Standardized reporting of amnion and amnion/chorion allograft data for wound care

Abstract

Background: The favorable biological and mechanical properties of the most common components of the placenta, the amnion and chorion, have been exploredfor regenerative medical indications. The use of the combination of amnion and chorion has also become very popular. But, published data from placental tissues in their final, useable form is lacking. During treatment with membrane product, the tissue is usually sterile, intact and laid on a wound or treatment area. The factors available to the treatment area from the applied product need to be elucidated and presented in a relatable form. Current reporting for eluted growth factor results are typically expressed per milliliter, which is not informative with respect to the area of tissue covered by the actual membrane and may differ among techniques.Methods: To address this inconsistency, amnion or amnion/chorion were isolated from human placentas and processed by a proprietary procedure. The final dry, sterilized product was evaluated for structural components and growth factor elution. Growth factors were quantified by multiplex panels and ELISAs and the values normalized to specific area and elution volume of finished product. This information allows extrapolation to all membrane sizes and affords cross-study comparisons.Results: Analysis of membrane supernatants show that dehydrated, sterilized amnion and amnion/chorion elute factors that are conducive to wound healing, which are available to recipient tissues. Importantly, these measurable factors eluted from dehydrated, sterilized membranes can be reported as a function of available factors per square centimeter of tissue. Conclusions:The standardized characterization of dehydrated, sterilized amnion and amnion/chorion as delivered to recipient tissues permits understanding and comparison of the products across various graft sizes, types, and eluate volumes. Further, reporting this data as a function of cm 2 of dehydrated tissue allows extrapolation by independent scientists and clinicians.

Clinical use of cryopreserved ultra-thick human amniotic membrane for anophthalmic socket contracture

“…The umbilical amnion has superior tensile strength due to a collagen-rich, thickened compact stromal layer. 29,30 Slentz DH, et al 2 reported the novel use of cryopreserved ultra-thick human amniotic membrane in three patients retrospectively with anophthalmia secondary to enucleation for blind painful eye (n = 2) and congenital anophthalmia (n = 1). An average follow-up duration of 12.3 months.…”

“…The umbilical amnion has superior tensile strength due to a collagen-rich, thickened compact stromal layer. 29,30…”

Retention of Key Characteristics of Unprocessed Chorion Tissue Resulting in a Robust Scaffold to Support Wound Healing

“…ECM proteins in their normal biological structures within intact tissues are known to stimulate and regulate cellular proliferation, migration, and differentiation through a number of mechanisms; therefore, the maintenance of the native ECM within a biological tissue is expected to exhibit greater responses than those whose ECM has been disrupted [23,26]. HSCM maintained ECM and key regulatory proteins that are characteristically present in unprocessed chorion membranes [17]. The distribution of ECM proteins and growth factors throughout HSCM was comparable to donor-matched unprocessed tissues.…”

“…While placental membranes as a whole have been widely studied and used clinically, there are limited studies evaluating the potential benefits of the chorion membrane independently. The chorion membrane, comprising the reticular, basement membrane, and trophoblast layers, is thicker than the amnion membrane with a robust ECM and has been reported to be a significant contributor of growth factors and cytokines, including tissue inhibitors of metalloproteases (TIMPs), which inhibit matrix metalloproteases (MMPs) [15,17,18]. While the balance of MMPs and TIMPs is known to be important for regulating collagen deposition, aberrant or prolonged expression of MMPs is known to be a major factor in non-healing and chronic wounds [19,20].…”

Recommendations from the COST action CA17116 (SPRINT) for the standardization of perinatal derivative preparation and in vitro testing

“…These critical factors include a precise description of the PnD used and adequate information on the in vitro tests used to characterize PnD. A recent study by Sabol et al (2022) , reported that published data from placental tissues in their final, useable form is lacking. In their study they highlighted the need for standardized data collection and reporting in the field of dry membrane allografts.…”