Methods of processing fetal support tissues, fetal support tissue powder products, and uses thereof
Inventors
Tseng, Scheffer • Tan, Ek Kia • Chua, Lorraine
Assignees
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Publication Number
US-9682044-B2
Publication Date
2017-06-20
Expiration Date
Abstract
Disclosed herein, are methods of preparing fetal support tissue powders. Further disclosed herein, are methods of using the fetal support tissue powder product.
Core Innovation
The invention relates to a method of preparing a fetal support tissue powder product by obtaining a frozen or previously frozen fetal support tissue comprising amniotic membrane, chorion, or a combination thereof, and lyophilizing the frozen tissue to produce lyophilized fetal support tissue. The core workflow converts fetal support tissues into a stable lyophilized starting material suitable for subsequent size reduction.
After lyophilization, the method includes grinding the lyophilized fetal support tissue to generate a fetal support tissue powder product. The disclosed approach includes optional pre-lyophilization handling steps, while keeping the key transformation as lyophilization followed by grinding to form the powder.
The fetal support tissue powder product is described for pharmaceutical compositions and delivery formats, including topical forms and injectable formulations. The product is described as anti-inflammatory, anti-scarring, anti-angiogenic, anti-adhesion, and promoting wound healing.
Claims Coverage
The independent claim covers two essential inventive features: lyophilizing a frozen fetal support tissue comprising amniotic membrane and/or chorion to form a lyophilized tissue, and grinding that lyophilized tissue to generate a fetal support tissue powder product. Dependent claims further refine the starting tissue composition, pre-lyophilization handling, and functional effects of the powder product.
Lyophilizing frozen fetal support tissue comprising amniotic membrane and/or chorion to produce lyophilized fetal support tissue
Lyophilizing a frozen or previously frozen fetal support tissue comprising amniotic membrane, chorion, or a combination thereof to produce lyophilized fetal support tissue.
Grinding lyophilized fetal support tissue to generate a fetal support tissue powder product
Grinding the lyophilized fetal support tissue to generate a fetal support tissue powder product.
Fetal support tissue composition including placenta and/or umbilical cord materials
The frozen or previously frozen fetal support tissue further comprises placenta, umbilical cord, umbilical cord amniotic membrane, or any combinations thereof.
Cutting frozen fetal support tissue into pieces prior to lyophilization
The method further comprising cutting the frozen or previously frozen fetal support tissue into pieces prior to the lyophilization step.
Rinsing frozen fetal support tissue prior to lyophilization
The method further comprising rinsing the frozen or previously frozen fetal support tissue prior to the lyophilization step.
Functional effects of the fetal support tissue powder product
The fetal support tissue powder product is anti-inflammatory, anti-scarring, anti-angiogenic, anti-adhesion, or promotes wound healing.
Using fetal support tissue obtained as fresh or previously frozen input
The method is performed using frozen fetal support tissue obtained from either fresh or previously frozen fetal support tissue.
Overall, the claim set is centered on producing a fetal support tissue powder product by lyophilizing a frozen fetal support tissue comprising amniotic membrane and/or chorion and then grinding the lyophilized tissue, with dependent claims specifying additional fetal support tissue components, pre-lyophilization cutting and rinsing, and attributing wound-healing and related functional effects to the powder product.
Stated Advantages
Minimally manipulated fetal support tissue powder product.
Lacks systemic effect.
Anti-inflammatory effects.
Anti-scarring effects.
Anti-angiogenic effects.
Anti-adhesion effects.
Promotes wound healing.
Ocular application described as not melting by 25% in 2 years for a stated patch thickness range.
Documented Applications
Pharmaceutical compositions and delivery formats including topical forms and injectable formulations for the fetal support tissue powder product.
Therapeutic uses associated with anti-inflammatory, anti-scarring, anti-angiogenic, anti-adhesion, and wound-healing effects.
Repairing multiple hernia types using the fetal support tissue powder applied on a substrate as a protective graft and/or tectonic or structural support.
Spinal disc herniation with annulus fibrosis repair, including dura or meningeal coverage.
Ocular tissue repair, including covering a glaucoma drainage device to address tube erosion and ocular uses described for epithelial defects and ocular ulcers.
Dura mater, pia mater, and arachnoid mater coverage and related spinal surgery indications described in the document.
Additional listed uses include fascia repair and other tissue replacement or supplement indications described in the document, including heart, pericardium, and peritoneum-related contexts.
Coronary tissue and coronary artery bypass contexts described in the document.
Heart valve, veins and arteries, nerve repair, including adhesion prevention, and neuroma formation contexts described in the document.
Spinal adhesions and scar adhesion contexts and laminectomy-related indications described in the document.
Bone-related indications including spinal fusion, bone regeneration at a tooth extraction site, inhibition of bone resorption, and related disorders described in the document.
Dermal filler uses and hypertrophic and keloid scars described in the document.
Clinical trial study designs are described for multiple indications, including osteoarthritis, herniated disc, wound healing, spinal adhesions, rheumatoid arthritis, atopic dermatitis, Crohn's disease, type I diabetes mellitus, endotoxic shock, graft-versus-host disease, angiogenesis inhibition for cancer, ankylosing spondylitis, periodontitis, dry eye, psoriasis, diabetes mellitus, and other topical, oral, and intravenous formulations.
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