August 9, 2020

The Niche

Knoepfler lab stem cell blog

Month: April 2019

3 min read

The New York State Attorney General (AG) filed suit this week against a Manhattan stem cell clinic. It’s a landmark case. The defendants are Image Plastic Surgery, LLC, Park Avenue Stem Cell, and Joel B. Singer, M.D. The clinic markets adipose stem cell injections for a variety of health conditions. Park Avenue Stem had belonged to the clinic chain Cell Surgical Network, which itself is facing both a federal lawsuit seeking a permanent injunction and a patient lawsuit naming them as a co-defendant.  An …Read More

2 min read

Yesterday we learned that the FDA issued a warning letter to the cord stem cell firm, Cord for Life. In this warning, the FDA indicated that the firm’s product is actually a drug product and lacks necessary pre-market approvals. In addition, the agency highlighted apparent deviations from CGMP practices. The most important part of the warning letter is the clarity it brings that, yes, allogeneic umbilical cord stem cell and other perinatal stem cell products generally are drugs requiring a cleared IND and a …Read More

3 min read

Some unproven stem cell clinics just make things up, but when a big medical organization like Seattle’s largest nonprofit health firm, Swedish Medical Group, has a marketing segment on TV with what in my view are odd and inaccurate claims related to regenerative medicine, the negative impact could be far greater. The segment in question was a sponsored content piece on KING 5 TV, essentially a medical ad for unproven stem cells and regenerative medicine. In my original post I list what I see …Read More