When the Biotechnological company Humacyte designed a study to see if its blood vessel raised in the laboratory worked, she decided to measure if the blood flowed freely through the high -tech tube 30 days after it was implanted in a person.
With the passage of those days, some of the 54 patients in the study came across trouble. The doctors have lost the trace of one. Four are dead. Four others had an amputated limb, including one who developed a clot and an infection in the artificial ship records, Food and Drug Administration Records.
Humacyte, which is exchanged on Nasdaq, considered all those patients as proof of success in talks with investors and in an article on Jama surgery.
At the FDA, however, scientists counted the dead, amputations and the case lost as failures, show the registers, noting a lack of information to determine if the ships were clear.
However, the agency approved ships in December without a public review of the study. The best officials authorized him for the concerns of the staff members who declared in the registers of the FDA that they had found the study seriously lacking or were alarmed by the terrible consequences for patients when the ships fell into pieces.
Now the company is increasing its marketing efforts to hospitals and for use on the battlefield.
When the blood vessel of a patient is damaged, doctors generally find a blood vessel from another part of the body and grafts it to repair blood flow. They turn to artificial vessels when patients are too seriously injured to collect a vein.
The Umocyte vase is made by a mesh tube sown with human heart cells. Cells grow for two months in a biorettor and at the end of the process human cells and genetic materials are removed. There remains a tube grown in the laboratory, mostly made of collagen developed by aortic cells.
Before the ship was approved, a medical auditor of the FDA stressed that 37 of the 54 patients were not evaluated in a safety check four months after obtaining the system, with many deaths or lost at follow-up. “There is a significant uncertainty regarding the safety and effectiveness of this product over 30 days,” says the report of the FDA.
Dr. Robert E. Lee, a vascular surgeon who took care of patients wounded by firearm in Detroit for 30 years, retired in the autumn by the FDA to protest against the matter. In a review of over 2,000 pages of the company’s registers conducted when he was a medical officer of the FDA, dr. Lee discovered that the ship could break without notice. Those events were “unpredictable, catastrophic and dangerous for life”, wrote in his review of the FDA, parts of which they were made public weeks ago.
“This is an unacceptable risk for any subtle benefit, if present, this product provides current standard treatments,” said Dr. Lee, who had been the auditor at the agency since 2015, in an interview. He observed that doctors currently use the patient ship, if available, or tubes made of gore-text.
A spokesperson for the FDA stated that the approval “is based on a careful evaluation of the data from clinical studies that have shown a clinically significant benefit in restoring the bloodstream in the interested limb and in the end the rescue of the limbs”.
Humacyte is also developing a graft for dialysis patients, for those who are subjected to cardiac bypass surgery and for children with a heart -related birth defect.
Dr. Laura Niklason, one of the company founders, said that the approval of the ship, called Symvess, was a “milestone for regenerative medicine in general”.
He had started working to create ships grown in the laboratory decades earlier. In its 20 years, the company had not recorded sales and matured over 660 million dollars of debt, they show financial relations.
In an interview, dr. Niklason said that the disagreement on how to label the patient’s deaths and amputations as successes or failures arose after the society decided to count cases as failures only when it was certain that the bloodstream had been interrupted. The FDA has adopted a more conservative approach to calculating the success rate for the product, said. “Rational people may not agree,” he added.
The registers of the FDA do not indicate whether the problems with ships have directly caused the deaths or amputations.
Dr. Niklason said that the company must use the number of product marketing numbers to customers, but that it could present its most favorable figure to investment analysts. He also said the study was published before the FDA made its decision.
BJ Schessele, the company’s Chief Commercial Officer, told investors this month that Humyte was in negotiations with 26 hospitals to start distribution. Schessele also said that the company hoped to sell ships to the defense department for accidents on the battlefield. The American army gave Humyte $ 6.8 million in 2017, embracing the product as an option for injured soldiers.
Each artificial ship costs $ 29,500 and Schessele said that the company hoped to market several thousand thousands every year in the United States.
Dr. Niklason said in an interview that his interest in engineering of a blood ship was twofold. As a young doctor, he had observed that arterial disease was devastating.
He described an experience as a doctor resident in the late 90s to look at a senior doctor to engrave after the engraving in the legs and arm of a patient, looking for a healthy ship to be used in a cardiac bypass surgery. Defined the “Barbaric” procedure.
“To provide a new blood vessel for a patient who needs it, we usually have to rob Peter to pay Paul,” he said.
Since Dr. Niklason began to meet with the FDA in 2015 on the start of a process for man, the agency has repeatedly found defects in the company’s efforts to study the use of the ship. His trial involved people who suffer from important trauma, such as wounded on firearm or fire injuries, in US hospitals and Israel. Participants had an average age of 30 years and half were black patients.
Humacyte also provided ships to doctors who treat soldiers injured in Ukraine.
By November 9, 2023, Dr. Niklason described the results of the studies to investors in a gain call in brilliant terms. Initially, he said that the blood flow rate through the 30 -day ships was 90 percent, beating the products existing on the market.
And the results in Ukraine were “remarkable,” he said. “We are proud to be able to help our Ukrainian surface colleagues save life and limb in this environment in war.”
During the following months, however, the Auditors of the FDA, including Dr. Lee, would examine the same studies and concluded that they did not seem as good.
As a vascular and general surgeon in Detroit, Dr. Lee has had decades of experience with victims of firearms, stabbing, car accidents and other victims of accidents that could receive such ships.
He said he was alarmed by the report of a man in Ukraine who started bleeding on the website of his surgical wound eight days after the ship system. The doctors discovered a hole of two millimeters in the Umbeyte ship and repaired it with sutures, according to the FDA records. Four days later, the patient bleed again, requesting the removal of the year the next day. The review suggested that an infection could have played a role.
Of the 71 cases that Dr. Lee examined a revision of security, seven people, or about 10 percent, had the shipments of the ship that led to important bleeding, according to the review of the FDA. Dr. Lee said that he was unheard of in his experience with Gore-Tex grafts.
“Plastic arteries, usually do not present themselves with catastrophic hemorrhage, unexpected in this way,” said dr. Lee. “You know that patients are sick”, with fever or other signs of infection, he continued. “You know that something is preparing and usually you have time to take care of it.”
Hoping to collect more information on the main cause of medium-sized outbursts to be sure that the doctors were aware of the possibility-the Dr. Lee started looking for a public consultancy audience on the device.
Thomas Zhou, biostatistica in the biological division of the FDA, has also reported the concerns of the United States arm of the study and data from Ukraine.
“Neither studies satisfied the usual criteria for an adequate and well controlled study,” he wrote.
The study of 16 patients treated in Ukraine was retrospective and observational, which means that researchers could look back at a wider pool of data and select the best cases. He showed “limited support for effectiveness”, in part because the lesions have been “distorted for the wounds by Shrapnel” and not the devastating wounds generally seen on the battlefield, he said.
The United States study was “scarcely conducted” and suffered “multiple changes” during the process, said the statistical review.
The registers also show that the FDA scientists have rejected the success of the patient’s deaths and amputations, citing a lack of information or imaging studies.
As a result, the FDA concluded that the ship’s success rate for that key study was 67 percent, rather than 84 percent of the company, show the registers of the FDA. In comparison, artificial grafts had already brought 82 percent blood, said the review.
The company also recorded a success rate of 84 % at 30 days in an article published in November in Jama Surgery, which is widely read by surgeons. The article stated that the Umyte ship “shows better results” than other artificial ships.
He also said that the nice “benefits” in “resistance to infections”. The revision of the FDA said that there is no clinical tests that demonstrate that extra effect.
Dr. Lee was unable to convince the best FDA officials to keep a meeting of the public consultative committee in which the results of the study could be discussed and revised by independent experts. The agency instead decided to send records to three external auditors, who in turn identified the failure of human ships “as a serious risk”, but added that “the appropriate patient population” would benefit from it, according to the documents.
In the announcement of the approval of the year on December 20, Dr. Peter Marks, head of the biological division, defined the vessels “innovative products that offer potentially life -saved benefits for patients with serious injuries”.
But the product is accompanied by a warning of the most serious black box of the agency-for failures that “can cause potentially lethal hemorrhage”. The FDA also requires the company to continue reporting the security data.
Dr. Hooman Noorarchashm, co -director of the security collaborative of the medical devices of Amy J. Reed at the Northeastern School of Law, said that the FDA should not have approved a product that its scientists considered lower to the existing options.
“If the graft falls apart,” he said, or if it is disconnected where he is attached to the ship, “is basically similar to the patient who is hit.”
Dr. Lee claimed to hope that the FDA, with a new leadership under the Trump administration, would still have held a public meeting.
“Every surgeon who uses him needs to see the things I did,” he said.