Adverse Event Report
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Category: Burn and Wounds
What are the properties of Cell-Amniosin?
Cell-Amniosin contains a matrix of collagen, fibronectin, laminin, proteoglycan and glycosaminoglycan. It is also rich in various growth factors and bioactive factors that stimulate epithelialization, anti-inflammatory properties, analgesic properties and prevent scarring.
Indications and clinical use:
• It is used to treat deep diabetic foot ulcers over a period of more than 6 weeks that extends through the middle membrane of the skin (Dermis) but is not exposed to tendons, muscles, joint capsules or open bones.
• In epidermolysis bullosa, an inherited disease of the skin tissues that causes painful bleeding blisters on the skin and mucous membranes.
• Stevens-Johnson syndrome
• Venous leg ulcer, a chronic wound that usually takes a long time to heal (more than 2 weeks).
• Acute wounds such as bed sores
• Wounds caused by trauma or physical injury
• Surgical incisions: ocular, GI (gastrointestinal), ENT (ear nose throat), gynecology, neurosurgey, cardiovascular, urology and aesthetic procedures
How to use?
Amniotic membrane can be used as a graft, patch or in multiple layers.
• In Graft, Amniotic membrane is used with the expectation that it will become epithelialized and incorporated into the host tissue (p).
• Patch is used to cover an area of the ocular surface. AM will eventually remove or fall off, epithelialization will occur beneath the membrane, with the membrane acting as a bandage (q).
• Patch and Graft: Both approaches can be combined in severe surface defects.
What are suitable conditions for storage of Cell-Amniosin?
Cell-Amniosin is prepared frozen in a transparent bag, containing a piece in the dimensions of 2.2, 3.3, 5.5, 5.10 and 10.10 square centimeters for single use. The product is delivered to the customer at a temperature of (5%) -80 ° C in a container containing dry ice.
Cell-Amniosin can be stored for up to two years at freezing (± 5) at -80 ° C.
Effectiveness of cryopreserved amniotic membrane transplantation in corneal ulceration:
• Reconstruction of the corneal epithelium by corneal epithelium healing rate (CEHR) and vision improvement rate (VIR)
• Improvement of best-corrected visual acuity (BCVA)
For adverse event report and contact with patient support unit
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Arta Pharmed Company, located in Tehran, Iran, is one of the new pharmaceutical companies that focuses on clinical studies, sales, marketing, market development, market access and scientific activities. This company, which was established in 2018, currently cooperates with more than 15 companies in various fields.
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