The COVID-19 pandemic quackery reached its logical conclusion. And this hair loss stem cell nano exosome therapy has just been approved by FDA.
It had to come to this. Old men die the most from COVID-19, hair loss is associated with old age and being male, the obvious solution to the pandemic is to use hair restoration products to survive the coronavirus. Throw in some “stem cells” and nanotechnology-flavoured “exosomes”, add pressure on FDA from Republican politicians like we had with chloroquine and ivermectin, and you got yourself the insane amalgam of mainstream pandemic quackery in one single biomedical scam.
You will surely recall proxalutamide, the Chinese hair-loss drug which was repurposed as the magic COVID-19 cure by a team of Brazilian fraudsters and their US business partners. The team around Flavio Cadegiani and Ricardo Zimerman not only falsified trial data, they also mass-poisoned hundreds of COVID-19 patients in Brazilian hospitals with a toxic mixture of medicines described as “standard therapy” in order to achieve a huge mortality rate in their trial control arms, which then made proxalutamide look like a magic life-saver.
Why not chemical castration (to escape COVID-19)?
Male boldness causes COVID-19 death, go figure. This ridiculous quackery from Brazil is based on fudged clinical trials, sponsored by an obscure Californian hair loss business, and even Torello Lotti is on board!
And of course we also had both stem cells and exosomes as the magic COVID-19 cure before. Both as it happens were pushed by Israeli scientists.
Professor Nadir Arber of Tel Aviv University was celebrated by the Israeli government as the Messiah who saved the world from COVID-19 using “exosomes” (actually just cell culture supernatant) from CD34-overexpressing HEK 293 cells. An amazing success rate was reported at his Ichilov hospital: COVID-19 patients who were as good as dead dead rose to complete health the matter in hours, thanks to Dr Arber’s “EXO-CD34” weapon dispelling the dangerous “cytokine storm”. Then-prime minister Benjamin Netanyahu not only met Arber, he even personally promoted his COVID-19 cure as Israel’s gift to the world.
Operation Cytokine Storm
Exceptional times call for exceptional men. In Israel, men of science boldly step forward to face the coronavirus, armed with miracle cures. Pandemic, like a good war, is always good for business.
Also the Greek government was so impressed that they let Arber run clinical trials in Greece, and of course also there miraculous success rates were reported. But soon after, all news about Arber’s magic exosome cure suddenly stopped. The media, once orgiastic and ecstatic, quietly moved onto other topics and another bullshit COVID-19 cures.
Naturally, stem cells were pushed for COVID-19 early on as well. Even earlier than exosomes! In fact, just when the pandemic started in USA and Europe, in March 2020, the Rutgers University professor Martin Grumet called to “save lives now” with the mesenchymal (bone marrow) stem cell product Remestemcel-L (or Ryoncil) by the Australian biotech Mesoblast. The company later partnered with Novartis and run promising clinical trials only to spectacularly fail in phase 3, as mentioned in this press release from September 2021:
“Mesoblast has been put on blast by the FDA yet again after the agency requested another trial for its failed, Novartis-backed COVID-19 respiratory treatment. The Australian cell therapy biotech will have to conduct another study of remestemcel-L to have a shot at an emergency use authorization from the FDA. […]
The treatment failed last December in a phase 3 study in 222 ventilator-dependent COVID-19 patients with moderate to severe ARDS and was halted early for showing no signs of reducing death in patients over the age of 65. Remestemcel-L showed a 48% reduction in death for patients under 65 years old after 90 days.”
The pharma giant Novartis dropped Mesoblast like a hot potato right after, as a December 2021 press release reported, and the start-up’s once soaring stocks crumbled. And now, Mesoblast is being sued by its investors in USA and in Australia in a series of class action lawsuits:
“Mesoblast is already facing multiple class action lawsuits in the US after being accused overseas of making false or misleading statements to investors, as well as failing to disclose material adverse facts about Remestemcel-L.
Phi Finney McDonald said in documents sent to investors the claim will allege that Mesoblast misrepresented the efficacy and potential benefit of treating patients with Remestemcel-L; misrepresented the significance of trial results; did not disclose to the market material information, including the deficiencies in study design and statistics presented.”
Also early in the pandemic, the Israeli company Pluristem tried to pivot from peddling placenta-derived “stem” cells as a cure for acute radiation sickness (in case Iran attacks with nukes) to peddling these same placenta-derived “stem” cells for COVID-19.
Stem cells to cure COVID-19 because why not
Israeli scientists discovered a cure for coronavirus! Their proprietary PLX cells from placenta deliver 100% survival rate both against COVID-19 and a nuclear holocaust. The stocks soar.
In December 2021, Pluristem reported the results of its phase 2 clinical trial in USA, Germany, Israel and Bulgaria:
That was unfortunate, because prior to that Pluristem terminated its Phase 3 clinical trial for limb ischaemia, which used the same placenta cell product. Most recently, in July 2022, Pluristem reported that their Phase 3 clinical trial for muscle regeneration (again, same placenta product) also “did not meet the primary endpoint“. The company doesn’t give up though and decided to re-focus on lab-grown meat business, as apparently every Israeli “stem cell” and COVID-19 entrepreneur does these days.
From COVID-19 to Lab-Grown Meat
Enterprising Israeli Scientists show how these things are connected.
This is the crux with phase 3 clinical trials. You can bullshit your way through phase 1 and 2 relatively easily, but phase 3 trials are very large, very expensive and thus independently overseen.
And now FDA green-lighted a phase 3 clinical trial for the US company Direct Biologics for their revolutionary regenerative medicine drug for COVID-19. Who can say no to “stem cells” AND “exosomes”? I daresay I know how all this will end.
A groundbreaking extracellular vesicle
A US company’s press release announced in April 2022:
“Direct Biologics, an innovative biotechnology company with a groundbreaking extracellular vesicle (EV) platform drug technology, announced that the U.S. Food and Drug Administration (FDA) has awarded their EV drug product ExoFlo with a Regenerative Medicine Advanced Therapy (RMAT) designation for the treatment of Acute Respiratory Distress Syndrome (ARDS) associated with COVID-19.”
The press release explains what the FDA-approved drug ExoFlo is:
“ExoFlo is an acellular human bone marrow mesenchymal stem cell (MSC) derived extracellular vesicle (EV) product. These nanosized EVs deliver thousands of signals in the form of regulatory proteins, microRNA, and messenger RNA to cells in the body, harnessing the anti-inflammatory and regenerative properties of bone marrow MSCs without the cost, complexity and limitations of scalability associated with MSC transplantation. ExoFlo is produced using a proprietary EV platform technology by Direct Biologics, LLC.”
What is this company, you might wonder, and how did they arrive to this amazing COVID-19 cure?
Well, the company offers this on its website:
The products, presumably including this amazing ExoFlo, are already available to paying customers via “compassionate use”. Not just for COVID-19! Actually, ExoFlo was designed as a therapy for hair loss! As one partner of Direct Biologics advertises:
“ExoFlo is a safe and natural preparation of exosome stem cells that contain growth signals to promote hair growth.
These exosomes signal dormant hair follicles to become reinvigorated in order to produce the growth of new hair cells.”
The price tag for ExoFlo therapy for hair loss ranges between $3,000 and $10,000. The product is injected into your scalp.
But for COVID-19, ExoFlo is injected intravenously. Presumably, it makes hair grow there as well?
I think I have a mechanistic explanation here, perfectly scientific. ExoFlo treatment for COVID-19 must work this way: the stem cell derived nano-exosomes cause hair growth inside your lung capillaries and alveolae. The virus gets trapped by this intra-pulmonal hair and is coughed out as a hairball.
Don’t laugh, I am sure my mechanistic model is much more sophisticated than anything the two “scientists” running Direct Biologics business as Chief Medical officer and Associate Chief Medical Officer, Vikram Sengupta and his wife Sascha Sengupta, can come up with. Together they own an infusion business, which qualifies them to know exactly how to inject cell supernatant into people’s veins.
And now they will be managing this phase 3 clinical trial, approved by FDA in April 2022:
“Receiving FDA approval for Phase 3 is a key milestone for Direct Biologics,” said Mark Adams, Co-Founder and CEO. “Coupled with the RMAT designation, we are now on an accelerated path towards commercialization with a potential life-saving drug—ExoFlo. This Phase 3 trial titled “Extinguish Covid-19” is an international, multicenter, double-blind, randomized, placebo-controlled Phase 3 trial. Our objective is to enroll patients with ARDS in hospital sites across US, Spain, India, Jordan, Egypt, Lebanon, and South Africa, and to demonstrate a significant mortality reduction following treatment with ExoFlo compared to standard of care alone. As pioneers in the field of regenerative medical therapies, we at Direct Biologics are changing the future of medicine.”
“Extinguish COVID-19“, I like that trial title, so Fireman Sam-esque. Let’s see who is prepared to be duped into sponsoring it. Maybe Novartis again?
Prior to that, a phase 2 clinical trial was reported in an April 2022 press release as a resounding success:
“Overall, ExoFlo demonstrated a robust safety and efficacy profile that warrants further clinical investigation with a pivotal Phase III study. In addition to an unequaled reduction in 60-day mortality rate of 37.6% in comparison to placebo, no reportable adverse events were observed,” said Dr. Vikram Sengupta, Chief Medical Officer. “ExoFlo also substantially outperformed placebo with respect to time to discharge and ventilator free days. Additionally, subgroup analysis revealed a larger mortality benefit among patients who were severely hypoxic at randomization,” he said.”
This was the phase 2 trial NCT04493242 with 120 participants, the press release doesn’t say how many ended up analysed, and no results were posted and no research paper was published, because you just have to trust the press release. The phase 2 trial was approved based on this phase 1 clinical trial publication where the Senguptas and other authors insisted to have no conflicts of interests whatsoever:
Vikram Sengupta , Sascha Sengupta , Angel Lazo, Jr. , Peter Woods , Anna Nolan , Nicholas Bremer Exosomes Derived from Bone Marrow Mesenchymal Stem Cells as Treatment for Severe COVID-19 Stem Cells and Development (2020) doi: 10.1089/scd.2020.0080
This shameless contortion to deny obvious personal business interests passed peer review:
“This study was supported by Drs. Vikram and Sascha Sengupta in collaboration with Christ Hospital. None of the authors were compensated for this study. Thrivewell Infusion, LLC provided acquired, commercially available product from Direct Biologics, LLC, Austin, TX, storage, medical supplies, transportation, legal resources, as well as supportive administrative and clinical personnel.”
It was “a prospective nonblinded nonrandomized primary safety trial at a single hospital center” run in April 2020. The patients ranged from moderately sick with COVID-19 to mechanically ventilated and unable to give consent personally. This was the not-really-detailed description of the therapy they received:
“In total, 15 ml of ExoFlo was added to 100 mL of normal saline and administered intravenously for 60 min.”
All 27 COVID-19 patients were treated in parallel with hydroxychloroquine and azithromycin, and it appears they had to pay privately for the stem cell nano exosome nonsense. It is not discussed if they grew hair inside their blood vessels. In the end, the study declared ExoFlo to be able to “restore oxygenation, downregulate cytokine storm, and reconstitute immunity” compared to, well, there was no control arm, nothing to compare to, but this is exactly why it worked so great.
The Senguptas et al were asked by concerned scientists (Kim et al 2020) why they ran a trial seemingly without an ethics approval. To this, the COI-free Direct Biologics employees declared:
Which IRB approval? Issued by whom? None of your business. Kim et al also wanted to know what this ExoFlo exactly was, how it was supposed to work, and how safe it was. The Senguptas et al explained:
“The bone marrow (BM) cell source used in the manufacture of this ExoFlo lot is from the iliac crest aspiration of a single donor. […] Based upon the current BM MSC-derived EV literature, and internal characterization and potency studies, a primary mode of action for ExoFlo is to communicate changes in host immune response. […] Consistent with the years of mechanism of action studies performed to assess the MSCs themselves, the secreted biomolecule milieu is complex, and the primary mode of action is dependent on the environment into which it is introduced into the body.”
The stem cell faith healers, or magic inside your bone marrow
Bone marrow stem cells are magic, they can do everything. If you don’t believe it, you are simply a loser scientist and will never get funded. Prior to his bombastic fall from grace, the celebrity surgeon and professor of regenerative medicine Paolo Macchiarini was considered a genius stem cell wizard and a miracle healer. He…
Basically, it’s bone marrow stem cell magic. You must believe in it or it won’t work. And in this response, suddenly Conflicts of Interest were declared. No, not for the Senguptas, they still have none. But we are told that the newly added co-authors Kevin C. Hicok and Timothy Moseley “serve as chief science officer and director of research and development, respectively, at Direct Biologics LLC, Austin, TX, from which they receive their paychecks and have a vested financial interest in the success of ExoFlo as a therapy.“
How do they know there are any bona fide “exosomes”, i.e. cell-secreted lipid vesicles and not just dead cell debris, in the cell culture supernatant? The Senguptas et al explain that they prove it “by traditional nanoparticle tracking analysis under both light scatter and fluorescence evaluation” and by “single particle interferometric reflectance imaging sensor technology to visualize and quantify fluorescent antibody-labeled particles“.
It sounds fancy, high-tech and very nanotechnological, but convincing it is not. But I am the last person to ridicule trash nanotechnology here, as you all well know.
Thomas Webster to save the world with COVID-19 nanoparticles
The world is in the grip of COVID-19 pandemic. Thousands dead, infection rates explode, nations in lockdown. Perfect timing for troll scientists to offer their bullshit cures. Like Thomas Webster of Northeastern University.
You might wonder how that nonsense gained FDA approval, especially after the gigantic Mesoblast-Novartis cock-up. Simple answer: political meddling and institutional corruption. They are even proud of it, as a placed promo article celebrated already in October 2021:
“One of the treatment’s biggest supporters is Congressman Michael McCaul, representative for District 10. McCaul’s district covers the territory from Austin, where the drug was developed, through Katy and into parts of West Houston.
Direct Biologics appealed to McCaul for his support in helping the treatment gain FDA approval. When McCaul learned about the success of the drug, he championed for its approval.
“Navigating the FDA can seem onerous when first starting out,” McCaul said. “That is why when Direct Biologics approached me for assistance, I was passionate about helping them bring this life-saving treatment to Americans.”
McCaul is a Republican, here is his email from 2020 to FDA’s then-director Stephen Hahn:
Just as hydroxychloroquine got approved by FDA as a COVID-19 medicine under pressure from Trump and other Republicans, so was the quack hair-loss therapy ExoFlo green-lighted after a pushy Republican politician smelled money.
In case ExoFlo predictably fails in Phase 3 clinical trial, Direct Biologics is prepared to market it for other diseases, like “chronic non-healing wounds, soft tissue injuries and repetitive motion injuries“. And right now, phase 1 clinical trials for ulcerative colitis and Crohn’s Disease (NCT05176366 and NCT05176366, respectively) are starting, also there ExoFlo to be administered intravenously.
My only criticism is that Direct Biologics forgot to mention that ExoFlo not only cures COVID-19 while returning your long-lost hair, it is bound to rejuvenate you and extend your life. The Senguptas et al forgot the buzzwords “Anti-aging” and “Senolytics”. Because this is how the best COVID-19 therapies work:
Send in the Senolytics!
“The authors declare no competing financial interests.”
Never-ageing Anti-aging to cure COVID-19
Scientists David Sinclair and Michael Lisanti have an ingenious solution to COVID-19: anti-aging drugs. If a disease kills old people, stop being old!
Hyperbaric Oxygen Therapy extends life, the telomeres, and everything
Telomere dysfunction is a common problem in older men. Dr Shai Efrati can help: Book your appointment for Hyperbaric Oxygen Therapy now!
Oh, and by the way, German expert Prof Dr Dr Dr Stehling recommends bone marrow or belly fat “stem cell exosome” therapy for erectile dysfunction. Watch out for the next therapeutic market for ExoFlo to penetrate!
Get your hard-on with Prof Dr Dr Dr Stehling’s liposuction
“Prof. Dr. Dr. Dr. M. K. Stehling, the founder of ANOVA IRM and the Vitus Prostate Center , is a radiologist (MD) and holds a PhD in physics. […] ANOVA IRM GmbH, located in Offenbach, near Frankfurt am Main, Germany, is an officially controlled German medical company. We have permits to harvest, process and manufacture…
I would like to thank Elizabeth Woeckner for finding the ExoFlo story and doing most of the research.
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Is this available as a cream? I mean, hypothetically, if one were to rub it… oh, i forgot my question.
It needs to be injected. Just a little prick!
I just came off the phone with Dr Sengupta. Yes, ExoFlo can be used against erectile dysfunction. As explained, “the primary mode of action is dependent on the environment into which it is introduced into the body”.
You can also visit Prof Dr Dr Dr Stehling’s stem cell exosome clinic here in my neighbourhood:
“the secreted biomolecule milieu is complex, and the primary mode of action is dependent on the environment into which it is introduced into the body”.
Ah, so the results can be different (depending on where it’s injected), and if there are no results at all, well that’s complexity for you.
But injected intravenously it cures both covid and crohn’s….
“the stem cell derived nano-exosomes cause hair growth inside your lung capillaries and alveolae. The virus gets trapped by this intra-pulmonal hair and is coughed out as a hairball”.
I like how that singer dude in one of those ExoFlo ads explained his drastic vocal range changes overnight after ExoFlo was administered into his scalp. He assumed that exosome stuff comes down and migrated from head to his vocal cords and he was able to sing notes which he even didn’t hope to sing before. I wonder if it is due to hair growth inside of vocal cords?
Gosh, where else did the stuff migrate to and which other talents did the paying customer develop overnight thanks to ExoFlo?
I am unable to find an IRB registration that matches information in the phase 1 trial publication.
Nothing for CarePoint in Jersey City, NJ and the single entry for Christ Hospital is in Ohio
FDA regulations require all IRBs that review FDA regulated products to register with HHS and so would appear in the OHRP database.
What happened here?
Hairy blood vessels sounds like a rock band.
During the Trump administration I believe the FDA made some very questionable decisions about OK’ing new trials and other efforts on experimental cell therapies for COVID. Not much of any good data to back it up I’d say.
Politics was likely involved in quite a bit of it. Readers may find some of my posts of interest.
This blog post makes me worried the problem is continuing at the FDA with cells for COVID stuff.
Thanks for bringing this to light.
Many among the regmed stem cell quacks recognised that lab grown meat scam is a faster and safer way to money. I expect to see Mesoblast and Direct Biologics there soon!
I believe Hahn’s text message refers to Peter Marks. Perhaps you might try to interview him for the Niche. Maybe ask why ExoFlo is marketed without an approval
Also, the phase 1 publication says patients got ExoFlo via compassionate access, which in FDA speak is also called a single patient protocol or single patient IND. The foundation of an IND that supports first in man testing is the Drug Master File. Compiling a DMF involves a ton of work to describe the product and its manufacture. Is FDA allowing single patient INDs or phase 1 trials for COVID based on a partial or no DMF?
I share your worry and would add the issue is all the more concerning because some COVID patients (at least in the ExoFlo trial) were unable to provide informed consent due to their medical condition. Yes permission was sought from legally authorized representatives but it’s not the same as obtaining valid legally effective informed consent from the research subjects.
These are good points. I was thinking to reach out to CBER. It seems like when it comes to COVID that cell therapies are being held to a relatively low standards by the agency before being used in people via compassionate use or emergency authorization. Even some IND clearances. It’s risky. I have some evidence that in past years political pressure was being exerted to make things move forward more quickly even without much data, which fits with what Leonid seems to have found more recently too.
Even the more sane ones, who speak fluent ancient Latin, are difficult to believe unless one understands doll-speak (Small Brains Considered – 2)
What can we expect next … COVID-19 healing sessions by mystical quantum souls? Top physicists are declaring that quantum mechanics involves “the quantum soul” (Small Brains Considered – 7).
Bullshit and a lot of imagination never ends in science. Wondering if these scientists should not get a job in Hollywood instead.
Do not forget the pump and dump possibilities that come from this type of paid FDA congressional approval. The heads of these companies/law firms will eventually roll with this approval and benefit financially…but by that time..the bad actors will have gotten away Scott free. With zero intent to produce a product for market, meanwhile further destroying the validity of the words ‘extracellular vesicles’….and the potential they represent for humanity and future pharmaceuticals.
Contact your congressman and Elizabeth Warren…following…
After this post: https://ipscell.com/2022/09/fda-leader-stephen-hahn-was-pressured-to-aid-texas-firm-direct-biologics/
Note how Elizabeth Warren warns against these SPAC public companies ..and that they manipulate the stock price to $10 per share prior to their mergers. There is no requirement of physical proof beyond financial statements.
Click to access SPACS.pdf
Then note the GWII stock price at $10 per share. With a spike after the direct biologics announcement. Who benefitted on the way down? Are those records public?
I’ve now comprehensively reviewed the ExoFlo Phase I trial paper that was published in the journal Stem Cells & Development and found many red flags. Also some very strange surprises like the 1st author apparently (according to another site) receiving the drug himself from the 2nd author at home. https://ipscell.com/2022/11/review-of-exoflo-paper-used-to-push-direct-biologics-ind-inside-fda-finds-red-flags/
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