Methods of manufacture of 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 method of making a placental dispersion comprising the steps of:
a) obtaining chorionic tissue from which trophoblasts have been removed; and
b) physically or mechanically disrupting the chorionic tissue to form a placental dispersion, wherein the placental dispersion comprises placental cells.
2. The method of claim 1 , wherein the placental dispersion is a homogenate.
3. The method of claim 1 , wherein the placental dispersion comprises placental tissue pieces.
4. The method of claim 1 , wherein the physical or mechanical disruption comprises mincing.
5. The method of claim 1 , wherein the trophoblasts were removed by dissection and/or enzymatic digestion of a chorionic tissue sample.
6. The method of claim 1 , further comprising before step b), enzymatically digesting the chorionic tissue from which trophoblasts have been removed.
7. The method of claim 1 , wherein the placental cells comprise one or more of mesenchymal stem cells, embryonic stem cells, placenta-derived mesenchymal progenitor cells, placental mesenchymal stem cells, fibroblasts, epithelial cells, placental mesenchymal cells, stromal cells, and macrophages.
8. The method of claim 1 , wherein the placental cells are endogenous to the chorionic tissue.
9. The method of claim 1 , wherein the placental cells are present at a concentration of at least about 20,000 per ml of the placental dispersion.
10. The method of claim 1 , wherein the placental dispersion further comprises one or more placental-derived factors.
11. The method of claim 10 , wherein the one or more placental-derived factors comprises one or more of extracellular matrix proteins, angiogenic factors, chemokines, cytokines, growth factors, matrix metalloproteinases, or combinations thereof.
12. The method of claim 1 , further comprising incubating the placental dispersion for 30-60 minutes in a cryopreservation medium.