US 12,168,029 B2
Methods and compositions for treatment of penile defects
Michael P. Zahalsky, Parkland, FL (US)
Filed by Michael P. Zahalsky, Parkland, FL (US)
Filed on Nov. 24, 2020, as Appl. No. 17/103,248.
Application 16/711,673 is a division of application No. 15/158,101, granted, now 10,548,925, issued on Feb. 4, 2020, previously published as PCT/US2016/016934, filed on Feb. 8, 2016.
Application 15/158,101 is a division of application No. 14/363,142, granted, now 10,751,374, issued on Aug. 25, 2020, previously published as PCT/US2013/023830, filed on Jan. 30, 2013.
Application 17/103,248 is a continuation in part of application No. 16/711,673, filed on Dec. 12, 2019, granted, now 11,160,835.
Application 17/103,248 is a continuation in part of application No. 15/541,988, filed on Jul. 6, 2017, abandoned.
Claims priority of provisional application 61/592,108, filed on Jan. 30, 2012.
Prior Publication US 2021/0077538 A1, Mar. 18, 2021
This patent is subject to a terminal disclaimer.
Int. Cl. A61K 35/48 (2015.01); A61K 9/00 (2006.01); A61K 31/568 (2006.01); A61K 35/16 (2015.01); A61K 35/28 (2015.01); A61K 35/35 (2015.01); A61K 35/50 (2015.01); A61K 35/545 (2015.01); A61K 38/09 (2006.01); A61K 38/18 (2006.01); A61K 38/24 (2006.01); A61K 38/27 (2006.01); A61K 38/39 (2006.01); A61K 38/48 (2006.01); A61K 45/06 (2006.01); A61K 47/42 (2017.01); A61L 27/22 (2006.01); A61L 27/24 (2006.01); A61L 27/36 (2006.01); A61L 27/38 (2006.01); A61L 27/54 (2006.01); A61L 27/58 (2006.01); C12N 5/00 (2006.01); C12N 5/071 (2010.01); C12N 5/0775 (2010.01)
CPC A61K 35/48 (2013.01) [A61K 9/0019 (2013.01); A61K 9/0024 (2013.01); A61K 9/0034 (2013.01); A61K 31/568 (2013.01); A61K 35/16 (2013.01); A61K 35/28 (2013.01); A61K 35/35 (2013.01); A61K 35/50 (2013.01); A61K 35/545 (2013.01); A61K 38/09 (2013.01); A61K 38/18 (2013.01); A61K 38/24 (2013.01); A61K 38/27 (2013.01); A61K 38/39 (2013.01); A61K 38/4886 (2013.01); A61K 45/06 (2013.01); A61K 47/42 (2013.01); A61L 27/225 (2013.01); A61L 27/24 (2013.01); A61L 27/3633 (2013.01); A61L 27/3834 (2013.01); A61L 27/54 (2013.01); A61L 27/58 (2013.01); C12N 5/00 (2013.01); C12N 5/0667 (2013.01); C12N 5/0683 (2013.01); A61L 2300/41 (2013.01); A61L 2300/414 (2013.01); A61L 2400/06 (2013.01)] 9 Claims
 
1. A composition comprising: a mixture of a population of isolated penile stem cells free of red blood cells mixed with amnion and/or amniotic fluid, the mixture having a pH from 6.46 to 8.3 achieved by the addition of buffer solutions or excipients to bring the solution to isotonicity including sodium phosphate, sodium chloride, bicarbonate, or pharmaceutically acceptable agents, and the mixture further having one or more of testosterone, human chorionic gonadotropin (hCG), human growth hormone (HGH), somatropin or a combination thereof;
at least one extracellular matrix component, wherein the extracellular matrix component comprises collagen and collagenase, the collagenase being clostridial collagenase, wherein the collagenase breaks down collagen while introducing collagen; and
wherein the isolated penile stem cells are obtained from a whole blood specimen taken from a penis of a subject separated from the whole blood into fractions of platelet-rich plasma (PRP) and red blood cells in a first spin, wherein the red blood cells are discarded and the platelet-rich plasma (PRP) is concentrated in a second spin forming a supernatant of platelet poor plasma (PPP) which is removed leaving the platelet-rich plasma (PRP) having the isolated penile stem cells, the isolated penile stem cells being expanded and thereafter mixed with the amnion and/or amniotic fluid to form the composition to which collagenase is added to aid in breaking down disorganized collagen in plaques associated with Peyronie's disease.