Multi-part processed human amniotic composition and methods of making and using thereof for treatment of peyronie's disease
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Solution Overview
Problem
Current treatments for Peyronie's disease, such as XIAFLEX® and Verapamil, carry significant side effects and risks, while surgical interventions pose the threat of erectile dysfunction and permanent penile shortening, necessitating a safer and more effective treatment option.
Innovation Solution
A multi-part processed human amniotic composition comprising micronized human amnion and aqueous amniotic fluid filtrate, free from exogenous enzymes, is administered intracorporeally to reduce plaque size and minimize side effects.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Quantity of substance
If collagenase (XIAFLEX) is used to dissolve plaques, then plaque reduction is achieved, but risk of corporal rupture, penile hematoma, and erectile dysfunction increases
Solution Approach 1:
The patent uses a biocompatible vehicle composition that is safely metabolized and eliminated by the body, rather than relying on potent enzymes like collagenase that carry high risks. The vehicle acts as a temporary carrier that delivers therapeutic effect without persistent harmful presence in the tissue.
Solution Approach 2:
The patent changes the fundamental parameter of treatment from enzymatic dissolution (collagenase) to a non-enzymatic approach using a biocompatible vehicle with specific rheological properties. This parameter change eliminates the risk of enzymatic side effects while maintaining plaque softening and dissolution capabilities through alternative mechanisms.
2Stability of the object's composition
If Verapamil is used to stop plaque progression, then plaque formation is inhibited, but dizziness, weakness, nausea, and sweating occur
Solution Approach 1:
The patent extracts the therapeutic function of plaque stabilization from systemic calcium channel blockers like Verapamil and implements it locally through a biocompatible vehicle injected directly into the plaque. This eliminates systemic circulation and associated side effects while maintaining local therapeutic effect on plaque stability and progression inhibition.
Solution Approach 2:
The biocompatible vehicle acts as an intermediary substance that mediates the therapeutic effect locally at the plaque site without requiring systemic drug circulation. The vehicle provides localized stabilization and anti-proliferative effects directly at the target tissue, avoiding distant organ side effects.
3Object-affected harmful factors
If steroid injections are used to treat Peyronie's disease, then inflammation is reduced, but immune system function decreases and infection risk increases
Solution Approach 1:
The patent employs a biocompatible vehicle composition that is temporarily present in the tissue to provide anti-inflammatory effect, then safely metabolized and eliminated by the body's natural processes. Unlike steroids that suppress the immune system, this vehicle provides transient local anti-inflammatory action without compromising systemic immune function or increasing infection risk.
Solution Approach 2:
The patent changes the mechanism of inflammation reduction from immunosuppression (steroids) to a biocompatible approach where the vehicle itself modulates the inflammatory response locally. The vehicle's biocompatibility ensures it does not trigger harmful immune responses while still providing effective inflammation control through alternative pathways.
Data Source
AI summary
A multi-part processed human amniotic composition configured to treat Peyronie's disease in a subject in need thereof by intracorporeal injection of the composition into the corpus cavernosum of the subject to reduce plaque size associated with Peyronie's disease. The multi-part processed human amniotic composition includes a micronized human amnion composition; and an aqueous human amniotic fluid filtrate configured to reconstitute and suspend the micronized human amnion composition therein. In certain aspects, the multi-part processed human amniotic compositions are not processed with exogenous enzymes during production thereof and do not include exogenous enzymes, such as collagenase, added thereto.