Important questions about cell based treatments!

[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.

[Artista]

First thing that came to mind when reading the comments....
"The Pessimist is half-licked before he starts, The Optimist has won half the battle.." - Thomas A. Buckner"

[534623]

First thing that came to mind when reading the comments....
"The Pessimist is half-licked before he starts, The Optimist has won half the battle.." - Thomas A. Buckner"

...the most important half that applies to himself, when he begins his approach to a subject with the proper mental attitude. The optimist may not understand, or if he understands he may not agree with, prevailing ideas; but he believes, yes, knows, that in the long run and in due course there will prevail whatever is right and best."

Do you have a quote by Buckner, where he defines "in the long run" more specific?

[garethbale]

Do you have a quote by Buckner, where he defines "in the long run" more specific?

you're a strange little fellow...

[StinkySmurf]

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

Hey Desmond. Thanks for the really informative answers. I've been following this forum for a while, but I finally gave in and signed up because I couldn't stand not asking you these questions so thanks!

(1) I'm wondering if you can really compare TGN1412 to something like the Aderans or Replicel trials just because TGN1412 was a Phase 1 trial. TGN1412 had new problems that only showed up when they went from testing mice to testing people, but don't you think an Aderans or Replicel Phase 2 or Phase 3 trial is a bit safer because it's already been safety tested on people at that point? Isn't the risk of something like TGN1412 more for a Phase 1 trial like with Cell-Innovations that just started up in Australia?

Do you know of any good examples of toxic medicines like this where it didn't show up until phase 2 or phase 3 that it was suddenly deadly?

(2) What does your gut instinct tell you about the safety of Aderans and Replicel?

Logically speaking a new cell therapy presents the same risks as TGN1412 as you've shown already, but in terms of probability, how do you see the chances with Hair Multiplication?

Would you say that multiplying hair cells in a lab and injecting them back into your scalp is inherently an safer process than what TGN1412 was introducing into your system just because the hair cells are basically unmodified?

[Desmond84]

Hey Desmond. Thanks for the really informative answers. I've been following this forum for a while, but I finally gave in and signed up because I couldn't stand not asking you these questions so thanks!

(1) I'm wondering if you can really compare TGN1412 to something like the Aderans or Replicel trials just because TGN1412 was a Phase 1 trial. TGN1412 had new problems that only showed up when they went from testing mice to testing people, but don't you think an Aderans or Replicel Phase 2 or Phase 3 trial is a bit safer because it's already been safety tested on people at that point? Isn't the risk of something like TGN1412 more for a Phase 1 trial like with Cell-Innovations that just started up in Australia?

Do you know of any good examples of toxic medicines like this where it didn't show up until phase 2 or phase 3 that it was suddenly deadly?

(2) What does your gut instinct tell you about the safety of Aderans and Replicel?

Logically speaking a new cell therapy presents the same risks as TGN1412 as you've shown already, but in terms of probability, how do you see the chances with Hair Multiplication?

Would you say that multiplying hair cells in a lab and injecting them back into your scalp is inherently an safer process than what TGN1412 was introducing into your system just because the hair cells are basically unmodified?

You're welcome dude

In terms of risks you are right!

When it comes to clinical trials, Phase I is the riskiest of them all followed by Phase 2 and Phase 3 (hence the Tegenero tragedy)

If a drug has passed Phase 3, it is more than likely relatively safe so I wouldn't worry too much.

In my opinion, you can usually detect potential risks of a therapy based on the types of adverse effects reported during their trials. I'm talking about common adverse effects btw, there's always a very small minority that just don't tolerate a particular therapy. Based on these finding, you can extrapolate with high possibility what would be the worst possible scenario.

Here are some examples:

1) During Merck's Propecia trial, the main adverse event reported was impotence and ejaculation disorders, but all those subjects suffering managed to return to normal upon discontinuation of Propecia. So Merck assumed no risk would be involved! But we now know with hind sight, such adverse events may take a considerable amount of time to reverse in a small minority of people say 1 in 10 000.

2) Vioxx and Prexsig were anti-inflammatory drugs that were marketed for Arthritis. During the trials they simply detected slight changes in Liver function tests but no serious liver events were reported. Once they came on the market, fatal liver toxicity were reported all over the place which resulted in these drugs being taken off the market.

3) Now here's a hypothetical example: Let's say Histogen/Replicel/Aderans detected higher than normal levels of White Blood cell count post-injection, and the animal studies showed a potential for cancer (say at 1000 times the dose given to humans). Using this information, you could potentially worry that there may be a risk of cancer such as B cell lymphoma, etc.

Now, none of these cell-based companies have fully published their Phase 2 trials, once they do we will have a better picture of what to expect.

Moreover, I can promise you that me and a lot of ppl on this forum and in the medical field will be looking closely at every bit of info being released to evaluate the potential risks of these therapies. So make sure you stay tuned in the coming years

Hope that helps,

P.S. Replicel & Aderans are not exactly hair multiplication in the true sense of the word. They DON"T grow hairs in a lab and transplant it. They simply replicate specific cells that surround the hair follicle and provide the follicle with growth factors and nutrients. These therapies simply rejunevate existing follicles rather than making new ones. (This bit is from their latest update at Mesa btw. They announced: "They don't seem to be creating new follicles but rather rejuvenating existing ones"). Sad, but could be worse right