Search Results for: lawsuit

Suit against Dr. Alvaro Skupin & Dra Nancy Alvarez over blinding at clinic is settled

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Dra Nancy Alvarez, Alvaro Skupin

A patient who got scientifically unproven and non-FDA-approved stem cells from Dr. Alvaro Skupin, filed suited against him, his wife who is often known as Doctora Nancy or Dra Nancy Alvarez, and associated businesses. These firms include the stem cell clinic known as Mother Stem Cell Institute in Florida, where the injections apparently took place. […]

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FDA warns more perinatal cell therapy firms: RenatiLabs & Cell Genuity

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Dr. Leonid Macheret, FDA warning

Starting last year the FDA has focused much of its cell therapy oversight resources on birth-related firms, including both clinics and suppliers. The latest warnings went to RenatiLabs & Cell Genuity. Warnings to unproven perinatal cell therapy firms Earlier this summer the agency warned Regenative Labs. There have been quite a few letters to others in this

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Did US Stem Cell Clinic defy FDA injunction? New injured patient suit sparks questions

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Dr. Antonio E Blanco MD, US Stem Cell

It feels like I’ve been writing about the Florida clinic US Stem Cell for a very long time. The FDA has been aware of them for about as long. It was only after reports of patient injuries that the FDA at last took action on US Stem Cell and its subsidiary US Stem Cell Clinic. Several

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Weekly reads: BioCardia, HeLa suit, illegal bio lab in CA

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mesenchymal cells

A days ago the news came about Mesoblast not getting FDA approval for its MSC product for GvHD. The MSC area has had a rough few years with various clinical trials including for COVID. The “stem cells for heart disease” arena has also had a tough time. Here’s more news along these lines: BioCardia pauses enrollment in PhIII trial

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Review of where Kimera Labs fits into sphere of exosome companies

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Kimera labs exosome

Today’s post takes a close look at the exosome manufacturer Kimera Labs in the context of the main exosome companies. What are exosomes? Exosomes are microscopic bubbles or vesicles produced by cells. Exosomes contain many cellular substances that are biologically active. Some of these materials may be helpful clinically, while others could pose risks. Clinical outcomes

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Superior Healthcare stem cell clinic to pay $250K+ in AG settlement

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Justin-Paulk-a-defendant-in-suit-by-Georgia-AG-for-alleged-stem-cell-clinic-violations.

State regulators are starting to catch up with stem cell clinics and Georgia is a hot spot at the moment with a firm formerly known as Superior Healthcare now getting a large monetary hit. It was just a couple of weeks ago that we heard that a Georgia court in a different case sentenced a

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3rd Invitrx warning highlights FDA oversight weakness

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The FDA seems oddly slow in oversight of unproven stem cell clinic-related firms like one here in California called Invitrx Therapeutics. I’ve written before about Invitrx, but interactions between them and the FDA have continued including a new warning letter. It’s become a puzzling situation. More broadly, the FDA has done relatively little in the past

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