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 a placental tissue comprising chorionic tissue, wherein the chorionic tissue comprises trophoblasts;
b) removing trophoblasts from the chorionic tissue;
c) after step b), physically or mechanically disrupting the chorionic tissue to form a placental dispersion, wherein the placental dispersion comprises placenta cells and placental tissue pieces; and
d) cryopreserving the placental dispersion.
2. The method of claim 1 , wherein the placental dispersion is a homogenate.
3. The method of claim 1 , wherein the physical or mechanical disruption is by mincing.
4. The method of claim 1 wherein the trophoblasts are removed by dissection.
5. The method of claim 1 , wherein the placental dispersion comprises one or more extracellular matrix proteins; protease inhibitors; angiogenic factors; or placental derived factors.
6. A product made by the method of claim 1 .
7. The method of claim 1 further comprising thawing the placental dispersion after the cryopreservation.
8. The method of claim 1 , wherein removing the trophoblasts from the chorionic tissue comprises enzymatic digestion.
9. The method of claim 7 , wherein the placental dispersion comprises at least about 40% viable cells in the thawed placental product after at least one freeze-thaw cycle.
10. The method of claim 7 , wherein the placental dispersion comprises at least about 50% viable cells in the thawed placental dispersion after at least one freeze-thaw cycle.
11. The method of claim 7 , wherein the placental dispersion comprises at least about 70% viable cells in the thawed placental dispersion after at least one freeze-thaw cycle.
12. The method of claim 8 , wherein the enzymatic digestion is a dispase digestion.
13. The method of claim 1 , wherein the placental dispersion comprises one or more placental factors.