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Last Updated: April 26, 2024

Claims for Patent: 10,426,796

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Summary for Patent: 10,426,796

Title:	Compositions for biological systems and methods for preparing and using the same
Abstract:	A composition for influencing biological growth includes a solution having a first volume and having low pH fluid base including dextrose, and albumin, wherein the concentration of albumin in the solution is between about 10 mg/ml and about 150 mg/ml.
Inventor(s):	Jones; Christopher D. (Eagle, ID), Quintanar; Nathan (Boise, ID), Patel; Roshan (Daly City, CA)
Assignee:	SMART Surgical, Inc. (Boise, ID)
Application Number:	15/619,467
Patent Claims:	1. A composition for performing a medical therapy, comprising: a low pH fluid base, wherein the low pH fluid base comprises dextrose; mononuclear cells obtained from human umbilical cord blood; and albumin, wherein the concentration of albumin is between about 10 mg/ml and about 150 mg/ml, and wherein the composition is configured for implantation within a human subject. 2. The composition of claim 1, wherein the pH of the composition is between 5.0 and 7.4. 3. The composition of claim 1, wherein the pH of the composition is between 4.1 and 7.2. 4. The composition of claim 1, wherein the pH of the composition is between 4.1 and 6.2. 5. The composition of claim 1, wherein the pH of the composition is between 5.0 and 6.2. 6. The composition of claim 1, further comprising sodium bicarbonate. 7. The composition of claim 1, further comprising calcium bicarbonate. 8. The composition of claim 1, wherein the albumin is from commercially available human serum. 9. The composition of claim 1, wherein the albumin is from donor-derived serum. 10. The composition of claim 1, wherein the albumin is from human umbilical cord blood. 11. The composition of claim 1, wherein the concentration of albumin is between about 10 mg/ml and about 120 mg/ml. 12. The composition of claim 1, wherein the concentration of albumin is between about 50 mg/ml and about 150 mg/ml. 13. The composition of claim 1, wherein the concentration of albumin is between about 105 mg/ml and about 150 mg/ml. 14. The composition of claim 1, wherein the composition does not contain dimethyl sulfoxide (DMSO). 15. The composition of claim 1, wherein the low pH fluid base further comprises dextran. 16. The composition of claim 1, wherein the low pH fluid base further comprises dimethyl sulfoxide (DMSO). 17. The composition of claim 1, wherein the low pH fluid base further comprises a cryopreservative. 18. The composition of claim 1, further comprising stem cells. 19. The composition of claim 18, wherein the stem cells consist of non-expanded cell populations. 20. The composition of claim 18, wherein the stem cells comprise hematopoietic stem cells (HSC). 21. The composition of claim 18, wherein the stem cells comprise mesenchymal stem cells (MSC). 22. The composition of claim 1, wherein the composition comprises between about 100,000 and about 75 million live mononuclear cells per ml. 23. The composition of claim 1, wherein the composition comprises between about 10 million and about 30 million live mononuclear cells per ml. 24. The composition of claim 1, wherein the composition comprises between about 2.5 million and about 10.2 million live mononuclear cells per ml. 25. The composition of claim 1, wherein the mononuclear cells are derived only from umbilical cord blood of a single donor. 26. The composition of claim 1, further comprising one or more bioactive agents. 27. The composition of claim 26, wherein the one or more bioactive agents comprise one or more cytokines. 28. The composition of claim 26, wherein the one or more bioactive agents comprise one or more growth factors. 29. The composition of claim 26, wherein the one or more bioactive agents are selected from the group consisting of macrophage inflammatory protein alpha (MIP-1.alpha.), macrophage inflammatory protein beta (MIP-1.beta.), interferon gamma-induced protein 10 (IP-10), interleukin 1 Beta (IL-1.beta.), interleukin 2 (IL-2), interleukin 4 (IL-4), interleukin 5 (IL-5), interleukin 6 (IL-6), interleukin 7 (IL-7), interleukin 8 (IL-8), interleukin 9 (IL-9), interleukin 10 (IL-10), interleukin 12 (IL-12), interleukin 13 (IL-13), interleukin 15 (IL-15), interleukin 17 (IL-17), interleukin 18 (IL-18), interleukin 21 (IL-21), interleukin 22 (IL-22), interleukin 23 (IL-23), interleukin 27 (IL-27), interleukin 31 (IL-31), interferon alpha (INF.alpha.), a lymphokine, granulocyte macrophage colony stimulating factor (GM-CSF), stem cell factor (KL), tumor necrosis factor alpha (TNF-.alpha.), vascular endothelial growth factor (VEGF), nerve growth factor, platelet-derived growth factor (PDGF), fibroblast growth factor 2 (FGF-2), epidermal growth factor (EGF), keratinocyte growth factor, transforming growth factor (TGF), insulin-like growth factor, des(1-3)-IGF-I (brain IGF-I), neurotrophin-3 (NT-3), brain-derived neurotrophic factor (BDNF), eotaxin, CXC ligand 1 (GRO.alpha.), interleukin 1 receptor antagonist (IL-1RA), interleukin 1 alpha (IL-1.alpha.), leukemia inhibitory factor (LIF), placental growth factor (PLGF), chemokine ligand 5 (RANTES), stem cell factor (SCF), stromal cell derived factor (SDF1.alpha.), and tumor necrosis factor (TNF .beta.).

Details for Patent 10,426,796

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Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Grifols Therapeutics Llc	ALBUKED, PLASBUMIN-20, PLASBUMIN-25, PLASBUMIN-5	albumin (human)	For Injection	101138	10/21/1942	⤷ Try a Trial	2036-06-13
Baxalta Us Inc.	BUMINATE, FLEXBUMIN	albumin (human)	Injection	101452	03/03/1954	⤷ Try a Trial	2036-06-13
Csl Behring Ag	ALBURX	albumin (human)	Injection	102366	07/23/1976	⤷ Try a Trial	2036-06-13
Grifols Biologicals Llc	ALBUTEIN	albumin (human)	Injection	102478	08/15/1978	⤷ Try a Trial	2036-06-13
Instituto Grifols, S.a.	HUMAN ALBUMIN GRIFOLS	albumin (human)	Injection	103352	02/17/1995	⤷ Try a Trial	2036-06-13
Instituto Grifols, S.a.	HUMAN ALBUMIN GRIFOLS	albumin (human)	Injection	103352	06/11/2003	⤷ Try a Trial	2036-06-13
>Applicant	>Tradename	>Biologic Ingredient	>Dosage Form	>BLA	>Approval Date	>Patent No.	>Expiredate

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