{"id":15836,"date":"2017-08-17T09:11:20","date_gmt":"2017-08-17T09:11:20","guid":{"rendered":"http:\/\/r3stemcell.com\/amniotic-membrane-allograft\/?page_id=15836"},"modified":"2024-11-11T12:43:31","modified_gmt":"2024-11-11T12:43:31","slug":"regulatory-and-safety","status":"publish","type":"page","link":"https:\/\/r3stemcell.com\/amniotic-membrane-allograft\/products\/regulatory-and-safety\/","title":{"rendered":"Regulatory and Safety"},"content":{"rendered":"<p>[vc_row css_animation=&#8221;&#8221; row_type=&#8221;row&#8221; use_row_as_full_screen_section=&#8221;no&#8221; type=&#8221;full_width&#8221; angled_section=&#8221;no&#8221; text_align=&#8221;left&#8221; background_image_as_pattern=&#8221;without_pattern&#8221;][vc_column][vc_empty_space][vc_row_inner row_type=&#8221;row&#8221; type=&#8221;full_width&#8221; text_align=&#8221;left&#8221; css_animation=&#8221;&#8221; el_class=&#8221;contact_form&#8221;][vc_column_inner width=&#8221;2\/3&#8243;][vc_column_text]<\/p>\n<h2 style=\"text-align: center;\">Regulatory Information<\/h2>\n<p>&nbsp;<\/p>\n<p><img loading=\"lazy\" decoding=\"async\" class=\"alignleft size-medium wp-image-16067\" src=\"http:\/\/r3stemcell.com\/amniotic-membrane-allograft\/wp-content\/uploads\/2017\/08\/Vendaje-image2-194x300.png\" alt=\"\" width=\"194\" height=\"300\" srcset=\"https:\/\/r3stemcell.com\/amniotic-membrane-allograft\/wp-content\/uploads\/2017\/08\/Vendaje-image2-194x300.png 194w, https:\/\/r3stemcell.com\/amniotic-membrane-allograft\/wp-content\/uploads\/2017\/08\/Vendaje-image2-768x1185.png 768w, https:\/\/r3stemcell.com\/amniotic-membrane-allograft\/wp-content\/uploads\/2017\/08\/Vendaje-image2-664x1024.png 664w, https:\/\/r3stemcell.com\/amniotic-membrane-allograft\/wp-content\/uploads\/2017\/08\/Vendaje-image2-700x1080.png 700w, https:\/\/r3stemcell.com\/amniotic-membrane-allograft\/wp-content\/uploads\/2017\/08\/Vendaje-image2.png 805w\" sizes=\"auto, (max-width: 194px) 100vw, 194px\" \/>Vendaje products are processed from human tissue according to FDA Current Good Tissue Processing (CGTP) standards, and is regulated as a human cell, tissue, or cellular or tissue-based product (HCT\/P) under Section 361 of the Public Health Service Act.<\/p>\n<p>&nbsp;<\/p>\n<p>Vendaje products are minimally manipulated, dehydrated, non-viable cellular amniotic membrane allografts that contain multiple extracellular matrix proteins, growth factors, cytokines and other specialty proteins present in amniotic tissue to provide a barrier membrane that enhances healing.<\/p>\n<p>&nbsp;<\/p>\n<p>Vendaje products may be stored at ambient conditions for up to 5 years. With a variety of sizes available,<strong> Vendaje offers<\/strong> size-appropriate grafts to minimize waste.<img loading=\"lazy\" decoding=\"async\" class=\"alignright size-medium wp-image-16069\" src=\"http:\/\/r3stemcell.com\/amniotic-membrane-allograft\/wp-content\/uploads\/2017\/08\/Vendaje-image1-300x208.png\" alt=\"\" width=\"300\" height=\"208\" srcset=\"https:\/\/r3stemcell.com\/amniotic-membrane-allograft\/wp-content\/uploads\/2017\/08\/Vendaje-image1-300x208.png 300w, https:\/\/r3stemcell.com\/amniotic-membrane-allograft\/wp-content\/uploads\/2017\/08\/Vendaje-image1-768x531.png 768w, https:\/\/r3stemcell.com\/amniotic-membrane-allograft\/wp-content\/uploads\/2017\/08\/Vendaje-image1-700x484.png 700w, https:\/\/r3stemcell.com\/amniotic-membrane-allograft\/wp-content\/uploads\/2017\/08\/Vendaje-image1.png 853w\" sizes=\"auto, (max-width: 300px) 100vw, 300px\" \/><\/p>\n<p>&nbsp;<\/p>\n<p><strong>Our Amniotic<\/strong> Membrane Allograft:<\/p>\n<ul>\n<li>Enhances Healing<\/li>\n<li>Modulates Inflammation<\/li>\n<li>Reduces Scar Tissue Formation<\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<p><strong>Harvesting<\/strong><\/p>\n<p>&nbsp;<\/p>\n<p>The amniotic membrane products are harvested from live, healthy US based donors. These donors are consented and undergo a scheduled c-section procedure and have agreed to donate their amniotic fluid and placental tissue.<\/p>\n<p>&nbsp;<\/p>\n<p><strong>SCREENING &amp; TESTING<\/strong><\/p>\n<p><strong><br \/>\n<\/strong>All donated tissues are determined to be suitable for transplantation by a licensed physician, Medical Director of the Tissue Bank. Prior to processing, serological and microbial testing is performed.<\/p>\n<p>&nbsp;<\/p>\n<p>Communicable disease testing is performed by a laboratory that is registered with FDA and certified to perform testing on human specimens under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) and 42 CFR part 493, or equivalent requirements.<\/p>\n<p>&nbsp;<\/p>\n<ul>\n<li>Antibody to Human Immunodeficiency Virus 1 &amp; 2 (HIV 1 &amp; 2)<\/li>\n<li>Nucleic Acid Test for HIV-1 RNA<\/li>\n<li>Hepatitis B Virus (HBV) Surface Antigen<\/li>\n<li>Hepatitis B Virus (HBV) Core Antibody (Total)<\/li>\n<li>Nucleic Acid Test for HBV RNA<\/li>\n<li>Antibody to Hepatitis C Virus (HCV)<\/li>\n<li>Nucleic Acid Test for HCV RNA<\/li>\n<li>Antibody to Human T Cell Lymphotrophic Virus 1 &amp; 2 (HTLV 1 &amp; 2)<\/li>\n<li>Rapid Plasma Reagin (RPR) Screen, or Syphilis Treponemal Specific (STS) Test<\/li>\n<\/ul>\n<p>[\/vc_column_text][\/vc_column_inner][vc_column_inner el_class=&#8221;contact_form&#8221; width=&#8221;1\/3&#8243;][vc_column_text]Contact Us and We&#8217;ll Get Back to You ASAP to discuss!<\/p>\n<p>(844) GET-STEM[\/vc_column_text][vc_widget_sidebar sidebar_id=&#8221;Contact Form SIdebar New&#8221;][\/vc_column_inner][\/vc_row_inner][vc_empty_space][\/vc_column][\/vc_row]<\/p>\n","protected":false},"excerpt":{"rendered":"<p>[vc_row css_animation=&#8221;&#8221; row_type=&#8221;row&#8221; use_row_as_full_screen_section=&#8221;no&#8221; type=&#8221;full_width&#8221; angled_section=&#8221;no&#8221; text_align=&#8221;left&#8221; background_image_as_pattern=&#8221;without_pattern&#8221;][vc_column][vc_empty_space][vc_row_inner row_type=&#8221;row&#8221; type=&#8221;full_width&#8221; text_align=&#8221;left&#8221; css_animation=&#8221;&#8221; el_class=&#8221;contact_form&#8221;][vc_column_inner width=&#8221;2\/3&#8243;][vc_column_text] Regulatory Information &nbsp; Vendaje products are processed from human tissue according to FDA Current Good Tissue Processing (CGTP) standards, and is regulated as a human cell, tissue, or cellular or tissue-based&#8230;<\/p>\n","protected":false},"author":2,"featured_media":0,"parent":15711,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"footnotes":""},"class_list":["post-15836","page","type-page","status-publish","hentry"],"_links":{"self":[{"href":"https:\/\/r3stemcell.com\/amniotic-membrane-allograft\/wp-json\/wp\/v2\/pages\/15836","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/r3stemcell.com\/amniotic-membrane-allograft\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/r3stemcell.com\/amniotic-membrane-allograft\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/r3stemcell.com\/amniotic-membrane-allograft\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/r3stemcell.com\/amniotic-membrane-allograft\/wp-json\/wp\/v2\/comments?post=15836"}],"version-history":[{"count":9,"href":"https:\/\/r3stemcell.com\/amniotic-membrane-allograft\/wp-json\/wp\/v2\/pages\/15836\/revisions"}],"predecessor-version":[{"id":16251,"href":"https:\/\/r3stemcell.com\/amniotic-membrane-allograft\/wp-json\/wp\/v2\/pages\/15836\/revisions\/16251"}],"up":[{"embeddable":true,"href":"https:\/\/r3stemcell.com\/amniotic-membrane-allograft\/wp-json\/wp\/v2\/pages\/15711"}],"wp:attachment":[{"href":"https:\/\/r3stemcell.com\/amniotic-membrane-allograft\/wp-json\/wp\/v2\/media?parent=15836"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}