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 …
Where Kimera Labs fits into sphere of exosome companies Read More »
Occasionally when I write a post there is an angry reaction to it in the blog comments, which was the case for my recent fact-check of the LifeWave X39 patches. As you can see in that post, I didn’t find convincing data to either back up the claimed stem cell connection. In my opinion, there …
Weekly reads: bat stem cells & viruses, Lineage Cell, He Jiankui visa Read More »
What is the cell therapy for ALS called NurOwn? How strong is its potential as a treatment for ALS? I’ve been following the biotech BrainStorm Cell Therapeutics for many years. Patients keep asking me about NurOwn ALS prospects. They’re looking for hope. Today’s post is a close look at NurOwn and at BrainStorm as a …
Does NurOwn from BrainStorm Cell Therapeutics still provide hope for ALS? Read More »
Toward the end of each year, I make stem cell & regenerative medicine predictions for the coming year. It’s a fun tradition here on The Niche that goes way back. The stem cell field has changed dramatically as reflected in each year’s predictions. Here’s a list of past predictions with my grades of how they …
2023 stem cell & regenerative medicine predictions Read More »
It’s that time of year again when I grade my previous year’s predictions for the stem cell & regenerative medicine space. Overall, I did better than a typical year. I give the 2022 predictions an A- overall. This exercise can be kind of fun but also humbling. For example, I tend to be too optimistic …
Grading my 2022 regenerative medicine predictions Read More »
I wrote recently about how political pressure on FDA Commissioner Stephen Hahn in 2020 may have helped the Texas firm Direct Biologics move their product ExoFlo forward inside the agency. Today I analyze the ExoFlo Phase I clinical trial paper used in that push on Hahn to get the firm the IND for a Phase II …
Review of ExoFlo paper used to push Direct Biologics IND inside FDA finds red flags 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 »
The big news of the week was the big FDA stem cell in court by Judge Jesus Bernal here in California, who ruled in favor of a chain of stem cell clinics called Cell Surgical Network. The FDA had been seeking an injunction against the clinics. I believe the ruling was founded in part on …
Weekly reads: CRISPR, FDA stem cell loss, pioneering AMD study, MS, Verve Therapeutics Read More »
Exosome therapy is a still-experimental cell therapy approach aimed at treating specific diseases using secretions from cells. It’s novel since most attention on cell therapies has been given to using the actual cells themselves. In addition, this approach is a newer idea than using cells as the drug to treat diseases. Interestingly, the term “cell …
Fact-checking exosome therapy: costs, risks, & lack of data Read More »
I’ve tried to find some time to do some stem cell and other regenerative medicine reading too, but it’s been a busy week of teaching for me as a professor in our new academic year for the UC Davis School of Medicine. I help to teach the Histology part of the first-year curriculum. It’s an …
Regenerative medicine reads: retraction, FDA warning, CAR-T, ARM CEO Read More »