If its not FDA approved, it won't make it to USA and will need to go through the FDA's labyrinth and years (decades?) long clinical trials before they approve it.
You're better off by taking your money and spending it in another country; it'll be cheaper, you'll get it faster, despite the cost of a flight you'll still save money and get a small vacation out of it too.
You want change in USA and the FDA? You'll let them know with your wallet, that's where it will hurt them most.
Clinical trial starting using Jahoda's method !
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It is possible that a remodeling process after DP spheroid transplantation may reshape or resize the DP spheroid during HF regeneration, leading to variation of thickness of regenerated hair. Further work to mantain the integrity of implanted DP spheroid, such as modification of the extracelular matrix or enhancement of the extracellular adhesion, may help to control the size of regenerated HFs.Study Conclusion
We characterize the effect of hydrophilicity on DP cells by varying ethylene and vinyl alcohol content in polymer substratum. We developed a method for scalable production of controllable DP spheroids from rat and human cells. For DP spheroids from each cell origin, efficiency of HF regeneration is progressively enhanced by encreasing size/cell number in each microtissue. However, the size of regenerated hairs seems to be stochastic and does not correlate with size/cell number in DP spheroids transplanted.
Also of note is that, in our experiment, we used new born mouse keratinocytes from the trunk for HF induction in hair regeneration assay. The trunk pelage hair from mice is thinner than rat whiskers and human scalp terminal hair. In feathers it has been shown that origin of keratinocytes can affect the final architecture of regenerated follicles. It is possible that in our conditions new born mouse keratinocytes play an instrucitve role in determining the final thickness of hair fibers, and both human and rat DP spheroids regenerate hairs thinner than that of the original follicles where DP cells were derived.
(...)It has been shown that specific morphogen singaling pathways, such as BMP, noggin, Wnts/b-catenin, etc. are able to affect the size of follicles in the developmetnal stage. In combination with the ability to control DP spheroids size reported here, we will be able to test whether we can control the size of regenerated HFs through manipulating this signaling pathways in DP spheroids.Leave a comment:
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If it works will it still need FDA approval or not? Cause this basically isn't a medication you take, but rather cells from yourself that are cultured and being injected, so no harm done, right?Leave a comment:
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Obviously they have either solved that issue in theory or at least come up with some promising ideas. Why should they suddenly start their trials on 400 humans' scalps without having any new knowledge?Leave a comment:
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So there's more to the equation than only increasing size and amount of cells translplanted.Study Conclusion
We characterize the effect of hydrophilicity on DP cells by varying ethylene and vinyl alcohol content in polymer substratum. We developed a method for scalable production of controllable DP spheroids from rat and human cells. For DP spheroids from each cell origin, efficiency of HF regeneration is progressively enhanced by encreasing size/cell number in each microtissue. However, the size of regenerated hairs seems to be stochastic and does not correlate with size/cell number in DP spheroids transplanted.
Hairs grown randomly, independently from size/amount of cells.
This only complicates the situation, as it means there is some other mystery they have to break.Leave a comment:
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So has the study being executed now indeed been planned since 2006 already?Leave a comment:
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2013 - "Scalable production of controllable dermal papilla spheroids (...)"
Study Conclusion
We characterize the effect of hydrophilicity on DP cells by varying ethylene and vinyl alcohol content in polymer substratum. We developed a method for scalable production of controllable DP spheroids from rat and human cells. For DP spheroids from each cell origin, efficiency of HF regeneration is progressively enhanced by encreasing size/cell number in each microtissue. However, the size of regenerated hairs seems to be stochastic and does not correlate with size/cell number in DP spheroids transplanted.Leave a comment:
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Sung-Jan Lin
National Taiwan University Hospital
Abstract: This study is to try to maintain cultured dermal papilla cells in spherical structure in vitro before transplanting into dermis in vivo. Also, this study is aimed in clarifying actual mechanism of inducing hair follicle by dermal papilla cells.
Taking a look at their 2012-2013 paper (scalable production..), we can have some insight into why it took them so long to start with the clinical trial. It seems they needed to come up with a "method that can be automated for mass production of human and rat DP spheroids with wide-range controllable size and cell number"Leave a comment:
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2013 -"Scalable production of controllable dermal papilla spheroids(...)
Current surgical treatment of hair loss mainly relies on transplanting the remaining HFs to hairless areas. With the advent of tissue engineering and regenerative biology, bioengineering for HF neogenesis is of promising potential for treating such disorders. Before this technology can be applied clinically, a number of properties of the regenerated hairs need to be controlled to restore the natural look of hair patterns, including the number, thickness, spacing, alignment, color, etc. Since hair shows a patterned variation in sizes among body regions and up to thousands of new hairs can be needs in a single patient, a desirable thickness (or the diameter of the regenerated hair) and a high regenerative efficiency are vital to favorable clinical outcome. Prior work has focused more on the preservation of trichogenic ability of cells or the regeneration of the HF with a proper architecture. Whether and how the size of the regenerated HF can be controlled is yet to be explored. To achieve a reproducible high regenerative efficiency by an engineering approach will also help to bring such technology closer to clinical application.
HF is an ectodermal organ composed of two main parts, including the epithelium of keratinocytes and the mesenchyme of dermal papilla (DP) cells. HF development is regulated through a sophisticated epithelial – mesenchymal interaction. In adult mammals spontaneous HF neogenesis after injury is rarely observed with only few exceptions, such as deer antler regeneration and a large wound of a younger mouse. In addition to such spontaneous neogenesis, it was also found that freshly isolated or low-passage cultured DP cells are able to induce HF neogenesis when they are associated with competent epithelial keratinocytes. We and other groups have shown that the HF inductivity of cultured DP cells is better maintained when they are cultured as multicellular aggregates, a structure similar to the natural intercellular organization in vivo. Compared with mouse or rat DP cells, human DP cells expanded without Wnt/ b-catenin signaling activation are unable to induce HF neogenesis when they are transplanted as dissociated cells. Even freshly isolated human DP cells are not efficient in regenerating new HFs when they were directly transplanted. How to enhance the HF induction efficiency of cultured human DP cells is among the priority issues to be solved in bioengineering for clinical HF regeneration.
To tackle the issue of numbers and to control the spacing of regenerated HFs, we have proposed a 3 step procedure for clinical HF regeneration: expansion of DP cells in vitro, mass production of injectable DP aggregates in a bioreactor, and transplantation of DP aggregates to skin with appropriate spacing and arrangement. We have developed methods for mass production of DP aggregates or HF organ gems through substratum-facilitated self-assembly. Though DP aggregates obtained are able to induce HF neogenesis, there is variation of the size of regenerated HFs. Due to the inhomogeneous sizes of the DP aggregates generated by our previous methods, it is unclear whether the variation of the size of regenerated HFs is caused by the size inhomogeneity of transplanted DP aggregates or is a stochastic nature during HF regeneration.
In adult human, the variation of the hair thickness is believed to be controlled by the volume of DP. A larger DP containing more DP cells supports the growth of a larger HF. Comparing the cell numbers of a DP and the diameter of the hair shafts of rat whiskers, we also found a positive correlation of the DP cell numbers with the diameter of hair shafts. Though not tested yet it is intriguing to speculate that inductive DP aggregates of a larger volume or higher cell numbers may be able to induce neogenesis of larger HFs. This issue has not been systemically been investigated, possibly due, at least in part, to the lack of a reliable method of scalable production of size-controllable injectable DP spheroids for reproducible experimental testing. Several methods have been developed to culture dense microtissues including rotation, two-step rotation and flotation and hanging drop. However this methods are not suitable for automated scalable production of highly inductive DP spheroids and the ability to tightly control the size and cell number in each spheroid has not yet been demonstrated. Here, we develop a method that can be automated for mass production of human and rat DP spheroids with wide-range controllable size and cell number. We also examined the effect of the size of DP spheroids on the inductive efficiency and thickness of regenerated hairs.Leave a comment:
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The treatment to create more hair comes down to Follica or Taiwan National University Hospital (TNUH) hair cloning. Seriously doubt anyone else is close and I would tend to believe it is TNUH hair cloning or litterally not anything else within the next decade.The treatment to create more hair comes down to Follica or Taiwan National University Hospital (TNUH) hair cloning. Seriously doubt anyone else is close and I would tend to believe it is TNUH hair cloning or litterally not anything else within the next decade.
The good thing given the patience size of TNUH Hair Loss treatment that if information is not overtly provided to the public it will be found invertly through a few of the 400 participants telling what there results are and probably with photos too.
As we should begin to hear about the results starting in June, just a guess based they stated they are about to start and if they start March 1 it takes 3-4 weeks for them to grow millions of cloned cells then it takes 6 weeks for those cells to get hair to a point to break the skin level so to speak. Then hair grows at 1/2 inch a month. Thus in June or July we should begin to here reports about hair growing, if it works.
Then we need to know about thickness, density, texture, angle, color, quality and success rate on the different patient types. And, I believe since it does not involve new drugs that if it really does work expect to see it 3 years from now. Why so fast? It is just a person's own hair cells being injected, why they are calling it a medical procedure. And people like us are going to push hard to make them to allow this one medical procedure be allowed ASAP expediting the process.
Either way just get this perfected ASAP or let it be known it does not work as I will no longer follow this cr@p and do not care if they have a real cure 10 years from now I just will not care.
We can go to the moon, achieve Fusion, do heart transplants but apparently growing Normal hair again on top of a person's head is impossible at least in a time period I care about. You will be seeing more posts about me on the TNUH cloned hair thread over the coming months. For me this treatment works over the coming months which I know is a long shot or forget about this topic forever. Not trying to be negative just tired of Waiting.
Well at least we find out if this treatment works in 3-4 months then it is over either way. I am going to assume 34 1/2 more months and I think that is a real target date until it hits the market, I am an optimist. Or, I throw my new combs get tossed in the trash can and I forever forget this topic.
It all comes down to the next 3-4 months for me. Good lluck.
Don´t forget Tsuji Lab. If the dp expansion problem is solved, their technique wouldn't be that far from testing and clinical application (quite similar to a hair transplant)
Besides, there might be other options we don't know about, as happened with this case.Leave a comment:
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3 months? 30 years? both seems equally unrealistic to me. we have never been so close and never had such a promising perspective. Of course things will look different if they fail totally, but till that day, we have no reason to talk about another 30-50 years to wait.Leave a comment:
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Great!Leave a comment:
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This is a much more productive post than the ones you usually spew.Just to touch up on this...
'It will be many years'. Also pay attention to her remark about the FDA (effing gatekeepers).
So uh... what needs to be done in order to go from Point A to Point B in LESS than many years? I'm sure all of us would vomit the next we heard '3-5 years'... what do we do?
ASKING, how we can solve a problem. Instead of complaining about a problem. That is a good first step, and if you want to take it a step further, do your own research and resist complaining when noone does it for you.Leave a comment:
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Just to touch up on this...
'It will be many years'. Also pay attention to her remark about the FDA (effing gatekeepers).
So uh... what needs to be done in order to go from Point A to Point B in LESS than many years? I'm sure all of us would vomit the next we heard '3-5 years'... what do we do?Leave a comment:
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Hi, sorry for getting back to you so late.Hey brother
yeah I managed to get my hands on ine of the papers but not all of them. Uploading them would be fantastic 
Btw southern just posted some more studies. Is anyone able to maybe just copy paste the studies on here? This way we can have a great database of everything to do with this technique
If you can post a compiled list of exactly what you're after I'll track them down tomorrow for you.
Edit: Positive things will happen for hair loss suffers sooner than later, as time goes on the half life of knowledge decreases.Leave a comment:
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