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Our Technology

Overview:

Cellphire’s stabilization technology is based on a unique, patented, methodology for introducing high concentrations of a simple natural sugar (Trehalose) and other small molecular weight compounds into the cellular compartments, enabling stabilization of the cells in a dry state following freeze drying (lyophilization).

The basis of the technology is derived from nature. There are plants and animals able to withstand severe heat or cold by making the sugar, Trehalose, which replaces the water that evaporates over time. Once re-exposed to a humid atmosphere or water they then “come back to life” and are fully functional. There are many examples of the way nature uses Trehalose to protect a plant or animal in the dry state and return it to the living when exposed to water.

Cellphire applied this lesson learned from nature to human platelets, using Trehalose as a stabilizing agent combined with other proprietary excipients, buffers and methods to produce three different products: Thrombosomes® to treat and stop internal bleeding; Thromboderm™, for stopping external bleeding, promoting healing and treating joint strains or tears; and Thrombogent™ for use as a quality control reagent in hematology laboratories.

Each product is designed to be stable at room temperature for months to years and easily used by rehydrating with water. The Company’s lyophilized platelet product can be stored at ambient temperatures for long periods, omitting the need for refrigeration equipment and cold chain distribution. The light weight of the product favors its unconstrained transportation and availability in emergency situations.

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Cellphire Products:


Many Biological products are not easily stabilized and rely on "cold-chain" storage. At Cellphire we provide a unique solution for stabilizing cells in the dry-state. This is done by the application of a naturally occurring cryoprotectant (Trehalose). We've received funding from NIH, DARPA, US Army, and private investments and in September of 2013 we received a grant of up to $57 million from BARDA.

Cellphire Thrombosomes®

Cellphire Thrombosomes®, are a freeze-dried, functional platelet transfusion hemostatic agent. Thrombosomes® will be targeted for cardiopulmonary bypass and emergency trauma and in indications that require costly coagulation therapies and be packaged in a dry powder ready for immediate use or for long term stockpiling

Meeting an unmet Need:
Platelets are currently being used to treat hemorrhages. They have a 5-day shelf life which will limit the availability and the results in out-dating 10-20% of collections. 200 Million dollars is wasted annually.

Currently there is no drug or agent that will control massive hemorrhage in trauma. There is also no hemostatic agent available for use in military medicine.

Advantages of Thrombosomes®

  • You can isolate from 2-3 day old Apheresis units, or separate from whole blood.
  • Heat treatment for sterilization
  • Increased availability
  • Shelf life up to 24-36 months at ambient temperature
  • Ease of use re-hydration between 5-10 minutes with sterile water
  • Improved care
  • Decreased amount of waste
Thrombogent™

Thrombogent™, an easily rehydrated platelet product for use as a control reagent for hematology and clinical diagnostic analysis and drug development.

Thromboderm™

Thromboderm™, an advanced freeze-dried, platelet based topical hemostatic agent that will for the first time enable clotting, sealing and wound healing in the same application. Thromboderm™ can be incorporated with a variety of healing materials such as collagen and/or different types of polymers and applied through a dry bandage.

Cellphire Publications:


Dried platelets in a Swing Model of Liver Injurt

Kenji Inaba,* Galinos Barmparas,* Peter Rhee,† Bernardino C. Branco,‡ Michael Fitzpatrick,§ Obi T. Okoye,* and Demetrios Demetriades*

Lyophilization may facilitate production of a safe, portable, easily storable, and transportable
source of platelets for bleeding patients. The objective of this study was to examine the impact of lyophilized human and porcine platelets in a swine liver injury model of nonsurgical hemorrhage.

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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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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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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 unment 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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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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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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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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The Cellphire Method

Cellphire has developed a proprietary method for the stabilization of blood in the dry state. First application of this technology will be the long term stabilization of blood platelets (freeze-dried platelets).