AmnioPlast 2TM allografts are derived from human amniotic tissue and it's appearance may vary between donors. Variations in color (tan to light brown), opacity, and thickness in the membrane allograft are normal due to the nature of the tissue.
Layers: Amnion & Chorion
Thickness: Not less than 60 microns
Moisture Content: Not more than 15%
Transparency: Clear membrane (>70% clarity)
Total Protein: Not less than 200 μg/cm^2
Embossing: “LC”, “L” or “C” as a guide to support correct placement on the wound
AmnioPlast 2 is composed of:
Extracellular matrix (ECM) of the Human Amnion Chorion Membrane: Acts as a natural biocompatible scaffold and a biological barrier
Donated placental tissues go through the steps of
Donor Screening: Includes testing for presence of infectious agents
Tissue Washing & Dehydration: Microbial and red cell contaminants removed and tissue is air dried
Cutting & Packaging: Tissues are cut using lasers, placed inside multiple poly-foil peel pouches and then in an outer carton
Sterilization: Terminally sterilized using gamma irradiation
AmnioPlast 2 is available in the form of a square-shaped allograft measuring 3 cm x 3 cm
Immunologically privileged due to very low levels of HLA antigens and no immune rejection, and therefore can safely be used as an allograft without requiring tissue matching between donor and patient
Terminal sterilisation provides additional safety by ensuring that the product is free from microbial contaminants
Rigorous donor screening and selection protocols that meet or exceed industry standards
Screens for infectious agents like:
- HIV-1/2 antibody & HIV antigen
- Hepatitis B surface antigen
- Hepatitis B core antibody
- Hepatitis C antibody
- Syphilis
- Malaria
- HTLV I & II antibody
- CMV IgG
- HIV-1 (NAT)
- HCV (NAT)
Does not require refrigeration and can be stored in a clean and dry environment at ambient room temperature.
Shelf-life of 2 years
Easy-to-apply and ready-to-use
Single-step rehydration
Optimised sizes and specifications for different wound types
Easy to determine the orientation of membrane allografts (2 distinct sides: amnion and chorion membrane)
Conjunctival Fornix: Loose tissues connecting conjunctival membrane lining the inner eyelid and the eyeball
Symblepharon: An abnormal adhesion of the membrane covering the white of the eye and the inner eyelids
Pterygium: A membranous growth that starts on the white of the eye and can spread to the cornea
Large Corneal Perforations: A corneal anomaly resulting from injury to the corneal surface
Stevens Johnson Syndrome: A rare skin and mucous membrane disorder that results in ocular manifestations
Deep Corneal Ulcers: Inflammation caused by microbial invasion resulting in corneal epithelial defect
Ocular Surface Squamous Neoplasia: An ocular surface malignancy ranges from mild epithelial dysplasia to invasive squamous carcinoma.
Outcome: AmnioPlast 2 completely dissolved healing the area with no scars and pain
Outcome: AmnioPlast 2 completely dissolved healing the area with no scars and pain and gave excellent surface reconstruction
Unpacking:
Unpack the outer and inner cover carefully maintaining sterility
Resizing:
Check whether resizing is required or not. If resizing is needed - measure the pathologically defective area with the help of a caliper. Then considering double the amount of the defect, resize the Amniotic Membrane (AM) while it is in a dry state. Resizing is done with the help of corneo-scleral scissors
Soaking:
Post resizing, the AM is moistened with any sterile solution to help soften it. If resizing is not required, then the AM is directly put into the sterile solution
Glued or Sutured:
After managing the affected corneal ocular surface properly, the AM is placed over it and glued or sutured. Suturing is done with the help of 10-0 monofilament nylon or vicryl sutures (depending on situational requirement) or adhesion is done with the help of fibrin glue
Proprietary Technology
Produced using LifeCell's proprietary AGNES processing technology, to provide an effective allograft with excellent handling characteristics
Licenced & Accredited
First Tissue Bank outside the US to be accredited with AATB for placental tissues, and licenced by NOTTO (National Organ and Tissue Transplant Organization)
Quality Assurance
Designed and developed by strictly adhering to Good Manufacturing Practices (GMP) & Good Tissue Practices (GTP) protocols
Wish To Know More?
Any disorder in the cornea, conjunctiva, eyelids and lacrimal glands is known as an ocular surface disorder. These include dry eye disease (DED), blepharitis and meibomian gland dysfunction (MDG), allergic eye diseases (AED), chemical and thermal burns, etc. (1).
Prior to donation, the donor’s medical and social history are screened for medical conditions or diseases that contraindicates its use for allogenic (non-self) purposes.
As per national and/or international accreditations adhered by LifeCell, donor blood samples taken at the time of collection are tested negative/non -reactive for relevant communicable and infectious disease agents like:
In addition, LifeCell provides a certificate of analysis (CoA) for more details, on request.
Yes, all our products are ready-to-use.
No, each product is for single use only.
No, each product is for single patient use only.
Yes, the products should be stored in a clean, dry environment at ambient room temperature . However, there is no need for refrigeration or freezing.
Yes, all our products are gamma-irradiated to warrant a sterility assurance level of 10^-6.
No, our products do not contain any live cells.
No, our products are non-immunogenic.
Application techniques may vary depending on the indications. For further details, please refer to our section on application instructions.
AmnioPlast 2™ is for single use only and is to be only used by a licensed physician.
The wound healing depends on the severity of the wound and the prescribed treatment.
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