February 28, 2021

Regenerative reads: brain organoids, Clinicaltrials.gov change

Regenerative reads: brain organoids, Clinicaltrials.gov change


Sometimes change takes a very long time, but with brain organoids or advocating for better information for patients at Clinicaltrials.gov, after waiting you can see some interesting developments.  These are two of the regenerative medicine stories of the week, along with some striking research papers.

Clinicaltrials.gov

Some of us have been advocating for improvements at Clinicaltrials.gov for a long time. Stem cell clinics selling unproven injections have been using Clinicaltrials.gov as a marketing tool. For many years the government website run by NIH was unable to do much about it.

Regenerative reads: brain organoids, Clinicaltrials.gov change
Clinicaltrials.gov warning about stem cell clinics accompanying searches for stem cell trials.

You can see this early interview I did with the past Director of Clinicaltrials.gov Deborah Zarin that first identified some of the problems.

Now the site has a new feature where if you search for stem cell-related trial listings a cautionary box pops up (see screenshot). What’s so good about this box is that it directs the searcher (often patients) to FDA warnings about stem cell clinics.

Way to go, Clinicaltrials.gov. A needed additional tweak is to have the warning box pop up when searches look for trials specifically from stem cell clinics. When I did a few test searches for trials by clinics selling stem cell interventions their listings popped up without the warning box.

Note that UC Irvine has a helpful video tutorial on Clinicaltrials.gov, which I’ve pasted below.

Long-term brain organoids

Brain cell clusters, grown in lab for more than a year, mirror changes in a newborn’s brain, Science, Kelly Servick. The big deal here is the report that older organoids have some features of later-stage developing human brains.

Here’s the original Nature Neuroscience paper: Long-term maturation of human cortical organoids matches key early postnatal transitions.

Regenerative reads: brain organoids, Clinicaltrials.gov change
Brain organoids grown for almost a year have similarities to aspects of fetal brain development. S. Pasca Lab at Stanford.

You might find my journal club-like review of last week’s Neanderthal brain organoids paper interesting.

The way things are going just 2 months in, I probably should have included brain organoids make big news again as a prediction among my 20 predictions for the stem cell and regenerative medicine field in 2021.

Media including on CNS disease

Yale scientists repair injured spinal cord using patients’ own stem cells, Yale News. This one is a problem. It is premature to claim “repair” here. The key phrase is “Results were not blinded and there were no placebo controls.” Also, the rationale doesn’t seem clear. Overall, I’d say there’s not much there yet. Let’s see how this develops with more data.

The biotech Brainstorm gets another headache. After FDA feedback, a biotech’s ALS therapy faces murky path forward. Adam Feuerstein has more on this on STAT+.

Other notable pubs



Click Here To read Original Story