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Updated: May 23, 2026

Basic Research in Plasma Medicine - A Throughput Approach from Liquids to Cells
Published on: November 17, 2017
Next generation spray-dried on-demand plasma: A multicenter, randomized, dose-escalation, first-in-human safety study
Jose A Cancelas1,2, Lisa Buckley3, Susan F Leitman3
1Connell and O'Reilly Families Cell Manipulation Core Facility, Dana-Farber Cancer Institute, Boston, Massachusetts, USA.
Spray-dried plasma (ODP) shows safety comparable to frozen plasma in a first-in-human trial. This novel product offers potential for improved prehospital resuscitation and emergency care.
Area of Science:
- Emergency Medicine
- Transfusion Medicine
- Biotechnology
Background:
- Prehospital plasma transfusion is vital for hemorrhagic shock but faces logistical challenges.
- Current plasma products require cold-chain storage, limiting availability.
- A novel spray-dried plasma (ODP) aims to overcome these limitations.
Purpose of the Study:
- To conduct the first-in-human clinical evaluation of spray-dried plasma (ODP).
- To assess the safety and tolerability of ODP in healthy volunteers.
- To compare ODP with standard frozen plasma (PF24) in a crossover study.
Main Methods:
- A dose-escalation study involving 24 healthy volunteers.
- Plasma was processed into both frozen (PF24) and spray-dried (ODP) forms.
- Participants received escalating doses of ODP or a comparison of ODP vs. PF24, followed by 28-day monitoring.
Main Results:
- Spray-dried plasma (ODP) demonstrated preserved protein content.
- All infusions were well-tolerated with no serious adverse events.
- Treatment-emergent adverse events were infrequent and comparable between ODP and PF24 groups.
Conclusions:
- Spray-dried plasma (ODP) exhibits a safety profile similar to standard frozen plasma.
- No thromboembolic events were observed, supporting its safety.
- ODP's stability and rapid reconstitution suggest potential for widespread prehospital and austere use.
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