Amniotic fluid composition and method of using

Abstract

A composition for treating a patient with a tissue disease or malformity has a composition containing amniotic fluid. The amniotic fluid has a quantity of gender specific amniotic fluid based on a gender of a fetal source. A method of treating a patient with a tissue disease or malformity comprises the steps of: identifying the tissue region to be treated and selecting a location to apply either topically or by injection or inhalation a composition containing amniotic fluid; selecting the composition containing amniotic fluid wherein the amniotic fluid has a quantity of gender specific amniotic fluid based on a gender of a fetal source allowing more specific targeted growth factors to be used for specific disease processes; and applying or injecting the composition at or into the selected location.

Claims

1. A method of treating a patient with a tissue disease or malformity comprises the steps of: identifying a tissue region to be treated and selecting a location to apply either topically or by injection a composition containing amniotic fluid, wherein the tissue disease or malformity is in a penis; selecting the composition containing amniotic fluid wherein the amniotic fluid comprising a quantity of gender specific amniotic fluid based on a gender of a fetal source, wherein the gender specific amniotic fluid of a female fetal source or a male fetal source exhibits a total of about 1500 growth factors and cytokines when tested under mass spectrometry; each gender specific amniotic fluid of a female fetal source exhibiting a number of growth factors differing in concentration from a male fetal source wherein the female fetal source amniotic fluid exhibits a number of growth factors in a higher concentration than the male fetal source amniotic fluid and wherein each of the number of growth factors concentration higher in each gender specific amniotic fluid is greater than 25 and less than 50 of the total of about 1500 and the selected composition with amniotic fluid for the penis is the female fetal source amniotic fluid and 5 or more of the following growth factors or proteins are present in the female fetal source amniotic fluid: NP_001306130.1 protein S100-A8 isoform d, NP_002956.1 protein S100-A9, NP_065723.1 protein S100-A14, NP_005611.1 protein S100-A11, NP_005538.2 involucrin, XP 016870146.1 annexin Al isoform Xl, NP_001531.1 heat shock protein beta-1, NP_001303936.1 protein S100-A16, NP_000415.2 keratin, type II cytoskeletal 5, NP_775109.2 keratin, type II cytoskeletal 6C, NP_057274.1cornulin, NP_002263.3 keratin, type II cytoskeletal 4, NP_705694.2 keratin, type I cytoskeletal 13 isoform a, NP_002267.2 keratin, type I cytoskeletal 19, NP_005545.1 keratin, type II cytoskeletal 6C, NP_001435.1 fatty acid-binding protein, epidermal, NP_000587.1 insulin-like growth factor-binding protein 1 precursor, NP_001276737.1 alpha-crystallin B chain isoform 1, NP_001313.1 cystatin-SA precursor, NP_444513.1 dermcidin isoform 1 preproprotein, NP_001186757.1 cornifin-A, XP_016880078.1 junction plakoglobin isoform Xl, NP_002696.3 periplakin, NP_001186652.1 cellular retinoic acid-binding protein 2, NP_004406.2 desmoplakin isoform I, XP 016873759.1 neuroblast differentiation-associated protein AHNAK isoform X2, NP_002266.2 keratin, type I cytoskeletal 15, NP_001005337.1 plakophilin-1 isoform 1a, XP_016881722.1 choriogonadotropin subunit beta variant 1 isoform Xl, NP_056932.2 keratin, type II cytoskeletal 2 oral, NP_002855.2 pregnancy zone protein precursor, NP_005969.1 protein S100-A2, NP_000688.2 arachidonate 12-lipoxygenase, 12S-type, NP_443112.2 phosphoinositide-3-kinase-interacting protein 1 isoform 1 precursor, NP_001979.2 envoplakin isoform 2, NP_001116437.1 repetin, NP_057215.3 ras-related protein Rab-10, NP_001171712.1 voltage-dependent anion-selective channel protein 2 isoform 1, XP_005259194.1 40S ribosomal protein S16 isoform Xl, NP_001142.2 ADP/ATP translocase 1, NP_009140.1 60S ribosomal protein L35, NP_057671.2 chromobox protein homolog 3, NP_071404.2 p53 apoptosis effector related to PMP-22, NP_001001973.1 ATP synthase subunit gamma, mitochondrial isoform L (liver) precursor, NP_114409.2plasma alpha-L-fucosidase precursor, NP_001132929.1 B-cell receptor-associated protein 31 isoform a, NP_001135757.1 40S ribosomal protein S24 isoform d, NP_002943.2 40S ribosomal protein S2, NP_005637.3 probable methyltransferase TARBP1; those five or more growth factors in the female source exhibiting a higher ratio than those of a male source and wherein said five or more growth factors including XP_016881722.1 choriogonadotropin subunit beta variant 1 isoform Xl, NP_000587.1 Insulin-like growth factor-binding protein 1; prolongs the half-life of the IGFs and alters their interaction with cell surface receptors, NP_001531.1 Heat shock protein 27; provide thermotolerance in vivo, cyto-protection, and support of cell survival under stress conditions, stabilizing partially denatured proteins, protects actin filaments from fragmentation, XP_016870146.1 Annexin Al; inhibits various leukocyte inflammatory events, inhibit the two main products of inflammation, effect being much like that of NSAIDs, potentiating the anti-inflammatory effect, NP_000415.2 Keratin 5; in the stratified epithelium lining the skin and digestive tract forms the intermediate filaments (IF) that make up the cytoskeleton of basal epithelial cells, increases the elasticity; and applying or injecting the composition at or into the selected location.

2. The method of claim 1 wherein the female fetal source amniotic fluid has 49 growth factors statistically significantly greater than the male fetal source amniotic fluid.

3. The method of claim 1 wherein the selection of the composition with amniotic fluid is guided by differences in growth factors and cytokines between the female fetal source amniotic fluid and the male fetal source amniotic fluid.

4. The method of claim 1 wherein the tissue disease or malformity is Peyronie's disease.

5. The method of claim 1 wherein the tissue disease is erectile dysfunction.

6. The method of claim 1 further comprising NP_005545.1 Keratin 6A; shown to have antimicrobial properties, and is the main antimicrobial factor in the eye, NP_001276737 Alpha-crystallin B chain; bind improperly folded proteins to prevent protein aggregation, confer stress resistance to cells by inhibiting the processing of the pro-apoptotic protein caspase-3, increased during various stresses, which then may lead to prolonged survival of cells under these conditions, NP_001313.1 Cystatin-SA; found in a variety of human fluids and secretions, where they appear to provide protective functions, NP_444513.1 Dermcidin, anti-microbial peptides, secreted by human eccrine sweat glands onto the skin as a part of the innate host defense of the immune system, XP_016873759.1 Neuroblast differentiation-associated protein, neuronal differentiation, elasticity, structural scaffolding, and NP_002855.2 Pregnancy zone protein; role in immune-regulation during pregnancy.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

(1) The invention will be described by way of example and with reference to the accompanying drawings in which:

(2) FIG. 1 is a table showing the PSV wherein Female amniotic fluid was statistically significantly better than the male in treating Erectile Dysfunction and improving Penile Peak Systolic Velocity (P<0.05), P=0.012.

(3) FIG. 2 is a perspective view of a syringe with the amniotic fluid suitable for direct injection.

(4) FIG. 3 is a volcano plot graph showing male_1 way versus female (s/n) Volcano.

(5) FIG. 4 is a volcano plot graph showing male_1 way versus female (s/n) MvA.

(6) FIG. 5 is a graph showing standard deviation log 2 (FC).

(7) FIG. 6 SD male_1 way versus female (s/n) Volcano.

(8) FIG. 7 is a PCA graph.

(9) FIG. 8 is a PCA graph.

(10) FIG. 9 is a PCA graph.

DETAILED DESCRIPTION OF THE INVENTION

(11) The present invention is directed to a unique use of recovered amniotic fluid for treatment of various tissue conditions. The current use of amniotic fluid for soft tissue is known in the art as disclosed in the publication US 2017/004943 A1 which is being incorporated by reference in its entirety in the present invention. The processing of amniotic fluid occurs in a variety of ways, many of the process steps can damage the amniotic fluid and reduce its potential for maintaining its biological activity in particular its growth factors. The process of removing debris and unwanted particles from amniotic fluid as a result can also cause a loss of the biologic beneficial effects of the material. In some cases, the material is processed to a point that is simply represents virtually sterile water when completed and may have no medical value. The present invention, on the other hand, is relying on the use of amniotic fluid that has been processed in such a way that the material will maintain its biological growth factors that are commonly found in the native amniotic fluids. What is unique about the present invention is that this invention establishes that there are differences in amniotic fluids based on the fetal source. In particular, amniotic fluid is recovered from a mother planning to have a live birth pre-planned C-section. The amniotic fluid is recovered typically at 38 weeks from the pregnant mothers and provided in batches for sterilization. It is believed that this timing is somewhat arbitrary and could vary within a few weeks one side or the other of 38 weeks, for example 36 to 40 weeks could also provide amniotic fluid. In any event, the source of the amniotic fluid has always been simply the fluid surrounding the fetus that is withdrawn and typically used to be discarded and is now provided for use in soft tissue treatments and other treatments.

(12) What was of interest to the present inventor was whether or not there was any significant difference between the amniotic fluids of a male fetus vs a female fetus. In other words, there was a speculation by the inventor that it may make a difference whether or not the fetal source of the amniotic fluid was a male or female. As a result of this, the inventor investigated sampling amniotic fluid that was selected based on the gender of the fetus. Although Amniotic Fluid has been around since the inception of humans, and Amniotic Fluid as a treatment has been around for close to 10 years, no one has ever looked at the fetal Gender as being a factor that differentiates the amniotic fluid. And its ability to treat diseases as a whole or certain diseases. This is not obvious and very unique. In doing so, it was discovered that recovered amniotic fluid analysed using mass spectrometry had about 1500 growth factors and cytokines discovered. To be exact 1451 were reported in this study. In this study, it was also reported that there were 49 growth factors that were statistically significantly more present in Female Amniotic Fluid and 45 growth factors statistically significantly more present in Male amniotic fluid. Accordingly, it was established that there is a difference in the amniotic fluid based on the gender source of the fetus. This is a significant finding in that the amniotic fluid from one gender source may achieve beneficial results in certain treatments superior to those of the opposite gender. This has never been conceived of or done before in the literature.

(13) To test this theory, the inventor decided to treat patients' penises who exhibited either erectile dysfunction or Peyronie's disease. In doing so, the amniotic fluid was infected using a blind study wherein the urologist and the physician injecting had no idea which gender fetal source the amniotic fluid came from, but only provided direct injections into the penis. The penile peak systolic velocities of the patients' pre-injection and post-injection were tested. In the study it was determined that the amniotic fluid based on the gender of the fetal source of the amniotic fluid provided different growth factors that would have an effect on erectile dysfunction and Peyronie's disease. To the surprise of the inventor, the gender based amniotic fluid did have a very unexpected result in which the inventor found that female amniotic fluid was statistically significantly better than the male amniotic fluid in treating Erectile Dysfunction and improving Penile Peak Systolic Velocity (P<0.05), P=0.012. To the inventor, who is skilled in the art, this was incredible and unobvious and extremely novel.

(14) Similarly, the inventor discovered that the female sourced amniotic fluid seemed to improve Peyronie' s disease better. However, enough patients have not been tested to date to establish a clear confirmation that this is true. However, it is believed to have a similar beneficial effect superior to the effect of the male sourced amniotic fluid. In Peyronie' s Disease, Matrix Metalloprotinease Inhibition is important but can be stopped by TGF Beta. Female Amniotic Fluid has more tissue inhibitors of matrix metalloproteinase (TIMP) expression than male and may play an important role in helping with Peyronie's Disease. Also Male Amniotic Fluid works on the TGF Beta receptor so may play equally as important a role.

(15) The inventor believes that the use of amniotic fluid differentiated by the gender of the fetus has never been done before Amniotic fluid that was sourced from either a female or male fetus is believed to provide unique treatments for specific diseases such as the cases exhibited for erectile dysfunction and Peyronie's disease that would be benefited greatly by the use of female amniotic fluid based on the 49 growth factors occurring in higher concentrations in that fluid source. Interestingly, females have a lower rate of Sudden Infant Death Syndrome (SIDS), and it is unknown why this is. Females also have a significantly higher amount of NP_001142.2 in their amniotic fluid that can prevent Sudden Infant Death Syndrome. One possible treatment of infants at high risk for SIDS is female specific Amniotic Fluid Nebulizers and Inhalers. Alternatively, it is believed that male amniotic fluid would have better results treating or preventing other diseases, such as Pulmonary Chronic Obstructive Pulmonary Diseases, or Wound healing. This is based upon the gene charting we did by putting these genes in certain functional categories for our abstract that was accepted to the Society of Sexual Medicine Conference this year. In any event, it is clear that there are distinctions in patient treatments based on the gender source of the amniotic fluid. As a result, the present invention is directed to this ability to source amniotic fluid based on gender of the source. This invention can explain why sometimes physicians claim their amniotic fluid patient results are unreliable, when amniotic fluid is used as a treatment. It is likely dependent on the gender of the amniotic fluid fetus and the disease process being treated.

(16) TABLE-US-00001 TABLE 1 Growth Factors, Proteins, Female Dominant Abundance Abundance Ratio P- Ratio Adj. P- Growth Factors and Value: Value: Proteins (male)/(female) (male)/(female) NP_001306130.1 0.305 0.005510287 protein S100-A8 isoform d [Homo sapiens] S100A8 NP_002956.1 0.278 0.002675392 protein S100-A9 [Homo sapiens] S100A9 NP_065723.1 0.214 0.000273433 protein S100-A14 [Homo sapiens] S100A14 NP_005611.1 0.258 0.001497062 protein S100-A11 [Homo sapiens] S100A11 NP_005538.2 0.215 0.00029255 involucrin [Homo sapiens] IVL XP_016870146.1 0.208 0.000211106 annexin A1 isoform X1 [Homo sapiens] ANXA1 NP_001531.1 heat 0.3 0.004865982 shock protein beta-1 [Homo sapiens] HSPB1 NP_001303936.1 0.232 0.000582268 protein S100-A16 [Homo sapiens] S100A16 NP_000415.2 0.249 0.001099551 keratin, type II cytoskeletal 5 [Homo sapiens] KRT5 NP_775109.2 keratin, 0.214 0.000295615 type II cytoskeletal 6C [Homo sapiens] KRT6C; KRT6A NP_057274.1 0.189 8.49595E−05 cornulin [Homo sapiens] CRNN NP_002263.3 0.079 1.32454E−09 keratin, type II cytoskeletal 4 [Homo sapiens] KRT4 NP_705694.2 keratin, 0.075 6.08683E−10 type I cytoskeletal 13 isoform a [Homo sapiens] KRT13 NP_002267.2 keratin, 0.16 1.40704E−05 type I cytoskeletal 19 [Homo sapiens] KRT19 NP_005545.1 0.131 1.34666E−06 keratin, type II cytoskeletal 6C [Homo sapiens] KRT6A NP_001435.1 fatty 0.254 0.001280949 acid-binding protein, epidermal [Homo sapiens] FABP5 NP_000587.1 0.248 0.001059966 insulin-like growth factor-binding protein 1 precursor [Homo sapiens] IGFBP1 NP_443112.2 1.285 0.472931274 phosphoinositide-3- kinase-interacting protein 1 isoform 1 precursor [Homo sapiens] PIK3IP1 NP_001979.2 0.275 0.002473144 envoplakin isoform 2 [Homo sapiens] EVPL NP_001116437.1 0.149 5.69435E−06 repetin [Homo sapiens] RPTN NP_057215.3 ras- 0.299 0.004452985 related protein Rab-10 [Homo sapiens] RAB10 NP_001171712.1 0.225 0.000445982 voltage-dependent anion-selective channel protein 2 isoform 1 [Homo sapiens] VDAC2 XP_005259194.1 0.294 0.003044342 40S ribosomal protein S16 isoform X1 [Homo sapiens] RPS16 NP_001142.2 0.254 0.001107207 ADP/ATP translocase 1 [Homo sapiens] SLC25A4 NP_009140.1 60S 0.178 3.5374E−05 ribosomal protein L35 [Homo sapiens] RPL35 NP_057671.2 0.229 0.00052652 chromobox protein homolog 3 [Homo sapiens] CBX3; C15orf57; CCDC32 NP_071404.2 p53 0.181 3.31804E−05 apoptosis effector related to PMP-22 [Homo sapiens] PERP NP_001001973.1 0.277 0.002331947 ATP synthase subunit gamma, mitochondrial isoform L (liver) precursor [Homo sapiens] ATP5C1 NP_114409.2 plasma 0.15 9.52609E−06 alpha-L-fucosidase precursor [Homo sapiens] FUCA2 NP_001132929.1 B- 0.272 0.001161581 cell receptor-associated protein 31 isoform a [Homo sapiens] BCAP31 NP_001135757.1 40S 0.256 0.000823958 ribosomal protein S24 isoform d [Homo sapiens] RPS24 NP_002943.2 40S 0.301 0.003440049 ribosomal protein S2 [Homo sapiens] RPS2 NP_005637.3 0.271 0.00199776 probable methyltransferase TARBP1 [Homo sapiens] TARBP1 NP_001276737.1 0.196 0.000120054 alpha-crystallin B chain isoform 1 [Homo sapiens] CRYAB NP_001313.1 0.206 0.000191209 cystatin-SA precursor [Homo sapiens] CST2 NP_444513.1 0.232 0.000583814 dermcidin isoform 1 preproprotein [Homo sapiens] DCD NP_001186757.1 0.212 0.000187342 cornifin-A [Homo sapiens] SPRR1A XP_016880078.1 0.208 0.000211514 junction plakoglobin isoform X1 [Homo sapiens] JUP NP_002696.3 0.274 0.002423476 periplakin [Homo sapiens] PPL NP_001186652.1 0.269 0.002099494 cellular retinoic acid- binding protein 2 [Homo sapiens] CRABP2 NP_004406.2 0.212 0.000257882 desmoplakin isoform I [Homo sapiens] DSP XP_016873759.1 0.292 0.003976564 neuroblast differentiation- associated protein AHNAK isoform X2 [Homo sapiens] AHNAK NP_002266.2 0.215 0.000291601 keratin, type I cytoskeletal 15 [Homo sapiens] KRT15 NP_001005337.1 0.193 0.000103096 plakophilin-1 isoform 1a [Homo sapiens] PKP1 XP_016881722.1 0.248 0.001052441 choriogonadotropin subunit beta variant 1 isoform X1 [Homo sapiens] CGB1 NP_056932.2 0.154 9.09917E−06 keratin, type II cytoskeletal 2 oral [Homo sapiens] KRT76 NP_002855.2 0.269 0.002069415 pregnancy zone protein precursor [Homo sapiens] PZP NP_005969.1 protein 0.163 1.22605E−05 S100-A2 [Homo sapiens] S100A2 NP_000688.2 0.158 1.24344E−05 arachidonate 12- lipoxygenase, 12S- type [Homo sapiens] ALOX12

(17) With reference to table 1, this table shows and identifies 49 attributes such as growth factors and proteins in a first column that are of a higher proportion when gender specific amniotic fluid is from a female fetal source. The adjacent column reflects a ratio of the male/female proportions each of the attributes. As shown, all are substantially below 1. These listed growth factors and proteins are in a higher concentration than from a male fetal source as shown in the chart. These are in the second column called: “Abundance Ratio P-Value:(male)/(female)” (AA). The third column called “Abundance Ratio Adj P-Value:(male)/(female)” (AB). In this column, each protein is measured and adjusted to all 1451 proteins measured versus one individual protein. It is compared to all other proteins such that there is no random chance a specific one is elevated.

(18) The P value used to determine statistically significant differences was P<0.005. This is much more stringent than a usual P value of P<0.05. Some of these are over 10 times greater in female than male amniotic fluid.

(19) TABLE-US-00002 TABLE 2 Abundance Abundance Ratio P- Ratio Adj. P- Growth Factors and Value: Value: Proteins (male)/(female) (male)/(female) NP_036246.1 caspase- 4.37 0.000224368 14 precursor [Homo sapiens] CASP14 NP_002007.1 filaggrin 10.982 3.09098E−09 [Homo sapiens] FLG NP_001153392.1 2.966 0.002397936 vascular endothelial growth factor receptor 1 isoform 2 precursor [Homo sapiens] FLT1 NP_001159921.1 inter- 2.769 0.0035595 alpha-trypsin inhibitor heavy chain H4 isoform 2 precursor [Homo sapiens] ITIH4 NP_076956.1 gamma- 2.979 0.005795033 glutamylcyclotransferase isoform 1 [Homo sapiens] GGCT NP_000377.1 4.012 0.000497011 bleomycin hydrolase [Homo sapiens] BLMH NP_001289194.1 3.124 0.002654632 neutrophil defensin 1 isoform 1 preproprotein [Homo sapiens] DEFA1B; DEFA1 NP_005971.1 protein 2.689 0.005140474 S100-P [Homo sapiens] S100P NP_059118.2 5.621 1.70252E−05 calmodulin-like protein 5 [Homo sapiens] CALML5 NP_001014364.1 6.251 5.14524E−06 filaggrin-2 [Homo sapiens] FLG2 XP_005266835.2 serpin 3.945 0.000579305 B12 isoform X1 [Homo sapiens] SERPINB12 NP_001231367.1 3.528 0.001526005 arginase-1 isoform 1 [Homo sapiens] ARG1 NP_009175.2 proline- 2.936 0.006442024 rich protein 4 isoform 2 precursor [Homo sapiens] PRR4 NP_778253.2 keratin, 4.349 0.000235064 type II cytoskeletal 1b [Homo sapiens] KRT77 NP_006323.2 gamma- 4.058 0.000140941 interferon-inducible lysosomal thiol reductase preproprotein [Homo sapiens] IFI30 NP_002621.1 3.343 0.002374363 gastricsin isoform 1 preproprotein [Homo sapiens] PGC NP_001963.1 4.989 6.04516E−05 neutrophil elastase preproprotein [Homo sapiens] ELANE XP_011534801.1 2.909 0.00365075 cathepsin G isoform X1 [Homo sapiens] CTSG NP_001180262.1 3.38 0.001023141 coronin-1A [Homo sapiens] CORO1A NP_005441.1 noggin 4.593 4.59596E−05 precursor [Homo sapiens] NOG NP_006240.4 basic 2.809 0.003799462 salivary proline-rich protein 3 precursor [Homo sapiens] PRB3 NP_001019850.1 2.804 0.005355183 skin-specific protein 32 [Homo sapiens] C1orf68 NP_001691.1 4.412 7.21396E−05 azurocidin preproprotein [Homo sapiens] AZU1 XP_011541136.1 3.942 0.000115751 neutrophil collagenase isoform X1 [Homo sapiens] MMP8 XP_005247417.1 3.005 0.00207313 lysosome-associated membrane glycoprotein 3 isoform X1 [Homo sapiens] LAMP3 NP_068741.1 2.955 0.002748764 Fanconi anemia group E protein [Homo sapiens] FANCE NP_002143.1 3.064 0.002018187 sarcoplasmic reticulum histidine-rich calcium- binding protein precursor [Homo sapiens] HRC NP_064581.2 pre- 3.954 0.000216534 mRNA-splicing factor SYF1 [Homo sapiens] XAB2 XP_011525801.1 26.879 1E−17 dermokine isoform X4 [Homo sapiens] DMKN NP_002768.3 4.328 0.000312229 myeloblastin precursor [Homo sapiens] PRTN3 XP_011525797.1 14.715 2.03593E−12 dermokine isoform X1 [Homo sapiens] DMKN NP_775103.1 5.601 2.88672E−06 small proline-rich protein 4 [Homo sapiens] SPRR4 NP_291031.2 3.142 0.001370691 guanylin precursor [Homo sapiens] GUCA2A NP_991403.1 3.435 0.001902331 lipolysis- stimulated lipoprotein receptor isoform 2 [Homo sapiens] LSR NP_001138479.1 4.217 0.000314174 mucin-7 precursor [Homo sapiens] MUC7 NP_002414.1 3.949 0.000223214 matrilysin preproprotein [Homo sapiens] MMP7 NP_002099.1 3.374 0.002201512 histidine ammonia-lyase isoform 1 [Homo sapiens] HAL XP_016864371.1 3.128 0.001518546 chloride intracellular channel protein 6- like [Homo sapiens] LOC107986211 NP_000418.2 3.776 0.000853704 loricrin [Homo sapiens] LOR NP_543145.1 13.268 2.77156E−12 WAP four- disulfide core domain protein 12 precursor [Homo sapiens] WFDC12 NP_001078851.1 2.985 0.005700476 proactivator polypeptide-like 1 preproprotein [Homo sapiens] PSAPL1 XP_011546040.1 2.844 0.005070247 major histocompatibility complex, class II, DR beta 1 isoform X1 [Homo sapiens] HLA-DRB3; LOC100507709; LOC100507714; LOC105369230; HLA-DRB1

(20) As shown in table 2, is a second table showing and identifying the 42 attributes such as growth factors and proteins that are in a higher proportion when gender specific amniotic fluid is from a male fetal source than a female fetal specific source. In this case, the male fetal source amniotic fluid has a higher percentage of these growth factors and proteins when compared to a female fetal source amniotic fluid. Some of these are over 10 times greater in male than female amniotic fluid. As shown in table 2, the abundance ratio of male/female is substantially greater than 1.0.

(21) With reference to FIG. 1, a table is shown for the PSV, wherein the female fetal source amniotic fluid was statistically significantly better than the male fetal source amniotic fluid when treating erectile dysfunction and improving Penile Peak Systolic Velocity as discussed above.

(22) It is believed that this discovery and resultant amniotic fluid product based on gender can provide unique treatments. Such treatments can be provided as ointment based for treating wounds and other soft tissue. Alternatively, treatments can be provided as a fluid for direct injection as was the case in the study on erectile dysfunction and Peyronie's′ disease. The fluid can also be supplied as a nebulized or aerosolized treatment or suppository.

(23) With reference to FIG. 2, an exemplary syringe 30 with needle 32 is shown with an amount of amniotic fluid 100 suitable injection based on the gender of fetal source.

(24) It is important to note that during the analysis of amniotic fluid that the growth factors exhibited are interesting, some dealing with sudden infant death syndrome and may be useful in identifying precursors to such an event. Importantly, it is believed the ability to differentiate growth factors of amniotic fluid based on gender of the fetal source will be of value as it is applied to treating specific disease. Of note, most of the growth factors and cytokines deal with metabolic pathways and cell proliferation, cell differentiation, and cell death. As a result, it is believed that a sterile supply of amniotic fluid based on gender may result in unique treatment protocols heretofore not attempted. The results revealed one growth factor predominantly more in FEMALES, XP_016881722.1, that is a Choriogonadotropin, which is believed to be important.

(25) It is believed that a physician, knowing the differences in specific growth factors, can select from one or more of the gender differentiated amniotic fluids to select the one with the highest concentrations of these more prevalent growth factors and proteins to achieve the desired treatment results. Heretofore this has not been done. This is similar to stem cell research where individual cells are noted by their expressed marker. In this case the amniotic fluid is being distinguished based on its increased percentages of specific growth factors which would then be used to determine which gender based amniotic fluid can be used in particular treatments. In other words, this unique discovery is the first step in determining targeted biological exosome and growth factor therapy for diseases. Since we are able to isolate in higher concentrations specific growth factors and exosomes and cytokines with minimal manipulation of the Amniotic Fluid.

(26) The composition and method of the present invention can be used in combination with compositions and methods in U.S. Ser. Nos. 15/158,101; 14/363,142; and 15/541,988 all of which are being incorporated herein by reference in their entirety in the present invention.

(27) With reference to FIGS. 3-9, graphs and volcano plots are shown that illustrate differences between male and female samples of the gender specific amniotic fluid, female is indicated by blue or F and male is indicated in red or M.

(28) Variations in the present invention are possible in light of the description of it provided herein. While certain representative embodiments and details have been shown for the purpose of illustrating the subject invention, it will be apparent to those skilled in this art that various changes and modifications can be made therein without departing from the scope of the subject invention. It is, therefore, to be understood that changes can be made in the particular embodiments described which will be within the full intended scope of the invention as defined by the following appended claims.