Sickle cell patients and others who need long-term blood transfusions provided by clinical laboratories and others would benefit most from successfully lab-grown blood
Administering lab-developed red blood cells in humans in a clinical study conducted in the United Kingdom (UK) is being hailed as a significant step forward in efforts to supplement the supply of whole blood through the development of synthetic blood products. Of interest to those clinical laboratory managers overseeing hospital blood banking services, researchers were able to create this new blood product from normal blood pints collected from donors.
What caused this clinical study to gain wider attention is the fact that previous attempts to create synthetic whole blood products have proved to be unsuccessful. For that reason, this new research has raised hopes that lab-grown blood may be just around the corner.
The initiative, known as RESTORE, is a joint research project conducted by scientists from the UK’s:
According to the researchers, it is the first such clinical trial performed in the world. Partial funding for this clinical study was provided by an NIHR grant, according to an NHS press release.
Most hospital laboratories also manage a blood bank. Thus, this breakthrough will be of interest to many clinical laboratory managers and blood bankers who are concerned about the shortage of blood products. Plus, blood products are quite expensive. This research could develop solutions that both ease the tight supply of blood and lower the cost of these critical products while improving patient care.
“This research, backed by government investment, represents a breakthrough for patients and means treatment could be transformed for those with diseases including sickle cell,” said Neil O’Brien (above), Minister of State for Health, in an NHS press release. “Once again this shows the UK is leading the world when it comes to scientific innovation and collaboration while delivering high quality care to those who need it the most,” he added. If the lab-grown products prove clinically viable, medical laboratories in the UK may soon suffer less from a shortage of available blood. (Photo copyright: UK Parliament.)
Manufacturing Blood from Stem Cells
“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,” hematologist Farrukh Shah, MD, Medical Director Transfusion, NHS Blood and Transplant, told BBC News. “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.”
The process of manufacturing blood cells starts with a normal donation of a pint of blood. The researchers then use magnetic beads to single out flexible stem cells that can become red blood cells. Those flexible stem cells are grown in large quantities in the lab and then guided to transform into red blood cells.
“This challenging and exciting trial is a huge stepping stone for manufacturing blood from stem cells,” said Ashley Toye, PhD, Professor of Cell Biology at the University of Bristol in the NHS press release. “This is the first-time lab grown blood from an allogeneic donor has been transfused and we are excited to see how well the cells perform at the end of the clinical trial.”
The process to create the lab-grown blood cells takes about three weeks, and a pool of approximately half a million stem cells can result in 50 billion red blood cells. These cells are then clarified further to reap about 15 billion red blood cells that are at the optimum level to transplant into a human patient.
“Some blood groups are extremely rare, to the point that only 10 people in a country can donate blood,” Toye told BBC News. “We want to make as much blood as possible in the future, so the vision in my head is a room full of machines producing it continually from a normal blood donation.”
Transforming Care for Patients Who Need Long-term Blood Transfusions
To date, only two patients have taken part in the clinical trial. Next, the researchers plan to perform two mini transfusions on 10 volunteers at least four months apart. One transfusion will contain traditional donated red blood cells and the other will consist of the lab-grown cells. This experiment will show which blood cells last longer in the body. The findings could ultimately allow a patient to receive fewer transfusions and prevent iron overload, which can be a side effect of blood transfusions.
“We hope our lab-grown red blood cells will last longer than those that come from blood donors,” said Cédric Ghevaert, MD, Senior Lecturer in Transfusion Medicine at the University of Cambridge, in the NHS press release. “If our trial—the first such in the world—is successful, it will mean that patients who currently require regular long-term blood transfusions will need fewer transfusions in the future, helping transform their care.”
More research and clinical trials will be necessary to validate the efficacy and safety of these lab-grown blood products. However, such a breakthrough could potentially revolutionize treatments for patients with blood disorders, complex transfusion needs, and rare blood types, as well as reduce healthcare costs and curb blood shortages.
At the same time, this technology would also contribute to expanding the supply of useful blood products, a development that would be welcomed by those pathologists and clinical laboratory professionals overseeing the blood banks in their respective hospitals and integrated delivery networks (IDNs).
Study suggests AI-enabled technology can help clinical laboratories and hospital blood banks save thousands of dollars annually on expensive blood products
Artificial intelligence may prove to be a useful tool in helping hospitals better manage utilization of blood products. That’s one conclusion from a newly-published study done at New York’s Icahn School of Medicine at Mount Sinai. If so, this is a technology improvement that would be welcomed by blood bankers and clinical laboratory managers who must manage the cost and utilization of blood products.
There’s no way around it—blood is expensive. A typical 400- to 600-bed hospital likely budgets upwards of one million dollars annually just for blood products. Almost universally, in hospitals the medical laboratory manages the blood bank. This is where medical technologists trained in blood banking test patients and test blood to ensure whole blood units, or other blood products such as platelets, match and will not trigger a negative reaction when administered to the patient.
When left unmanaged, the cost and utilization of blood bank
products can put the budgets of hospital medical laboratories in the red. Hospitals
also invest a great deal of money training surgeons to accurately assess the
procedure and order the correct amount of blood components prior to surgery.
Therefore, new artificial intelligence (AI) technology that helps pinpoint patients’ blood loss during childbirth will be of interest to blood bankers and hospital laboratory administrators.
Can AI Help Clinical Labs Improve Utilization of Blood Products
in Hospitals?
Physicians at the Icahn School of Medicine at Mount Sinai recently investigated whether “Quantifying blood loss” would improve the use of blood during human childbirth. They published the results of their study in the International Journal of Obstetric Anesthesia.
Their research into 7,618 deliveries (vaginal and cesarean) involved “An observational study comparing blood loss, management, and outcomes between two historical cohorts (August 2016 to January 2017 and August 2017 to January 2018) at an academic tertiary care center. Patients in the intervention group (second period) had blood loss quantified compared with visual estimation for controls,” the research paper notes.
The researchers concluded that “Quantifying blood loss may
result in increased vigilance for vaginal and cesarean delivery. We identified
an association between quantifying blood loss and improved identification of
postpartum hemorrhage, patient management steps, and cost savings.”
The researchers, according to a press release, employed the Triton AI-enabled platform from Gauss Surgical, a silicon valley-based health technology company, to “monitor blood loss in all deliveries (vaginal and cesarean, n=3807) at Mount Sinai Hospital from August 2017 through January 2018 to support the institution’s stage-based hemorrhage protocol.”
The researchers found that use of a monitoring system was
associated with earlier postpartum hemorrhage
intervention and annual cost savings of $172,614 in lab costs and $36,614 in blood
bank costs.
Daniel Katz, MD (above), Director of Obstetric Anesthesia Research and Associate Professor Anesthesiology, Perioperative and Pain Medicine, at Mount Sinai Hospital in New York, said in the news release, “This study demonstrates that efficiently obtaining accurate, real-time blood loss information is critical to the successful implementation of a stage-based hemorrhage protocol.” Katz was the study’s lead author. (Photo copyright: Mount Sinai Hospital.)
Measuring Blood Loss: The Eye versus AI
Gauss has secured Food and Drug Administration (FDA) clearance for Triton and more than 50 US hospitals are using it. Triton provides, in real-time, images of blood-saturated surgical sponges and canisters and uses computer vision and machine learning to pinpoint blood loss, reported MD+DI.
Traditionally, physicians visually estimate blood loss
during procedures. When they are off in their estimates of postpartum
hemorrhage, harmful postpartum health complications and deaths can occur, the
Mount Sinai researchers explained in their paper.
And although other vital signs—heart rate, rhythm, blood
pressure, oxygen level, etc.— are monitored with equipment in the surgical
suite, blood usage is not.
“Blood loss in surgery has been an enigma for decades since the dawn of medicine,” Siddarth Satish, Founder and Chief Executive Officer of Gauss, told MD+DI. “We monitor many other vital signs in surgery, but ultimately there hasn’t been any direct indicator of a patient’s hemoglobin loss.”
Bleeding Better Recognized, Less Blood Transfusions
After the Mount Sinai researchers used the Triton system to
monitor blood loss during 3,807 vaginal and cesarean deliveries from August
2017 to January 2018 at Mount Sinai Hospital, they compared their findings to
3,811 deliveries from August 2016 to January 2017, during which doctors relied
solely on visual estimation of blood loss.
The study found the following, according to the news
release:
Improved hemorrhage recognition in vaginal deliveries of 2.2% and cesarean sections of 12.6% compared to .5% and 6.4%, respectively;
Less blood transfusions needed (vaginal patients): 47% with Triton compared to 71%;
Reduced blood transfusion dose (cesarean section): 1.90 units with Triton compared to 2.52 units;
Cost savings: $209,228 a year (the total of aforementioned lab and blood bank costs).
“What we like about [Gauss] is that it somewhat embodies precision medicine in the sense that you’re using more precise tools of measurement in their first use case,” Garrett Vygantas, MD, MBA, Managing Director for OSF Ventures, the financing arm of OSF Healthcare, who also serves on Gauss Surgical’s board, told MD+DI.
Possible New Resource for Hospital Medical Laboratories
So, will AI quickly become an omnipresent overseer in surgical suites? Hardly. However, AI is in the early stages of finding places in healthcare where it can be useful. “A lot of people are predicting that AI will play a huge role in healthcare … I think it’ll be ever-present. There will be a little bit of AI in everything you’re doing, but I think the actual practice of medicine in its truest form is going to carry forward,” Satish told Fierce Healthcare.
Hospital medical laboratories and blood blanks looking for
new tools to manage blood use may want to look into AI-enabled systems like
Triton. Saving money is not the only benefit. Less transfused blood is better
for patient care as well.
Pathologists and blood bankers in many hospitals are finding it easier to manage costs because, for a variety of reasons, utilization of blood and blood products has declined in recent years
Demand for blood products is declining across the nation. This is a positive trend for pathologists and clinical laboratory professionals who manage blood banks in hospitals and health systems throughout the United States.
In recent decades, blood banks regularly worried about blood shortages, particularly in light of the aging population. However, a host of new medical technologies and clinical advances has dramatically reduced the utilization of blood products. (more…)
In Connecticut and California, there are two medical technologists who have each put in 50 years on the job in their respective hospital laboratories
On opposite coasts of the United States, two medical technologists (MT) were each recognized by local newspapers for more than 50 years of service in clinical laboratories in their respective communities! As members of what is often called the “Greatest Generation”, these two long-serving med techs have much to teach the three younger generations now working in the nation’s medical laboratories.
For the last 51 years, Sandra Allard has worked in the laboratory at Waterbury Hospital, in Waterbury, Connecticut. The 69-year-old typically works in the blood bank, but pulls one night a week in chemistry, according to an article published by the Republican-American, a newspaper in Waterbury. Jeffrey Pinco, M.D., the Medical Director of the hospital laboratory, described Allard as an employee who cares about the hospital’s patients and brings old-fashioned values to her job. (more…)
