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Platelets: Frozen and Freeze-Dried Current Products in Development and Regulatory Licensing Challenges

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Damage Control Resuscitation

Abstract

Cryopreserved and lyophilized platelets have a long, but limited, history of human use that dates back to the 1950s yet involves a small number of total study subjects (Fig. 9.1). Despite decades of research characterizing the quality and nature of these products, questions remain regarding the relationship between in vitro performance and in vivo function to control bleeding. That said, results to date indicate promising in vivo hemostatic potential in several animal models. Although the data is retrospective and cannot definitively establish causality, human use of cryopreserved platelets in military settings also appears to be associated with benefit. The regulatory pathway for these products, particularly in the case of cryopreserved platelets, has been decades long, and more trials are needed to provide high-quality data to regulatory bodies. These products could be life-saving in settings where other good alternatives are limited or unavailable.

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Abbreviations

ACD:

Anticoagulant Citrate Dextrose Solution

ADF:

Australian Defense Force

ARC:

Australian Red Cross

BARDA:

Biomedical Advanced Research and Development Authority

BEST:

Biomedical Excellence for Safer Transfusion

CABG:

Coronary artery bypass grafting

CBER:

Center for Biologics Evaluation and Research

CD41a:

Cluster of differentiation 41a (GPIIb/IIIa)

CD42b:

Cluster of differentiation 42b (GPIb)

cGMP:

Current Good Manufacturing Practice

CLIP:

Cryopreserved Platelets Versus Liquid Platelets Trial

CPP:

Cryopreserved platelet product

DARPA:

Defense Advanced Research Projects Agency

DMSO:

Dimethyl sulfoxide

DoD:

Department of Defense

FDA:

Food and Drug Administration

FFP:

Fresh frozen plasma

GPIb:

Glycoprotein Ib

GPIIb/IIIa:

Glycoprotein IIb/IIIa

ICH:

International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use

LDH:

Lactate dehydrogenase

LSP:

Liquid-stored platelets

LyPt:

Lyophilized platelets

LyPt-P:

Lyophilized platelets stabilized with paraformaldehyde

LyPt-T:

Lyophilized platelets stabilized with trehalose

MTFs:

Medical treatment facilities

NATO:

North Atlantic Treaty Organization

NHP:

Non-human primate

NIH:

National Institutes of Health

NLAF:

Netherlands Armed Forces

NZWR:

New Zealand white rabbits

PAS:

Platelet additive solution

PVC:

Polyvinyl chloride

RT:

Room temperature, 20–24 °C

US:

United States

WB:

Whole blood

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Disclosure

Funding for some research studies reported here was from the US Army Medical Research and Materiel Command. The views, opinions, and/or findings contained in this report are those of the authors and should not be construed as an official Department of Defense position, policy, or decision unless so designated by other documentation.

Funding for some research studies reported here was provided in whole or in part with federal funds from the Biomedical Advanced Research and Development Authority, Office of the Assistant Secretary for Preparedness and Response, Office of the Secretary, Department of Health and Human Services, under Contract No. HHSO100201300021C.

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Authors and Affiliations

  1. Department of Clinical Affairs, Cellphire, Inc., Rockville, MD, USA

    Heather Pidcoke

  2. Vitalant Research Institute (VRI), Denver, CO, USA

    Kathleen Kelly & Larry J. Dumont

  3. Clinical Research and Development, Cellphire, Inc., Rockville, MD, USA

    G. Michael Fitzpatrick

  4. The Geisel School of Medicine at Dartmouth, Lebanon, NH, USA

    Larry J. Dumont

  5. University of Colorado School of Medicine, Denver, CO, USA

    Larry J. Dumont

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  1. Heather Pidcoke
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  2. Kathleen Kelly
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  3. G. Michael Fitzpatrick
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  4. Larry J. Dumont
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Correspondence to Larry J. Dumont .

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Editors and Affiliations

  1. School of Medicine, Washington University in St. Louis, St. Louis, MO, USA

    Philip C. Spinella

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Pidcoke, H., Kelly, K., Fitzpatrick, G.M., Dumont, L.J. (2020). Platelets: Frozen and Freeze-Dried Current Products in Development and Regulatory Licensing Challenges. In: Spinella, P. (eds) Damage Control Resuscitation. Springer, Cham. https://doi.org/10.1007/978-3-030-20820-2_9

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