{"id":15113,"date":"2025-03-24T18:46:24","date_gmt":"2025-03-24T18:46:24","guid":{"rendered":"https:\/\/site.itshrt.com\/worldnews\/fda-approved-artificial-blood-vessel-stirs-concerns\/"},"modified":"2025-03-24T18:46:24","modified_gmt":"2025-03-24T18:46:24","slug":"fda-approved-artificial-blood-vessel-stirs-concerns","status":"publish","type":"post","link":"https:\/\/site.itshrt.com\/worldnews\/fda-approved-artificial-blood-vessel-stirs-concerns\/","title":{"rendered":"FDA-Approved Artificial Blood Vessel Stirs Concerns"},"content":{"rendered":"<p> <script async src=\"https:\/\/pagead2.googlesyndication.com\/pagead\/js\/adsbygoogle.js?client=ca-pub-6606220950177433\"\r\n     crossorigin=\"anonymous\"><\/script>\r\n<!-- ItShrt World News -->\r\n<ins class=\"adsbygoogle\"\r\n     style=\"display:block\"\r\n     data-ad-client=\"ca-pub-6606220950177433\"\r\n     data-ad-slot=\"1882483372\"\r\n     data-ad-format=\"auto\"\r\n     data-full-width-responsive=\"true\"><\/ins>\r\n<script>\r\n     (adsbygoogle = window.adsbygoogle || []).push({});\r\n<\/script>\r\n<br \/>\n<\/p>\n<div data-testid=\"companionColumn-0\">\n<div class=\"css-53u6y8\">\n<p class=\"css-at9mc1 evys1bk0\">When the biotech company Humacyte designed a study to see if its lab-grown blood vessel worked, it decided to measure whether blood was flowing freely through the high-tech tube 30 days after it was implanted in a person.<\/p>\n<p class=\"css-at9mc1 evys1bk0\">As those days passed, some of the 54 patients in the study ran into trouble. Doctors lost track of one. Four died. Four more had a limb amputated, including one who developed a clot and infection in the artificial vessel, Food and Drug Administration records show.<\/p>\n<p class=\"css-at9mc1 evys1bk0\">Humacyte, which is traded on the Nasdaq, counted all those patients as proof of success in talks with investors and in <a class=\"css-yywogo\" href=\"https:\/\/jamanetwork.com\/journals\/jamasurgery\/fullarticle\/2826564\" title=\"\" rel=\"noopener noreferrer\" target=\"_blank\">an article<\/a> in JAMA Surgery.<\/p>\n<p class=\"css-at9mc1 evys1bk0\">At the F.D.A., though, scientists counted the deaths, amputations and the lost case as failures, records show, noting a lack of information to determine if the vessels were clear.<\/p>\n<\/div>\n<aside class=\"css-ew4tgv\" aria-label=\"companion column\"\/><\/div>\n<div data-testid=\"companionColumn-1\">\n<div class=\"css-53u6y8\">\n<p class=\"css-at9mc1 evys1bk0\">Still, the agency approved the vessels in December without a public review of the study. Top officials authorized it over the concerns of staff members who said in F.D.A. records that they found the study severely lacking or were alarmed by the dire consequences for patients when the vessels fell apart.<\/p>\n<p class=\"css-at9mc1 evys1bk0\">Now the company is ramping up its marketing efforts to hospitals and for use on the battlefield.<\/p>\n<p class=\"css-at9mc1 evys1bk0\">When a patient\u2019s blood vessel is damaged, doctors typically find a blood vessel from another part of the body and graft it to repair blood flow. They turn to artificial vessels when patients are too badly injured to harvest a vein.<\/p>\n<p class=\"css-at9mc1 evys1bk0\">The Humacyte vessel is made from a mesh tube seeded with cells from the human heart. The cells grow over two months in a bioreactor, and at the end of the process, the human cells and genetic material are removed. A lab-grown tube, mostly made of collagen developed from the aortic cells, remains.<\/p>\n<p class=\"css-at9mc1 evys1bk0\">Before the vessel was approved, one F.D.A. medical <a class=\"css-yywogo\" href=\"https:\/\/static01.nyt.com\/newsgraphics\/documenttools\/7ab3180e6e96e0f3\/288ac88f-full.pdf\" title=\"\" rel=\"noopener noreferrer\" target=\"_blank\">reviewer pointed out<\/a> that 37 of the 54 patients were not assessed in a safety check four months after getting the implant, with many dead or lost to follow-up. \u201cThere is significant uncertainty regarding the safety and effectiveness of this product beyond 30 days,\u201d the F.D.A. report says.<\/p>\n<p class=\"css-at9mc1 evys1bk0\">Dr. Robert E. Lee, a vascular surgeon who cared for gunshot-wounded patients in Detroit for 30 years, retired in the fall from the F.D.A. in protest over the matter. In a review of more than 2,000 pages of company records conducted when he was an F.D.A. medical officer, Dr. Lee found that the vessel could rupture with no warning. Those events were \u201cunpredictable, catastrophic and life-threatening,\u201d he wrote in <a class=\"css-yywogo\" href=\"https:\/\/static01.nyt.com\/newsgraphics\/documenttools\/daef6ab012645497\/e5b079d2-full.pdf\" title=\"\" rel=\"noopener noreferrer\" target=\"_blank\">his F.D.A. review<\/a>, parts of which were made public weeks ago.<\/p>\n<\/div>\n<aside class=\"css-ew4tgv\" aria-label=\"companion column\"\/><\/div>\n<div data-testid=\"companionColumn-2\">\n<div class=\"css-53u6y8\">\n<p class=\"css-at9mc1 evys1bk0\">\u201cThat\u2019s an unacceptable risk for whatever slim benefit, if any, this product provides above the current standard treatments,\u201d Dr. Lee, who had been a reviewer at the agency since 2015, said in an interview. He noted that doctors currently use the patients\u2019 own vessel, if available, or tubes made of Gore-Tex. <\/p>\n<\/div>\n<aside class=\"css-ew4tgv\" aria-label=\"companion column\"\/><\/div>\n<div data-testid=\"companionColumn-3\">\n<div class=\"css-53u6y8\">\n<p class=\"css-at9mc1 evys1bk0\">An F.D.A. spokeswoman said the approval \u201cwas based on a careful evaluation of data from clinical trials that demonstrated a clinically meaningful benefit in restoring blood flow in the affected limb and ultimately limb salvage.\u201d<\/p>\n<p class=\"css-at9mc1 evys1bk0\">Humacyte is also developing a graft for patients with dialysis, for those undergoing cardiac bypass surgery and for infants with a heart-related birth defect.<\/p>\n<p class=\"css-at9mc1 evys1bk0\">Dr. Laura Niklason, one of the company\u2019s founders, said approval of the vessel, called Symvess, was a \u201cmilestone for regenerative medicine overall.\u201d<\/p>\n<\/div>\n<aside class=\"css-ew4tgv\" aria-label=\"companion column\"\/><\/div>\n<div data-testid=\"companionColumn-4\">\n<div class=\"css-53u6y8\">\n<p class=\"css-at9mc1 evys1bk0\">She had begun work to create the lab-grown vessels decades earlier. In its 20 years, the company had logged no sales and accrued more than $660 million in debt, <a class=\"css-yywogo\" href=\"https:\/\/www.sec.gov\/ix?doc=\/Archives\/edgar\/data\/0001818382\/000181838224000199\/huma-20240930.htm\" title=\"\" rel=\"noopener noreferrer\" target=\"_blank\">financial reports<\/a> show.<\/p>\n<p class=\"css-at9mc1 evys1bk0\">In an interview, Dr. Niklason said the disagreement over how to label the patient deaths and amputations as successes or failures arose after the company decided to count cases as failures only when it was certain that blood flow was cut off. The F.D.A. took a more conservative approach to calculating the success rate for the product, she said. \u201cRational people can disagree,\u201d she added.<\/p>\n<p class=\"css-at9mc1 evys1bk0\">The F.D.A. records do not indicate whether the problems with the vessels directly caused the deaths or amputations.<\/p>\n<p class=\"css-at9mc1 evys1bk0\">Dr. Niklason said that the company must use the agency numbers in marketing the product to clients but that it could present its more favorable figure to investment analysts. She also said <a class=\"css-yywogo\" href=\"https:\/\/jamanetwork.com\/journals\/jamasurgery\/fullarticle\/2826564\" title=\"\" rel=\"noopener noreferrer\" target=\"_blank\">the study<\/a> was published before the F.D.A. reached its decision.<\/p>\n<p class=\"css-at9mc1 evys1bk0\">B.J. Scheessele, the company\u2019s chief commercial officer, told investors this month that Humacyte was in talks with 26 hospitals to begin distribution. Mr. Scheessele also said the company was hoping to sell the vessels to the Defense Department for battlefield injuries. The U.S. Army gave Humacyte <a class=\"css-yywogo\" href=\"https:\/\/mtec-sc.org\/project-highlights\/mtec-members-human-acellular-vessel-hav-treats-injured-in-ukraine\/\" title=\"\" rel=\"noopener noreferrer\" target=\"_blank\">$6.8 million<\/a> in 2017, embracing the product as an option for wounded soldiers.<\/p>\n<\/div>\n<aside class=\"css-ew4tgv\" aria-label=\"companion column\"\/><\/div>\n<div data-testid=\"companionColumn-5\">\n<div class=\"css-53u6y8\">\n<p class=\"css-at9mc1 evys1bk0\">Each artificial vessel costs $29,500, and Mr. Scheessele said the company hoped to market several thousand each year in the United States.<\/p>\n<p class=\"css-at9mc1 evys1bk0\">Dr. Niklason said in an interview that her interest in engineering a blood vessel was twofold. As young doctor, she had observed that arterial disease was devastating.<\/p>\n<p class=\"css-at9mc1 evys1bk0\">She described an experience as a medical resident in the late 1990s watching a senior doctor make incision after incision in a patient\u2019s legs and arm, seeking a healthy vessel to use in a heart bypass surgery. She called the procedure \u201cbarbaric.\u201d<\/p>\n<p class=\"css-at9mc1 evys1bk0\">\u201cTo provide a new blood vessel for a patient who needs one, we usually have to rob Peter to pay Paul,\u201d she said.<\/p>\n<p class=\"css-at9mc1 evys1bk0\">Since Dr. Niklason first began meeting with the F.D.A. in 2015 about starting a trial in humans, the agency repeatedly found fault with the company\u2019s efforts to study the vessel\u2019s use. Its trial involved people suffering major trauma, such as gunshot or car crash injuries, took place in U.S. hospitals and in Israel. The participants had an average age of 30, and half were Black patients.<\/p>\n<\/div>\n<aside class=\"css-ew4tgv\" aria-label=\"companion column\"\/><\/div>\n<div data-testid=\"companionColumn-6\">\n<div class=\"css-53u6y8\">\n<p class=\"css-at9mc1 evys1bk0\">Humacyte also provided the vessels to doctors treating injured soldiers in Ukraine.<\/p>\n<p class=\"css-at9mc1 evys1bk0\">By Nov. 9, 2023, Dr. Niklason described results of the studies to investors on an earnings call in glowing terms. Initially, she said the rate of blood flow through the vessels at 30 days was 90 percent \u2014 beating existing products on the market.<\/p>\n<p class=\"css-at9mc1 evys1bk0\">And the results in Ukraine were \u201cremarkable,\u201d she said. \u201cWe\u2019re proud to be able to help our Ukrainian surgeon colleagues save life and limb in this wartime setting.\u201d<\/p>\n<p class=\"css-at9mc1 evys1bk0\">Over the ensuing months, though, reviewers at the F.D.A., including Dr. Lee, would examine the same studies and conclude that they did not look nearly as good.<\/p>\n<p class=\"css-at9mc1 evys1bk0\">As a vascular and general surgeon in Detroit, Dr. Lee had decades of experience with victims of gunshots, stabbings, car crashes and other accident victims who might receive such vessels.<\/p>\n<p class=\"css-at9mc1 evys1bk0\">He said he was alarmed by the account of a man in Ukraine who began bleeding at the site of his surgical wound eight days after the vessel was implanted. Doctors discovered a two-millimeter hole in the Humacyte vessel and repaired it with sutures, according to F.D.A. records. Four days later, the patient was bleeding again, requiring removal of the graft the next day. The review suggested that an infection could have played a role.<\/p>\n<\/div>\n<aside class=\"css-ew4tgv\" aria-label=\"companion column\"\/><\/div>\n<div data-testid=\"companionColumn-7\">\n<div class=\"css-53u6y8\">\n<p class=\"css-at9mc1 evys1bk0\">Of 71 cases that Dr. Lee examined for a safety review, seven people, or about 10 percent, experienced vessel failures that resulted in major bleeding, according to the F.D.A. review. Dr. Lee said that was unheard-of in his experience with Gore-Tex grafts.<\/p>\n<p class=\"css-at9mc1 evys1bk0\">\u201cPlastic arteries, they don\u2019t usually present with catastrophic hemorrhage, unexpected like this,\u201d Dr. Lee said. \u201cYou know the patients are sick,\u201d with a fever or other signs of an infection, he continued. \u201cYou know something\u2019s brewing, and you usually have time to take care of it.\u201d<\/p>\n<p class=\"css-at9mc1 evys1bk0\">Hoping to glean more information about the root cause of the mid-vessel blowouts \u2014 and to be sure doctors were aware of the possibility \u2014 Dr. Lee began seeking a public advisory hearing on the device.<\/p>\n<p class=\"css-at9mc1 evys1bk0\">Thomas Zhou, a biostatistician in the biologics division of the F.D.A., also flagged concerns from the U.S. arm of the study and the data from Ukraine.<\/p>\n<p class=\"css-at9mc1 evys1bk0\">\u201cNeither study met the usual criteria for an adequate and well-controlled trial,\u201d he wrote.<\/p>\n<p class=\"css-at9mc1 evys1bk0\">The study of 16 patients treated in Ukraine was retrospective and observational, meaning researchers could look back at a larger pool of data and select the best cases. It showed \u201climited support of efficacy,\u201d partly because the injuries were \u201cskewed to shrapnel injuries\u201d and not the devastating wounds typically seen on the battlefield, he said.<\/p>\n<\/div>\n<aside class=\"css-ew4tgv\" aria-label=\"companion column\"\/><\/div>\n<div data-testid=\"companionColumn-8\">\n<div class=\"css-53u6y8\">\n<p class=\"css-at9mc1 evys1bk0\">The U.S. study was \u201cpoorly conducted\u201d and underwent \u201cmultiple major changes\u201d during the trial, the statistical review said.<\/p>\n<p class=\"css-at9mc1 evys1bk0\">The records also show that F.D.A. scientists dismissed as successful the patient deaths and amputations, citing a lack of information or imaging studies.<\/p>\n<\/div>\n<aside class=\"css-ew4tgv\" aria-label=\"companion column\"\/><\/div>\n<div data-testid=\"companionColumn-9\">\n<div class=\"css-53u6y8\">\n<p class=\"css-at9mc1 evys1bk0\">As a result, the F.D.A. concluded that the vessel\u2019s success rate for that key study was 67 percent, rather than the company\u2019s 84 percent, F.D.A. records show. In comparison, artificial grafts already had blood flow rates of 82 percent, the review said.<\/p>\n<p class=\"css-at9mc1 evys1bk0\">The company also reported an 84 percent success rate at 30 days in <a class=\"css-yywogo\" href=\"https:\/\/jamanetwork.com\/journals\/jamasurgery\/fullarticle\/2826564\" title=\"\" rel=\"noopener noreferrer\" target=\"_blank\">an article published<\/a> in November in JAMA Surgery, which is widely read by surgeons. The article stated that the Humacyte vessel \u201cdemonstrates improved outcomes\u201d over other artificial vessels.<\/p>\n<\/div>\n<aside class=\"css-ew4tgv\" aria-label=\"companion column\"\/><\/div>\n<div data-testid=\"companionColumn-10\">\n<div class=\"css-53u6y8\">\n<p class=\"css-at9mc1 evys1bk0\">It also said the Symvess \u201cprovides benefits\u201d in \u201cinfection resistance.\u201d The F.D.A. review said there was no clinical evidence demonstrating that extra effect.<\/p>\n<p class=\"css-at9mc1 evys1bk0\">Dr. Lee failed to persuade top F.D.A. officials to hold a public advisory committee meeting where the study results could be discussed and reviewed by independent experts. The agency decided instead to send records to three external reviewers, who in turn identified failure of the Humacyte vessels \u201cas a serious risk,\u201d but added that \u201cthe appropriate patient population\u201d would benefit, according to documents.<\/p>\n<p class=\"css-at9mc1 evys1bk0\">In <a class=\"css-yywogo\" href=\"https:\/\/www.fda.gov\/news-events\/press-announcements\/fda-approves-first-acellular-tissue-engineered-vessel-treat-vascular-trauma-extremities\" title=\"\" rel=\"noopener noreferrer\" target=\"_blank\">announcing approval of the<\/a> graft on Dec. 20, Dr. Peter Marks, head of the biologics division, called the vessels \u201cinnovative products that offer potentially lifesaving benefits for patients with severe injuries.\u201d<\/p>\n<p class=\"css-at9mc1 evys1bk0\">But the product is accompanied by a black box warning \u2014 the agency\u2019s most serious \u2014 for failures that \u201ccan result in life-threatening hemorrhage.\u201d The F.D.A. also is requiring the company to continue reporting safety data.<\/p>\n<p class=\"css-at9mc1 evys1bk0\">Dr. Hooman Noorchashm, co-director of the Amy J. Reed Medical Device Safety Collaborative at Northeastern School of Law, said the F.D.A. should not have approved a product that its scientists deemed inferior to existing options.<\/p>\n<\/div>\n<aside class=\"css-ew4tgv\" aria-label=\"companion column\"\/><\/div>\n<div data-testid=\"companionColumn-11\">\n<div class=\"css-53u6y8\">\n<p class=\"css-at9mc1 evys1bk0\">\u201cIf the graft falls apart,\u201d he said, or if it disconnects to where it is attached to the vessel, \u201cit is basically akin to the patient getting shot.\u201d<\/p>\n<p class=\"css-at9mc1 evys1bk0\">Dr. Lee said he hoped the F.D.A., with new leadership under the Trump administration, would still hold a public meeting.<\/p>\n<p class=\"css-at9mc1 evys1bk0\">\u201cEvery surgeon who uses it needs to see the things that I did,\u201d he said.<\/p>\n<\/div>\n<aside class=\"css-ew4tgv\" aria-label=\"companion column\"\/><\/div>\n<p><script async src=\"https:\/\/pagead2.googlesyndication.com\/pagead\/js\/adsbygoogle.js?client=ca-pub-6606220950177433\"\r\n     crossorigin=\"anonymous\"><\/script>\r\n<!-- ItShrt World News -->\r\n<ins class=\"adsbygoogle\"\r\n     style=\"display:block\"\r\n     data-ad-client=\"ca-pub-6606220950177433\"\r\n     data-ad-slot=\"1882483372\"\r\n     data-ad-format=\"auto\"\r\n     data-full-width-responsive=\"true\"><\/ins>\r\n<script>\r\n     (adsbygoogle = window.adsbygoogle || []).push({});\r\n<\/script>\r\n<br \/>\n<br \/><a href=\"https:\/\/www.nytimes.com\/2025\/03\/24\/health\/fda-artificial-blood-vessel-trauma-humacyte.html\">Source link <\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>When the biotech company Humacyte designed a study to see if its lab-grown blood vessel worked, it decided to measure<\/p>\n","protected":false},"author":1,"featured_media":15114,"comment_status":"","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[38],"tags":[4802,4187,2751,934,164,232,4804,4803,99,2503,219,268,639,400,168,409,162],"class_list":["post-15113","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-science","tag-amputation","tag-biotechnology-and-bioengineering","tag-blood","tag-clinical-trials","tag-defense-department","tag-food-and-drug-administration","tag-humacyte","tag-implants","tag-israel","tag-medical-devices","tag-regulation-and-deregulation-of-industry","tag-research","tag-surgery-and-surgeons","tag-ukraine","tag-united-states","tag-united-states-army","tag-united-states-defense-and-military-forces"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v24.2 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>FDA-Approved Artificial Blood Vessel Stirs 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