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Sterile Dehydrated Bilayered Human Amnion Chorion Membrane Allograft
AmnioPlast 2
AmnioPlast 2™ is a sterilized, dehydrated, minimally manipulated, bilayered allograft made from human amnion chorion membranes that aids in the treatment of ocular wounds
₹1,350.00
- About Product
AmnioPlast 2TM is aseptically processed and dehydrated while preserving the structure of the placental membrane. It is: -Designed to act as an ocular bandage for an array of Ocular Surface Disorders (OSDs) - Also intended for use as a biological membrane patch graft applied to the ocular surface following repair or reconstruction procedures
Product Specifications
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
Composition
AmnioPlast 2 is composed of:
Extracellular matrix (ECM) of the Human Amnion Chorion Membrane: Acts as a natural biocompatible scaffold and a biological barrier
AGNES Proprietary Processing Technology
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
Shapes and Sizes
AmnioPlast 2 is available in the form of a square-shaped allograft measuring 3 cm x 3 cm
- Product Advantages
The human amniotic membrane which natively plays the role of providing a protective barrier for the fetus in the womb, essentially plays the same function in wound care management and works as an ideal ocular wound cover. Here are some of its advantages
Safety
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)
Storage and Shelf-life
Does not require refrigeration and can be stored in a clean and dry environment at ambient room temperature.
Shelf-life of 2 years
Ease of Use
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)
- Clinical Uses
The amnion-chorion bilayered allografts like AmnioPlast 2 act as a biological barrier and is relatively transparent for good cosmetic outcomes. Such allografts have been previously used in the following surgical applications
Supports Reconstruction & Repair
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.
- Case Studies
Here are some of the case studies showcasing how AmnioPlast 2TM, as a biological wound cover has helped in the management and recovery of various types of occular wounds
Ocular Surface Squamous Neoplasia | 65 Year Old Female
Outcome: AmnioPlast 2 completely dissolved healing the area with no scars and pain
Ocular Surface Squamous Neoplasia | 55 Year Old Female
Outcome: AmnioPlast 2 completely dissolved healing the area with no scars and pain and gave excellent surface reconstruction
Surgical Application
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
Why Choose LifeCell?
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
Frequently
Asked Questions
Frequently Asked Questions
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:
- 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)
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.
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