The following are frequently asked questions from physicians, nurse practitioners, and patients. These inquiries provide insight into Wound Care Distribution Center’s services and offer valuable information on amniotic membranes.
What is Amniotic Tissue?
Amniotic tissue comprises the innermost portion of the placenta during pregnancy and consists of the amniotic membrane and amniotic fluid.
The amniotic membrane is composed of two layers: the chorion (outer layer) and the amnion (inner layer). The amnion surrounds and contains the amniotic fluid, which, in turn, surrounds and protects the developing embryo/fetus.
Amniotic tissue contains vital nutrients and growth factors that are essential for fetal growth, protection, and development.
Where does Amniotic Tissue come from?
Fetal sacrifice is not required for the collection of amniotic tissue.
The amniotic tissues used in Wound Care Distribution Center allografts are obtained from consenting, healthy women, aged 18-45, who have elected to deliver a healthy, full-term infant via Cesarean section. To ensure donor suitability, a thorough medical and social history is obtained. Donor blood samples are collected and rigorously screened for communicable diseases.
How is Amniotic Tissue classified by the FDA?
FDA Classification of Amniotic Tissue:
The FDA classifies amniotic tissue as a Human Cells, Tissues, and Cellular and Tissue-Based Product (HCT/P). HCT/Ps are regulated under section 361 of the PHS Act and 21 CFR part 1271 if they meet the following criteria (21 CFR 1271.10(a)): minimal manipulation, homologous use, non-combination with other cells or tissues, non-dependence on systemic effect or metabolic activity of living cells for primary function, and a localized effect in vivo.
Amniotic tissue products that do not meet all criteria in 21 CFR 1271.10(a) are regulated as drugs, devices, and/or biological products, requiring pre-market review.
Is the procurement of Amniotic Tissue ethical?
Ethical Acquisition of Amniotic Tissue:
The procurement of placental tissues poses no risk to the health of the newborn or mother.
Amniotic tissue, consisting of the amniotic membrane and fluid, is obtained from the placenta’s innermost layer following live births via elective Cesarean section. Maternal consent is secured for the donation of these tissues, which are typically considered medical waste. Fetal sacrifice is not required for placental/amniotic tissue collection.
How is Amniotic Tissue used in wound repair?
Amniotic tissue serves as a regenerative bio-matrix, optimizing the wound healing environment through its unique composition.
This composition includes:
- Cytokines, amino acids, carbohydrates, hyaluronic acid, and cellular components.
- Key growth factors and extracellular matrix proteins.
- Amniotic tissue exhibits properties that aid in wound repair, such as:
Anti-inflammatory, anti-bacterial, re-epithelialization, and anti-fibrotic effects.
Clinical efficacy in wound care is documented in published studies dating back over 100 years.
Additionally, it minimizes immunogenicity and the risk of adverse reactions by mitigating the expression of class II antigens.
What ECM proteins are found in Amniotic Tissue?
Key Extracellular Matrix Components and Their Role in Amniotic Tissue:
The following extracellular matrix components are present in amniotic tissue and play specific roles in wound healing:
- Collagen Types I, III, IV, V, and VII: Provide structural framework and mechanical strength.
- Laminin: Supports cell attachment and movement during tissue repair.
- Tissue Inhibitors of Metalloproteinases (TIMPs): Control matrix breakdown for proper tissue remodeling.
- Fibronectin: Facilitates cell binding and migration for effective healing.
- Proteoglycans: Regulate tissue water content and cell communication.
- Hyaluronic Acid: Manages tissue moisture and inflammatory responses.
What growth factors are found in Amniotic Tissue?
Key Growth Factors Present in Amniotic Tissue:
The following growth factors are identified in human amniotic tissue:
- Fibroblast Growth Factor (FGF)
- Epidermal Growth Factor (EGF)
- Vascular Endothelial Growth Factor (VEGF)
- Transforming Growth Factor beta 1 (TGF-β1)
- Platelet-Derived Growth Factor (PDGF) AA and BB
- Cytokines
What are Amniotic Tissue Allografts?
Amniotic tissue allografts are minimally manipulated human amniotic membrane tissues presented in a patch format.
These allografts function to cover, protect, and nourish tissue, similar to their role in utero. Amniotic tissue is a useful wound biomaterial due to its natural covering and protective abilities, as well as its unique composition of growth factors, cytokines, and anti-inflammatory properties, all of which are essential for wound healing.
In what types of wounds can Amniotic Tissue Allografts be applied?
Wound Types Treatable with Amniotic Tissue Allografts:
Regenerative amniotic tissue allografts offer versatility in wound care, with successful application for both topical and in vivo use across a range of wound types, including:
- Open surgical incision wounds
- Trauma-induced wounds
- Chronic non-healing wounds (e.g., diabetic ulcers)
Are Amniotic Tissue Allografts safe?
Safety Protocols:
- Procurement is performed by qualified partners adhering to stringent protocols.
- Donors undergo rigorous pre-screening, including intensive medical history review and prenatal examination.
- Communicable disease testing is conducted by an FDA-registered, CLIA-certified laboratory.
- Allografts are subjected to stringent USP testing prior to release.
What are the storage requirements for Amniotic Tissue Allografts?
Why Choose Wound Care Distribution Center Amniotic Tissue Allografts?
Wound Care Distribution Center provides comprehensive support beyond product delivery, ensuring successful reimbursement and minimizing the risk of future clawbacks.
To achieve this, Wound Care Distribution Center employs dedicated wound billing specialists who offer personalized guidance on medical necessity documentation, imaging, and coding to optimize reimbursement and prevent clawbacks.
