THERAPEUTIC PRODUCTS COMPRISING VITALIZED PLACENTAL DISPERSIONS
This invention provides a fluid therapeutic placental product comprising placental cells and a placental dispersion comprising placental factors. The placental cells and the placental dispersion are derived from placental tissue. A placental tissue can optionally be an amnion, chorion, or a trophoblast-depleted chorion. The placental product of the present invention is useful in treating a patient with a tissue injury (e.g. wound or burn) by applying the placental product to the injury. Similar application is useful with ligament and tendon repair and for engraftment procedures such as bone engraftment.
1 . A placental product comprising:
a. a first fraction of placental cells isolated from a first portion of a chorionic membrane, wherein the first fraction of placental cells comprise viable cells that are not expanded ex vivo;
b. a disrupted chorionic membrane derived from a second portion of the chorionic membrane, the disrupted chorionic membrane comprising pieces of native chorionic membrane tissue and a second fraction of placental cells,
wherein the disrupted chorionic membrane is depleted in functional CD14+ macrophages; and
c. one or more placental factors comprised in or released by the first fraction of placental cells, the pieces of native chorionic membrane tissue, and the second fraction of placental cells, and
wherein the first fraction of placental cells, the second fraction of placental cells, or the first fraction of placental cells and the second fraction of placental cells comprise at least stromal cells and placental stem cells.
2 . The placental product of claim 1 , wherein the placental product was previously refrigerated.
3 . The placental product of claim 2 , wherein the placental product was previously refrigerated in a cryopreservation medium.
4 . The placental product of claim 2 , wherein the placental product was previously refrigerated at a temperature of 2-8° C. for about 30 minutes to about 60 minutes.
5 . The placental product of claim 1 , wherein the placental product is cryopreserved.
6 . The placental product of claim 1 , wherein the placental product was previously refrigerated and cryopreserved.
7 . The placental product of claim 6 , wherein the placental product was refrigerated in a cryopreservation medium at a temperature of 2-8° C. for about 30 minutes to about 60 minutes prior to cryopreservation.
8 . The placental product of claim 6 , wherein the placental product is thawed after refrigerating and cryopreserving, and wherein the thawed placental product comprises at least about 70% viable cells.
9 . The placental product of claim 1 , wherein the first fraction of placental cells comprises at least 70% viable cells.
10 . The placental product of claim 1 , wherein cell viability is determined after cryopreserving and thawing the placental product.
11 . The placental product of claim 1 , wherein the placental product is further depleted of trophoblasts.
12 . The placental product of claim 1 , wherein the pieces of native chorionic membrane tissue are greater than 100 μm in length.
13 . The placental product of claim 1 , wherein the first fraction of placental cells, the second fraction of placental cells, or the first fraction of placental cells and the second fraction of placental cells further comprise placental progenitor cells, placental mesenchymal cells, fibroblasts, epithelial cells, or a combination thereof.
14 . The placental product of claim 1 , wherein the product is comprised in a dermatologically acceptable pharmaceutical formulation.
15 . The placental product of claim 1 , wherein the one or more placental factors comprise one or more extracellular matrix proteins, one or more protease inhibitors, one or more growth factors, one or more angiogenic factors, and one or more MMPs.
16 . The placental product of claim 1 , wherein the disrupted chorionic membrane is frozen or lyophilized, and wherein the first fraction of placental cells is added to the frozen or lyophilized disrupted chorionic membrane.
17 . The placental product of claim 1 , wherein the first fraction of placental cells and the disrupted chorionic membrane have not been frozen or lyophilized.
18 . A method of treating a tissue injury comprising administering to a subject in need thereof a placental product of claim 1 .
19 . The method of claim 18 , wherein the tissue injury is a burn, wound, ulceration, or laceration.
20 . The method of claim 18 , wherein the placental product is topically administered to the site of the tissue injury.
21 . The method of claim 18 , wherein the placental product reduces adhesion or fibrosis of the tissue injury, promotes migration of epithelial cells into the tissue injury, or a combination thereof.