When the Biotech company designed a study by Humacyte, when the blood of the laboratory worked, he decided whether blood is technologically, until 30 days of implant.
As the days passed, some of the 54 patient patients had problems. Didctors lost one. They were killed four. The four more had a limb, among other things, the artificial container, which developed a glue and an infection in the show of food and drug administration records.
Humacyte, traded in NASDAQ, counts all these patients with researchers and anywhere An article Jama Surgery.
In the FDA, however, scientists show records, amputations, and lost cases, lacking information to determine whether the containers were clean.
However, the agency approved the vessels in December without a public review of the study. The concerns above officials were allowed to say that employees in the FDA records were seriously lacking research or the lattices of patients were worried when the vessels fell.
Now the company makes its marketing efforts to use hospitals and battlefield.
When the blood vessel of a patient is damaged, doctors usually find another part of the body in the blood sound and solve the flow of blood. Patients go to artificial vessels that they are badly injured to combine veins.
Humacyte ship is made from a network of seeds from the human heart to cells. The cells grow in two months in a bioreactor, and at the end of the process, human cells and genetic material are removed. A lab tube, mostly collagen by collagen, is left from aortic cells.
Before accepting the ship, a doctor FDA Reviewer noted 54 patients in 37 are not security evaluated after four months after achieving the implant, losing many dead or continued. “There is a great uncertainty about the safety and efficiency of this product beyond 30 days,” says FDA reports.
Dr. Robert E. Lee has been wounded gun for 30 years, with a vascular surgeon for 30 years, retiring in FDA’s fall. A FDA medical officer was a review of more than 2,000 pages in the company, Dr. Lee discovered that the ship was ruined without warning. These events were “unpredictable, catastrophic and life-threatening,” he wrote Review of his FDAThe parts were made a few weeks ago.
“It is an unacceptable risk, regardless of today’s standard treatments”, 2015. Since the year, Lee, 2015, since he said in an interview. He warned that the doctors use the patient’s boat today, if available or used pipes made by Gore-Tex.
A FDA spokesman said the acceptance was based on a specific evaluation of clinical essays, which proved a clinically advantage of the affected body flow and ultimately body rescue “.
Humacyte is also developing vaccination for patients with dialysis, for babies with heart detour surgery and heart birth defect.
Dr. Laura Niklason, one of the founders of the company, said to accept the ship, called Symvess, was a military regeneration milestone.
Boats grown in the laboratory began work earlier. In 20 years, the company did not register for sales and gained more than $ 660 million in debt, Financial reports Show.
In an interview, Dr. Niklason labeled the disagreement on how the patient’s deaths and amputations were labeled, only when the company had failed blood flow. The FDA took a more conservative approach to calculate the success rate of the product, he said. “Rational people can’t agree,” he added.
FDA records do not indicate whether the vessels have caused direct deaths or amputations.
Dr. Niklason said that the company should use the product to market customers, but that he could have a more investment analyst figure. He also said examination The FDA was published before making his decision.
BJ Scheessele, the company’s main commercials, told investors this month that Humacyte had 26 hospitals with 26 hospitals. Mr. Scheessele also said the company was expected to sell the boat to the defense department for the battlefield. The US Army gave Humacyte $ 6.8 million In 2017, internalizing the product as an opportunity for injured soldiers.
Each artificial vessel cost $ 29,500 and Mr. Scheessele said the company expected several thousand marketing every year in the United States.
Dr. Niklason said in an interview that the engineering blood vessel was double. As a young doctor, he saw that the arterial disease was destructive.
He described an experience as a doctor who lives in the late 1990s, after a higher medicine cut into the legs of a patient and after cutting his arm, looking for a healthy bowl for use in a heartbid. He called the “Barbaric” procedure.
“To give a new blood vessel in a patient who needs, we usually refuse Peter Paid to pay,” he said.
Since the beginning of the Doctor Niklason in 2015, since a trial in humans, the agency repeatedly found the efforts to study the use of vessels. People who suffer from great trauma for trial, such as guns or car accidents were injuries, in the US hospitals and Israel. Participants were on average 30 years, and half were black sick.
Humacyte also gave vessels to doctors who treat wounded soldiers in Ukraine.
Until November 9, 2023, Dr. Niklas won investors to call the results of research to investors. Initially, the blood flow rate through vessels was 90 percent in 30 days, beating products on the market.
And the results of Ukraine were “prominent”. “We are proud to help our Ukrainian surgeon to help save life and body life in this warning.”
In the coming months, however, the FDA evaluators, including Dr. Lee, would examine the same examinations and that they do not look almost good.
As a vascular and general detroit surgeon, Dr. Lee had decades of guns, blows, car accidents and other victims that may receive such vessels.
The account of a man in Ukraine said he was worried, when his wound began bleeding, embarking on the ship and began eight days. Doctors found a two-millimeter hole in the Humayte ship and fixed with sutures, according to FDA records. Four days later, the patient was again bleeding again, required to remove vaccination on the next day. The revision suggested that an infection could be a role.
Dr. Lee examined about seven people, or about 10 percent, were large blood bleeding, depending on the review of the FDA. Dr. Lee said this was not any experience with GORE-TEX inserts.
“Plastic arteries, usually not presented with catastrophic bleeding, accidentally,” Dr. Lee said. “You know that patients are sick,” he continued with another sign of a fever or infection. “You know something, and you usually have time to take care of it.”
For more information about the cause of the center of the center of the ship, and make sure the doctors had the opportunity to have the opportunity – Dr. Lee began to seek public advice on the device.
Thomas Zhou has also marked concerns about the biostatistical biostatistical of FDA, from the US exam and Ukrainian data.
“Studies have not found the usual criteria for proper and well-controlled judgment,” he wrote.
The study of 16 patients treated in Ukraine was retrospective and observation, means that researchers could go back to a larger data set and select the best cases. He showed “limited efficiency support” because it stained the injury to the “blade injuries” and is not the destructive wounds that are usually seen on the battlefield.
The US exam was “wrong” and “some important changes” during trial, statistical reviews said.
Records shows that the FDA scientists have been successful in patients and amputations of patients, quoting information or images without information or images.
As a result, the FDA concluded that the key rate of the ship was 67%, than the company shows the FDA records than 84 percent. In comparison, artificial vaccinations had already had 82 percent of blood rates, reviewed by the review.
The company also had an 84% success rate in 30 days Published article In November Jama Surgery, which is very read by surgeons. The article stated that Humayte vessels “show better results above artificial other vessels.
The Simbation “benefits” offers “infection resistance”. The FDA review said it was not a clinical evidence that it shows an extra effect.
Dr. Lee failed to convince FDA officials to make a public advice committee meeting, where independent expert study results can be discussed and reviewed. The agency has decided to send the records to the three external evaluators, but identified the failure of the “serious risk” of humayte vessels. It would be beneficial for “the right population of patients”, according to documents.
At Announcing acceptance GRAFT 12. On December 20, Dr. Peter Marks, the Biological Division Heads, called “innovative products that offer lifestyles for patients with serious suppliers.”
But the product is a warning of a black box – it is the most serious agency – “can cause bleeding to endanger life.” The FDA company also requires reporting security data.
Dr. Amy J. Noorchashm, Director of the Medical Security School Security of the Northeastern Legal School.
“If the vaccination is separated,” he said, or disconnects where the ship is tied, “it is essentially a patient’s shot.”
Dr. Lee said that the FDA expected, according to Trump Administration that the new leadership will have a public meeting.
“Every surgeon used should see things I made,” he said.
2025-03-24 21:21:00
