The FDA took some big action last week and issued a major statement today on stem cell clinics (see my post here). I asked Dr. Mark Berman of the Cell Surgical Network if he had any statement regarding the recent action and statement from the FDA today that involved flagship network member clinic, California Stem Cell […]
Stem cell clinic group, Cell Surgical Network, fires PR back at FDA Read More »
Is the largest affiliated group of stem cell clinics in America, Cell Surgical Network, now using laboratory-proliferated stem cells in patients? Do they already have some kind of final FDA approval for this clinical approach given that lab-grown stem cells are generally viewed as drugs requiring premarket approval? Over the years I’ve reached out to
The Cell Surgical Network is a for-profit network of clinics offering various stem cell-related interventions, which began with the California Stem Cell Treatment Center. I have interviewed Drs. Elliot Lander and Mark Berman of the Network in past (Part 1, Part 2) and I raised some concerns about the network in a follow up Part 3 post,
Update on Cell Surgical Network IRB Status Read More »
I recently interviewed Drs. Elliot Lander and Mark Berman of the Cell Surgical Network. It’s an affiliated chain of clinics selling stem cell interventions for more than a dozen medical conditions. You can read Part 1 here and Part 2 here of the interview where we cover 10 important questions. Today is Part 3, where I explain why their answers
Cell Surgical Network Series Part 3: Key Concerns Read More »
Today I am posting Part 2 of my interview with Drs. Lander and Berman of the Cell Surgical Network. You can read Part 1 here, which is an interesting look inside the Network. The final portion of this blog post series, Part 3, is my take on their answers and you might not be surprised that
Cell Surgical Network Interview Part 2: SVF, FDA, & Homologous Use Read More »
The Cell Surgical Network is a large and growing group of affiliated stem cell clinics across the US. The Network providers use stromal vascular fraction (SVF) interventions for a host of conditions on a for-profit basis. Drs. Elliot Lander and Mark Berman lead the Network. They agreed to do a Q&A interview with me. Below is Part 1,
Elliot Lander & Mark Berman Interview Part 1: A Window into Cell Surgical Network Read More »
Something seems to have dramatically changed with the FDA at its Center for Biologics Evaluation and Research or CBER. Did they start handing out free Red Bull by the case? So many recent FDA warnings on cell and tissue biologics CBER is the part of the FDA that regulates regenerative medicine products like stem cells,
I’ve written before about so-called test-tube burgers and bacon and other lab grown meat. Test-tube burgers Cells like muscle and fat progenitor cells are the basis for these products. Sometimes stem cells may come into play for such “test-tube burgers” as I generally call this type of lab meat. Cost seems to be a main
Weekly reads: test-tube burgers, CRISPR for space travel, more tuft cells Read More »
I think the FDA has been holding its breath on one level for about two years. How freely could it regulate certain unproven fat cell therapies sold by more than a hundred clinics throughout the US? This authority hung in the balance. Now the agency just got a federal court ruling that could free them
FDA wins big in key federal stem cell clinic court case Read More »
One of the most contentious areas in the regenerative medicine arena is whether a fat tissue product called stromal vascular fraction or SVF is a drug. The FDA says SVF, even in autologous form, is a drug. It is seeking an injunction against a California-based network of SVF clinics but lost the initial case. That
Recommend reads: FDA SVF warning, big Aspen grant, CSI finale invokes stem cells Read More »