Will a shelf-stable whole blood substitute be FDA approved for human use by 31 December 2030?
Started
Jan 23, 2025 06:00PM
Closed Feb 12, 2025 04:59AM (2 days ago)
Closed Feb 12, 2025 04:59AM (2 days ago)
The development of a shelf-stable whole blood substitute has been a long-standing goal in medical research, with significant implications for emergency medicine, military operations, and remote healthcare. In early 2023, a consortium of universities and biotech companies received substantial funding to develop a whole blood equivalent with a long shelf life that can be freeze-dried for easy portability and reconstituted when onsite. The aim is to create a product that can be easily used in the field by medics at the point of injury, potentially revolutionizing trauma care (Association for the Advancement of Blood and Biotherapies).
The ideal blood substitute would combine artificial red blood cells, platelets, and plasma components. Current research focuses on developing each of these components separately. For instance, ErythroMer, a biosynthetic red blood cell substitute, has shown promise in preclinical testing and could potentially be more durable and versatile than natural red blood cells (Association for the Advancement of Blood and Biotherapies).
Currently, there are no FDA-approved blood substitutes available for routine use. Previous attempts have faced challenges in clinical trials due to safety concerns and efficacy issues. The approval process for such products is complex, as they may be classified as drugs, biologics, devices, or a combination thereof (PubMed).
Resolution Criteria:
This is an unscored question that closes for forecasting on 11 February 2025. Although this is an unscored question, we outline the theoretical resolution criteria here.
This question would be resolved using official FDA documentation such as press releases and databases of approved products (Purple Book, Drugs@FDA). To count towards a “Yes” resolution:
- A whole blood substitute product must receive full FDA approval for routine human use by 31 December 2030. This approval must be for standard clinical use, not just for emergency use authorization, expanded access, compassionate use, or investigational status.
- The approved product must be shelf-stable, meaning it can be stored without refrigeration for an extended period (at least several months) without losing its efficacy.
- The product must be designed to replace all major components of whole blood (red blood cells, platelets, and plasma) or provide equivalent functionality. Plasma expanders and volume replacements will not be considered.
This question is part of a series on emerging capabilities in biotechnology and the biomedical sciences.
This question has ended, but is awaiting resolution by an admin.
Possible Answer | Final Crowd Forecast |
---|---|
Yes | 6% |
No | 94% |