Methods of making a wound treatment composition
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Publication Number
US-11944667-B2
Publication Date
2024-04-02
Expiration Date
Abstract
The present invention provides a method of making a wound treatment composition, wherein the method comprises; i) fractionating a whole blood sample into multiple samples including a platelet rich plasma (PRP) sample, a platelet poor plasma (PPP) sample and a erythrocyte sample, wherein the PRP sample has a haematocrit level of 1-10%, ii) processing a portion of the PPP and/or PRP sample to facilitate cleavage of autologous pro-thrombin present in the PPP and/or PRP to produce autologous thrombin, and iii) combining the PRP sample with a portion of the PPP sample and a portion of the thrombin produced in step (ii) to produce the wound treatment composition; wherein step ii) is performed at less than 15° C. In preferred embodiments the PRP has a haematocrit level of 2 or 8%. Wound treatment compositions produced by the methods are also provided as are compositions for use in treating chronic and acute wounds.
Core Innovation
The method produces a wound treatment composition that is fully autologous by fractionating human whole blood into platelet rich plasma (PRP), platelet poor plasma (PPP), and an erythrocyte fraction. The PRP sample has a haematocrit level of 1–10%, and portions of the PRP sample and PPP sample are combined with autologous thrombin to produce the wound treatment composition.
Autologous pro-thrombin present in the PPP sample is processed to facilitate cleavage to produce autologous thrombin. This processing is carried out at a temperature of less than 15°C, enabling low-temperature thrombin generation.
The resulting wound treatment composition provides for prolonged release of growth factors and has a final hematocrit level of 0.5 to 10%. The document further emphasizes improved solidity/shape retention for about 10 minutes and stability in situ for more than 48 hours, supporting prolonged growth factor release. The composition is suitable for use by 35 minutes from obtaining the human whole blood sample.
Claims Coverage
The partial content includes one independent claim directed to making a wound treatment composition, with multiple dependent claims narrowing process and composition parameters. Across the independent claim, the inventive aspects are centered on autologous fractionation of whole blood, low-temperature cleavage of autologous pro-thrombin to autologous thrombin, and combining PRP with PPP-derived thrombin to obtain a composition with prolonged growth factor release.
Fractionating whole blood into PRP, PPP, and erythrocyte fractions for autologous gel composition
A method of making a wound treatment composition by centrifuging a human whole blood sample into a PRP sample, a PPP sample, and an erythrocyte sample, where the PRP sample has a haematocrit level of 1–10%.
Low-temperature cleavage of autologous pro-thrombin to produce autologous thrombin
Processing a portion of the PPP sample to facilitate cleavage of autologous pro-thrombin present in the PPP sample to produce autologous thrombin, wherein the processing step is carried out at a temperature of less than 15°C.
Combining PRP, PPP, and produced autologous thrombin to enable prolonged growth factor release
Combining the PRP sample with a portion of the PPP sample and a portion of the thrombin produced in the cleavage step to produce the wound treatment composition, where the wound treatment composition provides for prolonged release of growth factors and has a final hematocrit level of 0.5 to 10% and is suitable for use by 35 minutes from obtaining the human whole blood sample.
Overall, the independent claim coverage centers on producing PRP/PPP/erythrocyte fractions from autologous whole blood, generating autologous thrombin via cleavage of autologous pro-thrombin in PPP at less than 15°C, and combining PRP with PPP and the produced thrombin to yield a composition configured for prolonged growth factor release with defined hematocrit and usability timing.
Stated Advantages
Prolonged release of growth factors.
Improved solidity/shape retention for about 10 minutes.
Stability in situ for more than 48 hours.
Suitable for use by 35 minutes from obtaining the human whole blood sample.
Documented Applications
Wound treatment composition use for acute versus chronic wound settings (as described via leukocyte-rich versus leukocyte-reduced PRP haematocrit-linked leukocyte content), including mention of diabetic patients and wound volume reduction outcomes in a small patient cohort.
Treatment of wounds with a fully autologous gel/composition that maintains shape and remains stable in situ, supporting prolonged growth factor release.
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