Frequently Asked Questions

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Amniotic tissue makes up the inner most portion of a woman’s placenta during pregnancy. It consists of amniotic membrane and amniotic fluid.

​Amniotic membrane is made up of two layers, chorion on the outside and amnion on the inside. The amnion surrounds and contains the amniotic fluid. Amniotic fluid surrounds and protects the growing embryo/fetus.

Amniotic tissue contains vital nutrients and growth factors that are essential for fetal growth, protection, and healing.

 The US Food and Drug Administration (FDA) classifies amniotic tissue as a HCT/P (Human Cells, Tissues, and Cellular and Tissue-Based Products). An HCT/P is regulated solely under section 361 of the PHS Act and 21 CFR part 1271 if it meets all the following criteria (21 CFR 1271.10(a)): the tissue is minimally manipulated, intended for homologous use and is not combined with other cells or tissues. There can be no systemic effect or dependence on the metabolic activity of living cells to achieve its primary function and the tissue has to have a localized effect in vivo.”

If an HCT/P does not meet all of the criteria in 21 CFR 1271.10(a) it will be regulated as a drug, device, and/or biological product and a pre-market review would be required. 

Collection of placental tissues causes absolutely no harm to the new born baby or mother.

​Amniotic tissue, which includes amniotic membrane and amniotic fluid, is taken from the inner most layer of the placenta. The placenta is collected AFTER a live birth delivered via elective cesarean section. The mother has volunteered to donate her placental tissues, which are typically discarded after the birth. Placental / amniotic tissue collection DOES NOT require fetal sacrifice.

COLLECTION
Placental tissues are collected at several facilities around the country, following strict guidelines and consistent with industry best practices. At the time of Cesarean delivery (also known as C-section), the baby is delivered and the placenta and amniotic fluid, which are typically discarded, are saved. There is no harm to the new born baby or mother. All tissues are then tested to ensure viability and safety.

PROCESSING
The collected placental tissues (amniotic membrane and amniotic fluid) are processed to the highest standards in a state-of-the-art American Association of Tissue Banks (AATB) accredited facility. Our process maintains the original characteristics of the amniotic tissue including its cellular components, growth factors, and collagen, and keeps the extracellular matrix intact. This specialized technique results in a graft that maintains the original healing characteristics and protective barrier properties of the amniotic tissue. All processed tissues are tested per USP guidelines prior to release.

Amniotic tissue is a regenerative biofactory, with key components known to optimize the wound healing environment.
Its unique make-up:

• Includes cytokines, amino acids, carbohydrates, hyaluronic acid, and cellular components.
• Contains key growth factors and extracellular matrix proteins.
• Offers anti-inflammatory, anti-bacterial, re-epithelialization, and anti-fibrotic properties.
• Has published studies on its benefits and efficacy in wound care dating back over 100 years.
• Mitigates the expression of class II antigens, minimizing immunogenicity and reducing the risk of adverse reaction.

Amniotic tissue is known to contain the following extracellular matrix elements:

• Collagen Types, I, III, IV, V and VII
• Laminin
• Tissue Inhibitors of Metalloproteinases (TIMPs)
• Fibronectin
• Proteoglycans
• Hyaluronic Acid

• 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

 Amniotic tissue allografts are human amniotic membrane tissues that have been minimally manipulated into a patch format.
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Amniotic tissue allografts can be placed on or around a wound to serve the same function that they do in utero, which is to cover, protect and nourish tissue. Amniotic tissue makes an attractive wound biomaterial, not only for it’s natural ability to cover and protect, but also for its unique make-up of growth factors, cytokines and anti-inflammatory properties – factors all known to be critical in wound healing. 

Regenerative amniotic tissue allografts have been used successfully in wound care to cover and aid in healing a variety of wound types both topically and in vivo, including:

• Incision wounds made during open surgical procedures
• Trauma wounds caused by an accident or repeated use
• Hard to heal or chronic wounds, like diabetic ulcers

  Safe Tissue Handling 

• Procurement is done by qualified partners following stringent protocols.
• Donors are pre-screened through an intensive medical review and prenatal examination.
• Communicable disease testing is performed by an FDA-registered, CLIA laboratory.
• Allografts are subjected to stringent USP testing prior to release

Patient Reaction

• Class II antigen expression is mitigated in amniotic tissue minimizing immunogenicity and reducing the risk of graft versus host reaction.
• Unlike other amniotic tissue allografts on the market, GotWound.com allografts do not contain chorion, further reducing the risk of an adverse reaction.
• Amniotic tissue has been used in wound care for over 100 years.
• There have been no reported adverse reactions to GotWound.com allografts.

 Amniotic Allografts can be safely stored at ambient temperature on a shelf up to 5 years 

We don’t just sell you product, we also make sure you get reimbursed without any clawbacks years down the road. We hired an outside wound billing specialist that will be dedicated to walking you through your medical necessity notes, pictures, and codes to ensure you not only get reimbursed, but to ensure you don’t get a clawback.

Our focus on the true science behind amniotic tissue and allograft technologies has allowed us to produce superior products.

• Chorion Removal – Research has shown that chorion contains
  maternal antigens that may trigger an immune reaction. To improve safety, we remove the chorion from all amniotic tissues used in the allografts. Over 55,000 patients have been treated with these chorion-free allografts and with no known adverse events.
• Processing Technique – Our scientists have spent countless hours refining our processing technique in order to maintain the viability and concentration of the key healing properties found in amniotic tissue.