Vitals

High risks and high costs for young blood donations to older people

Some private clinics have started selling lifesaving plasma from young donors with potentially deadly side effects


Screen Shot 2019-09-03 at 12.31.03 PM
By Shanley Pierce | September 3, 2019

A California-based biopharmaceutical company announced in August that its proprietary mixture made of plasma proteins from young donors stopped cognitive decline in mild-to-moderate Alzheimer’s patients after six months.

In a randomized clinical study by the company, Alkahest, 39 patients intravenously received either 100 milliliters or 250 milliliters of the distilled plasma proteins for five consecutive days during the first week and again for five consecutive days during the 13th week.

No detailed data on the study has been released yet, but Alkahest said in a press release that “these plasma fractions enhance neurogenesis, improve age-related deficits in learning and memory, and reduce neuroinflammation” in animal models. The company plans to present its findings at the Clinical Trials in Alzheimer’s Disease Conference in December.

Whole plasma can be lifesaving or potentially life-threatening, depending on the medical situation. Over the past few months, this straw-colored component of blood—which carries blood cells and proteins, contains antibodies, glucose, clotting factors, electrolytes and hormones—has been shrouded in controversy.

In legitimate emergency situations (such as trauma and burns) and rare chronic conditions (such as autoimmune disorders and hemophilia), plasma is essential for survival. The World Health Organization includes fresh frozen plasma on its WHO Model List of Essential Medicines, which outlines the most important and integral medicines for a basic health care system.

But in other scenarios, including using plasma infusions from young donors to tap into a so-called “fountain of youth,” medical experts say plasma can be life-threatening.

Earlier this year, the U.S. Food and Drug Administration (FDA) issued a warning against the use of plasma infusions from young donors in hopes of treating dementia, Alzheimer’s disease, Parkinson’s disease, multiple sclerosis, heart disease, post-traumatic stress disorder and other age-related conditions.

“When companies are giving plasma just to deal with neurologic symptoms without any good medical evidence, it’s a risky thing to do,” said Modupe Idowu, M.D., associate professor of hematology at The University of Texas Health Science Center at Houston’s McGovern Medical School.

Risks include transfusion-related acute lung injury, transfusion-associated circulatory overload and allergic and anaphylactic reactions, along with infections, febrile non-hemolytic transfusion reactions and hemolytic transfusion reactions. A single unit of plasma contains 250 milliliters of plasma, typically from four to eight donors, according to Idowu.

“It’s exposing the patient to multiple donors at the same time,” she said.

Studies have explored the benefits of young blood in experiments with mice. In 2013, Stanford University researchers conjoined the veins of an old mouse to a young mouse to share the same blood circulation, resulting in the reversal of cardiac hypertrophy (the abnormal enlargement of the heart muscle) and some improvements in cognitive abilities in the older mouse.

However, clinics selling plasma from young donors are not replicating the same experimental conditions, said Vivien Sheehan, M.D., Ph.D., assistant professor of hematology-oncology at Baylor College of Medicine.

One California-based company, Ambrosia, sold participation in a clinical trial that offered each client one liter of human plasma harvested from young adults. Ambrosia charged $8,000 for that one liter, but since the FDA warning, the company has shut down. The Ambrosia trial raised major safety concerns.

“I’ve never seen an alleged trial that only had one inclusion criteria: that you be over 35,” Sheehan said. “There were no other safety measures taken to make sure you’ve never had a transfusion reaction, to make sure you can handle the volume, to make sure you’re not hypercoagulable. There was nothing in there to protect the individual and screen out people for whom this would be more dangerous. … This was clearly just an advertisement masquerading as a clinical trial. I can’t emphasize enough how disturbing it is that patients are being put at risk for something that is so unproven. The thing that is proven is that plasma can kill you. The thing that is unproven is that it would have any benefit whatsoever, so the risk-benefit ratio is completely off.”

Jesse Karmazin, CEO of Ambrosia, recently opened a new venture and is continuing to sell 1 liter of blood plasma for $8,000 and 2 liters for $12,000.

“Ambrosia was dissolved, but Ivy Plasma is open for business. Ivy Plasma provides off-label plasma treatments, which is legal,” Karmazin wrote in an email to TMC Pulse. “I can’t comment on the potential risks or benefits of this treatment due to restrictions on off-label marketing of medications by the FDA.”

Ultimately, scientific evidence that shows young blood plasma can counteract age-related diseases remains sparse.

“If there are some factors in younger blood that could be helpful to an older patient, the key would be to identify them, do the real work of fractionating and identifying what proteins or micro RNA or factor that would be beneficial to older people, then find a way to either deliver it pharmacologically or genetically,” Sheehan said. “The whole plasma approach is kind of a dumb strategy.”




Social Posts

profile_image

BCMHouston

@bcmhouston

RT @BCMCancerCenter: Learn about the latest updates in immunotherapy as well as hear from other cancer patients about their experience with…

7 mins ago
profile_image

MD Anderson Cancer Center

@MDAndersonNews

@Majormac1 Sending good vibes your way, Robin.

14 mins ago
profile_image

BCMHouston

@bcmhouston

RT @jsuliburk: Great stuff here from @TheAAES ! September is #thyroid #cancer awareness month. #checkyourneck get a #neckcheck . Ultras…

15 mins ago
profile_image

Harris Health System

@harrishealth

Happy Fall! https://t.co/wjF8teaVxm

39 mins ago
profile_image

Texas Children's

@TexasChildrens

Learn more about the rise of the anti-vaccination movement in @TexasChildrens second season of Outcomes. Listen here: https://t.co/4a9hcW4WyQ #OutcomesPodcast #TexasChildrens https://t.co/MxsKLH8Ory

45 mins ago
profile_image

TexasHeartInstitute

@Texas_Heart

RT @MoveItMonday: You don't have to leave your chair to #MoveItMonday! Try these three simple chair yoga exercises to stretch away stress,…

51 mins ago
profile_image

University of Houston

@UHouston

RT @houstonalumni: Naming the mascot “Shasta” was an idea that came in 1947 when Alpha Phi Omega service fraternity bought UH’s first live…

56 mins ago
profile_image

MD Anderson Cancer Center

@MDAndersonNews

#Clinicaltrials are at the core of our mission to #endcancer. Learn from our Dr. Patrick Hwu how they help us discover new treatments to benefit future and current patients: https://t.co/ENqWbPrvNt https://t.co/Jkuu9JlXbg

1 hour ago
profile_image

Veterans Affairs

@DeptVetAffairs

Today’s #VeteranOfTheDay is Army Veteran Charles J. Gestrich, who served as a railway mail clerk during the Korean War from 1951 to 1953: https://t.co/6mzBvGdZtR

1 hour ago
profile_image

Veterans Affairs

@DeptVetAffairs

@USMC Veteran Kionte lost his leg in an IED blast. During recovery, he experienced depression and sought support. Visit https://t.co/tBxE005jeW to hear more about Kionte’s journey back to physical and mental health.

1 hour ago
profile_image

Rice University

@RiceUniversity

Malawi’s national adoption of affordable neonatal CPAP technology developed at @Rice360atRiceU resulted in sustained improvements in the survival of babies with respiratory illness, according to a new study in the journal Pediatrics. https://t.co/mYtNlEf8uz

2 hours ago
profile_image

Veterans Affairs

@DeptVetAffairs

@USMC Veteran Kionte lost his leg in an IED blast. During his recovery, he experienced depression and sought support. Visit https://t.co/tBxE005jeW to hear more about Kionte’s journey back to physical and mental health.

2 hours ago
profile_image

Rice University

@RiceUniversity

RT @RiceUNews: Here's to 10 years of fun and fitness!@ricerec is celebrating its 10th anniversary with a week of events, starting today…

2 hours ago
profile_image

BCMHouston

@bcmhouston

Happy 20th Birthday to the Baylor International Pediatric AIDS Initiative! Find out how this program has grown over the last two decades. https://t.co/S5PSODwhVt #BIPAI

2 hours ago
profile_image

Houston Methodist

@MethodistHosp

@lesmiskid @blummer27 @JuliaMorales @RealToddKalas @astros Thanks for sharing this great pic!

3 hours ago