amnioplast-test
- About Product
AmnioPlast THICK™ allografts are intended for use as a biological ocular bandage that can be directly applied to the ocular surface for repair or reconstruction procedures. It is:
-Designed to act as a protective barrier to support the healing post Ocular Surface Reconstructive procedures.
-Used as a patch graft in ocular conditions like glaucoma shunt surgery for the protection of Glaucoma Drainage Device tube.
Product Specification
AmnioPlast THICK™ is a dry, aseptically processed, umbilical cord tissue derived allograft intended for use when durable tensile strength is indicated.
Layers:Umbilical Cord Lining comprising Amnion and Wharton's Jelly
Thickness: Not less than 100 microns
Tensile Strength: Not less than 0.25N
Sterility: SAL value 10-6
Transparency: Clear membrane (>70% clarity)
Total Protein: Not less than 200 μg/cm^2
Moisture Content: Not more than 15%
Embossing: "LC" as a guide to support correct placement on the wound
Composition
AmnioPlast THICK is composed of :
Umbilical cord lining: The cord lining is made up of the amnion, which provides a protective barrier & supports wound healing.
Wharton's Jelly: A gelatinous connective tissue found within the umbilical cord and largely made up of mucopolysaccharides like hyaluronic acid (HA) and chondroitin sulfate.
Extracellular matrix (ECM): It acts as a natural biocompatible scaffold and a biological barrier that is composed of collagen, hyaluronic acid, fibronectin, laminin, over 200 growth factors, cytokines, and chemokines which enable and promote cell migration and proliferation, while also stimulating paracrine responses in the native cells.
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
Sizes and Shapes
AmnioPlast THICK is available in the form of a rectangle-shaped allograft measuring
2 cm x 1.5 cm
- Product Advantages
AmnioPlast THICKTM acts as a biological bandage that can be applied to the ocular surface following repair or reconstruction procedures. 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 patientTerminal sterilisation provides additional safety by ensuring that the product is free from microbial contaminantsRigorous donor screening and selection protocols that meet or exceed industry standardsScreens 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
Stored at room temperature in a cool dry place between 15-30°CDoes not require refrigerationShelf-life of 2 years 
Ease of Use
Easy-to-apply and ready-to-useSingle-step rehydrationOptimised sizes and specifications for different wound types Easy to determine the orientation of membrane allografts (2 distinct sides: epithelial and basement
membrane) - Clinical Uses
Umbilical cord-derived allografts like AmnioPlast THICK have been used as an ocular biological barrier, are suturable, and also relatively transparent for good cosmetic outcomes.
Shields Repairs & Reconstructs
The thickness and superior tensile strength of umbilical cord allografts make them an excellent option to shield and prevent erosion of Glaucoma Drainage devices following shunt surgery.Such allografts have also previously been used in the following repair and reconstructive surgical applications.
-Corneal perforations: Corneal trauma following an accident, surgery, or a persistent epithelial defect post a corneal ulcer
-Corneal descemetocele: A rare but grave result of progressive corneal ulceration causing herniation of the corneal descemet membrane.
-Ocular Surface Squamous Neoplasia (OSSN): A common ocular surface malignancy that can range from mild epithelial dysplasia to invasive squamous carcinoma. - Case Studies
Here is a case study showcasing how AmnioPlast THICK was used as a patch graft for tectonic support of Glaucoma Drainage Device.
Congenital Glaucoma | Support for Glaucoma Drainage Device | 2 Year 10 month old Female
Outcome: Regular follow up (monthly) was done and after 2 years, no shunt tube exposure was observed. - Application Procedure
Here is a case study showcasing how AmnioPlast THICK was used as a patch graft for tectonic support of Glaucoma Drainage Device.
Step 1: Unpacking:
Unpack the outer and inner cover carefully maintaining sterility.
Step 2: 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.
Step 3: 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. 
Step 4: Glued or Sutured:
Post resizing, the AM is moistened 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, licenced by NOTTO (National Organ and Tissue Transplantion Organization) and ISO/IEC 27001:2013 & ISO 9001:2015 certified.
Quality Assurance
Designed and developed by strictly adhering to Good Manufacturing Practices (GMP) & Good Tissue Practices (GTP) protocols.
Dr. Tanya Malhotra
Motherhood, Bengaluru
Dr. Tanya Malhotra
Motherhood, Bengaluru
Dr. Tanya Malhotra
Motherhood, Bengaluru
Dr. Tanya Malhotra
Motherhood, Bengaluru
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.
Yes, the products should be stored in a clean, dry environment at ambient room temperature (15-30C). 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.
AmnioPlast THICK is made up of the fetal umbilical cord lining cells that are known to be immunologically priviliged in nature. This means, it will be able to tolerate the introduction of antigens without inducing an inflammatory response response.
Application techniques may vary depending on the indications. For further details, please refer to our section on application instructions.
Yes, both AmnioPlast I, II, and THICK function in a similar manner. However, AmnioPlast THICK is the best choice when a thicker graft and tectonic support is necessary, especially in patients with deeper defects such as descemetoceles, perforations, and scleral melts.
The thickness, post-operative outcomes like function & cosmesis, ease of handling, and cost-effectiveness of AmnioPlast THICK are some important characteristics that make it a feasible alternative for ocular surface reconstructions.
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