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 …
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 »
It was a shock to learn today that New York Stem Cell Foundation CEO and Co-Founder Susan Solomon had passed away yesterday after a long battle with ovarian cancer. I met Susan a few times over the years and was always struck by her positive energy. At a practical level she got big things done …
Tributes to NYSCF leader & stem cell advocate Susan Solomon Read More »
Over the past dozen years as I’ve written about stem cell clinics here on The Niche I’ve gotten to know many of those running the clinics including Dr. Mark Berman of Beverly Hills. It was therefore kind of a shock to learn that Berman died of last month. Michael Hiltzik of the LA Times reported …
Thoughts on death of stem cell clinic leader Dr. Mark Berman Read More »
One of the most interesting parts of running a website like The Niche is that reader’s questions can sometimes be so striking including recent ones on human cloning. They got me thinking about cloning again. Human cloning & loss of a loved one: things to consider Several readers have recently asked about whether human cloning …
If you lost a loved one, could you turn to human cloning? Read More »