d-MAPPS Ocular Solution for Tear Homeostasis
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Solution Overview
Problem
Current treatments for dry eye disease (DED) and tear hyperosmolarity (THO) provide only temporary relief and do not effectively address the underlying disease state, leading to chronic discomfort and potential vision impairment.
Innovation Solution
The use of d-MAPPS™ regenerative biologics platform technology, which includes MSC-sourced growth factors, anti-inflammatory cytokines, and chemokines, to stabilize the tear film, enhance natural cytokine communication, and suppress detrimental immune responses.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If artificial tears and over-the counter eye drops are used to soothe eye irritation, then temporary relief from discomfort is provided, but the underlying disease state remains unaddressed and requires several daily reapplications
Solution Approach 1:
The patent uses human amniotic membrane (HAM) as an intermediary carrier that delivers therapeutic factors directly to the ocular surface. The HAM serves as a mediator between the treatment system and the eye, providing sustained release of immunomodulatory and regenerative factors that address the underlying disease state rather than just temporary symptom relief
Solution Approach 2:
The patent applies human amniotic membrane in advance to prevent further deterioration of the ocular surface. By placing the HAM before significant damage occurs, the treatment proactively addresses the disease state and prevents the need for repeated interventions, extending the duration of effective treatment
2Reliability
If human amniotic membrane is used to treat eye surface injuries, then effective treatment is achieved, but severe vision impairment occurs during treatment due to non-transparency of the membrane
Solution Approach 1:
The patent extracts only the essential therapeutic components from the human amniotic membrane while removing the opaque membrane structure itself. This extraction approach isolates the immunomodulatory and regenerative factors that provide treatment effectiveness while eliminating the vision-obscuring physical barrier
Solution Approach 2:
The patent creates a functional copy of the therapeutic benefits provided by the intact HAM without using the physical membrane. By replicating the immunomodulatory and regenerative effects through extracted factors or derived products, the treatment maintains effectiveness while achieving optical transparency for uninterrupted vision
3Reliability
If amniotic membrane procedure is performed to treat eye conditions, then therapeutic benefits are achieved, but the benefits last only as long as the membrane is in place and additional expense is imposed on patients
Solution Approach 1:
The patent enables the ocular surface to heal itself by delivering growth factors and immunomodulatory agents that activate the eye's own regenerative capabilities. This self-service approach allows the tissue to continue repairing and maintaining itself after the initial treatment, extending benefits beyond the presence of the membrane
Solution Approach 2:
The patent establishes continuous therapeutic action through sustained release mechanisms or repeated low-dose applications of amniotic membrane-derived factors. This continuity ensures that immunomodulatory and regenerative effects persist over time, maintaining treatment benefits without requiring the physical membrane to remain in place
Data Source
AI summary
The present disclosure is directed to compositions, formulations, and methods for treating diseases of the eye and other disorders. Specifically, d-MAPPS compositions, which may include d-MAPPS solutions (e.g., in liquid form and/or administered as eye drops), in addition to macromolecular proteins, growth factors, mesenchymal stem cells (MSC), can be used for topical application to the eye and treatment of, for instance, tear hyperosmolarity (TH), dry eye, dry eye disease, dry eye discomfort, tear hyperosmolarity, and tear hyperosmolarity-induced pathological changes in the eyes of patients. The d-MAPPS solutions can contain mesenchymal stem cells (MSC), MSC-derived exosomes (MSC-Exos), one or more MSC-sourced growth factors, and/or immunoregulatory proteins. In some embodiments, the d-MAPPS solutions can include a sterile de-cellularized human amniotic fluid (D-HAF). In embodiments, the d-MAPPS solutions are amenable to long-term storage without the loss of biological potency.