Cellese AnteAGE System: general discussion
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free skin care · Mon Apr 09, 2012 5:55 am

I am a dispute mediator by training and profession, so excuse me for my tendency to always seek a bottom line, a final analysis if you will.

It seems the bottom line here is that with respect to these new product developments, they are not yet fully fleshed out, although preliminary evidence appears promising.

BFG

free skin care · Mon Apr 09, 2012 6:13 am

doodles wrote:

Hi Dr J, I haven't posted on this thread before but have been following it closely. I have a few questions for you that I haven't seen answered yet. How would you use the serum post dermarolling with the 1.5mm? Can I use it immediately following the roll or should I wait a few hours/days? Is the accelerator ok for extremely acne prone skin? And lastly I was wondering if and when you will start shipping to Canada? Thanks, Doodles

Hi doodles,

This was posted on April 5th on page 2 of the thread. Very Happy

DrJ wrote:

lipglossdoll wrote:

I would like to know if international shipping will be offered in the future?

I am in Canada, will you eventually ship here? Very Happy

Canada is easy, we will have that set up within a few days. We will be adding a few more countries in the coming weeks (Australia is at the top of that list).

free skin care · Mon Apr 09, 2012 7:54 am

Barefootgirl wrote:

I am a dispute mediator by training and profession, so excuse me for my tendency to always seek a bottom line, a final analysis if you will.

It seems the bottom line here is that with respect to these new product developments, they are not yet fully fleshed out, although preliminary evidence appears promising.

BFG

Well said, BFG. Now, keep in mind that it takes time to build an evidence base in medicine. There will always be products on the leading edge (new, promising). By the time they are "established" time has relegated them to standard status, tried and true (maybe a little boring?).

People are philosophically disposed along a spectrum that goes from "early adopters" to "laggards" in terms of willingness to try new things. In science & technology, I am a risk taker, an early adopter type. I always want the newest iPad. Scientists in general are innovators, always looking for the next great thing. But I fully appreciate the need/desire to minimize risk when making choices in health (including healthy skin).

free skin care · Mon Apr 09, 2012 8:17 am

jom wrote:

Dr J, this paragraph is from an article you wrote on BFT about cytokines:

"Every time you go out into the sun (especially if unprotected) your skin undergoes injury. The DNA in your skin cells is damaged. Chemicals are released. Some of those cells will be repaired. Some will die. But repeated insult and repair leads to photoaging. Spots, wrinkles, sags, etc. Add to that some intrinsic (genetically programmed) aging. With chronic, repeated injury there are changes that take place in the skin (subsurface scarring). This is why cosmetic surgery, lasers, devices, and various skin concoctions are prevalent in the marketplace."

I'm interested in this statement "Some of those cells will be repaired. Some will die."

Would you say that by using MSC a greater number of the cells will be repaired? Does MSC help repair damaged cells thereby slowing down phototaging? Is MSC preventative? How do the cells that get repaired get repaired? Is that what anti-aging is all about, trying to repair as many damaged cells as possible? Pardon my ignorance.

jom, this question goes to the very heart of uur work, and is a major source of investigation & debate in anti-aging medicine. I won't be able to do it justice here, but will give you a reference or two and maybe do a BFT post in the near future.

This is all about cell senescence, and why we don't live forever. The balance between cell immortality and cancer.

I'm going to just give you a couple of tantalizing sentences, then set you off on a journey to discover (any who are so interested).

Skin cells undergo constant bombardment from the environment. They get damaged, which can lead to mutations at the DNA level. The older a cell, the more likely it is to mutate. To prevent that happening, our cells stop dividing after a certain point (become senescent) which means they cannot become cancerous (which is all about growth). Now senescent cells still function. Common pigmented moles really are groups of senescent cells. They still metabolize. They are alive. Now the problem with senescent cells is that they tend to make inflammatory cytokines. The wrong kind if you want healthy looking skin. And inflammation and aging are linked as well. Our work is all about working out the problem at the cytokine level (for skin - but has implications for all cells). Look at this NYT article, and watch for references to cytokines.

http://www.nytimes.com/2011/11/22/science/in-bodys-shield-against-cancer-a-culprit-in-aging-may-lurk.html?pagewanted=2&_r=3

Here is an oldie but goodie academic article on wound healing & cell senescence (remember - wound healing tells us a lot about aging too).

http://www.nature.com/cdd/journal/v12/n7/pdf/4401632a.pdf

Thanks for asking a question on one of my favorite topics!

free skin care · Mon Apr 09, 2012 8:23 am

doodles wrote:

Hi Dr J, I haven't posted on this thread before but have been following it closely. I have a few questions for you that I haven't seen answered yet. How would you use the serum post dermarolling with the 1.5mm? Can I use it immediately following the roll or should I wait a few hours/days? Is the accelerator ok for extremely acne prone skin? And lastly I was wondering if and when you will start shipping to Canada? Thanks, Doodles

Hi Doodles, How often are you dermarolling? For how long? I would use the serum about 1/2 hr after dermarolling. We had a handful of acne prone women in the study and only one had a breakout, and even she went back to using the accelerator after it resolved. Do you currently use anything for moisturizing? Everyone is a bit different on this. Canada is within a day or two I am told.

free skin care · Mon Apr 09, 2012 9:09 am

DrJ wrote:

doodles wrote:

Hi Dr J, I haven't posted on this thread before but have been following it closely. I have a few questions for you that I haven't seen answered yet. How would you use the serum post dermarolling with the 1.5mm? Can I use it immediately following the roll or should I wait a few hours/days? Is the accelerator ok for extremely acne prone skin? And lastly I was wondering if and when you will start shipping to Canada? Thanks, Doodles

Hi Doodles, How often are you dermarolling? For how long? I would use the serum about 1/2 hr after dermarolling. We had a handful of acne prone women in the study and only one had a breakout, and even she went back to using the accelerator after it resolved. Do you currently use anything for moisturizing? Everyone is a bit different on this. Canada is within a day or two I am told.

Hi Dr J, I've only rolled twice - two months apart. I roll quite aggressively and it takes four or five days until my skin looks mostly normal again. I use retin-a .1 every night to help control my acne and I only moisturize around my eyes and mouth using cetaphil or cerave lotion. Can I use the Anteage serum during the day and the accelerator at night either under the retin-a or on alternate nights? Thanks, Doodles

free skin care · Mon Apr 09, 2012 9:37 am

DarkMoon wrote:

doodles wrote:

Hi Dr J, I haven't posted on this thread before but have been following it closely. I have a few questions for you that I haven't seen answered yet. How would you use the serum post dermarolling with the 1.5mm? Can I use it immediately following the roll or should I wait a few hours/days? Is the accelerator ok for extremely acne prone skin? And lastly I was wondering if and when you will start shipping to Canada? Thanks, Doodles

Hi doodles,

This was posted on April 5th on page 2 of the thread. Very Happy

DrJ wrote:

lipglossdoll wrote:

I would like to know if international shipping will be offered in the future?

I am in Canada, will you eventually ship here? Very Happy

Canada is easy, we will have that set up within a few days. We will be adding a few more countries in the coming weeks (Australia is at the top of that list).

Thanks DM

free skin care · Mon Apr 09, 2012 9:45 am

You are welcome doodles. Very Happy

free skin care · Mon Apr 09, 2012 9:46 am

doodles wrote:

DarkMoon wrote:

doodles wrote:

Hi Dr J, I haven't posted on this thread before but have been following it closely. I have a few questions for you that I haven't seen answered yet. How would you use the serum post dermarolling with the 1.5mm? Can I use it immediately following the roll or should I wait a few hours/days? Is the accelerator ok for extremely acne prone skin? And lastly I was wondering if and when you will start shipping to Canada? Thanks, Doodles

Hi doodles,

This was posted on April 5th on page 2 of the thread. Very Happy

DrJ wrote:

lipglossdoll wrote:

I would like to know if international shipping will be offered in the future?

I am in Canada, will you eventually ship here? Very Happy

Canada is easy, we will have that set up within a few days. We will be adding a few more countries in the coming weeks (Australia is at the top of that list).

Thanks DM

If you are using Retin-A, I would start with the serum, day and night. I can work out for you some additional ways to get what you are going to miss from the accelerator.

free skin care · Mon Apr 09, 2012 9:58 am

Dr. J,

Hello, I am a RA user with very tolerant skin, are you saying that we should avoid the Accelerator when using Retin A? I have not ever had any irritation from using it I am on 0.05% and can and do use every night.

Thanks

free skin care · Mon Apr 09, 2012 10:44 am

People are philosophically disposed along a spectrum that goes from "early adopters" to "laggards" in terms of willingness to try new things.

Very true. An apt analogy, IMO - comparing cosmetic lotions with technological gadgets~!

As is the case with many gadgets, many people acknowlege that what they are already have (or do!) works, but they are willing to vote with their wallets to see if they can squeeze out just a little bit more.

As a legal type, I tend to hold until the hype tapers off and the herd thins a bit and we see who truly has it down.
Not an early adopter, but definitely way ahead of those who arrive late to the game.

Next up, I'll be posting a summary of Skin, Inc's February 2012 analysis of up and coming anti-aging advancements. Stem cell is the new buzz word, apparently.

BFG

free skin care · Mon Apr 09, 2012 11:14 am

Barefootgirl wrote:

Very true. An apt analogy, IMO - comparing cosmetic lotions with technological gadgets~!

Stem cells are health care and skin care technology.

free skin care · Mon Apr 09, 2012 11:53 am

DarkMoon wrote:

Dr. J,

Hello, I am a RA user with very tolerant skin, are you saying that we should avoid the Accelerator when using Retin A? I have not ever had any irritation from using it I am on 0.05% and can and do use every night.

Thanks

No, you can use both together. If you are using RA for acne its a bit of a different issue. The accelerator includes a retinoid, so there is a bit of overlap, but all that means is you might want to adjust your RA knowing that. Of course there are lots of other actives we don't want you to miss.

free skin care · Mon Apr 09, 2012 12:01 pm

DrJ wrote:

DarkMoon wrote:

Dr. J,

Hello, I am a RA user with very tolerant skin, are you saying that we should avoid the Accelerator when using Retin A? I have not ever had any irritation from using it I am on 0.05% and can and do use every night.

Thanks

No, you can use both together. If you are using RA for acne its a bit of s different issue. The accelerator includes a retinoid, so there is a bit of overlap, but all that means is you might want to adjust your RA knowing that. Of course there are lots of other actives we don't want you to miss.

Thanks,

Knowing my tough hide I am guessing no adjustment would be necessary. I am using it as an antiaging only, never in my 58 years have I broken out! Very Happy

free skin care · Mon Apr 09, 2012 12:38 pm

DrJ wrote:

jom wrote:

Dr J, this paragraph is from an article you wrote on BFT about cytokines:

"Every time you go out into the sun (especially if unprotected) your skin undergoes injury. The DNA in your skin cells is damaged. Chemicals are released. Some of those cells will be repaired. Some will die. But repeated insult and repair leads to photoaging. Spots, wrinkles, sags, etc. Add to that some intrinsic (genetically programmed) aging. With chronic, repeated injury there are changes that take place in the skin (subsurface scarring). This is why cosmetic surgery, lasers, devices, and various skin concoctions are prevalent in the marketplace."

I'm interested in this statement "Some of those cells will be repaired. Some will die."

Would you say that by using MSC a greater number of the cells will be repaired? Does MSC help repair damaged cells thereby slowing down phototaging? Is MSC preventative? How do the cells that get repaired get repaired? Is that what anti-aging is all about, trying to repair as many damaged cells as possible? Pardon my ignorance.

jom, this question goes to the very heart of uur work, and is a major source of investigation & debate in anti-aging medicine. I won't be able to do it justice here, but will give you a reference or two and maybe do a BFT post in the near future.

This is all about cell senescence, and why we don't live forever. The balance between cell immortality and cancer.

I'm going to just give you a couple of tantalizing sentences, then set you off on a journey to discover (any who are so interested).

Skin cells undergo constant bombardment from the environment. They get damaged, which can lead to mutations at the DNA level. The older a cell, the more likely it is to mutate. To prevent that happening, our cells stop dividing after a certain point (become senescent) which means they cannot become cancerous (which is all about growth). Now senescent cells still function. Common pigmented moles really are groups of senescent cells. They still metabolize. They are alive. Now the problem with senescent cells is that they tend to make inflammatory cytokines. The wrong kind if you want healthy looking skin. And inflammation and aging are linked as well. Our work is all about working out the problem at the cytokine level (for skin - but has implications for all cells). Look at this NYT article, and watch for references to cytokines.

http://www.nytimes.com/2011/11/22/science/in-bodys-shield-against-cancer-a-culprit-in-aging-may-lurk.html?pagewanted=2&_r=3

Here is an oldie but goodie academic article on wound healing & cell senescence (remember - wound healing tells us a lot about aging too).

http://www.nature.com/cdd/journal/v12/n7/pdf/4401632a.pdf

Thanks for asking a question on one of my favorite topics!

Interesting, so it seems that one way to slow down the aging process is to get rid of the senescent cells. I'll take that drug!

In the meantime, I think I'm still trying to understand a little bit more about how your product works and what the benefits of MSC are.

Does MSC do anything to deal with "the problem with senescent cells is that they tend to make inflammatory cytokines."

I've looked back on some of the older posts on the cytokine thread and put that information in quotes and italics.

"Cytokines are also known as “signaling peptides” They are small proteins that cells send out to talk to one another. It’s like the signal corps, rallying the troops."

So there are good cytokines and bad (inflammatory)cytokines, yes?

I understand that the work you have done is "We have learned how to farm these specialized healing cells and to maximize their production of the good stuff (cytokines & growth factors)."

"The thing about these cells, and the cytokines and growth factors that they produce, is that we are talking about something that is entirely natural. These mesenchymal stem cells are our body’s natural producers of healing biochemicals."

So what is the MSC going to heal?

"But when a cocktail containing a blend of cytokines and growth factors, formulated not by humans but by these very clever cells, you can get the good effects without the bad. In fact, in 3 clinical trials, I have yet to see an adverse effect. It’s because we are mimicking nature. We aim to replicate what your own body would do when you were a newborn."

Senescent cells are swept away less efficiently as a person ages, does the MSC do anything to help sweep away the senescent cells more efficiently? Or, what does our own body do when we are a newborn that you are trying to replicate with the MSC?

free skin care · Mon Apr 09, 2012 1:29 pm

I'm interested in purchasing both products but I have a few questions about incorporating both the serum and accelerator into my routine:

1. Do I need to use both the serum and accelerator twice per day? Or can I simply use the Cellese products in the evening and still see benefits?

2. Since I'm looking to incorporate these products into my current routine, are there any contraindications or conflicting ingredients I should be aware of in my other products -- for example, I already use products with matrixyl, argireline, and copper peptides -- would these or similar ingredients enhance or reduce the effectiveness of AnteAge?

3. How long can I expect 1oz of serum and 1.7oz of accelerator to last if used twice per day -- 1 month, 2 months?

4. Are there ways to maximize the benefits? For example, by applying the serum before using Lightstim (I don't think the accelerator can be used before an LED because it contains retinols)

Thanks for your responses ... and I wasn't kidding about snail slime in my response in the latest ingredient thread -- it is being highly touted for its ability to moisturize Very Happy

free skin care · Mon Apr 09, 2012 4:02 pm

Merrylass wrote:

I'm interested in purchasing both products but I have a few questions about incorporating both the serum and accelerator into my routine:

1. Do I need to use both the serum and accelerator twice per day? Or can I simply use the Cellese products in the evening and still see benefits?

We have only tested it at twice a day, so that is an unknown, but you should at least get 1/2 the benefit (or it may just take twice as long to get there?). You can be the first 1/2 dose point on the "dose response curve".

2. Since I'm looking to incorporate these products into my current routine, are there any contraindications or conflicting ingredients I should be aware of in my other products -- for example, I already use products with matrixyl, argireline, and copper peptides -- would these or similar ingredients enhance or reduce the effectiveness of AnteAge?

I would suggest you eliminate the matrixyl (overlap) and argireline (because if it really worked you would have droopy eyelids). Cu++ peptides you could keep.

3. How long can I expect 1oz of serum and 1.7oz of accelerator to last if used twice per day -- 1 month, 2 months?

Average is closer to two months, but double that if you only use once a day.

4. Are there ways to maximize the benefits? For example, by applying the serum before using Lightstim (I don't think the accelerator can be used before an LED because it contains retinols)

Theoretically yes, but we don't have enough data yet. We have seen it used "post-procedure" (after lasers & surgery) and casually observe more rapid healing, which makes total sense if you have read about how it works. We are starting a group on dermarolling to test that out - very excited to see those results.

Thanks for your responses ... and I wasn't kidding about snail slime in my response in the latest ingredient thread -- it is being highly touted for its ability to moisturize

It's basically mucous, and you have to stress the snail to get them to produce it. We can say proudly "no molluscs harmed in the making of this product"

Very Happy

free skin care · Mon Apr 09, 2012 8:07 pm

I got my AnteAGE products in the mail today. I only ordered the serum but there must have been a mix-up in the shipping department because they sent me both products! I wasn’t interested in the accelerator because it has retinol in it and I use Retin A but since I got it I’ll use it. I’m going to use both products in the morning only.

My very first impression is very good. The packaging and the delivery system are first class. These products will look pretty in the bathroom. I tested the products on the back of my hand and I can tell these are high-quality products. There is a lot of substance to them and they are both quite moisturizing. The serum is light but somewhat creamy. It’s not a clear liquid like Vitamin C serums. The accelerator is a lotion, it’s not too heavy. One of my tests of a product is whether or not I will enjoy using it and applying it and I can tell I will enjoy using and applying these products.

According to the Cellese website …”By replenishing lost cytokines in a topical product on the skin, we are able to effectively reengage your skin’s healing process. Your skin knows how to become more youthful looking – it always has but needs the proper signals. The stem cytokines in AnteAGE are the same ones each of us produces throughout life – a lot when we are young, less and less as we age. Stem Cytokines are 100% natural products.” I’m going to see what the products can do for me.

I’m going to test the products by using the same 12 parameters Dr. J used in his study. This is my baseline:
Tone – I usually think of tone as cool or warm so I’m not sure what to look for here maybe it is muscle tone. I’ll need Dr. J’s help defining that parameter so I know what to look for.
Softness – My skin is pretty soft, not soft as a baby’s behind but it’s already kind of soft.
Redness – I do have some redness, especially on my chin, from Retin A use.
Texture – My skin is smooth.
Dryness – My skin is not overly dry. I do at times have some peeling from the Retin A.
Age spots – I have gotten rid of my problems with brown spots with Vitamin C, AHA’s and Retin A so I don’t have a problem with age spots.
Pore size – I have some visible pores on my nose and on either side of my nose, would love to reduce those.
Color blend – Not sure what to look for here my skin seems pretty even-colored.
Brightness – I use a serum with niacinamide in it and have noticed a lot of added brightness to my skin from using it. I am going to replace that serum with the AnteAGE serum so I’ll see if I get even more brightness.
Blotchiness - I don’t have any blotchiness.
Fine lines – I have fine lines under my eyes which have been helped with Retin A but I’d like more help.
Deep lines – I don’t have any deep lines.

As more background – I like my skin and think it is pretty good condition so I may not be the best person to test these products. I get compliments on my skin sometimes. I also look about ten years younger than I am. I am the kind of person who does get results from products. I know there are people on the forum who do not get results so just be forewarned that I do get results. About ten years ago I had a bad problem with brown spots on my skin. I started using Skinceuticals CE Ferulic and they started going away. I started using AHA’s and they went away more then I started using Retin A and they went away more so I don’t have a problem with age spots any more. I don’t know what AnteAGE can do for me that other products haven’t already done. I would like my undereye area to look more youthful and my pores to be smaller and to get rid of some redness. Those are the things I’ll be focused on seeing if I experience any results from AnteAGE. (Actually I would love it if I could find a product that would help the corners of my mouth turn up! LOL) What else should I be looking for Dr. J? I’m also interested in prevention. Will my skin look better five years from now if I continue to use these products than it would look if I didn’t use the products? In short, do I really NEED these products, no. I’m just really curious and like to try new things every once in a while. I’ll let you know how it goes.

free skin care · Mon Apr 09, 2012 8:29 pm

Jom - congratulations on your "bonus". I can picture Dr making some hurried phone calls to the shipping department!

Could I ask what age group you're in? Also be sure and note how long each product lasts.

free skin care · Mon Apr 09, 2012 8:35 pm

Keliu wrote:

Jom - congratulations on your "bonus". I can picture Dr making some hurried phone calls to the shipping department!

Could I ask what age group you're in? Also be sure and note how long each product lasts.

I'm 49 and I'm expecting the products to last at least 3 months if not longer because I'll only be using them once per day. The instructions on the serum say to apply 2 pumps but I'll probably only use one and the instructions on the accelerator say to use three pumps but I'll probably only use one (maybe one and a half). I have a small face.

free skin care · Tue Apr 10, 2012 12:05 am

Paracrine Factors of Mesenchymal Stem Cells Recruit Macrophages and Endothelial Lineage Cells and Enhance Wound Healing

Chronic wounds are common diseases and difficult to heal. The best treatments available can only achieve 50% wound closure which is often temporary. In our previous study, we found that implantation of BM-MSCs enhanced wound healing [25]; however, the mechanisms involved have not been fully understood. In this study, we show that BM-MSC-conditioned medium containing high levels of growth factors and chemokines enhances wound healing in mice, implying a critical role of paracrine factors in MSC-mediated enhanced wound healing.
Enhancement of wound healing by human multipotent stromal cell conditioned medium: the paracrine factors and p38 MAPK activation.
Mesenchymal stem cell transplantation ameliorates motor function deterioration of spinocerebellar ataxia by rescuing cerebellar Purkinje cells

Apply to face according to instructions for optimal benefit. One without the other and expect less than half if anything for results is my bet.

Runs off in search of the Fountain of Youth in a Cheap Plastic Bottle... Laughing

free skin care · Tue Apr 10, 2012 1:38 am

I am posting this yet again below in blue, all the abstracts in science and where is the one(s) done by the pair-o-docs and co.? If it was indeed studied for wound healing in diabetes That would be classified as DRUG USAGE and one would expect that something along the lines of the following would be proudly posted?(bold with link)

Where were the drug trials done?

FDA approval?

Not actually finished?

Never passed?

Never done?

A country without any regulation?

Treatment of non-healing wounds with autologous bone marrow cells,
platelets, ﬁ brin glue and collagen matrix
HASSAN RAVARI 1,DARYOUSH HAMIDI-ALMADARI 1,2, MOHSEN SALIMIFAR 3, SHOKOFEH BONAKDARAN 3, MOHAMMAD REZA PARIZADEH 2 & GEORGE KOLIAKOS4.. Done by Informa Health Care......Cytotherapy, 2011; Early Online, 1–7

http://www.biohellenika.gr/Treatment_of_non-healing_wounds.pdf

I had asked on one thread where Dr. J was posting wouldn't they have some pharmaceutical or university funding since it is posted on BFT site that their initial research was in wound healing for diabetics? I would think that would require some abstracts on the medical aspect of their cytokins on skin. That question was never addressed.

http://barefacedtruth.com/the-truth-pair-o-docs/

free skin care · Tue Apr 10, 2012 2:26 am

From Bare Faced Truth.com

Our interest in stem cell biology grew out of our work in diabetes. Diabetics heal wounds very slowly. We discovered about three years ago that you could coax mesenchymal stem cells to do all sorts of marvelous things. They are the ones that live in bone marrow and respond to emergencies anywhere in the body. They communicate via cytokines, to each other and to nearby cells. There are hundreds of cytokines, peptides and small proteins, and they have a really complex family tree. We have spent the last few years learning their “language” (cytokines patterns, like words in a sentence), which is the key to our discoveries. That, and stuff like understanding the differences between wound healing and photoageing (some overlap, some key differences), where the key metabolic entry points are, how to deliver peptides to the right place, etc., etc. Can’t reveal too much more as still writing patents.

http://barefacedtruth.com/the-truth-pair-o-docs/

free skin care · Tue Apr 10, 2012 3:42 am

Investigational New Drug (IND) Application

Current Federal law requires that a drug be the subject of an approved marketing application before it is transported or distributed across state lines. Because a sponsor will probably want to ship the investigational drug to clinical investigators in many states, it must seek an exemption from that legal requirement. The IND is the means through which the sponsor technically obtains this exemption from the FDA.
During a new drug's early preclinical development, the sponsor's primary goal is to determine if the product is reasonably safe for initial use in humans, and if the compound exhibits pharmacological activity that justifies commercial development. When a product is identified as a viable candidate for further development, the sponsor then focuses on collecting the data and information necessary to establish that the product will not expose humans to unreasonable risks when used in limited, early-stage clinical studies.
FDA's role in the development of a new drug begins when the drug's sponsor (usually the manufacturer or potential marketer) having screened the new molecule for pharmacological activity and acute toxicity potential in animals, wants to test its diagnostic or therapeutic potential in humans. At that point, the molecule changes in legal status under the Federal Food, Drug, and Cosmetic Act and becomes a new drug subject to specific requirements of the drug regulatory system.

http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/InvestigationalNewDrugINDApplication/default.htm

free skin care · Tue Apr 10, 2012 3:57 am

DM - where are you going with all of this? Are you saying that the AnteAge Serum should be classified as a pharmaceutical. Presumably, Celesse already has FDA approval.

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