Yup, people are just jaded/biased because this specific industry has been a dead zone for new approvals for so long with companies struggling for funding or posting clinically insignificant results. Once a company gets a product into a clinical setting and the results/safety are good and funding is available, the product can hit the market pretty quickly (ie 2-3 years).
Hair Multiplication/Cloning Human Trials 2023: Yokohama National University
- Thread starter trialAcc
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I expect failure. I'm hopeful but I expect replicel levels of failure.
I dont blame them for being jaded. We've heard the cure is around the corner for over 20 years. They've had articles about hair cloning in 1999. So the idea was around for over 20 years and where are we? Nowhere. A lot of these articles you see today about "scientists may have found a cure" are always articles from a university paper and the reality about a lot of these studies is that they are mostly BS.
See:
A lot of these studies are tweaked because they have to publish something or no tenure.
99% of the time studies don't actually find what the clickbait headlines in the media say they do. We are not at the same place we were in 1999. So much has been learned since then. There are proteins that are important in hair follicle biology which weren't even known to exist in 1999. Prolactin's role in hair loss has only slowly been revealed over the last 20 years and we didn't have any way to manipulate that until the last few years. Now a prolactin antagonist is entering phase II trials over the next few months.
agree
If you have a drug on hand, then its not uncommon it takes +10 years to get it to market.
Sure regenerative medicine got a "fast track" but its still takes many years to get from discovery to a phase 2 conditional market release. We still have to see a treatment going from discovery to conditional market release within 5 years.
Are we then taking FDA approval into account, and condense that down to ONLY clinical trails, we are talking +5 years. We also need to take into account that FDA needs to do final approval which takes almost a year (if you are a "Priority Review", so we are beyond +6 years. All of this if it all the stars aligns and no problems are met during the trails, like all test subjects are available on day 0 (which they rarely are), supply chain is consistent, and data analysis take 1 day and we do all clinical days back to back, and again have test subjects on day 0.
So the rule of thumb with +10 years isn't far of. And that is, when its almost smooth sailing.
I'm not sure you understood my post. The rule of thumb is 10 years from drug discovery, not ten years from start of clinical trials. From phase I it is 5-7 years for drugs, and less for regenerative medicine. We are almost to phase I with multiple HM treatments, so it won't take over 10 years for one of them to finish. That is being insanely pessimistic.
Well who do we have that is within your timeframe?
All i know within hair regenerative is Replicel, and they are way beyond 7 year mark, and they have done already one phase 2 trial, and is on their second phase 2 trial for conditional market release.
10 years is not pessimistic, frankly speaking is very optimistic
Replicel is the company you're always defending so don't use them as an argument. I'm the one who wrote them off long ago as ineffective. Stemson and Tsuji's trials won't be failures like Replicel's, you can't seriously compare these hair multiplication companies to Replicel's garbage injections.
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You can write off whoever you want to.
But facts are, Replicel does human trials, Stemson and Tsuji is not even on the doorstep to do any kind of human trials.
We know that Tsuji took 7 years to establish a supply chain, and that was in a period when they didn't even do human trials.
Stemson, is what, starting to do human trials? no only animal trials.
I'm still waiting for your example for your own timeline. Someone bringing their regenerative treatment to market within 7 years.
Something like PRP, af from the 1970ties and is just being widely used in the start of 2010ties.
So please do share your extensive knowledge and history for regenerative medicine coming to market within those 7 years of clinical trials.
You're an idiot, that's all I have to say. I've never communicated with a Dane with such poor English skills.
You have very strong arguments for your 7 years timeline.
I mean, CRISPR didn't even really exist 7 years ago (I think the original paper was published in 2012 or 2013) and there are almost a dozen approved uses of it the USA with many more on the doorstep. So, there is your proof lol. That's pre-clinical discovery, IND enabling, human trials and NDA approvals in 7 years for regenerative medicine.
crispr is never going to be industrialized, it have been written in many papers. And yes cripsr with unveiled in 2012, but have of course been underway many years before that.
But crispr is gene editing you literally go in and edit in the DNA string. Its a method, not a treatment.
Okay, I agree with @pegasus2, you don't really have any clue what you're talking about. CRISPR is already industrialized, I literally just told you there are over 10 approved products with it in the USA right now. And no, it wasn't "underway" many years before that, until the late 2000s scientists had no idea it could be used to edit DNA. There were no pre-clinical CRISPR programs in the 2000s.
It certainly has roadblocks to being used in more complex situations, but that's not really the point here.
He asked for examples of regenerative medicine being approved in under 7 years, I gave him 12 examples.
Crispr is a technique and still not a treatment, it makes no sense what you are point out. Crispr is a "dna scissor" not a treatment, you wouldn't call scissors a treatment would you?
I think you don't understand the term "industrialized". And now that we have established that crispr is a "dna scissor" then we can look at the other problem that crispr carries with it.
Off-Target Effects
A major concern for implementing CRISPR/Cas9 for gene therapy is the relatively high frequency of off-target effects (OTEs), which have been observed at a frequency of ≥50%TALEN VS Crispr
“With CRISPR, you’ll start seeing cutting where you want; and as you increase, you’ll see more efficacy as the frequency goes up,” explains Sourdive. “But then, after a certain amount of product, you’ll start seeing off-target cleavage somewhere else.”
These off-target effects happen one of two ways. First, guided RNA isn’t discrete, as it can match different DNA sequences, and second, Cas9 can recognize other RNAs and use them as well. Effectively, neither the RNA nor the enzyme are 100% specific. To make matters worse, these effects are not detectable.
As a result, CRISPR is less efficient than TALEN when it comes to scaling up edited genomes so it will not be a satisfactory method when it comes to industrialization. As Sourdive told us, TALEN’s precision preserves yields quite well.
Remarking on the high rate of off-target effects, a director at the prominent UK fund, Syncona, noted that “after editing with CRISPR, you need to sequence all the cells to verify off-target effects, which becomes super complicated. CRISPR is good for screening, but this is not useful once the product is in development.” His fund reportedly thought long and hard about investing but ultimately passed on the opportunity. It recognized an “enormous opportunity” in agriculture but wasn’t confident in health.
We are talking about the topic....
Alright, you're being ignored, this is a ridiculous conversation.