Answers to all your questions
What is Amniotic Tissue?
Amniotic tissue is derived from the innermost layer of a woman’s placenta during pregnancy, consisting of the amniotic membrane and amniotic fluid. The amniotic membrane has two layers: the chorion on the outside and the amnion on the inside. The amnion contains the amniotic fluid, which surrounds and protects the growing embryo or fetus. This tissue is rich in essential nutrients and growth factors that support fetal growth, protection, and healing.
Where does Amniotic Tissue come from?
Amniotic tissue used in JXHcare allografts is ethically sourced from healthy women, aged 18-45, who have delivered a full-term baby via elective cesarean section. These tissues are collected with the consent of the mothers, who volunteer to donate their placental tissues, which would otherwise be discarded. The collection process involves a thorough medical and social history review, as well as communicable disease screening to ensure the safety and viability of the donated tissue.
How is Amniotic Tissue classified by the FDA?
The U.S. Food and Drug Administration (FDA) classifies amniotic tissue as an HCT/P (Human Cells, Tissues, and Cellular and Tissue-Based Products). According to FDA regulations (21 CFR 1271.10(a)), HCT/Ps are regulated under section 361 of the Public Health Service (PHS) Act if they meet specific criteria, including being minimally manipulated, intended for homologous use, and having no systemic effect. If these criteria are not met, the tissue may be regulated as a drug, device, or biological product, requiring pre-market review.
Is obtaining Amniotic Tissue ethical?
Yes, the collection of amniotic tissue is entirely ethical and causes no harm to either the newborn baby or the mother. The tissue is collected after the live birth during an elective cesarean section, with the mother’s consent. The process is voluntary, and the collected tissues are those that would otherwise be discarded post-delivery. No fetal sacrifice is involved.
How is Amniotic Tissue collected and processed?
Collection:
Amniotic tissue is collected following strict industry guidelines. During a cesarean delivery, the placenta and amniotic fluid, which are typically discarded, are preserved. The process does not harm the mother or baby. The collected tissues are then tested to ensure their viability and safety.
Processing:
The collected placental tissues, including the amniotic membrane and fluid, are processed to maintain their original characteristics, such as cellular components, growth factors, and collagen. The process keeps the extracellular matrix intact, resulting in a graft that retains the healing properties and protective barrier functions of the original amniotic tissue. All processed tissues undergo testing per USP guidelines before being released for use.
How is Amniotic Tissue used in wound repair?
Amniotic tissue serves as a regenerative biofactory, providing key components that optimize the wound healing environment. Its unique composition includes cytokines, amino acids, carbohydrates, hyaluronic acid, and cellular components that promote healing. The tissue’s natural properties offer anti-inflammatory, anti-bacterial, re-epithelialization, and anti-fibrotic benefits, making it highly effective in wound care.
What ECM proteins are found in Amniotic Tissue?
Amniotic tissue contains several extracellular matrix (ECM) proteins, including:
- Collagen Types I, III, IV, V, and VII
- Laminin
- Tissue Inhibitors of Metalloproteinases (TIMPs)
- Fibronectin
- Proteoglycans
- Hyaluronic Acid
What growth factors are found in Amniotic Tissue?
Human amniotic tissue is known to contain several growth factors, including:
- FGF (Fibroblast Growth Factor)
- EGF (Epidermal Growth Factor)
- VEGF (Vascular Endothelial Growth Factor)
- TGF-β1 (Transforming Growth Factor beta 1)
- PDGF (Platelet-Derived Growth Factor AA and BB)
- Cytokines
What are Amniotic Tissue allografts?
Amniotic tissue allografts are minimally manipulated human amniotic membrane tissues prepared in a patch format. These allografts are applied to wounds to replicate their natural function of covering, protecting, and nourishing tissue. Their unique composition, rich in growth factors, cytokines, and anti-inflammatory properties, makes them ideal for promoting wound healing.
On what types of wounds can you apply Amniotic Tissue Allografts?
Amniotic tissue allografts have been successfully used in wound care for a variety of wound types, including:
- Incision wounds from surgical procedures
- Trauma wounds from accidents or repetitive use
- Chronic wounds, such as diabetic ulcers
Are Amniotic Tissue Allografts safe?
Safe Tissue Handling:
- Procurement is done by qualified partners following stringent protocols.
- Donors undergo a thorough medical review and prenatal examination.
- Communicable disease testing is performed by an FDA-registered, CLIA laboratory.
- Allografts are subjected to rigorous USP testing before release.
Patient Reaction:
- Amniotic tissue minimizes the risk of immunogenicity and adverse reactions by mitigating the expression of class II antigens.
- JXHcare’s recommended allografts do not contain chorion, further reducing the risk of an adverse reaction.
- Amniotic tissue has been used in wound care for over a century with no reported adverse reactions to JXHcare allografts.
How are Amniotic Tissue Allografts stored?
JXHcare Amniotic Allografts can be stored at ambient temperature on a shelf for up to five years.
Why choose Amniotic Tissue Allografts from JXHcare?
JXHcare’s allografts are designed to offer superior healing properties, safety, and ethical sourcing, making them a reliable choice for advanced wound care. Our commitment to quality and innovation ensures that healthcare providers and patients receive the best possible care.
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