Do three blinded US Stem Cell clinic patients with major or complete vision loss constitute a significant adverse outcome? I would say so and a new paper details how this happened apparently at a particular publically-traded South Florida stem cell clinic business. You can see the damaged retinas of one such patient below in an image […]
NEJM paper links 3 blinded patients to US Stem Cell clinic Read More »
Concerns over stem cell clinics allegedly causing blindness or other vision problems have been increasing in 2016. If this is in fact happening, the extra sad part of this is that some clinics have claimed that they are doing the opposite: improving vision in patients. What are the concerns? Earlier this year a publicly-traded stem
2nd lawsuit alleging a U.S. stem cell clinic caused blindness Read More »
What’s better for stem cell trials such as for vision loss or Parkinson’s Disease: allogeneic or autologous cells? In a major shift earlier this year, the induced pluripotent stem (IPS) cell trial in Japan for treatment of macular degeneration (MD) switched gears from using the patients’ own cells (called “autologous”) to using banked cells from
Parkinson’s IPS cell trial in Japan switching to allogeneic Read More »
StemCells Inc. is a top biotech company developing stem cell-based therapies. They have a deep pipeline that includes already ongoing trials for a variety of diseases. I invited company leadership to do an interview and they graciously accepted. Below is the interview with CFO Greg Schiffman (picture at left from LinkedIn) including what I thought
Interview with StemCells Inc. leadership on hot topics Read More »
The FDA has given Advanced Cell Technology (ACT) the go ahead to begin their clinical trial using retinal progenitor cells derived from hESC by clearing the company’s IND application, bringing hope to those with vision loss and even blindness. The trial will be a combined Phase I/II to treat Stargardt’s Macular Dystrophy and has huge
The FDA just warned a Florida stem cell clinic firm called Mother Stem Institute run by Dr. Alvaro Skupin. Background: Mother Stem Institute past issues I’ve written about this clinic and Dr. Skupin in the last few years. Just about a year ago I blogged the news that a patient suit against the clinic was
FDA warns Mother Stem Institute & Alvaro Skupin Read More »
Nevada has a relatively new 2023 law legalizing non-FDA-approved biological and gene therapies. I use the word “therapies” here loosely. They are not scientifically or medically proven to work or be safe so they could lead to substantial harm. This is yet another early step in a likely growing trend of states challenging FDA authority
Each year I make predictions for the stem cell and regenerative medicine field for the following year. Today’s prediction post is focused on what to expect in 2024. You can also see my stem cell predictions for 2023 and my grades on how I did. I also have made a video version of these predictions so please
20 stem cell & regenerative medicine predictions for 2024 Read More »
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
3rd Invitrx warning highlights FDA oversight weakness Read More »
An FDA FOIA dump of text messages of former Commissioner Stephen Hahn suggests that a Texas regenerative firm called Direct Biologics benefited from political pressure on him in mid-2020. Then he was asked again to help in early 2021. This was shortly before he resigned at the start of the Biden Administration. The push came from
FDA leader Stephen Hahn was pressured to aid Texas firm Direct Biologics Read More »