d-MAPPS Biologics for Ocular Tissue Regeneration

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Solution Overview

Problem

Current treatments for ocular disorders such as dry eye and graft-versus-host disease are inadequate, as they provide limited relief, require frequent reapplications, and can cause severe side effects, and lack the ability to modify the underlying disease state or promote long-term regeneration of ocular tissues.

Innovation Solution

The development of d-MAPPS regenerative biologics platform technology, which includes MSC-sourced growth factors, anti-inflammatory cytokines, and chemokines, administered as eye drops or other formulations to alter the immune response and promote healing in ocular tissues, using MSC-derived exosomes and de-cellularized human amniotic fluid to deliver therapeutic molecules directly to the eye.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Duration of action of moving object

If artificial tears and over-the counter eye drops are used to treat dry eye, then eye irritation and dryness are soothed, but the relief is minimal and requires several daily reapplications

Engineering Contradiction:
Improveduration of reliefVSAvoidfrequency of reapplication
Core Design Contradiction:
Duration of action of moving objectVSProductivity

Solution Approach 1:

The patent uses amniotic membrane allografts to preliminarily establish a therapeutic effect before symptoms fully develop or worsen. The graft is applied in advance to prevent severe dry eye complications, providing sustained protection rather than reactive treatment. This preliminary intervention reduces the need for frequent reapplications by establishing long-term therapeutic action.

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The amniotic membrane allograft provides continuous therapeutic action through sustained release of growth factors and anti-inflammatory agents. The graft remains in place and continuously delivers beneficial effects, eliminating the need for intermittent reapplication of artificial tears. This continuous action maintains therapeutic levels without gaps, providing prolonged duration of relief.

Inventive Principle:
Principle #20Continuity of useful action

2Reliability

If human amniotic membrane is used to treat eye surface injuries, then healing is promoted, but severe vision impairment occurs during treatment due to non-transparency

Engineering Contradiction:
Improvehealing effectivenessVSAvoidvision impairment
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The patent extracts the therapeutic components (growth factors, anti-inflammatory agents, healing promoters) from the opaque amniotic membrane and delivers them through transparent eye drop formulations. This separation allows the beneficial healing properties to be retained while removing the harmful opacity that causes vision impairment. The active ingredients are isolated and reformulated without the membrane structure.

Inventive Principle:
Principle #2Taking out (Extraction)

Solution Approach 2:

The patent uses transparent carriers or delivery vehicles as intermediaries to transport the therapeutic agents extracted from amniotic membrane. These intermediaries (such as eye drop formulations) deliver the healing factors without the opacity of the original membrane, thus mediating between the therapeutic need and the vision preservation requirement.

Inventive Principle:
Principle #24Intermediary (Mediator)

3Reliability

If amniotic membrane procedure is performed, then treatment of eye surface injuries is achieved, but additional expense is imposed on patients

Engineering Contradiction:
Improvetreatment effectivenessVSAvoidtreatment cost
Core Design Contradiction:
ReliabilityVSQuantity of substance

Solution Approach 1:

The patent employs cost-effective eye drop formulations that can be easily manufactured and distributed compared to expensive surgical procedures. These disposable eye drops provide the necessary therapeutic effect without the high costs associated with amniotic membrane procurement, surgical application, and follow-up care. The simplified delivery system reduces overall treatment expense while maintaining effectiveness.

Inventive Principle:
Principle #27Cheap short-living objects (Disposable)

4Object-affected harmful factors

If conventional treatments are used for ocular disorders, then symptoms are temporarily relieved, but the underlying disease state is not modified and long-term regeneration is not promoted

Engineering Contradiction:
Improvesymptom reliefVSAvoidlong-term disease modification
Core Design Contradiction:
Object-affected harmful factorsVSDuration of action of moving object

Solution Approach 1:

The patent changes the therapeutic parameters by introducing growth factors and immunomodulatory agents that fundamentally alter the disease process rather than merely masking symptoms. These agents modify the underlying pathophysiology by promoting tissue regeneration, reducing inflammation at the molecular level, and stimulating cellular repair mechanisms. This parameter change enables long-term disease modification and sustained therapeutic effect.

Inventive Principle:
Principle #35Parameter changes

Solution Approach 2:

The patent applies therapeutic agents that act preliminarily to prevent disease progression and promote regeneration before irreversible damage occurs. By intervening early with regenerative factors, the treatment modifies the disease course from the outset rather than reacting to established damage. This preliminary regenerative action establishes long-term protective effects and prevents recurrence.

Inventive Principle:
Principle #10Preliminary action

Data Source

PatentUS20240216437A1Methods and compositions for treating ocular graft versus host disease and other ocular conditions
Publication Date: 2024.07.04 MAM HOLDINGS OF WEST FLORIDA LLC
  • US20240216437A1 patent drawing
  • US20240216437A1 patent drawing

AI summary

Disclosed herein are compositions, formulations, and/or methods of using d-MAPPS™ regenerative biologics platform technology (“d-MAPPS”). Specifically, d-MAPPS compositions, which may include d-MAPPS solutions (e.g., in liquid form and/or administered as eye drops), can be used for topical application to the eye, which is useful for the treatment of ocular conditions (e.g., dry eyes, Sjogren's syndrome, cataracts, burns, and injuries to the eye tissues). The d-MAPPS compositions can contain mesenchymal stem cells (MSC), MSC-derived exosomes (MSC-Exos), and/or one or more MSC-sourced growth factors and/or immunoregulatory proteins. In at least other embodiments, the d-MAPPS compositions can include a sterile de-cellularized human amniotic fluid (D-HAF). The d-MAPPS compositions are amenable for long-term storage without the loss of biological potency. 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.