Claims for Patent: 10,314,861

Summary for Patent: 10,314,861

Title:	Flowable tissue matrices
Abstract:	Disclosed herein are flowable tissue matrix compositions comprising small pieces of partially or completely decellularized tissue suspended in a gelatinized tissue or gelatin gel comprising partially or completely decellularized tissue or synthetic gelatin. The flowable tissue matrix compositions can contain factors that promote or enhance native cell migration, proliferation, and/or revascularization after implantation into a subject. Also disclosed are methods of making and using the flowable tissue matrix compositions. The compositions can be implanted into a tissue in need of repair, regeneration, healing, treatment, and/or alteration, and can promote or enhance native cell migration, proliferation, and/or revascularization.
Inventor(s):	Sun; Wenquan (Warrington, PA)
Assignee:	LifeCell Corporation (Madison, NJ)
Application Number:	15/684,402
Patent Claims:	1. A flowable tissue matrix composition, comprising small pieces of partially or completely decellularized tissue, wherein a majority of the small pieces of partially or completely decellularized tissue have surface area to volume ratio of less than about 6 mm.sup.2/mm.sup.3 and wherein the small pieces of partially or completely decellularized tissue are suspended in a gelatin gel comprising less than about 20% of the composition on a volume/volume (v/v) basis. 2. The composition of claim 1, wherein the small pieces of partially or completely decellularized tissue in the composition have an increased resistance to degradation or resorption as measured using a type I collagenase digestion assay, as compared to a homogenized acellular tissue, while also retaining the ability to flow into and mold to the shape of an implant site. 3. The composition of claim 1, wherein the small pieces of partially or completely decellularized tissue have a length, a width, and a height ranging from about 1.0 mm to about 5.0 mm. 4. The composition of claim 3, wherein the length, width, and height of the majority of the small pieces of partially or completely decellularized tissue ranges from about 2.0 mm to 4.0 mm. 5. The composition of claim 1, wherein the majority of the small pieces of partially or completely decellularized tissue in the composition have a surface area to volume ratio of greater than about 1.5 mm.sup.2/mm.sup.3 and less than about 6 mm.sup.2/mm.sup.3. 6. The composition of claim 1, wherein the majority of the small pieces of partially or completely decellularized tissue in the composition have a surface area to volume ratio of less than about 4.5 mm.sup.2/mm.sup.3 and greater than about 2.0 mm.sup.2/mm.sup.3. 7. The composition of claim 1, wherein the gelatin gel is crosslinked. 8. The composition of claim 1, wherein the small pieces of partially or completely decellularized tissue are derived from an animal selected from a group consisting of human, nonhuman primate, pig, cow, horse, goat, sheep, dog, cat, rabbit, guinea pig, gerbil, hamster, rat, and mouse. 9. The composition of claim 1, wherein the small pieces of partially or completely decellularized tissue are derived from a tissue selected from a group consisting of bone, skin, dermis, intestine, vascular, urinary bladder, tendon, ligament, muscle, fascia, neurologic tissue, vessel, liver, heart, lung, kidney, and cartilage tissue. 10. The composition of claim 1, wherein the flowable tissue matrix composition lacks alpha-galactose moieties. 11. The composition of claim 1, further comprising one or more viable cells. 12. The composition of claim 11, wherein the one or more viable cells are mammalian cells. 13. The composition of claim 11, wherein the one or more viable cells are stem cells. 14. The composition of claim 1, further comprising at least one additional factor selected from a group consisting of an anti-inflammatory agent, an analgesic, a cell growth factor, an angiogenic factor, a differentiation factor, a cytokine, a hormone, and a chemokine. 15. The composition of claim 14, wherein the at least one additional factor is encoded by a nucleic acid sequence contained within an expression vector. 16. The composition of claim 15, wherein the expression vector is contained within one or more viable cells. 17. The composition of claim 1, wherein the flowable tissue matrix composition has been subjected to a sterilization process. 18. The composition of claim 1, wherein the gelatin gel comprises a gelatinized tissue that has been heated to at least about 50.degree. C. and then allowed to cool. 19. The composition of claim 18, wherein the gelatinized tissue comprises homogenized acellular or partially decellularized tissue in an aqueous solution at a concentration of about 0.1-10.0% weight/volume (w/v). 20. The composition of claim 1, wherein the gelatin gel comprises at least one of a hydrogel or a starch gel.

Details for Patent 10,314,861

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Smith & Nephew, Inc.	SANTYL	collagenase	Ointment	101995	06/04/1965		2032-04-24