Two new FDA inspection reports called 483s provide fresh insights on a stem cell clinic, the network of clinics that it belongs to, and adverse events in patients. These reports detail issues the FDA found at the stem cell clinic California Stem Cell Treatment Center and its parent chain of clinics, Cell Surgical Network. The […]
New FDA Inspection 483s: Insights on Stem Cell Clinic & Cell Surgical Network Read More »
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 »
The U.S. Supreme Court could soon have a historic opportunity to limit the scope of FDA stem cell oversight. A large stem cell clinic firm now says it plans to ask SCOTUS to review a case it recently lost on appeal to the FDA. If SCOTUS takes the case, the FDA could find its powers
FDA stem cell oversight at risk as clinics to ask SCOTUS to weigh in Read More »
Did you predict the major events in the stem cell and regenerative medicine field this year? I tried and today’s post are the grades on my predictions. Prediction is a key part of being a scientist even if we may not think about it that much. For instance, we have to try to predict what
Grading my 20 stem cell & regenerative medicine predictions for 2024 Read More »
Toward the end of each year I make predictions for the stem cell and regenerative medicine field for the coming year. I’ve been doing this for more than a dozen years in various forms. In this post I’m looking at the (gene-edited, stemness enriched) tea leaves for 2025 for the regenerative arena. These predictions include
25 stem cell & regenerative medicine predictions for 2025 Read More »