US 12,263,191 B2
Micronized compositions for wound healing prepared from intact human amnion-chorion tissue having an intact intermediate spongy layer positioned there between
Jason V. Matuszewski, Boca Raton, FL (US); and Wendy W. Weston, Coral Springs, FL (US)
Assigned to BioStem Technologies, Inc., Pompano Beach, FL (US)
Filed by BioStem Technologies, Inc., Pompano Beach, FL (US)
Filed on Mar. 1, 2024, as Appl. No. 18/593,225.
Application 18/593,225 is a continuation of application No. PCT/US2023/026436, filed on Jun. 28, 2023.
Claims priority of provisional application 63/356,628, filed on Jun. 29, 2022.
Claims priority of provisional application 63/391,032, filed on Jul. 21, 2022.
Prior Publication US 2024/0245731 A1, Jul. 25, 2024
Int. Cl. A61K 35/50 (2015.01); A61K 31/726 (2006.01); A61K 31/728 (2006.01); A61K 38/17 (2006.01); A61K 38/18 (2006.01); A61K 38/20 (2006.01); A61K 38/39 (2006.01); A61K 41/10 (2020.01)
CPC A61K 35/50 (2013.01) [A61K 31/726 (2013.01); A61K 31/728 (2013.01); A61K 38/179 (2013.01); A61K 38/1833 (2013.01); A61K 38/2006 (2013.01); A61K 38/39 (2013.01); A61K 41/10 (2020.01)] 21 Claims
 
1. A sterile micronized composition prepared from intact human placental tissue that is configured for wound healing, the sterile micronized composition comprising:
(a) micronized human amnion;
(b) micronized human chorion; and
(c) micronized human intermediate spongy layer;
wherein the composition is prepared from intact placental tissue in cross-section comprising a human amnion layer, human chorion layer, and an intact human intermediate spongy layer positioned between and connecting the human amnion layer to the human chorion layer such that immediately before micronization the human amnion layer and the human chorion layer are not separated from one another;
wherein the composition is prepared without the use of exogenous enzymes; and
wherein the composition comprises at least four of the following:
(a) IL-1ra ranging from 1.0×102 to 5.0×104 pg/cm2;
(b) HGF ranging from 5.0×102 to 1.0×104 pg/cm2:
(c) VEGFR1 ranging from 5.0×102 to 5.0×103 pg/cm2;
(d) HA ranging from 1.0×107 to 1.0×108 pg/cm2;
(e) GAGs; and
(f) Collagen.