Bone induction system and methods
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Publication Number
US-11419961-B2
Publication Date
2022-08-23
Expiration Date
Abstract
An osteogenic composition suitable for use in bone and soft tissue reparative procedures is provided for herein. Methods for preparing osteogenic composition from blood and bone marrow are also provided for. The osteogenic compositions contain therapeutically effective concentrations of one or more osteogenic agents such as BMP-2, TGF-β, PDGF and VEGF.
Core Innovation
The invention relates to a method of preparing an osteogenic composition by deriving one or more osteogenic agents from a biological sample comprising whole blood, bone marrow aspirate, or a combination of whole blood and bone marrow aspirate. The method produces a lysate that comprises solid material and one or more osteogenic agents, and includes acidifying the biological sample by contacting it with a hydrochloric acid solution to form an acidified lysate. The approach is directed to obtaining an osteogenic composition enriched for the one or more osteogenic agents.
After acidification, the acidified lysate is neutralized. The lysate is then separated into a first fraction and a second fraction, where the first fraction comprises the one or more osteogenic agents and the second fraction comprises the solid material. The first fraction is collected and concentrated to obtain an osteogenic composition enriched for the one or more osteogenic agents. The osteogenic agents include BMP-2, VEGF, PDGF and TGF-β.
In the described workflow, the enriched osteogenic agents are produced from whole blood and/or bone marrow aspirate through lysing, neutralizing, fractionating, and concentrating. The preparation is characterized as applicable to an osteogenic composition and is further refined in dependent aspects by specifying alternative lysing and processing operations and particular separation and concentration unit operations and constraints.
Claims Coverage
The document includes one independent claim directed to a method of preparing an osteogenic composition, with multiple dependent claims refining specific processing steps and optional formulation aspects. The independent claim includes four main inventive features that together derive and enrich osteogenic agents from whole blood and/or bone marrow aspirate.
Acidified lysate preparation from whole blood or bone marrow aspirate
Obtaining a biological sample comprising whole blood, bone marrow aspirate, or a combination; at least partially lysing the biological sample to produce a lysate comprising solid material and one or more osteogenic agents, wherein lysing comprises acidifying the biological sample by contacting it with an amount of a hydrochloric acid solution, thereby producing an acidified lysate.
Neutralizing acidified lysate
Neutralizing the acidified lysate.
Fractionation into osteogenic-agent fraction and solid-material fraction
Separating the lysate into a first fraction and a second fraction, said first fraction comprising the one or more osteogenic agents, and said second fraction comprising the solid material.
Collecting and concentrating the osteogenic-agent enriched fraction
Collecting and concentrating the first fraction, thereby obtaining an osteogenic composition enriched for the one or more osteogenic agents, including one or more of BMP-2, VEGF, PDGF and TGF-β.
Overall claim coverage is centered on deriving osteogenic agents from whole blood and/or bone marrow aspirate by acidifying with hydrochloric acid to form an acidified lysate, neutralizing, separating into fractions enriched for osteogenic agents versus solid material, and then collecting and concentrating the osteogenic-agent-enriched first fraction to form an osteogenic composition enriched for BMP-2, VEGF, PDGF and TGF-β.
Stated Advantages
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