ARI did not fail to produce anything, they failed to produce enough consistency.
How many patients is Dr. Nigam throwing at the wall to produce a few that stick?
It isn’t just that ARI didn’t produce results consistently in all test subjects; it’s also that ARI’s results were unimpressive even when the treatment did work. On the other hand Dr. Nigam’s pictures indicate he’s able to regrow more hair.
[quote]Everyone here has seen the before and after photos of ARI’s test patients and Dr. Nigam is getting much better results and I would like some help figuring out why.
[postedby]Originally Posted by cal[/postedby]
ARI did not fail to produce anything, they failed to produce enough consistency.
How many patients is Dr. Nigam throwing at the wall to produce a few that stick?[/quote]
[quote]well, Roger there is the important similarity between Dr. Nigam’s treatment and ARI’s treatment that they are both culturing cells and injecting those cultured cells back into the balding areas of the scalp.
Can you please list some specific reasons why Dr. Nigam’s cellular cultivation/re-implantation would produce dramatically improved results where as ARI’s treatment won’t? One thing you’ve already said is that Dr. Nigam’s allowed to “cultivate stem cells and progenitor cells beyond a couple passes.” what exactly does that mean? Also, please elaborate on any other reasons why Dr. Nigam’s hair cell cultivation/re-implantation is different from ARI’s.
[/quote]
Jarjar, focusing on the similarities is misleading because LOTS of researchers and clinicians have been doing things with cells for a long time, and haven’t produced demonstrably great results. Not just Aderans, but Replicel, Intercytex, Bioamide, Gho, Unger (you may not remember him, but this doctor in Canada was doing serious clinical experimentation with DP cells for a long time, and finally admitted he failed)… there are others on the list, too.
What I mean is exactly what I say. There are most likely CRITICAL differences between Dr. Nigam’s work and what ARI was able to do. Focusing on the similarties only, or over-emphasizing the similarities, gives a completely wrong impression and distracts you from understanding the differences.
Dr. Nigam has already said very clearly, several times, that in India he is able to CULTURE STEM CELLS AND PROGENITOR CELLS. (I haven’t confirmed that he is actually doing this, of course, but we are all basically taking his word for it here…)
In any event, it is not regulated in India as it is in the West.
This is the key. Don’t get distracted by all the vague “similarities”…
The issue about the number of “passes” is something which is a technicality that different countries and regulatory regimes put into their regulations.
It’s about how many generations of cell replications a researcher is legally allowed to perform in the laboratory.
The thinking of the regulators is that if a clinician or researcher tries to culture [prohibited] stem cells or progenitor cells beyond a certain [very low] number of passes (generations), it means he/she is aiming to use them clinically, which is categorically prohibited by law in these countries without having express permission from the government, and that permission is VIRTUALLY IMPOSSIBLE TO GET, reguiring what amounts to many years of very expensive regulatory review and intense scrutiny.
And that would include a company like Aderans/ARI as well. When I say “VIRTUALLY IMPOSSIBLE TO GET”, I am clearly including the mighty Aderans/ARI in that lot. I believe that if the FDA had ever eventually granted them permission to work with hair follicle stem cells or progenitor cells, we would have heard it clearly from them, in a press release.
But we never heard that!
You have to remember that when they first began (and submitted their initial application for clinical trials), their “protocol” had NOTHING TO DO WITH CULTURING STEM CELLS OR PROGENITOR CELLS.
I believe that never changed.
Their permission was only about DP cells, keratinocytes, and possibly different types of fibroblasts. It actually started out, I believe, with DP cells alone.
None of these cells are considered of the “pluripotent” variety like stem cells and progenitor cells. So they government does not consider culturing them, or using them clinically, as inherently dangerous. (Some people may argue with me and say that DP cells are pluripotent. The point is they’re not VERY pluripotent, like stem cells and progenitor cells, therefore injecting them is not considered by government regulators to be fundamentally “risky”.)
Therefore it was not extremely difficult for companies like Aderans/ARI and Intercytex to get approval from their respective governments to run clinical trials for DP cells, keratinocytes, and fibroblasts.
I repeat: THE ADERANS/ARI, REPLICEL, and INTERCYTEX clinical trials were NOT about stem cells, nor about progenitor cells.
Is this clear??
Has anyone even confirmed what the regulations are in India on this kind of research? I think someone simply claimed this at some point and we have been taking this at face value. Might be worth investigating.
Secondly, if it turns out to be true that Indian regulation is so much more lax than in western europe/US the question arises, why western companies conducting such research do not outsource their facilities to India where their research would be legally much less restrained.
To be honest, I want to believe that Dr Nigam is actually doing what he claims, but the burdon of proof is still upon him, imho.
[quote]well, Roger there is the important similarity between Dr. Nigam’s treatment and ARI’s treatment that they are both culturing cells and injecting those cultured cells back into the balding areas of the scalp.
Can you please list some specific reasons why Dr. Nigam’s cellular cultivation/re-implantation would produce dramatically improved results where as ARI’s treatment won’t? One thing you’ve already said is that Dr. Nigam’s allowed to “cultivate stem cells and progenitor cells beyond a couple passes.” what exactly does that mean? Also, please elaborate on any other reasons why Dr. Nigam’s hair cell cultivation/re-implantation is different from ARI’s.
[postedby]Originally Posted by roger_that[/postedby]
Jarjar, focusing on the similarities is misleading because LOTS of researchers and clinicians have been doing things with cells for a long time, and haven’t produced demonstrably great results. Not just Aderans, but Replicel, Intercytex, Bioamide, Gho, Unger (you may not remember him, but this doctor in Canada was doing serious clinical experimentation with DP cells for a long time, and finally admitted he failed)… there are others on the list, too.
What I mean is exactly what I say. There are most likely CRITICAL differences between Dr. Nigam’s work and what ARI was able to do. Focusing on the similarties only, or over-emphasizing the similarities, gives a completely wrong impression and distracts you from understanding the differences.
Dr. Nigam has already said very clearly, several times, that in India he is able to CULTURE STEM CELLS AND PROGENITOR CELLS. (I haven’t confirmed that he is actually doing this, of course, but we are all basically taking his word for it here…)
In any event, it is not regulated in India as it is in the West.
This is the key. Don’t get distracted by all the vague “similarities”…
The issue about the number of “passes” is something which is a technicality that different countries and regulatory regimes put into their regulations.
It’s about how many generations of cell replications a researcher is legally allowed to perform in the laboratory.
The thinking of the regulators is that if a clinician or researcher tries to culture [prohibited] stem cells or progenitor cells beyond a certain [very low] number of passes (generations), it means he/she is aiming to use them clinically, which is categorically prohibited by law in these countries without having express permission from the government, and that permission is VIRTUALLY IMPOSSIBLE TO GET, reguiring what amounts to many years of very expensive regulatory review and intense scrutiny.
And that would include a company like Aderans/ARI as well. When I say “VIRTUALLY IMPOSSIBLE TO GET”, I am clearly including the mighty Aderans/ARI in that lot. I believe that if the FDA had ever eventually granted them permission to work with hair follicle stem cells or progenitor cells, we would have heard it clearly from them, in a press release.
But we never heard that!
You have to remember that when they first began (and submitted their initial application for clinical trials), their “protocol” had NOTHING TO DO WITH CULTURING STEM CELLS OR PROGENITOR CELLS.
I believe that never changed.
Their permission was only about DP cells, keratinocytes, and possibly different types of fibroblasts. It actually started out, I believe, with DP cells alone.
None of these cells are considered of the “pluripotent” variety like stem cells and progenitor cells. So they government does not consider culturing them, or using them clinically, as inherently dangerous. (Some people may argue with me and say that DP cells are pluripotent. The point is they’re not VERY pluripotent, like stem cells and progenitor cells, therefore injecting them is not considered by government regulators to be fundamentally “risky”.)
Therefore it was not extremely difficult for companies like Aderans/ARI and Intercytex to get approval from their respective governments to run clinical trials for DP cells, keratinocytes, and fibroblasts.
I repeat: THE ADERANS/ARI, REPLICEL, and INTERCYTEX clinical trials were NOT about stem cells, nor about progenitor cells.
Is this clear??[/quote]
Dr. Nigam himself has stated that here several times, plus he also stated it very clearly in an extremely detailed message to me including a lot of relevant information that he has not stated on here.
Increasingly US and Western pharmaceutical companies ARE starting to do clinical trials in countries like India and China, but this trend is still in its infancy, so to speak, and since the number of actual companies that are testing cell therapies for hairloss is still exceedingly small, we still can’t expect a massive flood of this kind of activity into India just yet. Plus, maybe it only recently occurred to ARI that they were probably never going to get great results only with DP cells, keratinocytes, and fibroblasts. But by the time that really occurred to them, Aderans decided to pull the funding. So, they were behind the curve.
OK, I’ll forgive that kind of question if you don’t have a big background in biology.
I don’t have a highly technical, scientifically detailed answer to that question, but I’m familiar enough with the subject matter to say quite categorically that it is at least a very reasonable assumption given everything I know. Suffice it to say that there are enough fundamental, HUGE differences in the properties of stem cells as opposed to say, DP cells, that it is more than enough to expect that HF stem cells (or the closely related progenitor cells, which are like activated HF stem cells) would have much better hair-inducing properties than simply DP cells or fibroblasts.
If you want a detailed understanding of the “why”, I suggest you begin the long climb towards studying everything available about human biology, embryology, endocrinology, genetics, cell biology and biochemistry now, because to get a grasp of why this might be possible, you have to start from the ground up in understanding what a cell is, how cells interact, how biochemical signalling works, what the role of stem cells is in the body and in different organs, and how stem cells are different from regular somatic cells. After you’ve reviewed all that material, then read some of Dr. Cotsarelis’ (and other researchers like Dr. Christiano) research papers, particularly on HF stem cells and HF progenitor cells.
I can’t explain all this in a post on HairSite. If you want to understand it, either start studying the stuff yourself, or ask some willing scientist or biology professor who will take the time to tutor you in the subjects.
I explained the issue of “number of passes” in a response to Jarjar.
This is just one part of some critical differences between ARI and Dr. Nigam which if it’s not immediately evident to people, then I have to assume their understnading of cell biology is virtually nil, i.e., just what they’ve casually gleaned from interacting with people on the internet.
A “passage” or shorthand: “pass”, is a term used in laboratory cell culturing.
“A passage number is the number of times a cell culture has been subcultured, and knowing the passage number can make or break an experiment.”
Very true. See this website…
http://cellculture.bitesizebio.com/articles/cell-culture-passage-number-explained/
You also have to understand that stem cells/progenitor cells are VASTLY different in terms of properties, role, and interaction with other cells than DP cells, keratinocytes, and HF fibroblasts are.
Regardless of what your understanding level is in human biology and cytology, if you can’t comprehend that or at least acknowledge it, then you really need to read up on these things and prepare to be confronted with these kinds of concepts, before you can absorb any type of relevant information on the subject.
People want easy “silver bullet” answers to their questions, when no such quick-and-dirty answers exist. Much of my understanding comes from years studying this stuff in university and grad school classes. I don’t mean to dismiss those who haven’t studied this stuff, but there are no simplistic answers.
I get your point about how and why the cells that Dr. Nigam is using are different from the cells that ARI was using…a lot different.
Where is Follica doing trials right now on humans?
Can anyone show us even one article, paper or link that indicates they are currently conducting human clinical trials? What are they trialing?
I’m sorry, I’ve been out of the loop lately because of family matters, so maybe I missed something.
Thanks…