Amniotic membrane derived dry matrix (human)
Omnigen
A unique ‘off the shelf’, transportable biological matrix that can be used as an effective regenerative therapy for a range of wound care indications, including ocular surface indications. Through the Tereo manufacture process, Omnigen uniquely overcomes the reported limitations associated with conventional cryo- and dry preservation techniques, to retain the natural regenerative properties of fresh amnion in a dry and stable transplant matrix. Omnigen will equip civilian, military and veterinary clinicians with an easy access and easy to use regenerative therapy, allowing them to effectively treat ocular surface disease and trauma in surgery, in the clinic or in the emergency room.
No refrigeration required – simple storage
Omnigen is dry and contains no viable cells. It may be stored at room temperature (25˚C), so it is ready to use straight from the sterile pack. There is no longer any need to be concerned with keeping amnion frozen, thawing it, having to pre-plan use or risk wastage.
Tereo processed – originality preserved
Our objective has been to retain the originality of amnion. Omnigen is manufactured using a patented preparation and drying process called Tereo. This process allows retention of the natural trophic components present in fresh amniotic membrane, an element believed to be linked to wound healing performance (Allen C.L., et al 2013)
Stocked at the point of care – Ready when you are
Omnigen is a stable matrix developed so that it may be stored at the point of care, at room temperature. As a stock product, it is therefore ready to use immediately when clinically required. Omnigen can thus be routinely accessed in emergency situations as well as to treat the diseased ocular surface.
Easy to apply and orientate
Omnigen is easy to manipulate. Supplied in a bespoke delivery tray, it may be removed and applied dry, directly to the eye, where it can be rapidly rehydrated by ambient in vivo moisture of the eye. The epithelial side is marked for confident orientation.
Range of pre-cut sizes
Quality and Safety
Omnigen is processed from amniotic membrane donated by UK donors undergoing elective caesarean section births at NHS hospitals. Donor eligibility is assessed via the donor’s history, a face-to-face medical/social history interview, and mandatory blood tests. Omnigen is aseptically processed under Grade A clean room conditions and undergoes antibiotic decontamination. The culture negative microbiological status of the processed product is validated by an independent laboratory prior to release.
Why is amnion special
Amniotic membrane (amnion) is the thin avascular inner layer of the foetal membrane, which surrounds, protects and nurtures the foetus during pregnancy. The amnion produces important proteins, responsible for promoting the normal growth and development of the foetus [1]. These proteins exhibit immunoregulatory[2, 3], anti-fibrotic[4, 5] anti-inflammatory, antiangiogenic, non-tumorigenic[6, 7] and wound healing characteristics. When appropriately preserved, the beneficial effects of reducing inflammation and neovascularisation, and promoting wound healing can be maintained [8] to promote regeneration of healthy tissue. This foetal derived tissue[9], does not express antigens of histocompatibility and therefore delivers a low risk of immunogenicity[2, 6]. As a transplant therapeutic graft, amniotic membrane has the advantage over other biologic tissues that it is thinner and better tolerated by the patient.
- Lemke, A., et al., Human amniotic membrane as newly identified source of amniotic fluid pulmonary surfactant. Sci Rep, 2017. 7(1): p. 6406.
- Bailo, M., et al., Engraftment potential of human amnion and chorion cells derived from term placenta. Transplantation, 2004. 78(10): p. 1439-48.
- Wolbank, S., et al., Dose-dependent immunomodulatory effect of human stem cells from amniotic membrane: a comparison with human mesenchymal stem cells from adipose tissue. Tissue Eng, 2007. 13(6): p. 1173-83.
- Ricci, E., et al., Anti-fibrotic effects of fresh and cryopreserved human amniotic membrane in a rat liver fibrosis model. Cell Tissue Bank, 2013. 14(3): p. 475-88.
- Moodley, Y., et al., Human amnion epithelial cell transplantation abrogates lung fibrosis and augments repair. Am J Respir Crit Care Med, 2010. 182(5): p. 643-51.
- Ilancheran, S., et al., Stem cells derived from human fetal membranes display multilineage differentiation potential. Biol Reprod, 2007. 77(3): p. 577-88.
- Insausti, C.L., et al., Amniotic membrane induces epithelialization in massive posttraumatic wounds. Wound Repair Regen, 2010. 18(4): p. 368-77.
- Alio, J.L., M. Abad, and D.H. Scorsetti, Preparation, indications and results of human amniotic membrane transplantation for ocular surface disorders. Expert Rev Med Devices, 2005. 2(2): p. 153-60.
- Cross, J.C., Formation of the placenta and extraembryonic membranes. Ann N Y Acad Sci, 1998. 857: p. 23-32.
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