Search Results for: peter marks

FDA Regenerative Medicine Advanced Therapy RMAT designations jump to 36

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Peter-Marks-Regenerative-Medicine-Advanced-Therapy-Designation-RMAT-

This post includes my updated list of firms/products that have received FDA regenerative medicine advanced therapy designation or RMAT, which are in the public domain. The numbers really jumped in the last month. I’m assuming for the purposes of this resource page that all self-reports are accurate. Note that the links embedded into the firm […]

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Permanent injunction on clinic firm US Stem Cell is big blow to fat clinics

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US-Stem-Cell-Clinic-2

Today the United States District Court of the Southern District of Florida entered a permanent injunction against stem cell clinic firm US Stem Cell and co-defendants including U.S. Stem Cell Clinic. Patients have been harmed by the unproven treatments sold by these firms. US Stem had lost the case a couple weeks back, but now

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FDA cautions R3 Stem Cell & 50+ stem cell clinic affiliates

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R3-Stem-Cell-testimonials

Today the FDA put an Arizona firm called R3 Stem Cell, LLC and its leader Dr. David Greene on notice that what they and 50+ affiliates centers are selling in the way of stem cells were not approved by the agency. R3 Stem Cell markets perinatal (birth-related) stem cell offerings on its website. There’s a

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Perspectives: FDA warns umbilical firm & continues stream of “mini-warning” letters

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umbilical-cord-blood, umbilical cord blood stem cells

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

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Take-homes from new FDA NEJM stem cell piece including surprises

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Peter-Marks-Scott-Gottlieb-FDA

FDA Commissioner Scott Gottlieb and CBER Director, Peter Marks, have just published a new piece on stem cells and regenerative medicine in the New England Journal of Medicine (NEJM). What are the core points here and what can we learn from reading between the lines a bit? There are some expected things and then some

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FDA Issues 1st Stem Cell Warning Letter of 2018 to American CryoStem

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SVF2

The FDA started off 2018 with a bang on the direct-to-consumer stem cell clinic front with a warning letter on January 3rd to American CryoStem, a firm involved in processing and distributing adipose stem cells. The company’s ATCELL™ adipose stem cell product was the focus of much of letter. The FDA indicated in the warning

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Mesoblast gets FDA RMAT; List of 10 total designations so far

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Mesoblast-e1514313188176

Australian stem cell biotech Mesoblast announced that it has received regenerative medicine advanced therapy (RMAT) designation from the U.S. FDA. This is very good news for the company and an encouraging development for the field. Interestingly, last month the FDA clarified that there is expanded RMAT designation that can include gene therapies too. At the Meeting

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Mapping & driving the stem cell ecosystem: key points of my new paper

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stem-cell-ecosystem

When you think of an ecosystem, do you imagine something like a forest or jungle full of different organisms? I usually do, but over the last few years I’ve also been thinking about this concept in a different way. I’ve been viewing the broad stem cell arena as an ecosystem. In that spirit, I’ve recently

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Samantha Yammine: Multiple filters for stem cell research at Canadian stem cell conference

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stem-cell-pictures

By Samantha Yammine, PhD Candidate in Derek van der Kooy’s lab at the University of Toronto. See tweets live from #TMM2016 via @SamanthaZY here. Last week, 430 Canadian scientists, trainees, industry professionals, science communicators and international guests gathered in the picturesque ski town of Whistler, British Columbia for the annual Till & McCulloch meeting (TMM).

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