Materials and methods for hypothermic collection of whole blood

Inventors

Nicoud, Ian B. • Clarke, Dominic M. • Mathew, Aby J. • Rice, Michael

Assignees

Biolife Solutions Inc

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Publication Number

US-8642255-B2

Patent

Publication Date

2014-02-04

Expiration Date


Abstract

The present invention relates to materials and methods for hypothermic collection of whole blood, and components thereof, which can extend the holding time of blood beyond the current useable limit. Additionally, blood can be drawn directly into a hypothermic preservation solution without the addition of standard anticoagulants. This is enabled by providing sustained cellular viability under hypothermic conditions using a nutrient matrix devoid of animal proteins and containing energy substrates, free-radical scavengers, and impermeants that is ionically balanced for storage of biologic materials at low temperatures to prevent cellular stress-induced apoptosis.

Core Innovation

The invention describes hypothermic preservation of whole blood, particularly cord blood, using a preservation solution adapted for cellular osmotic balance. The method is described as supporting collection and storage without an exogenously introduced anticoagulant reagent. The preservation solution includes specified classes of ingredients, such as electrolytes, an impermeant anion, a sugar, an ATP-regeneration substrate, or a biological pH buffer.

The partial content reports that preserved samples retain blood-cell viability and allow recovery of viable nucleated, CD34-positive, and CD45-positive cells for isolation and possible cryopreservation. It also reports no observed clotting in the cord-blood examples and describes viability and recovery trends during storage. The background section is not included in the supplied content, so the problem identified there is not explicitly described in patent.

Claims Coverage

The supplied relevant claims identify one independent claim comprising three inventive features directed to hypothermic whole-blood preservation without an exogenously introduced anticoagulant reagent.

Hypothermic preservation of whole blood

The claim covers harvesting whole blood by combining it with a preservation solution adapted for cellular osmotic balance at hypothermic temperatures and maintaining the mixture under hypothermic conditions.

Absence of an exogenously introduced anticoagulant reagent

The claim specifies that the whole blood, preservation solution, and container are free from an exogenously introduced anticoagulant reagent.

Preservation solution composition

The claim specifies a preservation solution comprising one or more listed components or combinations thereof, including an electrolyte solution, an impermeant anion, mannitol, a macromolecular oncotic agent, a simple sugar, an ATP-regeneration substrate, or a biological pH buffer.

The independent claim covers hypothermic preservation of whole blood using a solution adapted for cellular osmotic balance, without an exogenously introduced anticoagulant reagent, and specifies classes of preservation-solution ingredients.

Stated Advantages

The disclosed approach supports collection and storage without an exogenously introduced anticoagulant reagent.

The partial content states that blood-cell viability is preserved and that viable nucleated, CD34-positive, and CD45-positive cells can be recovered.

Cord-blood examples report no observed clotting during storage.

Documented Applications

Collection and storage of whole blood, particularly cord blood.

Recovery of nucleated, CD34-positive, and CD45-positive cells for isolation and possible cryopreservation.

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