“Young blood” company dissolves after FDA red light, but don’t worry — it’s just hiding under new name

“Young blood” company dissolves after FDA red light, but don’t worry — it’s just hiding under new name

You can still get the treatment… if you know where to look

CultureAugust 15, 2019 By Will Brendza

Earlier this year we ran a story on Ambrosia Health, a forward thinking young blood transfusion company dedicated to making the rich and elderly feel young and healthy.

The idea was simple: take the blood plasma of young donors and inject it into older clients, who are willing and able to pay $8000 per liter.

Pump those paying customers full of young blood and, according to the owner and founder of Ambrosia Health, Jesse Karmazin, “They feel younger and more energetic and healthier and they say their memory is better and their muscle strength is improved.”

But, recently the FDA announced that “plasma therapy” like what Karmazin was offering at Ambrosia Health, could only be performed under the “Investigative New Drug” (IND) program — which requires preclinical testing, manufacturing information, investigator information, clinical trial protocols and commitments to obtain informed consent from the research subjects.

In light of that announcement, Karmazin sent this grim mass-email:

Hi, I'm writing to you because you contacted Ambrosia, LLC in the past through our website. I want to update you on the FDA's decision about young plasma.

“In February, the FDA announced that off-label young plasma treatments should be performed only under IND. As a result, Ambrosia, LLC was dissolved. I am sorry that I wasn't able to find a way for this company to continue its innovative treatments.”

No doubt, Karmazin was bummed to shut his company down. Creating a young blood plasma therapy center had been a dream of his since he was a student at Stanford medical school. It was there that he first learned about “parabiosis” and the preliminary mouse tests that had shown that maybe, possibly, it could be beneficial for older animals to be injected with young blood. It was there that the seeds of Ambrosia Health were planted.

But, now, with the meddlesome FDA insisting that young plasma transfusions can only be performed only under IND, he can no longer offer the same kind of treatment comercially.

He could, however, offer an “off-label” one.

Karmazin’s email ended with this upbeat update for potential customers:

On a brighter note, I've founded a new company which offers off-label plasma treatments. The URL is just below. I hope that you will visit the site and check out our treatment options. Please feel free to contact me if you have any questions.” 

Karmazin’s new company, Ivy Plasma, does everything Ambrosia Health did, except now the plasma treatments are “off-label.” I asked Karmazin what that means exactly.

Off-label prescribing means using a drug for a purpose other than that it was originally approved for,” he explains. “It is legal in the US.” He adds assuringly.

The new Ivy Plasma website is nearly identical to the old Ambrosia Health website: it uses the same kind of stock photos, the prices for plasma therapy are exactly the same, and it is void of any real information or scientific proof relating to the procedure and its effectiveness. In fact, the only written information on the entire page is a short four sentence blurb.

Which ends with this disclaimer: “We cannot make any claims on the effectiveness of this treatment due to restrictions by the FDA on the marketing of off-label treatments. We will advise you on the risks and benefits during the informed consent process.”

Aside from that, Ivy Plasma states that clients must be at least 30 years old or older. That’s it. That’s literally all they tell you at all about what they do, how they do it, what it supposedly does for people, who is eligible and how they know this works.

When we spoke last (back in January), Karmazin said that they had just finished some clinical trials and were going to be published soon. However, those results have not yet been published Karmazin tells me. Leaving the void of information as empty as ever.

If Karmazin is so convinced that his plasma therapy works, why not go through the process of having it legitimately tested and approved by the FDA? Why not get the treatment legitimized so that he could really ramp up production and dissemination of this ground-breaking therapy?

I would like to pursue FDA approval for an indication for young plasma, but it may take some time,” Karmazin says. In the mean time, he says, “Ivy Plasma is open for business.”

Whether or not plasma therapy actually works in humans is anybody’s guess. Karmazin says it makes people feel better. That single, preliminary laboratory test with surgically conjoined mice, suggested that young blood could have the potential to be useful.

Beyond that, though, there is no further evidence to support that young blood therapy actually has any positive health effects. Those two lab mice, and anecdotal reviews from Karmazin’s guinea-pig patients serve as his entire proof of concept.

Which, doesn’t seem to prove much of anything.