What are the latest developments in stem cells and regenerative medicine in this first week of 2017 and right before the end of the past year? Here are some of the headlines and papers that have popped up that seem notable or surprising. Be sure to also check out our stem cell & regenerative medicine meeting hub for 2017.
You can stop taking a pill or an injection treatment, but you can’t stop or retract stem cell treatments if there’s a bad side effect.
Unlike other kinds of medicines, once stem cells have been transplanted into patients, if something goes wrong you cannot stop the ‘treatment’. There’s no retraction possible because transplanted stem cells spread in the body and potentially integrate.
One of the striking things in the commercial stem cell arena in 2016 was the emergence of patient lawsuits against stem cell clinics including two proposed class action suits. These patients, and I count potentially now more than a dozen, allege a variety of harms ranging from tumors to blindness. The reason I mention this is that there appears to be huge potential for harm to patients from unapproved stem cell therapies. I know a lot of patients who would wish they could undo what the stem cell clinic did. It’s just not possible.
Even in an appropriately regulated stem cell trial context, there’s no easy way to undo stem cell transplants. There has been talk for years about suicide genes to be inserted into stem cells to provide “a net” should something go awry with stem cell treatments, but it’s not clear how well these would work and stem cell clinics aren’t interested in that anyway.
Last week I posted my list of 2017 predictions for the stem cell field. Today a couple of days into 2017 I’m more focused on hope than realism. What would I wish for in the stem cell and regenerative medicine arena in the coming year?
More stem cell clinical trial data posted and published. There are few things as exciting as stem cell and regenerative medicine clinical trials across the full spectrum of stem cell types including adult, embryonic, and IPSC. But we need to have actual trial data be peer reviewed and published or at least posted. Clinical trial updates only by press release are not helpful to patients or the field.
Clinicaltrials.gov adapts. This vital resource of trial listings adjusts to new realities. It either filters its listings to screen out for-profit entries that aren’t real trials or it provides more practically useful information such as at a minimum clear indications of whether a listing has an IND (this doesn’t need to violate any confidentiality rules) and whether the listing requires payment as an inclusion criteria. See my interview with the leader of Clinicaltrials.gov.
FDA speaks clearly. Whatever the FDA does or does not do in terms of actual stem cell & regenerative medicine-related actions in 2017, it is clear about it. This year I hope the FDA provides concrete, consistent explanations in the public domain that don’t require an FDA-ese jargon dictionary to try to understand.
FDA and its CBER center are consistentwith good & bad citizens of the stem cell arena. The FDA has a tough job overall and its CBER branch focusing on biologics including stem cells has its own specific challenging task set. However, for years CBER has held different players in the stem cell arena to different rules and expectations. Paradoxically, essentially the better a citizen you are, the more the FDA expects from you. On the flip side, if you are for instance a stem cell clinic with no intention of following the rules (no BLA, no IND, no pre-IND, no expertise in stem cells, no data, etc.) CBER has historically generally left you alone.
Each year I make a list of predictions for the stem cell and regenerative medicine field for the coming new year. Later in this post I list my top 20 stem cell predictions for 2017. In looking at my past predictions I realized this will now be my 7th year doing stem cell/regenerative medicine yearly predictions.
You can see below links to these predictions for past years, which sometimes seems rather far removed from today and in other cases strike me as strangely apropos of our times.