The year of 2018 has already been a wild one for stem cell news. There are many developments on a variety of fronts. Here are some of the most notable news bites of the last month or so.
RMATs
RMAT Wave. The FDA continues its warp-speed issuance of Regenerative Medicine Advanced Therapy (RMAT) designations with 20 such designations now in the public domain with Cellerant Therapeutics’ announcement and possibly a few more not yet out there. I wrote about the “carrot” of RMATs as relative to the “stick” of regulatory actions on risky, unproven stem cells in my perspectives piece in Cell Stem Cell a couple weeks ago. What do you think? Too many RMATs? Not enough? Just right?
Right to Try
National RTT: one quick zigzag. As of the past month, America has a new national Right-To-Try (RTT) law, which has raised numerous concerns including on the stem cell and regenerative medicine front. BrainStorm Cell Therapeutics quickly raised the possibility of offering investigational stem cell-based therapy to ALS patients via RTT, but then fairly quickly zagged to not do so. Sponsors choosing not to go the RTT route on their as yet unproven stem cell offerings may limit the negative impact of the federal and numerous state laws.
US Stem Cell
Stem cell clinic can’t shake bad news streak. There’s more bad news for stem cell clinic biz, U.S. Stem Cell (USRM), as a Florida ABC news affiliate posted an investigation.
The piece quotes one apparent part-owner of the firm, Bob Comella (pictured above in screenshot from ABC news video on the web).
There are several notable quotes from Comella including the stunner, “They were going to go blind anyway” regarding patients who lost vision via USRM-related eye injections. There’s also a, big unsupported claim in there of thousands of cures.
Yes, it appears Bob is the father of USRM’s leader Kristin Comella.
I haven’t heard any news as to the status of the FDA/DOJ lawsuit against USRM recently, but that’s percolating in the background too presumably.
MiMedx gets heat
Biotech MiMedx chaos? MiMedX has been an interesting biotech to follow over the years. On the good news side, it has got an RMAT, but there’s been a steady stream of bad news recently too. There was the bombshell this year of three VA employees being indicted allegedly for taking bribes from MiMedX. Yesterday, reportedly key leadership of the company departed. MiMedX (MDXG) is or at least was arguably the most politically connected stem cell-related biotech out there. MDXG stock has been falling off a cliff the last few months.
Broader good news. On the positive side of stem cell news, tons of cool stem cell research including some with major clinical implications continues. Here’s just one recent example of a review of such work “Macrophages stimulate mammary stem cells” from Nagarajan Kannan and Connie Eaves.
There are also many encouraging clinical trials that continue as well and I believe at least a few will succeed in producing new stem cell-related treatments that are proven safe and effective within about 5 years.
There haven’t been any new developments.
John. I think you are correct. Most of the bad news is about an old story. But for some reason the good news seems primarily to be about the “cool” stem cell research taking place. Could that reason be because Dr. Knoepfler is a researcher?
“Producing new stem cell-related treatments that are proven safe and effective within about 5 years”. Right! I’ve heard it said before that scientists are comfortable using the 5-10 year range as far as promising therapies becoming available are concerned. You see, five years is a short enough period of time to give patients and others hope. However in ten years they just forget about it. Of course these are pluripotent stem cell treatments you are talking about. Right, Dr. Knoepfler? No thanks! I’ll just stick to the regenerative clinic that I believe in with regard to safely and effectively managing my arthritis. I’ll put my money on multipotent therapies rather than pluripotent perpetual research any day of the week and twice on Sunday.
Amen!
Well $Celz is patented and going commercial with Caverstem, and has Amniostem and Spinestem in the works. No FDA or SEC issues unlike that other cone any addressed here regularly. Check it out.
Can’t you just leave USRM alone? Stock is already destroyed, and the lawsuit will continue without going on about it, day in and day out.
@John,
If there are new important developments, I will cover them now and then. The interview in the ABC story & family ties reported seemed particularly important.