When the Humacyte biotechnology company designed a study to see if the blood vessels planted in the laboratory were working, I decided to measure whether the blood flows freely through the super technology tube 30 days after it was implanted into someone.
With those days, some patients 54 faced a problem. Doctors lost one path. Four died. Four others have an amputation, including the person who developed a clot and infection in the artificial records, the food and medicine management records appear.
Humacyte, which is traded on the Nasdak Stock Exchange, is calculated all of these patients as evidence of success in talks with investors and in article In Gama surgery.
In the Food and Drug Administration (FDA), scientists calculate the deaths, nations and the missing issue as failures, as the records appear, noting that there is no information to determine whether the vessels are clear.
However, the agency agreed to ships in December without a general review of the study. Senior officials have authorized the concerns of the employees who said in the FDA records (FDA) that they found that the study was very lacking or was concerned about the severe consequences of patients when the vessels collapsed.
Now the company intensifies its marketing efforts for hospitals and use in the battlefield.
When the patient’s blood vessels are damaged, doctors usually find a bloody bowl of another part of the body and repair blood flow. They resort to artificial vessels when patients are severely injured by vein harvest.
Humacyte contains a mesh tube made of cells of the human heart. Cells grow over a period of two months in the biomas, and at the end of the process, human cells and genetic materials are removed. A tube that cultivates the laboratory remains, most of which are made of collagen developed from aortic cells.
Before approves the ship, one medical FDA The references indicated 37 out of 54 patients were not evaluated in the safety examination four months after obtaining the transplant, with a lot of dead or missing to follow up. “There is a great insecurity regarding the safety and effectiveness of this product after 30 days,” says the FDA report.
Dr. Robert E -Lee, a blood vessel surgeon who is interested in patients who were shot in Detroit for 30 years, retired in the fall from the FDA in this matter. In a review of more than 2000 pages of the company’s records when he was a medical official in the FDA, the doctor found that the ship could tear without any warning. “Unpredictable, catastrophic and aims to life,” he wrote in these events. Its review of the Food and Drug AdministrationParts of which were made weeks ago.
“This is an unacceptable danger to any minimal benefit, if any, this product provides higher than current standard treatments,” said Dr. Lee, who has been a reviewer since 2015. He pointed out that doctors are currently using the ship for patients, if any, or Gore-Tex tubes.
A spokeswoman for the FDA (FDA) said that the approval “is based on an accurate assessment of data from clinical trials that showed a clinical meaningful benefit in restoring blood flow to the affected end and saving the limbs in the end.”
Humacyte also develops the illegal gain for patients with dialysis, and for those who undergo surgery to override the heart and for children with a congenital heart defect.
Dr. Laura Nickelson, one of the company’s founders, said that the approval of the ship, called Simvis, was “a milestone for renewal medicine in general.”
She had started working to create cultivated ships in the laboratory decades ago. During the twenty years, the company did not record any sales and accumulation of more than $ 660 million of debt, Financial reports Show.
In an interview, Dr. Niklason said that the dispute over how the patient’s death and amputation classified with successes or failures after the company decided to calculate cases as failures only when it was certain that blood flow was cut. She said that the FDA has taken a more conservative approach to calculating the success rate of the product. She added, “Rational people can disagree.”
Food and drug administration records (FDA) does not indicate whether vessel problems caused death or amputation.
Dr. Niklason said that the company should use the agency numbers to market the product to customers, but it can provide its most suitable number for investment analysts. She also said the study It was published before the FDA reached its decision.
The company, the company’s chief trade official in the company, told investors this month that Humassite is in talks with 26 hospitals to start distribution. Mr. Schessele also said that the company was hoping to sell ships to the Ministry of Defense for the battlefield injuries. The US Army gave Humacyte 6.8 million dollars In 2017, the product embraced as an option for the injured soldiers.
Each artificial ship costs 29,500 dollars, and Mr. Schessele said that the company hopes to market several thousand every year in the United States.
Dr. Nickelson said in an interview that her interest in engineering was a two -folding bowl. As a young doctor, I noticed that the arteries were destroyed.
She described an experiment as a medical resident in the late 1990s as she watched a large doctor who is making a split after an incision in the patient’s feet and his arm, and he searches for a healthy container for use in surgery to overcome the heart. The “barbaric” procedure called.
She said: “To provide a new blood vessel for a patient who needs a person, and usually we must steal Peter to pay Paul.”
Since Dr. Niklason began meeting with the FDA (FDA) in 2015 about the start of a human experience, the agency has found a mistake repeatedly with the company’s efforts to study the use of the ship. Its trial included people with great shock, such as festivals or car collision, in American hospitals and Israel. Participants had a 30 -year -old average, half of them were black patients.
Humacyte also provided ships to doctors who treat the injured soldiers in Ukraine.
By November 9, 2023, Dr. Niklason described the results of studies for investors in a profit calling call. Initially, she said that the blood flow rate via ships in 30 days was 90 percent – overcoming the products on the market.
She said that the results in Ukraine were “great”. “We are proud to be able to help our Ukrainian fellow surgeons to save life and parties in this time in wartime.”
During the following months, though, reviewers of the FDA, including Dr. Lee, will study the same studies and conclude that they do not look almost good.
As a vascular surgeon and a general surgeon in Detroit, the doctor had contracts for experience with the victims of holidays, stabbing, car accidents and other accident victims who might receive such ships.
He said that he was anxious about the narration of a man in Ukraine, who began to bleed in his surgical location after eight days of planting the bowl. Doctors discovered a tangible hole in the Humacyte container and fix it with stitches, according to FDA records. Four days later, the patient was bleeding again, and required removing the graft the next day. The review suggested that the infection could have played a role.
Among the 71 cases by Dr. Lee by examining safety review, seven people, or about 10 percent, suffer from ship failures that led to great bleeding, according to the FDA review (FDA). Dr. Lee said that this was not heard in his experience with Gore-Tex.
Dr. Lee said: “The plastic arteries are usually not provided with catastrophic bleeding, not expected like this.” “You know that patients are sick,” with fever or other signs of infection, continued. “You know that something is brewing, and you usually have time to take care of it.”
Hoping to obtain more information about the radical cause of explosions in the middle of the bowl-and to ensure that the doctors were aware of this possibility-Dr. Lee started searching for a general advisory session on the device.
Thomas Zhu, a vital scientist in the FDA Department of Biology Department (FDA), has also reported concerns about the American arm of study and data from Ukraine.
“None of the study met the usual criteria for sufficient trial and good control,” he wrote.
The study of 16 patients was treated in Ukraine retroactively and monitoring, which means that researchers can look back in a larger set of data and choose the best cases. He said he showed “limited support for the effectiveness”, in part, due to the fact that the injuries were “deviated from fragments injuries” and not the destructive wounds that usually appear in the battlefield.
The statistical review said that the American study was “bad” and underwent “multiple major changes” during the trial.
The records also show that food and drug managers have been successful in the death and amputation of the patient, noting that there are no information or photography studies.
As a result, the FDA (FDA) concluded that the ship’s success rate for that main study was 67 percent, instead of 84 percent for the company. In comparison, artificial baits were already 82 percent blood flow rates, the review said.
The company also reported a success rate of 84 percent in 30 days in Publishing article In November from JAMA surgery, which surgeons are widely read. The article stated that the Humacyte ship shows improved results on other artificial ships.
He also said that symvess “provides benefits” in “infection resistance”. A review of the FDA (FDA) said that there is no clinical evidence explaining this additional effect.
Dr. Lee failed to convince senior FDA officials (FDA) to hold a meeting of a general advisory committee where the results of the study can be discussed and reviewed by independent experts. Instead, the agency decided to send records to three external auditors, who in turn identified the failure of the Humacyte ships as a dangerous danger, but added that the “appropriate sick population” will benefit, according to the documents.
in Announcing approval The illegal gain on December 20, Dr. Peter Marx, Head of Biology Department, called on ships “innovative products that provide possible benefits to save life for patients with serious injuries.”
But the product is accompanied by a warning of black boxes-the most dangerous agency-because of the failures that “can lead to life-threatening bleeding.” FDA (FDA) also requires the company to continue to report safety data.
Dr. Hoomer Norchen, co -director of Amy J
He said: “If the illegal gain collapses,” or if the connection is cut off to the place where it is attached to the ship, “it is closer to the patient who gets the bullets.”
Dr. Lee said that he hoped that the FDA will manage, with a new leadership under the Trump administration, a general meeting.
“Every surgeon uses it needs to see the things I have done,” he said.
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