AmnioPlast2
DEHYDRATED BILAYERED HUMAN
AMNION CHORION MEMBRANE
ALLOGRAFT
A Biological Ocular Bandage
Product Overview
AmnioPlast 2 TM is a minimally processed, dehydrated, non-viable, bilayered human amnion chorion membrane allograft. Its potent proteins and specialty growth factors offer a barrier membrane that enhances the healing process.
Technical Overview
Thickness
60
Microns Not less than
Tensile Strength
0.25
Not less than
Moisture Content
15%
Not more than
Shelf Life
1.5
Year
Unique Properties
- A natural skin substitute derived from the human placenta
- Acts as a biological barrier membrane
- Rich in multiple extracellular matrix proteins
- Contains more than 200 cytokines, chemokines and growth factors present in the human placental tissue
- Provides a matrix and retains biological activities that support cell proliferation and migration
- Non-immunogenic
- Ready-to-use and easy-to-handle
- Bio-absorbable
- Does not require thawing
- Ability to modulate inflammation, enhance wound healing and reduce pain and scar tissue formation
Highlights of Our Products
Bioabsorbable
Sterile
Gamma irradiated
Simple, single-step rehydration
Longer shelf-life when stored at room temp
Single-use
Non-toxic and not absorbed systemically
Do not require refrigeration or thawing
Effective on infected and non-infected wounds
Bioabsorbable
Intended Use
It is intended for use as a biological ocular bandage or barrier applied to the ocular surface following
repair or reconstruction procedures in the treatment of ocular surface disorders and/or abnormalities
including
- Fornix reconstruction
- Symblepharon
- Vast pterygium excision
- Large corneal perforations
- Stevens Johnson Syndrome
- Deep corneal ulcers
- Ocular surface squamous neoplasia
Available Sizes
- 3.0x3.0 cm2
- 2.0x1.5 cm2
- 1.5x1.5 cm2
- 1.0x1.0 cm2
- 3.0x3.0 cm2
Case Studies
Case
01
A 62 years old male patient with a chronic non healing diabetic foot ulcer in the plantar aspect of the base of the great toe. AmchoPlast is applied to the patient after the treatment with standard of care and surgical debridement
Case
02
A 49 years old male patient with chronic non healing venous ulcer on the gaiters area of the lateral aspect of the left leg. AmchoPlast has been applied on the wounded area after surgical debridement and standard of care as the initial treatment
Case
03
A 52 years old male patient with a non healing diabetic foot ulcer on the medial aspect of the mid foot. AmchoPlast is applied after the standard of care and surgical debridement of the wound.
Quality Assurance
The procured tissues are aseptically processed from donated human tissue according to current Good Tissue Practices (cGTP) and Good Manufacturing Practices (cGMP) regulations established by the CDSCO, D&C Act and Rules 1945, and Transplantation of Human Organs Act Rules 2014. In addition, each package is subjected to stringent quality control checks based on national and international quality standards including sterility test, ball burst test, BCA protein assay, and moisture content test.
Accreditations & Certifications
USFDA Human Cells, Tissues, and Cellular and Tissue-Based Products Establishment Registration
American Association of Tissue Banks (AATB) Certification
College of American Pathologists (CAP) Accreditation
- Head Office-Chennai
- Site 1-Gurgaon
- Collection, Processing, Testing, Storage and release of Human Umbilical Cord Blood for purpose of Human Transplantation
- Acquisition, Processing, Testing, Storage and release of Human Placental Tissues
National Organ and Tissue Transplant Organization Registration ( NOTTO)
Umbilical Cord Blood Stem Cells License, Drug Controller General of India ( DCGI )
Information Standard for Blood and Transplant (ISBT) 128
- Collection, Processing, Testing, Storage and release of Human Umbilical Cord Blood Stem Cells for Transplantation
- Development, Donor Eligibility, Assessment and Informed Consent, Acquisition, Processing, Testing, Storage and Distribution of HUman Birth Tissue for Transplantation
Frequently Asked Questions
Any wound that fails to respond to treatment even after four weeks or remains unhealed entirely in two months is regarded as a chronic wound. A chronic wound is often found to be further complicated due to underlying conditions like diabetes, circulation problems etc. due to the interruption of the body’s natural healing process. Some of the common chronic wound conditions include diabetic foot ulcers, venous ulcers, surgical site injuries, burn injuries and pressure ulcers.
Chronic, non-healing wounds can be debilitating for the affected individual and its management has become a major therapeutic challenge throughout the world. At present, moist dressings, debridement, infection control, and wound offloading are standard therapies to treat diabetic ulcers.
Antibiotics often fail to ‘cure’ an ulcer, although this might be because the systemic and/or topical delivery of antibiotics fails to reach the microbes owing to poor circulation and/or biofilm barriers.
Advanced therapies, such as bioengineered skin grafts, have been shown to accelerate wound closure, thereby resulting in a more consistent and faster wound healing compared with standard treatments.
Prior to donation, the donor’s medical and social history are screened for medical conditions or diseases that would contraindicate the donation of tissues in accordance with current policies and procedures approved by LifeCell. Donor blood samples taken at the time of collection are tested negative/non -reactive for relevant communicable and infectious disease agents at LifeCell International, which has requisite national and/or international accreditations.
- 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)
Are your products ready-to-use?
No, each product is for single use only.
Each product is for single patient use only.
The products can be stored in a clean, dry environment at ambient room temperature (15-30C). There is no need for refrigeration or freezing.
Shelf-life of each of the products vary. You may please refer to the Technical Overview for more details.
No, our products do not contain any live cells.
No, our products are non-immunogenic.
Yes, application techniques differ for products. For further details, please refer to the Product Brochure.
Depending on the severity of the wound and prescribed therapy or treatment, the number of applications may vary. Please talk to your doctor for further details.
Yes, our product can be used as an adjunct with other wound care therapies including VAC & NPWT.
Yes, our product can be used for both chronic and acute wounds.
Proprietary processing and validated sterilization methods are employed to eliminate potential deleterious components of the allograft. However with biological implants, the possibility of rejection still exists.
Possible significant adverse events may include microbial infection and transmission of viral disease. In addition, the product should be used with caution in patients with a known intolerance towards Ofloxacin, Vancomycin, and Amphotericin B antibiotics.
Yes, our product can be used at home under clinician’s directed supervision.