Esano ACA™
Esano ACA is a dehydrated amniotic/chorionic/amniotic membrane sheet designed to aid in wound management. It is composed of three layers: amnion, chorion, and amnion, providing enhanced rigidity and flexibility.
Key Features:
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Protective Covering: Provides a protective barrier for wound management.
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Non-Specific Orientation: Can be applied in any orientation, making it easy to position and reposition.
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Tensile Strength: Enhanced tensile strength ensures adherence and easy application.
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Versatility: Can be used in both hydrated and dehydrated states.
Clinical Efficacy: Esano ACA is intended for the repair, reconstruction, replacement, or supplementation of injured tissue. It retains important structural proteins and ECM biochemicals naturally present in placental tissue, promoting healing and regeneration. Research indicates the use of amniotic membrane derivatives like Esano ACA has a high success rate, with 86% to 90% efficacy in treating chronic wounds.
AmnioAMP-MP™
AmnioAMP-MP™ is a dual-layer, dehydrated human amnion membrane allograft derived from the amniotic lining of the placenta. It is chorion-free and processed using minimally manipulated techniques to retain the native extracellular matrix (ECM) qualities. The graft is designed to provide a protective barrier for soft tissue wounds.
Key Features:
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Quality and Safety: Processed in accordance with FDA regulations and AATB standards. The amniotic tissue is recovered from healthy mothers post full-term delivery.
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Storage and Application: Requires no up-front preparation and can be stored at ambient temperatures. It can be applied on either side of the graft and quickly hydrates in situ.
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Sterilization: E-Beam sterilization provides a sterility assurance level (SAL) of 10-6.
Clinical Efficacy: AmnioAMP-MP™ has been documented to protect diabetic ulcers, venous ulcers, pressure ulcers, burns, and other dermal ulcerations. The amniotic membrane’s therapeutic potential includes anti-inflammatory effects, reduced scarring, and enhanced epithelization. Studies indicate a high treatment efficacy, with 86% to 90% success rates in chronic wound healing.
Growth Factors and Proteins:
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Growth factors: EGF, bFGF, KGF, PDGF, VEGF, TGF-beta 1 and -beta 3, HGF, TIMP/MMP, NGAL.
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Proteins: Collagen I, III, IV, V, and VII, Elastin, Fibronectin, Laminin.
Innovation in Biologics
1. DONOR SCREENING CellGenuity only utilizes gestationally derived biologics from healthy consenting mothers who have delivered a full term healthy baby during a scheduled, elective Cesarean Section. All donors are subject to strict regulatory and quality assurance compliance, medical and social history screening, informed consent, and medical records history review.
2. TESTING Donor blood samples taken prior to or at the time of recovery were tested by laboratories certified under the Clinical Laboratory Improvement Amendments (CLIA) and were found negative using FDA required tests for: HBsAg: Hepatitis B Surface Antigen HBcAb: Hepatitis B Core Antibody HCVAb: Hepatitis C Antibody HIV 1/2/Ab: Human Immunodeficiency Virus Types 1/2 and O Antibody HCV NAT: Hepatitis C Virus HIV NAT: Human Immunodeficiency Virus HBV NAT: Hepatitis B Virus RPR/STS or Equivalent: Syphilis
3. COLLECTION/PROTECTION Donor tissue is recovered using the safest recovery techniques and sterile equipment to protect from contamination. Our careful multi-step “DAY-ONE” process, carefully collects, preserves and protects the native proteins and the gestational tissue maintains the tissue’s regenerative properties while expediting delivery.
4. TRANSPORTATION Donated tissue is immediately transported to the lab for processing following our careful collection processes. To comply with 21 CFR 1271.290 requirements, a Tissue Tracking/Transplant Record (TTR) is maintained to record chain-of-custody of every allograft. We record the patient information, the transplant facility name and address, the allograft tissue information and comments regarding tissue use on the TTR.
5. DAY-ONE LAB Timing matters. Our production lab begins processing immediately upon receiving the donated tissue to preserve integrity of the tissue. We maintain a highly controlled regulatory and quality assured processing environment with strict recovery techniques and sterile equipment to counter the risks of disease transmission at every step. Allografts meet the FDA’s stringent standards for minimally manipulated tissue.
6. QUALITY ASSURANCE All screening and testing results are reviewed according to the company’s quality management system, which is designed to meet the requirements specified in the FDA’s Good Tissue Practice regulations and in the standards of the American Association of Tissue Banks. All donor screening and testing records are reviewed and accepted by QA personnel. Only tissue from donors with approved test results are released. All policies and procedures for donor screening, serologic, and microbiologic testing comply with all current standards and regulations established by the FDA. There have been no reported adverse reactions associated with any CellGenuity products.
