{"id":9662,"date":"2021-10-11T21:14:31","date_gmt":"2021-10-11T21:14:31","guid":{"rendered":"https:\/\/usleadnetwork.net\/phwellness\/?p=9662"},"modified":"2021-10-11T21:14:31","modified_gmt":"2021-10-11T21:14:31","slug":"fda-361-compliant-whartons-jelly-umbilical-cord-allograft-is-available","status":"publish","type":"post","link":"https:\/\/usleadnetwork.net\/phwellness\/fda-361-compliant-whartons-jelly-umbilical-cord-allograft-is-available\/","title":{"rendered":"FDA 361 Compliant Wharton\u2019s Jelly Umbilical Cord Allograft is Available"},"content":{"rendered":"<p style=\"text-align: center;\"><a href=\"https:\/\/rebellabiologic.com\/product\/rebellawj\/\">FDA 361 Compliant Umbilical Cord Wharton&#8217;s Jelly Allograft Tissue<\/a><\/p>\n<p>Umbilical cord allograft tissue made with Wharton&#8217;s Jelly can be compliant with current FDA 361 regulations. While many doctors\/clinics using autologous bone marrow or adipose tissue would like you to believe none of it is compliant, it&#8217;s simply not true. (They say that falsely for competitive reasons.<\/p>\n<p><img loading=\"lazy\" decoding=\"async\" class=\"aligncenter size-full wp-image-9664\" src=\"https:\/\/usleadnetwork.net\/phwellness\/wp-content\/uploads\/2021\/10\/iStock-1288913695.jpg\" alt=\"umbilical cord allograft tissue FDA compliant\" width=\"728\" height=\"480\" data-id=\"9664\" \/><\/p>\n<p style=\"text-align: center;\"><span style=\"font-size: 14pt;\"><strong>FDA Definition of Minimal Manipulation Tissue<\/strong><\/span><\/p>\n<p>When it comes to regenerative allograft tissue, the FDA has two regulatory categories. One of these categories is termed \u201cminimal manipulation\u201d. What does that mean? Well the FDA divides it into 2 definitions:<\/p>\n<p>1) For structural tissue, processing that does not alter the original relevant characteristics of the tissue relating to the tissue\u2019s utility for reconstruction, repair, or replacement;<\/p>\n<p>2) For cells or nonstructural tissues, processing that does not alter the relevant biological characteristics of cells or tissues<\/p>\n<p>Along with the FDA\u2019s verbiage on minimal manipulation compliance, they have also stated, \u201cTissues that physically support or serve as a barrier or conduit, or connect, cover, or cushion in the donor are generally considered structural tissues for the purposes of determining the applicable regulatory definition. \u201c<\/p>\n<p>Examples of structural tissues include:<\/p>\n<ul>\n<li>Bone;<\/li>\n<li>Skin;<\/li>\n<li><strong>Amniotic membrane and umbilical cord;<\/strong><\/li>\n<li>Blood vessel;<\/li>\n<li>Adipose tissue;<\/li>\n<li>Articular cartilage;<\/li>\n<li>Non-articular cartilage; and<\/li>\n<li>Tendon or ligament.<\/li>\n<\/ul>\n<p>Please note that the FDA included \u201cumbilical cord\u201d in its definition of tissue that may fall into the minimal manipulation category. Processing umbilical cord tissue so that it continues to serve its structural support function is important. The FDA is clear that various enzymes should be avoided, along with expanding \u201cculturing\u201d the product.<\/p>\n<p>To complete this section, ReBellaWJ does fit the criteria for a minimally manipulated product. The processing is performed very carefully, and the result is a tissue that performs an amazing structural support function.<\/p>\n<p><img loading=\"lazy\" decoding=\"async\" class=\"aligncenter size-full wp-image-9663\" src=\"https:\/\/usleadnetwork.net\/phwellness\/wp-content\/uploads\/2021\/10\/iStock-96656092-1.jpg\" alt=\"FDA 361 whartons jelly tissue\" width=\"724\" height=\"483\" data-id=\"9663\" \/><\/p>\n<p>The second criteria is that a minimal manipulation product be used in a \u201chomologous\u201d fashion. Initially one might think of \u201chomologous\u201d as meaning being used in the same species. But that would be incorrect! The same species part is already assumed, and the FDA definition of homologous use is \u201chaving the same function in the recipient as it had in the donor.\u201d<\/p>\n<p>So if one looks at the function of the umbilical cord in the donor, a significant function is to provide structural support with protection, cushioning and lubrication. When a minimal manipulation umbilical cord tissue is used in a soft tissue or joint procedure, the function is the same! By providing this function, pain can be dramatically relieved in patients.<\/p>\n<p>This is referred to as being an FDA 361 compliant product. If the product does not fit that criteria, it becomes an FDA 351 product, and is regulated as a drug.<\/p>\n<p>As a primary function, homologous use needs to be maintained. In addition, the FDA states that the tissue can also have a secondary local metabolic effect, but not a systemic effect. What does this mean? Without delving too much into basic science, what it means is that it is fine if the umbilical cord tissue has cytokines, growth factors, exosomes and stem cells which produce a local metabolic function.<\/p>\n<p>So all of the companies that mention if umbilical cord tissue has live cells then it\u2019s automatically a \u201cdrug\u201d, are wrong. Having live cells and other elements is fine as long as they are not producing the primary structural support function.<\/p>\n<p><img loading=\"lazy\" decoding=\"async\" class=\"aligncenter size-full wp-image-9667\" src=\"https:\/\/usleadnetwork.net\/phwellness\/wp-content\/uploads\/2021\/10\/bPPt_ZsA.jpeg\" alt=\"umbilical cord wharton's jelly supplier\" width=\"2541\" height=\"914\" data-id=\"9667\" \/><\/p>\n<p>The FDA has made this very clear. What they have also published are examples of usage that do not constitute homologous use. For example, using a <a href=\"https:\/\/rebellabiologic.com\/\">Wharton\u2019s Jelly product<\/a> systemically to assist with cerebral palsy is not structural, but more in having a systemic effect. So one needs to look at each case use.<\/p>\n<p style=\"text-align: center;\"><span style=\"font-size: 14pt;\"><strong>In conclusion, ReBellaWJ is a minimal manipulation product that has plenty of options for homologous use in clinical situations. To order, contact Regen Suppliers today at (888) 568-6909 or email <a href=\"mailto:sales@regensuppliers.com\">sales@regensuppliers.com<\/a> today.<\/strong><\/span><\/p>\n","protected":false},"excerpt":{"rendered":"<p>FDA 361 Compliant Umbilical Cord Wharton&#8217;s Jelly Allograft Tissue Umbilical cord allograft tissue made with Wharton&#8217;s Jelly can be compliant with current FDA 361 regulations. While many doctors\/clinics using autologous bone marrow or adipose tissue would like you to believe none of it is compliant,&#8230;<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[81],"tags":[567,568,569],"class_list":["post-9662","post","type-post","status-publish","format-standard","hentry","category-umbilical-cord-stem-cells","tag-fda-compliant-umbilical-cord-tissue","tag-umbilical-cord-allograft-tissue","tag-whartons-jelly-allograft"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v20.8 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>FDA 361 Compliant Wharton\u2019s Jelly Umbilical Cord Allograft is Available - R3 Stem Cell<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/usleadnetwork.net\/phwellness\/fda-361-compliant-whartons-jelly-umbilical-cord-allograft-is-available\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"FDA 361 Compliant Wharton\u2019s Jelly Umbilical Cord Allograft is Available - R3 Stem Cell\" \/>\n<meta property=\"og:description\" content=\"FDA 361 Compliant Umbilical Cord Wharton&#8217;s Jelly Allograft Tissue Umbilical cord allograft tissue made with Wharton&#8217;s Jelly can be compliant with current FDA 361 regulations. 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