Amniotic fluid topical formulation

Abstract

A human amniotic fluid formulation has been developed for topical application to the eye, which is useful for the treatment of ocular diseases and injuries including dry eyes, Sjogren's Syndrome, cataracts, burns and injuries to the eye tissues. The formulation is a sterile de-cellularized human amniotic fluid (D-HAF), devoid of amniotic stem cells and elements of micronized membrane or chorion particles. Methods for treating, or preventing various ocular diseases, injuries and disorders using the formulation, optionally in combination with one or more therapeutic, prophylactic or diagnostic agents are described.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims benefit of U.S. Provisional Application No. 62 / 239,677, filed Oct. 9, 2015, which is incorporated by reference in its entirety.STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH

[0002] This invention was made without government support or Grants awarded by the National Institutes of Health. The government has no rights in the invention.FIELD OF THE INVENTION

[0003] The invention largely relates to the management of a diverse number of ophthalmic diseases, injuries and disorders (e.g., dry eye syndrome, chronic redness, ocular burns, cataract suppression and Sjogren's Syndrome) with a human amniotic fluid ocular formulation.BACKGROUND OF THE INVENTION

[0004] Diminished vision has a direct causal impact on a person's ability to perform basic functions such as walking, reading, driving and other common activities. Good ocular health contributes significantly to a person's quality of life and their ability to perform common da...

Examples

example 1

on of Human Amniotic Formulation

[0161]Materials and Methods

[0162]Human amniotic fluid is collected from selected caesarean sections, which make aspiration of the amniotic fluid in clean condition possible. Then the amniotic fluid is stored in refrigerated condition at 2° C. to 6° C. before the clarification and filtration process. The amniotic fluid is centrifuged at 5,000 to 10,000 rpm for 30 minutes to 1 hour in 50 mL to 250 mL swing out buckets. The supernatant is collected. When collecting the supernatant it is important to avoid detaching or aspirating insoluble components possibly coming from the pellet or from the fatty overlayer. If the supernatant still contains residual insoluble components, it may be pre-filtered with 5 to 10μ cellulose ester capsule pre-filters without TRITON® surfactant to avoid contamination in the filtration process. The liquid phase is collected and filtered with poly ether sulfone 1.0μ capsule filters and the liquid is collected. The liquid is then ...

example 2

of Dry Eye Patients with Amniotic Fluid Solution

[0168]Materials and Methods

[0169]Dr. M. Dieter initiated a non-scientific case study utilizing FOY™ REGENER-EYES®, Amniotic Fluid Ocular Solution, prepared as described in Example 1. Dr. Dieter is a licensed Optometrist, specializing in the treatment of Dry Eye Syndrome. Regenerative Processing Plant supplied several samples of Regener-Eyes to Dr. Dieter to distribute to a select group of his patient suffering from the discomfort and pain often accompanied with dry eyes.

[0170]The study was designed for ten patients. Three (3) patients entered too late to effectively chart their results. Ultimately, nine (9) patients were officially enrolled in the study.

[0171]Study patients were given a 30 day sample of REGENER-EYES® and instructed to add the therapy of 1-2 drops of REGENER-EYES® into both eyes twice daily (a.m. and p.m.), to their current prescribed treatments. The study included the following visual conditions:[0172]Glaucoma[0173]Chr...

example 3

ve Study on Treatment of Corneal Inflammation

[0198]Materials and Methods

[0199]The lyophilized powder of Example 1 was dissolved in 1 mL of sterile water to reconstitute 1 mL of the initial sterile filtered amniotic fluid. Two drops were applied on each eye of ten patients suffering from the dry eye syndrome. This treatment was repeated twice per day for ten days. Two other control groups of 10 patients similarly received either their own serum or a serum prepared from cord blood as described by Kyung-Chul Yoon (Umbilical cord and its blood: A perspective on its current and potential use in Ophthalmology, in “Regenerative Medicine Using Pregnancy-Specific Biological Substances” Springer ed. 2011).

[0200]Results

[0201]8 to 10 patients out of 10 in each group declared that they had experienced a significant benefit. For all patients, this clinical improvement was correlated with a partial or complete decrease of their initial corneal inflammation. Nine patient had “severe” dry eye, one w...

CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims benefit of U.S. Provisional Application No. 62 / 239,677, filed Oct. 9, 2015, which is incorporated by reference in its entirety.STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH

[0002] This invention was made without government support or Grants awarded by the National Institutes of Health. The government has no rights in the invention.FIELD OF THE INVENTION

[0003] The invention largely relates to the management of a diverse number of ophthalmic diseases, injuries and disorders (e.g., dry eye syndrome, chronic redness, ocular burns, cataract suppression and Sjogren's Syndrome) with a human amniotic fluid ocular formulation.BACKGROUND OF THE INVENTION

[0004] Diminished vision has a direct causal impact on a person's ability to perform basic functions such as walking, reading, driving and other common activities. Good ocular health contributes significantly to a person's quality of life and their ability to perform common da...

Examples

example 1

on of Human Amniotic Formulation

[0161]Materials and Methods

[0162]Human amniotic fluid is collected from selected caesarean sections, which make aspiration of the amniotic fluid in clean condition possible. Then the amniotic fluid is stored in refrigerated condition at 2° C. to 6° C. before the clarification and filtration process. The amniotic fluid is centrifuged at 5,000 to 10,000 rpm for 30 minutes to 1 hour in 50 mL to 250 mL swing out buckets. The supernatant is collected. When collecting the supernatant it is important to avoid detaching or aspirating insoluble components possibly coming from the pellet or from the fatty overlayer. If the supernatant still contains residual insoluble components, it may be pre-filtered with 5 to 10μ cellulose ester capsule pre-filters without TRITON® surfactant to avoid contamination in the filtration process. The liquid phase is collected and filtered with poly ether sulfone 1.0μ capsule filters and the liquid is collected. The liquid is then ...

example 2

of Dry Eye Patients with Amniotic Fluid Solution

[0168]Materials and Methods

[0169]Dr. M. Dieter initiated a non-scientific case study utilizing FOY™ REGENER-EYES®, Amniotic Fluid Ocular Solution, prepared as described in Example 1. Dr. Dieter is a licensed Optometrist, specializing in the treatment of Dry Eye Syndrome. Regenerative Processing Plant supplied several samples of Regener-Eyes to Dr. Dieter to distribute to a select group of his patient suffering from the discomfort and pain often accompanied with dry eyes.

[0170]The study was designed for ten patients. Three (3) patients entered too late to effectively chart their results. Ultimately, nine (9) patients were officially enrolled in the study.

[0171]Study patients were given a 30 day sample of REGENER-EYES® and instructed to add the therapy of 1-2 drops of REGENER-EYES® into both eyes twice daily (a.m. and p.m.), to their current prescribed treatments. The study included the following visual conditions:[0172]Glaucoma[0173]Chr...

example 3

ve Study on Treatment of Corneal Inflammation

[0198]Materials and Methods

[0199]The lyophilized powder of Example 1 was dissolved in 1 mL of sterile water to reconstitute 1 mL of the initial sterile filtered amniotic fluid. Two drops were applied on each eye of ten patients suffering from the dry eye syndrome. This treatment was repeated twice per day for ten days. Two other control groups of 10 patients similarly received either their own serum or a serum prepared from cord blood as described by Kyung-Chul Yoon (Umbilical cord and its blood: A perspective on its current and potential use in Ophthalmology, in “Regenerative Medicine Using Pregnancy-Specific Biological Substances” Springer ed. 2011).

[0200]Results

[0201]8 to 10 patients out of 10 in each group declared that they had experienced a significant benefit. For all patients, this clinical improvement was correlated with a partial or complete decrease of their initial corneal inflammation. Nine patient had “severe” dry eye, one w...