Back to results
US 11,077,148 B2Granted
Acellular biologic composition and method of manufacture
AssigneeVivex Biologics Group, Inc.
InventorsTimothy Ganey, Wendy W. Weston, Gaëtan Jean-Robert Delcroix
Life of this patent
Estimating the term…
Abstract
A biological composition has a mixture of mechanically selected allogeneic biologic material derived from placental tissue. 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 including non-whole cell fractions including one or more of exosomes, transcriptosomes, proteasomes, membrane rafts, lipid rafts. The mixture is compatible with biologic function.
Claims14
A method of making a biological composition comprises the steps of:
- collecting, recovering and processing placental tissue from a donor;
- mechanically separating cellular and non-cellular components or combinations thereof of placental tissue;
- concentrating by centrifugation and filtering to form a suspension of the cellular and non-cellular components;
- separating by density gradient centrifugation to form a cell pellet of the cellular components and a supernatant of the non-cellular components wherein the cellular components in the cell pellet are separated from the supernatant and removed and wherein the supernatant is further consisting of filtering through a 0.45 micron filter;
- collecting non-cellular fractions or non-cellular components or combinations thereof of predetermined density by increasing centrifugation strength;
- washing the non-cellular fractions or non-cellular components or combinations thereof;
- quantifying the non-cellular fractions or non-cellular components or combinations thereof separated by density gradient concentration is greater than zero;
- suspending the non-cellular fractions or non-cellular components or combinations thereof to a concentration with a blend of collected, recovered and processed placental tissue and bone particles to create a mixture in a cryoprotectant consisting of a polyampholyte cryoprotectant to create a biological composition, wherein the bone particles having a size range of 100 to 300 μm of demineralized cortical bone, mineralized cortical bone and mineralized cancellous bone intermixed with the non-cellular fractions or non-cellular components;
- and
- freezing the biological composition at a controlled rate.
7 more elements
A method of making a biological composition comprises the steps of:
- mechanically separating cellular and non-cellular components or combinations thereof of placental tissue;
- concentrating by centrifugation and filtering to form a suspension of the cellular and non-cellular components;
- separating by density gradient centrifugation to form a cell pellet of the cellular components and a supernatant of the non-cellular components wherein the cellular components in the cell pellet are separated from the supernatant and removed and wherein the supernatant is further consisting of filtering through a 0.45 micron filter;
- collecting non-cellular fractions or non-cellular components or combinations thereof of predetermined density by increasing centrifugation strength;
- washing the non-cellular fractions or non-cellular components or combinations thereof;
- quantifying the non-cellular fractions or non-cellular components or combinations thereof separated by density gradient concentration is greater than zero;
- suspending the non-cellular fractions or non-cellular components or combinations thereof to a concentration with a blend of collected and processed placental tissue to create a mixture in a cryoprotectant consisting of a polyampholyte cryoprotectant to form a biological composition;
- and
- freezing the biological composition at a controlled rate.
6 more elements
A method of making a biological composition comprises the steps of:
- collecting, recovering and processing placental tissue from a donor;
- mechanically separating cellular and non-cellular components or combinations thereof of placental tissue;
- concentrating by centrifugation and filtering to form a suspension of the cellular and non-cellular components;
- separating by density gradient centrifugation to form a cell pellet of the cellular components and a supernatant of the non-cellular components wherein the cellular components in the cell pellet are separated from the supernatant and removed and wherein the supernatant is further consisting of filtering through a 0.45 micron filter;
- collecting non-cellular fractions or non-cellular components or combinations thereof of predetermined density by increasing centrifugation strength;
- washing the non-cellular fractions or non-cellular components or combinations thereof;
- quantifying the non-cellular fractions or non-cellular components or combinations thereof separated by density gradient concentration is greater than zero;
- suspending the non-cellular fractions or non-cellular components or combinations thereof to a concentration with a blend of collected, recovered and processed placental tissue and bone particles to create a mixture in a cryoprotectant consisting of a polyampholyte cryoprotectant to create a biological composition, wherein the bone particles having a size range of 100 to 300 μm of demineralized cortical bone, mineralized cortical bone and mineralized cancellous bone intermixed with the non-cellular fractions or non-cellular components;
- and
- freeze-drying the biological composition.
7 more elements
A method of making a biological composition comprises the steps of:
- mechanically separating cellular and non-cellular components or combinations thereof of placental tissue;
- concentrating by centrifugation and filtering to form a suspension of the cellular and non-cellular components;
- separating by density gradient centrifugation to form a cell pellet of the cellular components and a supernatant of the non-cellular components wherein the cellular components in the cell pellet are separated from the supernatant and removed and wherein the supernatant is further consisting of filtering through a 0.45 micron filter;
- collecting non-cellular fractions or non-cellular components or combinations thereof of predetermined density by increasing centrifugation strength;
- washing the non-cellular fractions or non-cellular components or combinations thereof;
- quantifying the non-cellular fractions or non-cellular components or combinations thereof separated by density gradient concentration is greater than zero;
- suspending the non-cellular fractions or non-cellular components or combinations thereof to a concentration with a blend of collected and processed placental tissue to create a mixture in a cryoprotectant consisting of a polyampholyte cryoprotectant to form a biological composition;
- and
- freeze-drying the biological composition.
6 more elements
Dependencies are inferred from the claim text.