FROZEN THERAPEUTIC DOSE AND PACKAGE
A frozen therapeutic dose includes an amniotic material and is configured into a pack for easy administering of the dose to a treatment location. A frozen therapeutic dose may contain a concentration of live amniotic stem cells. A frozen therapeutic dose may be provided in a form, such as a multi-pack form, to enable a person to administer a dose to a treatment location without the need of traveling to a doctor's office or clinic. A frozen therapeutic dose package may be kept in a conventional freezer at −20° C., for example, for extended periods of time and a person may remove the package as needed for treatment. A frozen dose package or pack may contain a secondary material configured to mix with the frozen therapeutic dose. A secondary material may be configured within a single dose compartment with the frozen dose or within a separate compartment.
1 . A therapeutic dose package comprising:
a) a first compartment comprising:
i) a frozen therapeutic dose comprising:
amnion material.
2 . The therapeutic dose package of claim 1 , wherein the frozen therapeutic dose has a volume of no more than about 40 ml. The therapeutic dose package of claim 1 , wherein the frozen therapeutic dose comprises a therapeutic composition comprising:
i) acellular amniotic membrane particles;
ii) a carrier fluid comprising an acellular amniotic fluid;
wherein the acellular amniotic membrane particles consist essentially of micronized amniotic membrane; and
wherein the therapeutic composition is essentially free of any viable amniotic membrane cells or viable amniotic fluid cells.
3 . The therapeutic dose package of claim 1 , wherein the frozen therapeutic dose comprises a plurality of amniotic stem cells.
4 . The therapeutic dose package of claim 1 , wherein the frozen therapeutic dose comprises a plurality of non-amnion derived cells.
5 . The therapeutic dose package of claim 1 , wherein the non-amnion derived cells comprise stromal vascular fraction cells.
6 . The therapeutic dose package of claim 1 , wherein the non-amnion derived cells comprise stem cells.
7 . The therapeutic dose package of claim 1 , wherein the frozen therapeutic dose comprises a plurality of live amniotic stem cells.
8 . The therapeutic dose package of claim 1 , wherein the frozen therapeutic dose comprises a plurality of particles comprising micronized amniotic membrane particles.
9 . The therapeutic dose package of claim 8 , wherein the frozen therapeutic dose comprises live amniotic stem cells.
10 . The therapeutic dose package of claim 1 , wherein the frozen therapeutic dose comprises amniotic fluid.
11 . The therapeutic dose package of claim 10 , wherein the frozen therapeutic dose comprises live amniotic stem cells.
12 . The therapeutic dose package of claim 1 , wherein the frozen therapeutic dose comprises amnion derived materials selected from the group consisting of: cytokines, proteins, growth factors, and collagen.
13 . The therapeutic dose package of claim 1 , wherein the frozen therapeutic dose comprises:
a) a plurality of particles comprising micronized amniotic membrane particles; and
b) amniotic fluid.
14 . The therapeutic dose package of claims 13 , wherein the frozen therapeutic dose comprises live amniotic stem cells.
15 . The therapeutic dose package of claim 1 , wherein the frozen therapeutic dose is a solid.
16 . The therapeutic dose package of claim 1 , wherein the frozen therapeutic dose further comprising a cryoprotectant.
17 . The therapeutic dose package of claim 16 , wherein the cryoprotectant comprises DMSO.
18 . The therapeutic dose package of claim 1 , wherein the buffer comprises a pH buffer.
19 . The therapeutic dose package of claim 1 , wherein the frozen therapeutic dose further comprising a diluent.
20 . The therapeutic dose package of claim 19 , wherein the diluent comprises a plasma containing diluent.