Compositions and methods relating to pooled fetal support tissue
Described herein is a composition, methods comprising, pooled fetal support tissue, wherein the pooled fetal support tissue comprises a therapeutically effective amount of native HC-HA/PTX3 complex.
1 . A composition comprising a pooled umbilical cord and amniotic membrane (MAU) tissue, wherein the pooled MAU tissue comprises MAU tissue from a plurality of donors, wherein the pooled MAU tissue is lyophilized, wherein the lyophilized pooled MAU tissue comprises a native HC-HA/PTX3 (nHC-HA/PTX3) complex, wherein the nHC-HA/PTX3 complex possesses a therapeutic potency, and wherein the lyophilized pooled MAU tissue is enriched for total protein relative to non-pooled MAU tissue.
2 . The composition of claim 1 , wherein the composition comprises umbilical cord amniotic membrane, Wharton's jelly, or any combination thereof.
3 . The composition of claim 1 , wherein the composition is terminally sterilized, gamma irradiated, filtered, membrane filtered, electron beam sterilized or any combination thereof.
4 . The composition of claim 1 , wherein the pooled MAU tissue is cut, morselized, micronized, pulverized, ground, or any combination thereof.
5 . The composition of claim 1 , wherein the pooled MAU tissue is substantially free of metabolic activity.
6 . The composition of claim 1 , wherein the MAU tissue comprises an average particle size from about 0.01 micrometer (μm) to about 240 μm in diameter.
7 . The composition of claim 1 , wherein the MAU tissue comprises an average particle size of about 0.5 μm.
8 . The composition of claim 1 , wherein the composition is formulated as a gel, a powder, or a liquid.
9 . The composition of claim 1 , wherein the lyophilized pooled MAU tissue exhibits reduced variability of native HC-HA/PTX3 complex compared to non-pooled MAU tissue as determined by the ODI-TRAP assay; and wherein the pooled MAU tissue and the non-pooled MAU tissue are processed in the same manner and are obtained from the same type of tissue source.
10 . The composition of claim 9 , wherein the reduced variability of native HC-HA/PTX3 complex comprises a reduced variation as determined by a coefficient of variation.
11 . The composition of claim 10 , wherein the coefficient of variation is 3.0% or less.
12 . The composition of claim 1 , wherein the total protein is determined by a bicinchoninic acid (BCA) assay.
13 . The composition of claim 1 , wherein the composition inhibits TRAP activity by at least about 25% when compared to 50 μg/ml of RANKL.
14 . The composition of claim 1 , wherein the MAU tissue is cryopreserved or previously frozen.
15 . A method of making the composition of claim 1 , comprising obtaining MAU tissue from a plurality of donors and pooling the MAU tissue from the plurality of donors, thereby making pooled MAU tissue, wherein the pooled MAU tissue is lyophilized.
16 . The method of claim 15 , wherein the MAU tissue is not dehydrated.
17 . The method of claim 15 , wherein the MAU tissue is lyophilized before or after pooling the MAU tissue.
18 . The method of claim 15 , further comprising processing the MAU tissue by morselizing, pulverizing, micronizing, or a combination thereof.
19 . A method of treating a condition in an individual, wherein the condition comprises an inflammatory disorder, a bladder condition, a bone disorder, a wound, an ocular disorder, a scar condition, a pain disorder, a nerve disorder, spina bifida, or any combination thereof in an individual in need thereof, the method comprising administering the composition of claim 1 to the individual, thereby treating the condition.
20 . The method of claim 19 , wherein the inflammatory disorder comprises dry eye.
21 . The method of claim 19 , where in the pain disorder comprises pain in a shoulder.
22 . The method of claim 19 , wherein the bone disorder comprises osteoarthritis.
23 . The method of claim 19 , wherein the bone disorder comprises osteoporosis.
24 . The method of claim 19 , wherein the ocular disorder comprises dry eye, ocular surface inflammation or ulcerative keratitis.
25 . The method of claim 19 , wherein the wound comprises a complex wound.
26 . A method of determining the potency of the lyophilized, pooled MAU tissue composition of claim 1 , wherein the method comprises:
performing a potency cell-based assay on the composition of claim 1 ,
wherein the potency cell-based assay comprises:
(i) an osteoclast differentiation inhibition tartrate-resistant acid phosphatase (ODI-TRAP) assay;
(ii) a Nitric Oxide (NO assay); or
(iii) a macrophage polarization (M2) assay; and
wherein the lyophilized, pooled MAU tissue composition exhibits a statistically significant inhibition of bioactivity in the potency cell-based assays (i), (ii) or (iii) compared to a positive control assay.