De-cellularized Amniotic Fluid for Joint Pain and Cartilage Regeneration
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Solution Overview
Problem
Current treatments for joint pain, injury, and degeneration are limited in effectiveness, often relying on surgical procedures and palliative methods such as steroid injections or hyaluronic acid, which do not fully address chronic issues or promote significant healing and mobility improvement.
Innovation Solution
A sterile de-cellularized human amniotic fluid (D-HAF) formulation containing over 300 human growth factors is developed, administered via injection or other methods to treat joint conditions, promote healing, reduce inflammation, and increase mobility, while being free from amniotic stem cells and micronized membrane or chorion particles.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If surgical procedures or palliative injections (steroids, hyaluronic acid) are used to treat joint conditions, then pain relief may be achieved, but the treatment effectiveness is limited and does not promote significant healing or mobility improvement
Solution Approach 1:
The patent transforms amniotic fluid through de-cellularization and filtration to create a standardized formulation with controlled parameters (sterile, cell-free, particle-free) while preserving growth factors. This parameter transformation enables the fluid to serve as an effective therapeutic agent that promotes healing without the limitations of conventional treatments
Solution Approach 2:
The invention creates a composite therapeutic formulation by combining multiple growth factors and bioactive molecules present in amniotic fluid into a single injectable preparation. This composite material works synergistically to address multiple aspects of joint pathology simultaneously, improving both pain relief and tissue regeneration
2Reliability
If amniotic fluid is used to treat joint conditions, then healing promotion and pain relief are achieved, but the presence of stem cells and particulate matter may pose safety concerns
Solution Approach 1:
The patent applies extraction by removing stem cells and particulate matter from amniotic fluid through de-cellularization and filtration processes, while retaining the beneficial growth factors and bioactive molecules. This separation eliminates safety concerns associated with cells and particles while preserving therapeutic efficacy
Solution Approach 2:
The de-cellularized amniotic fluid formulation acts as an intermediary substance that delivers growth factors and healing-promoting molecules to injured tissues without introducing potential contaminants. The filtered fluid serves as a safe carrier that mediates the healing process without the risks associated with live cells or particulate matter
3Reliability
If harsh irradiation methods are used to sterilize amniotic fluid, then sterility is achieved, but the biological activity and safety of the formulation may be compromised
Solution Approach 1:
The patent replaces harsh chemical or physical sterilization methods (irradiation) with a mechanical filtration system that physically removes contaminants while preserving the biological integrity of growth factors. The multi-stage filtration process achieves sterility without the damaging effects of irradiation on bioactive molecules
Data Source
AI summary
A human amniotic fluid formulation has been developed for administration into a joint or associated soft tissue such as a tendon or ligament for treatment of pain, degeneration, or injury. 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, which has not been heat treated or treated with ethidium bromide. The formulation is optionally diluted, or concentrated, depending on the severity of the disorder or injury. Examples demonstrate efficacy in treatment of pain, disease, disorder, degeneration or injury of a joint or associated soft tissues.