4:15 pm on Friday, September 15.

IVECCS 2017

By |August 10th, 2017|Categories: News|0 Comments

StablePlate RX™ Launching in September at IVECCS 2017

This September, the world’s first injectable freeze-dried platelet derived product will be StablePlate RX™ for canines. StablePlate RX™ is a shelf stable hemostatic agent that couples the healing power of platelets with the stability and convenience of other medicines. BodeVet will release StablePlate RX™ on a limited basis at the International Veterinary and Critical Care Symposium (IVECCS). Visit BodeVet at IVECCS at Booth 502.

StablePlate RX™
IVECCS 2017

By |August 8th, 2017|Categories: News|0 Comments

Parent Company Cellphire Awarded Grant to Develop Elephant Endotheliotropic Herpesvirus (EEHV) Treatment

Thanks to a grant from the International Elephant Foundation, biotechnology company Cellphire, Smithsonian Global Health Program, Ringling Bros. Center for Elephant Conservation, Fort Worth Zoo, and Houston Zoo have made great strides in developing a novel treatment for a lethal virus afflicting baby Asian elephants around the globe. Elephant Endotheliotropic Herpesvirus (EEHV) is the leading cause of death among captive Asian elephants under 12 years of age. EEHV attacks blood vessels and frequently causes uncontrolled hemorrhage, causing the victim to die of blood loss.

The innovative treatment under development builds off of cutting-edge research in human platelet-products, a specialty of Cellphire. This ground-breaking treatment is shelf-stable and can stop bleeding from trauma and internal damage. The human product is targeted at situations as diverse as battlegrounds and Ebola outbreaks. Until now, there has not been a version for elephants. The biotech firm is aided by the extensive elephant health expertise from partner zoological veterinarians at diverse institutions. To date, blood from two Asian Elephants has been collected, stabilized, and prepared for separation into component parts. Separation was successful, and scientists isolated platelet-rich plasma, which was then freeze-dried using a proprietary process. The resulting lyophilized platelets are being subjected to a battery of quality control tests to evaluate shape, size, identity, activity, and purity.  So far, the platelet product reconstitutes appropriately and contains adequate size and number of particles. Samples have been tested for sterility, and the product meets or exceeds FDA regulations for an injectable blood product’s sterility. The product also passes tests for bacterial endotoxin. Partners are currently focused on optimizing protocols to appropriately utilize antibodies for confirmation of identity and purity. Assessing in vitro potency for activation and clot formation. These complicated laboratory procedures are designed to ensure that the final result is a treatment that is safe, effective, and reliable as a treatment for stopping the dangerous hemorrhage caused by EEHV.

Announcement from Smithsonian’s National Zoo & Conservation Biology Institute

By |July 20th, 2017|Categories: News|0 Comments

1-2017-K9 Trial for StablePlate RX™ Begins

The 1-2017-K9 trial for StablePlate RX™ is underway. StablePlate RX™ is being evaluated in canines with life-threatening bleeding secondary to thrombocytopenia. Safety and efficacy results are anticipated in fall 2017.

BodeVet is working with top veterinarians at academic and private hospitals to advance the standard of care for veterinary patients. StablePlate RX™ stands to revolutionize bleeding management – it is derived from the perishable blood cells that naturally stop bleeding, platelets. As a dry powder, StablePlate RX™ is a controlled, shelf-stable, and easy-to-use platelet substitute.

BodeVet expects that this pivotal trial for StablePlate RX™ may have implications in informing and galvanizing future trials, which may qualify StablePlate RX™ for use in more indications in more animals, or qualify entirely new products.

The healing properties of platelets extend beyond bleeding management, which leaves BodeVet excited to explore further veterinary applications for its platelet-derived products.

By |May 2nd, 2017|Categories: News|0 Comments

Platelet Lysate Therapy in Infectious Arthritis

The Grayson-Jockey Club has awarded a two year-grant to the University of North Carolina for equine platelet research. The study will examine the antibacterial properties of platelets in treating horses with joint infections, and measure the effect of platelet lysate therapy on morbidity and mortality. The grant funds were awarded as part of a larger, $1,478,542 effort in 2017 to advance the equine industry for the betterment of all horses.

“…We recently found that platelet-rich plasma (PRP), a therapy commonly used to help recovery from athletic injuries, is useful in fighting off bacterial infections.”

-Lauren Schnabel, North Carolina State University, www.grayson-jockeyclub.org

By |March 13th, 2017|Categories: News|0 Comments
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