Weekly reads: HIV from vampire facials, CAR-T, FDA warns Regenative Labs

Imagine regularly having someone rub your face all over with the equivalent of a small roller covered with spikes and doused with either your blood or someone else’s and you have what’s called vampire facials.

There’s more news that this is a very bad idea.

Vampire facials linked to more HIV cases

“Vampire facials” promoted by celebs are linked to new HIV cases, Ars Technica. This is a piece from the wonderful Beth Mole. I’ve written before about vampire facials and also more recently stem cell facials, which is also called stem cell microneedling. These are risky procedures typically using needle rollers with hundreds of spikes.

Even if you are just using your own blood or blood products in vampire facials, the rollers are difficult to clean and sterilize for reuse. As a result, you can get exposed to previous customers’ biologics and any pathogens therein. With the newer approach of stem cell microneedling we’ve also been seeing the use of allogeneic products, which raise risks of getting someone else’s pathogens and other issues.

This practice also raises the broader issue of the widespread use of allogeneic birth-related tissues and cells at unproven clinics. The conundrum here is that if the products are properly sterilized then the potentially useful stuff inside like cells and growth factors may be destroyed. If not properly sterilized then the disease transmission risk is high. It takes expertise and care to have sterile, but useful products in this space. The sterility is crucial though since these products are injected into the bloodstream or tissues.

More recommended reads

• CAR T Cells Derived From Stem Cells Open Door To Universal Donor Cell Lines, Forbes.
• Human stem cell-derived embryo models: Toward ethically appropriate regulations and policies, Cell Stem Cell. This is a helpful piece from Alessandro Blasimme and Jeremy Sugarman.
• Donor perspectives on informed consent and use of biospecimens for brain organoid research, Stem Cell Reports.
• FDA warning. An umbilical cord biologics supplier called Regenative Labs has drawn attention in recent years. Now the FDA sent Regenative labs a warning letter. The letter notes that the products appear to be drugs at least in part because of minimal manipulation and homologous use standards. As far as I can tell the firm does not have FDA approval to market the products. In addition, the FDA notes a variety of  problems with how the products are being made. For example, “FDA investigators documented evidence of significant deviations from current good manufacturing practice.(CGMP).”  Interestingly, the firm seems to have another name, Row1, Inc. I also noted the non-homologous use issue, which has been on my mind because it has come up in the autologous bone marrow cell therapy space as well, where the FDA has in some cases not taken action such as on MD Stem Cells. It’s not always clear what is homologous use or not and whether the agency will be up for taking action in some cases of apparent non-homologous use.
• T cells might boost stem cells for Parkinson’s? Regulatory T cells aid stem-cell therapy for Parkinson’s disease, Nature News.