Tag Archives: Anemia

Health

Lab-made blood could have enormous potential for people with rare blood conditions

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CNN
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Scientists have transfused lab-made red blood cells into a human volunteer in a world-first trial that experts say has major potential for people with hard-to-match blood types or conditions such as sickle cell disease. The research could someday mean an end to long searches for compatible donors or dangerous transfusion reactions.

The experimental transfusion was done at Addenbrooke’s Hospital in Cambridge, England, as part of a collaborative effort among UK scientists to understand how lab-made blood transfusions could work.

The scientists took whole blood from donors in a UK database and separated out the stem cells. These are the body’s raw materials – the cells from which all specialized cells, like a red blood cell, can generate.

The researchers grew red blood cells from those stem cells and transfused them into two healthy volunteers.

The transfusions involved only a tiny amount of blood: the equivalent of one or two teaspoons. A standard blood transfusion would involve many hundred times that amount.

This stage of the trial involves two mini transfusions at least four months apart, one with a standard donation of red cells and the other with lab-made cells from the same donor.

The researchers are closely monitoring the volunteers to determine whether the process was safe. They say there have been with “no untoward side effects” so far.

They’re also watching how long the lab-grown cells last compared with an infusion of standard red blood cells. Red blood cells typically last about 120 days, but a transfusion from a standard donation contains cells that are a variety of ages because the bone marrow continuously makes these cells.

Previous tests have shown that manufactured cells function like normal cells and that these lab-made cells are likely to survive longer overall while in circulation. This study will determine for the first time whether that’s true.

Further trials will be necessary to determine whether there could be a clinical use of this lab-grown product.

The research could eventually make a difference for people with sickle cell disease, those who develop antibodies against most donor blood types, or those with genetic disorders in which their body can’t make red blood cells or the blood cells they make don’t work well.

Red blood cells are the helper cells that carry oxygen from the lungs to the body’s tissues, which use this oxygen to produce energy. The process also generates waste in the form of carbon dioxide that the red blood cells take to the lungs to be exhaled out.

With sickle cell disease – also called sickle cell anemia – red blood cells take on a folded shape that can clog tiny blood vessels and cause organ damage and pain. People with sickle cell often need multiple transfusions over the course of their lives.

“This world leading research lays the groundwork for the manufacture of red blood cells that can safely be used to transfuse people with disorders like sickle cell,” Dr. Farrukh Shah, a researcher on the study and medical director of transfusion for NHS Blood and Transplant, said in a news release. “The need for normal blood donations to provide the vast majority of blood will remain. But the potential for this work to benefit hard to transfuse patients is very significant.”

Dr. Glenn Ramsey, medical director of the blood bank at Northwestern Memorial Hospital and a professor of pathology at Northwestern University Feinberg School of Medicine, said he has had many patients over the years who are extremely difficult to transfuse and would have benefited from a therapy like the one in this study.

Often, if there is not a local blood match, he has to turn to the American Rare Blood Donor Program – and even then won’t always find an appropriate donor. In one case a few Thanksgivings ago, it was so difficult to find a match for one patient that they had to turn to a world database and bring in blood from Canada.

“This doesn’t come up very often, and it’s an extreme example, but this would be the kind of problem that these kinds of cells could try to solve,” said Ramsey, who was not involved in the new research.

He found the work “quite exciting” and its potential enormous.

Scientists have been working on this issue for many years, he said.

“Down the road in years to come, this might be a way to replace transfusions as we know it,” Ramsey said. “It’s still a long way from getting to that point, but it certainly starts us down the road to see if this will even be feasible.”

Dr. Cheryl Maier, an assistant professor of pathology and laboratory medicine and a medical director at the Emory Center for Transfusion and Cellular Therapies, said the experiment is a “really exciting advancement.”

She is particularly interested in the possibilities of lab-made red blood cell for people with sickle cell.

“There hasn’t been a lot of attention on some of these diseases, especially sickle cell, which mostly affects African American patients, and it can be really frustrating and disheartening that there isn’t more attention to it,” said Maier, who wasn’t involved in this study.

“For certain patients, especially patients with sickle cell disease or other patients that need some kind of chronic transfusion therapy, if you gave them incompatible blood, they would have oftentimes a very strong bad transfusion reaction,” she said.

The research could lay the groundwork for studies of things like platelets, which are often in critically short supply, she said. If scientists find that lab-made red blood cell products last longer, it may also improve the quality of life for people who wouldn’t have to be transfused as regularly.

“Even in 2022, there are patients that we almost can’t find units for, and they get a delay in their treatment because we can’t find matching units for them,” Maier said. “I think it definitely has the ability to revolutionize how we support some patients that are really difficult to support with blood products currently.”

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Science

We Finally Know The True Extent of Space Destroying Astronauts’ Red Blood Cells

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The human body did not evolve to handle life in space, and it shows in our very blood.

Since our species first started to spend extended periods of time beyond our planet, researchers have noticed a curious and consistent loss of red blood cells among astronauts.

 

The phenomenon is called ‘space anemia’, and until recently, its cause was a mystery. Some experts have argued space anemia is only a short-term phenomenon – a brief compensation for the fluid changes in our bodies under microgravity.

A new study, however, points towards a more destructive and lasting mechanism.

During a six-month space mission flight, researchers found the human body destroys about 54 percent more red blood cells than it normally would.

The readings are far higher than expected, and they come directly from the breath and blood of 14 astronauts on the International Space Station (ISS).

“This is the best description we have of red blood cell control in space and after return to Earth,” says epidemiologist Guy Trudel from the University of Ottawa, Canada.

“These findings are spectacular, considering these measurements had never been made before and we had no idea if we were going to find anything. We were surprised and rewarded for our curiosity.”

The measurements were made via blood tests of iron and breath tests based on carbon monoxide. For every one molecule of carbon monoxide exhaled, a molecule of the pigment found in red blood cells is also destroyed, which makes it a useful approximation of red blood cell loss.

 

While still firmly grounded on Earth, astronauts in the study were creating and destroying about 2 million red blood cells a second. During their time in orbit, however, their bodies were destroying roughly 3 million blood cells a second.

In microgravity, the human body loses about 10 percent of the liquid flowing through our blood vessels, as blood accumulates in our head and chest. That’s why astronauts sometimes look swollen in their videos from the ISS.

For years, this was the explanation for space anemia. Perhaps the loss of red blood cells was our body’s way of compensating for a loss in blood volume.

But that’s not what the current study found. Instead of equalizing the makeup of our blood, the loss of red blood cells appears to continue unabated throughout space flight.

Even after 120 days, when all the red blood cells in an astronaut’s body had been created in space, the loss of red blood cells continued at a similar pace.

“Our study shows that upon arriving in space, more red blood cells are destroyed, and this continues for the entire duration of the astronaut’s mission,” says Trudel.

 

When the astronauts were in space, the loss of red blood cells appears to have led to a higher-than-normal circulation of iron serum in their blood. Without as many red blood cells to transport iron around the body, the astronauts gradually approached anemia, which can be classified into mild, moderate, and severe.

When they returned to Earth, five out of 13 astronauts (one didn’t get blood drawn on landing) had reached clinically diagnosable levels of anemia, defined as the condition where the body doesn’t have enough red blood cells for its physiological needs.

About three or four months after landing, their red blood cell levels returned to normal. But even a year after their space flight was done, the astronauts’ bodies were still destroying 30 percent more red blood cells than before their trip to space.

The study didn’t measure red blood cell production, but given that no astronaut suffered severe anemia, despite the significant losses of red blood cells, their bodies may also have been producing more red blood cells than normal while in space.

If that turns out to be true, astronaut diets will need to be adjusted accordingly. An increase in red blood cell production can put added pressure on bone marrow function, and this necessarily requires higher energy consumption.

 

If astronauts are not properly protected, they could risk damage to their heart, lungs, bones, brain and muscle systems when they return to Earth.

“Thankfully, having fewer red blood cells in space isn’t a problem when your body is weightless,” explains Trudel.

“But when landing on Earth and potentially on other planets or moons, anemia affecting your energy, endurance, and strength can threaten mission objectives. The effects of anemia are only felt once you land, and must deal with gravity again.”

The study was published in Nature Medicine.

 

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Science

Why do astronauts get “space anemia”? This study has an answer.

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A new analysis has found that space travel can lower red blood cell counts, leading to a condition known as “space anemia.” A collaboration between The University of Ottawa and the Ottawa Hospital examined the red blood cell counts of 14 astronauts who had been to space, and found that their bodies destroyed 54% more red blood cells in space than they did on Earth — providing an answer to long-held questions about the condition.

“Space anemia has consistently been reported when astronauts returned to Earth since the first space missions, but we didn’t know why,” said lead author Dr. Guy Trudel, a researcher at The Ottawa Hospital and professor at the University of Ottawa, in a press release. 

Prior to this study, space anemia was believed to be caused by a sudden shift of fluids into an astronaut’s upper body when they first entered space, causing the loss of 10% of the liquid in their blood vessels. It was also believed that their bodies would quickly destroy 10% of their red blood cells to balance this shift, and red blood cell count would return to normal after 10 days in space, the release said. 

But the research team discovered that being in space was actually the cause of the red blood cell destruction by measuring the red blood cell counts of the 14 astronauts over six months in space. The researchers didn’t measure red blood cell counts directly, but they used a measurement of carbon monoxide — which is released when a part of a red blood cell is destroyed — as a proxy. 

On Earth, human bodies create and kill 2 million red blood cells every second — but in space, they destroy 3 million every second, the researchers said. 

“Our study shows that upon arriving in space, more red blood cells are destroyed, and this continues for the entire duration of the astronaut’s mission,” Trudel continued. 

Both male and female astronauts experienced the same red blood cell destruction, and five of 13 astronauts were clinically anemic upon landing, the researchers said in the release. One astronaut did not have blood drawn upon landing.

Astronaut Tim Peake’s first blood draw completed in space. The sample was taken as part of the MARROW experiment.

NASA


“Thankfully, having fewer red blood cells in space isn’t a problem when your body is weightless,” Trudel said. “But when landing on Earth and potentially on other planets or moons, anemia affecting your energy, endurance, and strength can threaten mission objectives. The effects of anemia are only felt once you land, and must deal with gravity again.”

After the astronauts returned to Earth, it took three to four months for red blood cell counts to return to normal — but the scientists found that a year after landing, red blood cell death was still 30% higher than it was before the space mission.

“This is the best description we have of red blood cell control in space and after return to Earth,” said Trudel. “These findings are spectacular, considering these measurements had never been made before and we had no idea if we were going to find anything. We were surprised and rewarded for our curiosity.”

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Science

Astronauts experience ‘space anemia’ when they leave Earth

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When we’re on Earth, our bodies create and destroy 2 million of these cells per second. In space, astronauts experienced 3 million red blood cells destroyed per second, resulting in a loss of 54% more cells than people on Earth experience, according to a new study.

Lower red blood cell counts in astronauts is known as space anemia.

“Space anemia has consistently been reported when astronauts returned to Earth since the first space missions, but we didn’t know why,” said study author Dr. Guy Trudel, a rehabilitation physician and researcher at The Ottawa Hospital and professor at the University of Ottawa, in a statement.

Researchers took breath and blood samples from 14 astronauts before their six-month stays on the International Space Station. The astronauts also took samples four times during their flights. The researchers also collected blood from the astronauts up to a year after their spaceflight.

The flights of the 11 men and three women occurred between 2015 and 2020. The findings were published Friday in the journal Nature Medicine.

A surprising find

When astronauts are in space, they experience a shift of bodily fluids toward the upper body due to the lack of gravity. This results in increased pressure on the brain and eyes, causing cardiovascular issues and a loss of 10% of the liquid in their blood vessels.

Researchers believed that space anemia was the body’s way of adapting to the fluid shift, resulting in the destruction of red blood cells to restore the balance. They also thought that the red blood cell loss was only temporary, restoring itself after the astronauts adjusted after spending 10 days in the space environment.

Trudel and his team discovered a surprising result — the space environment is the actual culprit.

“Our study shows that upon arriving in space, more red blood cells are destroyed, and this continues for the entire duration of the astronaut’s mission,” he said.

The research team developed ways to measure red blood cell destruction, including measuring the amounts of carbon monoxide detected in breath samples from the astronauts. Each time one molecule of heme, or the signature red pigment in red blood cells, is destroyed, it creates a molecule of carbon monoxide.

The team was unable to directly measure the production of red blood cells in the astronauts, but they expect that the astronauts experienced the generation of extra red blood cells in response to increased destruction. If this had not occurred, all of the astronauts would have suffered the effects and health issues associated with severe anemia while in space.

“Thankfully, having fewer red blood cells in space isn’t a problem when your body is weightless,” Trudel said. “But when landing on Earth and potentially on other planets or moons, anemia affecting your energy, endurance and strength can threaten mission objectives. The effects of anemia are only felt once you land, and must deal with gravity again.”

Long-term effects

After returning to Earth, five of 13 astronauts were diagnosed as clinically anemic. One of the astronauts did not have a blood draw after landing.

Follow-up samples taken from the astronauts showed that space anemia is reversible because their red blood cell counts progressively returned to normal between three to four months after their return.

However, samples collected a year after the astronauts landed on Earth showed that the rate of red blood cell destruction was still increased, about 30% above what they experienced before their spaceflight.

The researchers believe this suggests that long-duration space missions could result in structural changes that impact red blood cells.

The findings are the first results published from MARROW, an experiment that examines bone marrow health and blood production when astronauts are in space.
The results highlight the importance of screening both astronauts and space tourists for health conditions that could be impacted by anemia and monitoring for any issues during missions. A previous study by Trudel and his team also revealed that longer space missions worsen anemia.

For now, it’s uncertain how long the human body can support an increased rate of both destruction and production of red blood cells.

In order to combat this risk, the researchers suggest that astronaut diets be changed to support better blood health.

The lessons learned from this research could also be applied to anemia patients on Earth, especially those who experience it after illness and prolonged bed rest. While the direct cause of this kind of anemia is unknown, it may be similar to what happens in space.

“If we can find out exactly what’s causing this anemia, then there is a potential to treat it or prevent it, both for astronauts and for patients here on Earth,” Trudel said. “This is the best description we have of red blood cell control in space and after return to Earth. We were surprised and rewarded for our curiosity.”

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Business

FGEN Stock Collapses After FDA Panel Rejects Anemia Treatment

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A Food and Drug Administration panel voted resoundingly against recommending approval for an anemia treatment from FibroGen (FGEN), and FGEN stock tanked on Friday.




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FibroGen is angling for approval in chronic kidney disease patients. But panelists voted 13-1 against recommending the FDA approve roxadustat in patients not dependent on dialysis. They voted 12-2 in the case of dialysis-dependent patients.

Members of the FDA’s Cardiovascular and Renal Drugs Advisory Committee expressed concern that roxadustat increases the risk of death and other dangerous side effects, SVB Leerink analyst Geoffrey Porges said in a note to clients.

“We believe that potential U.S. approval for roxadustat will be delayed by years,” he said. And the FDA could ultimately restrict roxadustat to patients who don’t respond to standard drugs known as erythropoietin stimulating agent “if FibroGen continues U.S. development at all,” Porges added.

But FibroGen continued to defend roxadustat.

“While we are disappointed with today’s outcome, we believe the scientific evidence supports roxadustat approval in the U.S. and will work with the FDA as it completes its review of the New Drug Application for roxadustat,” Chief Executive Enrique Conterno said in a written statement.

FGEN Stock Craters On Panel Vote

On the stock market today, FGEN stock collapsed 42.2%, ending the regular session at 14.35.

In testing, roxadustat increased the risk of death, thrombosis, stent occlusion and serious infectious, Porges said. He added it also could cause seizures and metabolic/gastrointestinal side effects.

“Almost all of these imbalances were unknown to investors, and we expect investors to demand changes to the company’s board, management, staffing, portfolio and expenses as a result of this complete rejection,” he said.

The FDA isn’t bound by the committee’s recommendation. In fact, the FDA is currently facing mounting criticism after it approved Biogen‘s (BIIB) Alzheimer’s drug, Aduhelm, despite a negative advisory committee vote.

But Porges doesn’t expect that to happen in this case. He slashed his expectations for approval in the U.S. to zero. He also cut his price target on FGEN stock to 35 from 56, though he kept his outperform rating.

Will Investors Seek A Restructure?

Roxadustat is already approved in China and Japan, where FibroGen nets profit-sharing and royalties, respectively, from partner AstraZeneca (AZN). The European Medicines Agency’s Committee for Medicinal Products for Human Use previously issued a positive opinion on roxadustat.

FGEN investors are looking forward to test results for pamrevlumab, an experimental treatment for pancreatic cancer and Duchenne muscular dystrophy. But those results aren’t expected until the second half of 2022. That means the drug couldn’t launch until 2023.

“The remaining value of FibroGen’s stock is the value of other geographies for roxadustat, the value of pamrevlumab and the company’s cash,” Porges said. “FibroGen may insist that they deserve value for their ‘platform’ and for earlier-stage assets, but they are unlikely in our view to get any.”

Porges expects FGEN investors to also call for FibroGen to restructure itself following the vote. He argues the company should become one-third smaller.

“Such a restructuring typically takes months to design and implement, but we expect investors to demand no less given the lack of opportunity for roxadustat and the time until proof of (effectiveness) for pamrevlumab in the ongoing pivotal trials,” he said.

FGEN Stock Takes Another Hit

Mizuho Securities analyst Difei Yang also chopped her price target on FGEN stock to 18 from 32. She kept her neutral rating on shares.

She noted FibroGen suggested it could launch roxadustat with a lower starting dose and a risk-mitigation strategy.

“However, a number of panelists wanted to see this proposal validated in clinical trials, and thus voted against approval at this juncture,” she said.

Yang now believes FGEN stock is a commercial sales story in Europe and China in the short term. She also lowered her expectation for roxadustat approval in the U.S. to nothing.

Follow Allison Gatlin on Twitter at @IBD_AGatlin.

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