January 22, 2021

The Niche

Trusted stem cell blog & resources

Kristin Comella

7 min read

Stem cell clinics and suppliers have been getting into the business of making promotional films to generate more revenue, but now there’s something very different in the cinematic stem cell arena called From Jail Cell to Stem Cell by filmmaker Doug Orchard. It is at its heart an exposé film about some in my view particularly concerning stem cell and exosome clinics and suppliers. The only other thing similar to this was 2019’s great podcast Bad Batch. Reviewing the movie From Jail Cell to Stem Cell Today’s …Read More

2 min read

US Stem Cell, Inc. reports in a new SEC filing that its key leader Kristin Comella has resigned as of September 1. I never thought I’d see the day when Kristin Comella and US Stem Cell, Inc. parted ways. To me Comella seemed like the driving force behind the company, which is now subject to an injunction after a big federal court loss. It is appealing the ruling, but faces a tough road ahead in my view. From the new SEC filing: “Effective September …Read More

3 min read

The unproven stem cell clinic firm US Stem Cell Inc. is in a world of hurt. If a federal judge says you can no longer sell your key commercial offering, how do you survive as a company? US Stem probably has been thinking about that possibility for months. Still, it’s not yet clear where the company goes from here now that this has become a reality. Where do things stand looking ahead? There’s financial pressure. The company’s stock ($USRM) has been a penny stock …Read More

5 min read

We’re seeing more muddy waters in the stem cell universe. A chiropractic stem cell and alternative medicine clinic has popped up calling itself, of all things, CIRM. On another front, an already controversial docuseries set to air tomorrow combines interviews with prominent academic stem cell scientists and unproven stem cell clinic folks, muddying the waters. Was that the goal? What’s the deal? As to the stem cell clinic referring to itself as CIRM, some of us in the stem cell world already know of …Read More

5 min read

A fitness guru named Ben Greenfield has now reported self-injecting non-FDA approved stem cells from US Stem Cell. He says the stem cells came from a clinic that lost a big federal court case 9 days ago. Greenfield posted a Facebook video of the actual injection, which he narrates. There’s some text along with the video. Together they raises many troubling questions. Date of video vs. date of court ruling Greenfield says in the text describing the video that the stem cells were sent …Read More

3 min read

As I broke the news yesterday, the high-profile fat stem cell clinic firm U.S. Stem Cell (USRM) just lost a groundbreaking court case. Here is the FDA’s official reaction today to the court ruling. Also, since the ruling major media have been covering the court ruling. Here are some examples: From the Washington Post from William Wan and Laurie McGinley we have FDA wins groundbreaking case against for-profit stem cell company. Michael Hiltzik of the LA Times has a blunter headline. Backing the FDA, a …Read More

3 min read

In a precedent-setting decision, a federal court has ruled for the FDA against a key stem cell clinic firm called U.S. Stem Cell, Inc. The court granted summary judgment for the FDA in its suit seeking a permanent injunction against the Florida stem cell clinic firm. While the company is likely going to appeal, this is a major defeat for them and for the hundreds of other unproven fat stem cell clinics in the U.S. It’s a big victory for science, regenerative medicine, and patients. …Read More

4 min read

It’s been less than a year since the FDA sued for a permanent injunction against a major stem cell clinic firm in Florida, but there has been much back and forth in court filings in the lawsuit between them and the firm, US Stem Cell. Now the case is with the judge. My prediction remains that the feds will prevail, but it seems worthwhile to look at some of US Stem Cell’s arguments. Note as a sort of disclaimer that I’m not an attorney …Read More

3 min read

The year of 2018 has already been a wild one for stem cell news. There are many developments on a variety of fronts. Here are some of the most notable news bites of the last month or so. RMAT Wave. The FDA continues its warp-speed issuance of Regenerative Medicine Advanced Therapy (RMAT) designations with 20 such designations now in the public domain with Cellerant Therapeutics’ announcement and possibly a few more not yet out there. I wrote about the “carrot” of RMATs as relative …Read More

5 min read

Will the adipose stem cell clinic firms facing permanent injunction suits by the FDA — U.S. Stem Cell Inc. (USRM) and California Stem Cell Treatment Center (CSCTC)/Cell Surgical Network (CSN) — cool it in the sense of voluntarily shutting down their commercial fat stem cell injections of customers soon pending the outcomes of the suits? Or will things heat up further? In the interview I did last week with Patti Zettler she mentioned the possibility of a voluntary stop by the clinics. The more …Read More