Important questions about cell based treatments!

[Breaking Bald]

Firstly, What are your guys opinions about how safe these treatments will be? I mean I am no scientist by ay means, but it would seem that they should be pretty safe seeing as they are using your own cells. But could these cells mutate for any reason? Would the body fight them? Could they turn cancerous or abnormal?

Secondly, if you have had a hair transplant, could that be a problem for these treatments?

I say this because, lets say you have had a hair transplant. New hair follicles have been placed on your head in a different position to where your original follicles were. Now lets say that one of these treatments manages to grow back all of your old original follicles. Now there may be a problem, because your old follicles are coming through next to your newer transplanted ones or on top of them!

This may:

1. Look odd because your originals will be coming through next to the transplanted ones which will most likely be going in a different direction.

2. Cause problems of regrowth. Lets say that some of the transplanted hair follicles have been moved to the exact spot where your original ones were. How is it going to grow back? It may even cause problems, not grow or cause irritation.

I think these are important questions, so I would be very interested to hear your thoughts on this

[Pate]

We just don't know, is the short answer.

Re safety, it's not inconceivable there could be issues, possibly even cancer. But so far none of them have reported safety issues, they've all passed Phase I.

Re transplants, my feeling is there will probably be a little bit of scar tissue around each graft which should prevent new follicles growing over old ones. According to the Replicel theory, the cells should migrate into an existing follicle is it's there instead of creating a new follicle anyway.

[534623]

... new follicles growing over old ones.

Seems he is thinking this way ...

[clandestine]

Seems he is thinking this way ...

Were you banned from hair site or something?

[534623]

Were you banned from hair site or something?

Sometimes yes, sometimes no – that depends on how much imaginary hairs some young cats can see from useless AGA “hope-therapies” …

[Breaking Bald]

That picture made me laugh. Anyway........so back on topic...anyone else actually have any input?

[2020]

That picture made me laugh. Anyway........so back on topic...anyone else actually have any input?

Yes, cell based treatments will fail 100%. Hair follicle is much complicated then that.

0 hope for Replicel.
0 hope for Aderans.

50% hope for Histogen, that is that it will make its way into the market but like I said before: if it's not costanza to fabio then it's considered a failure to me and they're wasting time...

[UK_]

I agree with 2020 - Aderans Replicel were both hallucinating when they saw higher hair counts in treated areas during all their clinical trials. A little fairy came down from the sky and sprinkled dust in their eyes making them see an improved hair count which was not actually there.

Everything is an illusion, the sentinels have set up a matrix to make everyone believe we are bald but in the real world morpheus has hair.

The architect is at the top and the illuminati lizard creatures control a hidden supply of tin foil headgear throughout the universe that is known to reverse the onset of prepubescent donkey genital failure.

(now look at 2020's avatar).

I rest my case.

[Breaking Bald]

Man this forum is making me more bi-polar than I am already am...everyday the mood goes from optimist to ridiculous pessimism. And you two are some of the main culprits for constantly bringing it down

For god sake the question was NOT 'Will these treatments be successful?' Go and re read my first post. How the heck do you know if they will fail? We barely know anything about their results because they are ridiculously secretive.

[Desmond84]

Man this forum is making me more bi-polar than I am already am...everyday the mood goes from optimist to ridiculous pessimism. And you two are some of the main culprits for constantly bringing it down

For god sake the question was NOT 'Will these treatments be successful?' Go and re read my first post. How the heck do you know if they will fail? We barely know anything about their results because they are ridiculously secretive.

Hey Breaking Bald,

Back in 2006, a German company called TeGeNeRo came up with a novel "Biological" treatment called TGN1412 which was meant to cure ALL autoimmune diseases!!! I'm talking, Diabetes, Eczema, MS, Crohn's, Ulcerative Colitis, etc etc...

So they started their Phase I clinical trial in 6 ppl in UK. But being a small company they didn't follow standard protocol and injected all 6 patients at the same time with different doses of TGN1412 rather than staggered dosing.

Long story short, within 1 hour of the injection, all 6 subjects developed a fatal condition called "Cytokine Storm", where they were banging their heads against the walls to try and kill themselves because they were in excruciating agony. Pretty much in most of them all their limbs solidified (turned into rock) and had to be amputated to save them!

Now, this happened very recently (2006) and the reason why it happened was because it was a "Biological". Now what biological refers to is a broad term that represent anything that is not a small molecule and is generally derived from animal or human tissues. This could be blood products, vaccines, proteins, or cell-based therapies.

Biologicals are VERY new in the field of medicine and a lot of regulatory authorities lacked expert scientists in these fields to carefully examine these products for potential harm.

Now, the TeGeNeRO incident changed EVERYTHING! The regulatory authorities realised the potential risks of biologicals and really amped up their regulatory requirements for these types of therapies.

I mean if you're involved in "regulatory affairs" you definitely know what a headache it is to get a biological agent approved!

So, even though there are potential risks associated, the FDA will be extremely stringent on Aderans to make sure every aspect of their trial proves safety to the best of their ability!

So, to make the story short, don't jump in to sign up for the trials but be patient. Once it is approved by the FDA, you can be pretty confident that it is a relatively safe therapy

Hope all this helps brother

[CAlex]

Hey Desmond. Quick question if you dont mind.

Ive pretty much stop coming on here because theres a few guys whos only joy in life sadly is being as negative as possible and posting under multiple names and I just got tired of sifting through all their b.s.

Im curious what your thoughts are on aderans and replicels chances.

Im still got my money on histogen and 2015/2017 but its hard to tell how impressive their results are because when they post stuff like 40% increase in hair within the treatment area that might only mean like 10 new hairs for some of the guys in the trial. Id love to know if they regenerate like 50 hairs/cm2.

lastly is aderans attempting to grow follicles in the lab and basically do a advanced transplant without surgery or using donor area up or is it like a growth coccktail injection? Im not a believer that any ht type treatments can yield good results vs promoting growth naturally from under the skin.

Hope the forum doesnt drag you down too. glad you're so up beat.

[RisingFist]

I think stem cells will be the best way to guarantee hair growth safely but I wouldn't expect procedures of that caliber until 10-20 years from now.

[Desmond84]

Hey Desmond. Quick question if you dont mind.

Ive pretty much stop coming on here because theres a few guys whos only joy in life sadly is being as negative as possible and posting under multiple names and I just got tired of sifting through all their b.s.

Im curious what your thoughts are on aderans and replicels chances.

Im still got my money on histogen and 2015/2017 but its hard to tell how impressive their results are because when they post stuff like 40% increase in hair within the treatment area that might only mean like 10 new hairs for some of the guys in the trial. Id love to know if they regenerate like 50 hairs/cm2.

lastly is aderans attempting to grow follicles in the lab and basically do a advanced transplant without surgery or using donor area up or is it like a growth coccktail injection? Im not a believer that any ht type treatments can yield good results vs promoting growth naturally from under the skin.

Hope the forum doesnt drag you down too. glad you're so up beat.

Hey Alex,

Sorry to hear that man! I'm a nooby here so I might be destined for a fall myself LOL

What do I think about Replicel & Aderans...hmmm

OK, so Aderans is definitely the one to keep your eyes on in the next few years. These guys are US-based and are conducting every trial with an FDA oversight which is great. Will they meet the 2014 timeline? Most probably not! I believe 2016 is the year of Aderans. By then, they will have convinced FDA on TWO important facts:

• Short-term safety of autologous (your own) cell transplantation
• Long-term risks of autologous cell transplantation

Don't forget that FDA has only approved ONE stem cell product to date which is called Hemacord, a cord blood-derived product used for disorders affecting the body’s blood-forming system.

Unfortunately, Replicel had high hopes for a court battle that was going on for the last 3 years and would have made their product available earlier than expected! Over the last 3 years, a regenerative company has been in a court battle against FDA to change the law regarding autologous cell transplants. They claimed that since autologous cell are your own, they are very safe and should NOT undergo such rigorous trial protocols! Not surprisingly however, in July 2012 the US district court rejected such claims on the basis that these cells are removed from the body and “processed/manipulated” with components not from the patient to make them grow and multiply, thereby introducing unknown risks.

Replicel was hoping that if FDA loses, they will be able to market their product by 2014 after they finish Phase 2 trial, which is no longer the case.

Now, I have done a bit of research and believe that TWO things will happen in the coming months:
a) Aderans will finish off their Phase 2 results and announce their findings.
b) There will be an 8-10 month hiatus period after their announcement, since they will need to develop an automated/mechanised method for mass-producing dermal cells, rather than on a small scale by 20 scientists in a laboratory.

Commercial success of a cell therapy requires a significant number of patients to be treated. Scaling up a manual laboratory scale process would require a large number of clean rooms and an even larger number of trained personnel to work the rooms. Even if the clean rooms were built and the staff hired and trained, maintaining the level of consistency and quality to satisfy the FDA regulatory requirements and process demands would be almost impossible.

This is where "Cell Therapy Automation" methods come in.

There will be a dramatic change in the manufacturing methods as they progress through clinical trials and into commercial production.

The trouble is if they don't do it now, future changes to these processes post-phase 3 will be prohibited by FDA and will most definitely require brand new trials, which would limit how many patients they can treat at a time!

So, they will be battling these hurdles throughout 2013. Their Phase 3 trials should begin sometimes in 2014 and end by June 2015. FDA will then need to assess their findings and finally approve their therapy which will happen sometimes in 2016.

Replicel will be at least 2 years behind Aderans.

With regards to how they work:

These therapies involve removing approximately 1 cm2 from your donor area which will have over 10000 dermal cells. They will then mass produce these to millions over a course of 3 months! They then inject these brand new cells into your balding areas making these areas DHT-resistant and hopefully rejuvenating semi-dead follicles! Can these cells generate new follicles? They're not sure yet, but they don't seem to be so far (based on Replicel data)!

Hope this helps

[Desmond84]

You also shouldn't forget Histogen

These guys seems to have come up with a relatively SAFE treatment that is producing remarkable results in their first ever trial! They still have at least 2-3 years to go but I would be rooting for these guys all the way till I get my hands on it

I personally am a lot less worried about safety of Histogen than Aderans/Replicel. Both treatment approaches still have a lot to show in terms of safety before they make it to market, but we should keep a close eye on every little detail they report in terms of adverse events!

[Breaking Bald]

Very interesting Desmond about TGN1412. I read up about it, feel so sorry for those guys. I guess you are right that it is better to be safe than sorry.