Cells Weekly is a digest of the most interesting news and events in stem cell research, cell therapy and regenerative medicine. Cells Weekly is posted every Sunday night!
1. Anti-aging trial uses young blood
New clinical trial (sanctioned by FDA!), launched by company Ambrosia has captured a lot of attention this week. It uses “young plasma” for evaluation of potential anti-aging effects in healthy volunteers. But volunteers have to pay:
… a startup company has now launched the first clinical trial in the United States to test the antiaging benefits of young blood in relatively healthy people. But there’s a big caveat: It’s a pay-to-participate trial, a type that has raised ethical concerns before, most recently in the stem cell field.
The firm’s co-founder and trial principal investigator is a 31-year-old physician named Jesse Karmazin. His company, Ambrosia in Monterey, California, plans to charge participants $8000 for lab tests and a one-time treatment with young plasma. The volunteers don’t have to be sick or even particularly aged—the trial is open to anyone 35 and older. Karmazin notes that the study passed ethical review and argues that it’s not that unusual to charge people to participate in clinical trials.
The trial was highly discussed and criticized on twitter due to ethical issues. I’d also recommend you to read a post on Science-based Medicine – Parabiosis – The Next Snakeoil:
As of right now, young blood transfusions as the next elixir of youth is enjoying its 15 minutes of fame. The science is genuinely interesting, and seems deserving of further research. What is clearly needed is high quality clinical research, before any clinical claims are made.
2. NIH to lift a ban of human-animal chimeras research funding
Last year, US funding agency NIH put a moratorium on human-animal chimera research, due to ethical considerations. This week, NIH announced that it could be reconsidered, based on public comments. From the STAT:
In the blog post, Wolinetz said the NIH was creating a steering committee that would advise NIH officials on funding decisions regarding early embryonic human-animal chimeras. Research conducted with nonhuman primate embryos would only be supported after a certain stage of embryonic development, she wrote. For now, the NIH is asking for feedback on the proposed rule changes through Sept. 4.
The blog post also said that the NIH is not going to fund research that involves the breeding of chimeras that include human egg or sperm cells. In theory, that could lead to a mostly human embryo being carried in a mouse womb, which would presumably be miscarried.
Very good news!
3. Global distribution of direct-to-consumer stem cell clinics
Very interesting study was published this week in Cell Stem Cell. The authors mapped 417 unique businesses, which marketing unproven stem cell-based interventions worldwide. Surprisingly, the highest concentration of clinics (websites) were in US and Australia. See maps here.
Our findings of increased overall activity at the global level lend new quantitative support to the large body of media and scholarly reports that direct-to-consumer stem cell marketing remains widespread. We show that the global industry engaged in direct-to-consumer marketing of stem cell interventions in English shows geographic concentrations in highly developed countries, including the US.
4. Big deals in cell-gene therapy industry
This week, two “big deals” in industry have captured my attention. First, Pharma giant Pfizer has acquired gene therapy startup company Bamboo Therapeutics. Potential size of the deal is more than $0.5 billions! With this acquisition, Pfizer “aims to become industry leader in gene therapy”! Great example of how small molecules drug companies may switch to gene therapy.
Second deal is related to CART-/TCR field. Biotech giant Regeneron jumped into CAR T-cell game through partnership with Aditcet Bio. Interestingly, Regeneron decided to jump in now, because developments in allo- CAR T-cells. Regeneron thinks that auto- CAR T-cell model is not commercially viable!
5. Profiling cellular immunotherapy
New York Times has posted a good long piece about history and key people behind of progress in cellular immunotherapy of cancer. My favorite part:
Somewhat predictably, success provoked jostling and envy. Rather than being allies against a disbelieving world, the pioneers now had something worth fighting over — credit, and the gleam of a possible Nobel Prize.
While the Sloan Kettering researchers had done some of the early genetic engineering, they did not publish strong results in five patients until 2013. By then, they had been scooped by Dr. Rosenberg with one patient and Dr. June with three.
6. Pay-to-participate “trials” in NCT database
The Washington Post has very interested story about a patient, who came across “pay-to-participate” trial, listed on ClinicalTrials.gov database:
She scoured the government-run website ClinicalTrials.gov, and focused on stem-cell therapy — a promising but unproven approach for her condition.
She thought she had scored with StemGenex Medical Group, a company in La Jolla, Calif., and called for more details about a study it was doing. The screener asked a long list of questions, then dropped a bomb: If Smith wanted in, she’d have to pay “associated” costs. Total charge: $14,000.
“I was outraged,” said Smith, a retired hospital administrator who knew enough about clinical studies to realize that the price tag was unusual. Most trials are free, and some even pay people to take part because of the possible risks and inconvenience involved.
ClinicalTrials.gov database is highly criticized for lack of information about potential charges and legitimacy of listings.