Therapeutic compositions
Inventors
Assignees
University of Utah • University of Utah Research Foundation Inc
Publication Number
US-11426433-B2
Publication Date
2022-08-30
Expiration Date
2037-03-06
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Abstract
A therapeutic composition can include an amount of amniotic fluid having a therapeutically effective amount of at least one protein, hyaluronic acid, or both. The therapeutic composition can be substantially free of lanugo, vernix, and cells harvested with the amniotic fluid.
Core Innovation
The invention is directed to therapeutic compositions comprising processed amniotic fluid containing a therapeutically effective amount of at least one protein and hyaluronic acid (HA), or both. The composition is substantially free of lanugo, vernix, and cells harvested with the amniotic fluid. The processed amniotic fluid retains beneficial components such as proteins and HA while removing particulates and cellular debris. The composition can further be lyophilized and formulated to achieve specific properties, such as reduced optical density and particle count.
The problem addressed by the invention is the need for therapeutic compositions that harness the regenerative, antimicrobial, immunomodulatory, and growth-promoting properties of amniotic fluid but avoid the unwanted components that may be present in harvested amniotic fluid. These unwanted components include lanugo, vernix, and cells, which can introduce variability, contamination, or undesired effects. The invention solves this by processing the amniotic fluid to remove these elements while preserving a high proportion of the beneficial proteins and HA.
Additionally, the invention provides detailed methods for manufacturing the therapeutic composition, including steps such as extraction from a pregnant female, centrifugation, filtration, and optional lyophilization. The processed compositions can be formulated with a pharmaceutically acceptable carrier and administered in various dosage forms and via different routes, such as injection, enteral, topical, transdermal, transmucosal, inhalation, or implantation. The compositions may also be supplemented with additional active agents, depending on the targeted therapeutic application.
Claims Coverage
The patent contains one independent claim, which defines a method for treating a subject with an adverse health condition using a specially processed amniotic fluid composition. The inventive features are centered around the properties, preparation, and administration of the composition.
Therapeutic method using processed amniotic fluid substantially free of lanugo, vernix, and cells
A process of treating a subject with an adverse health condition responsive to an amniotic fluid agent by administering a composition that contains: - A processed amniotic fluid with a therapeutically effective amount of protein and hyaluronic acid (HA) - The composition is substantially free of lanugo, vernix, and cells harvested with amniotic fluid - The protein is present in an amount from about 0.15 mg/mL to about 10 mg/mL - The composition is lyophilized - The composition has an optical density of less than 0.20 when exposed to electromagnetic radiation at a wavelength of 590 nm in a liquid form These requirements combine to define a distinct therapeutic composition and its use in treatment.
The patent’s claim coverage is limited to the administration of a specific processed, particulate/cell-depleted, and lyophilized amniotic fluid composition with defined protein content and optical density, targeting adverse health conditions responsive to amniotic fluid agents.
Stated Advantages
The therapeutic composition retains beneficial proteins and hyaluronic acid found in amniotic fluid while removing undesirable components such as lanugo, vernix, and cells.
Processing reduces particulate matter and cellular debris, resulting in greater optical clarity (lower optical density) and more consistent properties between compositions.
The processed amniotic fluid preserves a high proportion of key therapeutic constituents, including total protein, HA, and specific growth factors such as EGF.
The composition can be formulated for a variety of administration routes and dosage forms, providing flexibility for clinical use.
Documented Applications
Treatment of wounds including non-healing wounds, abrasions, lacerations, contusions, surgical wounds, and ulcers.
Treatment of respiratory conditions such as asthma, emphysema, COPD, acute respiratory virus, sinusitis, bronchitis, cystic fibrosis, tuberculosis, pneumonia, and related symptoms.
Treatment of inflammatory conditions including ankylosing spondylitis, rheumatoid arthritis, lupus, and vasculitis.
Management of chronic pain from sources including chronic inflammation, post-surgical pain, trauma, lower back pain, cancer, arthritis, and neurogenic pain.
Treatment of urological conditions such as urinary incontinence, erectile dysfunction, Peyronie's disease, prostatitis, urinary tract infections, and related symptoms.
Treatment of skeletal conditions including bone fractures, kyphosis, lordosis, scoliosis, osteoporosis, rickets, arthritis, and facilitation of new bone growth or bone grafting.
Treatment of ophthalmic conditions such as macular degeneration, glaucoma, retinal detachment, retinopathy of prematurity, cataracts, and other eye disorders.
Treatment of cardiovascular conditions such as aneurysm, atherosclerosis, high blood pressure, heart attack, heart failure, stroke, valve disease, congenital heart disease, and vascular disease.
Treatment of neurological conditions including Parkinson's disease, Alzheimer's disease, spina bifida, stroke, and injuries to the brain or spinal cord.
Treatment of digestive conditions such as acid reflux, Crohn's disease, ulcers, ulcerative colitis, pancreatitis, and liver disease.
Treatment of reproductive conditions including cervical cancer, prostate cancer, ovarian cancer, impotence, sexual arousal disorder, and related disorders.
Treatment of cosmetic conditions including skin wrinkles, laxity, scarring, hair loss, hyperpigmentation, acne, rosacea, dark circles, sun spots, varicose veins, stretch marks, and birth defects like cleft palate.
Facilitation of wound healing in cases such as chronic abdominal wounds, failed urethroplasty, and Martorell's ulcer, with documented evidence of improved wound closure.
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