Search Results for: exosomes

FDA letters to Chara Biologics & Evolutionary Biologics continue its unprecedented slew of warnings

Dr. Joy Kong, Chara Biologics, Chara Health

What is Chara Biologics? Why did the FDA just warn them and another firm? FDA’s CBER keeps up fast pace of warnings Before we get into that, the FDA biologics branch, CBER, has more generally kept up an unprecedented pace of warning letters over the past 13 months. I wrote late last year how 2024 […]

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Stem cell therapy side effects & risks at clinics

stem cell therapy side effects, stem cell risks

What are possible side effects of stem cell therapy ? Patients often reach out to ask about such risks They usually refer to unproven stem cell clinics. Today’s post addresses the scope of stem cell therapy side effects and risks based on available hard data. It’s also important to discuss possible unknown risks. Stem cell

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Weekly reads: NIH freeze even before RFK confirmation, FDA warnings, RP stem cell trial data

NIH freeze

RFK isn’t even confirmed as HHS Secretary and things are going south already with an NIH freeze. What do I mean? NIH freeze could do lasting damage to biomedical research The Trump Administration has frozen many NIH processes including meetings such as study sections that evaluate grant proposals. No study sections means almost no new

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Updated 2025 List of FDA-Approved Cell and Gene Therapies

FDA

What are the current FDA-approved cell and gene therapies? How many of those involve true stem cells? Many of us have wished for a more specific list of FDA-approved stem cell therapies. Patients and fellow scientists often asked me about such lists. They even wish for annotated lists. For that reason, I’ve made and kept

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Grading my 20 stem cell & regenerative medicine predictions for 2024

Stem cell, crystal ball, predictions

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

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25 stem cell & regenerative medicine predictions for 2025

regenerative medicine, stem cell predictions

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

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QC Kinetix review: concerns on huge regenerative clinic chain

Tyler Vail, QC Kinetix

QC Kinetix is a relatively new regenerative clinic brand in the U.S. selling unproven cell therapies. I see several specific red flags including a class action lawsuit. They report having 150+ locations, making it potentially the largest chain of unproven clinics in the U.S. Collectively, these clinics could be seeing tens of thousands of customers.

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Weekly reads: cancer stem cells, encouraging findings, Trump & NIH, proteomics

Liver cancer stem cells, cancer stem cells

Cancer stem cells are stem cell-like cells in many tumors that are key contributors to the ability of tumors to persist and recur after treatment. For those reasons, they are also thought to be major targets, including of emerging therapies. Data also suggest that some therapies may create new types of cancer stem cells leading

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Capricor seeks FDA approval of deramiocel for Duchenne based on encouraging data

Linda Marbán, Capricor

The cell therapy biotech Capricor recently released new data from their Duchenne Muscular Dystrophy (DMD) trial work. The data have generated excitement in the patient advocacy community. The stock has skyrocketed. How exciting are these new data? CEO Linda Marbán is quite upbeat and I think it’s justified. The firm is now seeking FDA approval

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FDA’s CBER fires off 3 more warning letters on cellular biologics for a total of 12 in 2024

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,

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