Biologic composition and method of manufacture
A biological composition has a mixture of mechanically selected allogeneic biologic material derived from bone marrow. The mixture has non-whole cellular components including vesicular components and active and inactive components of biological activity, cell fragments, cellular excretions, cellular derivatives, and extracellular components. The mixture is compatible with biologic function.
1. A method of preparing a biological composition for implantation into a patient, the method of preparing the biological composition comprises the steps of:
collecting, recovering and processing cadaverous bone including cortical bone, cancellous bone, and bone marrow cut from vertebral bodies from a cadaver donor;
mechanically separating cellular and non-cellular components of bone marrow from cadaverous bone by tumbling, sieving the cadaverous bone from a decanted fluid of the bone marrow containing the cellular and non-cellular components in a series of cycles, wherein in a first cycle, the decanted fluid is discarded, and in subsequent cycles, the decanted fluid is collected and commingled to form the decanted fluid;
concentrating the decanted fluid by centrifugation and filtering the decanted fluid through a blood filter to form a mixture including the cellular and non-cellular components separated from the marrow tissue and remaining cancellous and cortical bone that is discarded;
separating the mixture by density gradient centrifugation to form an interface of the cellular and non-cellular components;
collecting from the interface cells or non-cellular components or combinations thereof;
washing the cells or non-cellular components or combinations thereof in the mixture;
quantifying a cell concentration in the mixture, the cell concentration can be zero or greater;
suspending the mixture in a cryoprotectant to create the biological composition for implantation, the biological composition being configured to be directly implanted without washing or rinsing;
freezing the composition; and
packaging a volume of bone separate from the composition to be added upon thawing or within the composition prior to freezing the mixture and cryoprotectant.
2. The method of preparing the biological composition use of claim 1 by the steps of:
thawing the composition; and
implanting the composition with or without the bone being intermixed with the mixture and cryoprotectant by packing, injection or any other suitable means into a patient.
3. The method of preparing the biological composition of claim 2 wherein the step of thawing the composition comprises the step of placing the composition in a water bath for 2 to 3 minutes wherein the water bath has a temperature of 37 degrees C.
4. The method of preparing the biological composition of claim 2 further comprises the step of:
diluting the thawed composition in saline without spinning.
5. The method of preparing the biological composition of claim 3 further comprises the step of:
diluting the thawed composition in saline without spinning.