FAQ

Amniotic tissue collection does not require fetal sacrifice.

• The tissues are donated by consenting, healthy women (ages 18–45) who have just delivered a full-term, healthy baby through elective C-section.

• Medical and social histories are collected to ensure donor eligibility.

• Donor blood samples are collected and thoroughly screened for communicable diseases.

 The FDA classifies amniotic tissue as an HCT/P (Human Cells, Tissues, and Cellular and Tissue-Based Products).

• It is regulated under section 361 of the PHS Act and 21 CFR part 1271 if it meets certain criteria (minimally manipulated, intended for homologous use, not combined with other cells/tissues, and localized effect in vivo).

• If criteria aren’t met, it would be regulated as a drug, device, or biological product with pre-market review.

Yes. Collection of placental tissues causes no harm to the newborn baby or mother.

• The placenta is collected after a live birth via C-section.

• Mothers volunteer to donate tissues that are typically discarded after birth.

• This process does not require fetal sacrifice.

Collection:

• Collected at facilities nationwide following strict guidelines.

• Performed at time of C-section, saving placenta and amniotic fluid (usually discarded).

• No harm to baby or mother.

• All tissues tested for viability and safety.

Amniotic tissue is a regenerative biofactory that optimizes wound healing with:

• Cytokines, amino acids, carbohydrates, hyaluronic acid, and cellular components.

• Key growth factors and extracellular matrix proteins.

• Anti-inflammatory, anti-bacterial, re-epithelialization, and anti-fibrotic properties.

• Published studies over 100 years of efficacy.

• Mitigation of Class II antigens, reducing immunogenicity and adverse reactions.

• Collagen Types I, III, IV, V, VII

• Laminin

• Tissue Inhibitors of Metalloproteinases (TIMPs)

• Fibronectin

• Proteoglycans

• Hyaluronic Acid

• Cytokines, amino acids, carbohydrates, hyaluronic acid, and cellular components.

• Key growth factors and extracellular matrix proteins.

• Anti-inflammatory, anti-bacterial, re-epithelialization, and anti-fibrotic properties.

• Published studies over 100 years of efficacy.

• Mitigation of Class II antigens, reducing immunogenicity and adverse reactions.

• 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 minimally manipulated into a patch.

• Used to cover, protect, and nourish tissue.

• Contain growth factors, cytokines, and anti-inflammatory properties critical to wound healing.

• Incision wounds from open surgical procedures.

• Trauma wounds from accidents or repeated use.

• Hard-to-heal or chronic wounds, such as diabetic ulcers.

Safe Tissue Handling:

• Procurement by qualified partners following protocols.

• Donors pre-screened via intensive review and examination.

• Disease testing by FDA-registered, CLIA labs.

• Allografts tested per USP standards.

Patient Reaction:

• Class II antigen expression is mitigated, reducing graft vs host reaction.

• GotWound.com allografts exclude chorion, reducing adverse reaction risk.

• Used in wound care for 100+ years with no reported adverse reactions.

Can be safely stored at ambient temperature for up to 5 years.

Amniotic tissue products are commonly used for patients with:

• Non-healing wounds such as diabetic ulcers, venous leg ulcers, or pressure sores.

• Post-surgical wounds that are slow to heal.

• Traumatic injuries where tissue regeneration is needed.

Many amniotic tissue products are reimbursable by Medicare and private insurance if medically necessary. Coverage can depend on your condition and documentation provided by your healthcare provider.

No additional surgical procedure is required. The allograft is applied directly to the wound site, usually in a clinical setting, and is typically painless.