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WHERE INNOVATION AND REGENERATIVE MEDICINE MEET
Physicians and their patients often have questions about the human allograft tissue used in Surgilogix products. We hear questions like, “Where do the tissues come from?“, “Are amniotic tissue grafts safe?” and “What makes an amniotic membrane graft a good option for me?“
We’ve answered some of the most common questions below. If you have additional questions, please let us know.
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.
Amniotic tissue is collected after full-term, healthy cesarean section.
The amniotic tissues used in Surgilogix allografts are donated by consenting, healthy women between the ages of 18 – 45 who have just delivered a full-term, healthy baby through elective Cesarean section. A careful medical and social history is collected in advance to ensure donor mothers meet all eligibility requirements. Donor blood samples are collected and thoroughly screened for communicable diseases.
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.
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) 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 known to contain the following extracellular matrix elements:
Human amniotic tissue is known to contain the following growth factors:
Amniotic tissue allografts are human amniotic membrane tissues that have been minimally manipulated into a patch format.
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:
Safe Tissue Handling
Patient Reaction
Storage conditions and expiry dates are determined by the allograft type. Surgilogix’s allografts are stored at ambient/room temperature (15 – 30°C) and typically expiry is two year. Please consult the product insert for storage and expiration information for your specific allograft.
SXDBM™ is an effective alternative to autogenous bone grafts.
It is available in large quantities, does not require harvesting from the patient, and contains a rich quantity of bone morphogenetic proteins, which belong to the transforming growth factor superfamily of proteins.
References