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These
products are either derived from synthetic or natural means or derived
from your own body and used as a trigger mechanism to boost your own fibroblast
(collagen) production. Natural augmentation by natural means
-- possibly the next wave! In a sense they are semi-permanent,
as they will degrade as your other tissues naturally age. It is
biological so it is not indestructible, so to speak. But they
are usually irreversible due to it being a catalyst and not an actual
implant. So, you may have to have tissue removed if you dislike
the look. Although I highly doubt you will dislike it as it is a
slow process that can generally be controlled to a degree. |
I believe the
above reasons are a good thing because when you are 80 years old with firm
implants in your dermis, it may be very palpable (easily seen and felt) or
have that blanch effect (white showing through the skin). In my humble
opinion, they should make implants clear, or at least darker so that they
match the muscles or tissue.
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DermaCellagen
sometimes called Dermacollagen (technically:
unknown bio catalyst) This is a French based product or at least
European in origin as far as I know. I had to translate this from French from
a seminar so here goes my attempt:
"Dermacellagen™
Long Lasting Augmentation of Skin Defects With Dermacellagen™ - Don A
Kleinsek, A. Soto - USA
Dermacellagen™
is a long lasting cosmetic augmentation product for the repair of fine and
deep rhytids, scars and stretch marks among other defects. Based on the
company's proprietary autologous tissue engineering process Dermacellagen™
is an injectable product without the undesirable secondary effects of allergic
or immune reactions and without toxicity.
These reactions
are known to be important secondary effects of other non surgical cosmetic
correction techniques, such as bovine collagen injections. The long lasting
effects of DermaCellagen have been well demonstrated in a Phase 1/2 clinical
study conducted in humans. NO major adverse events were encountered in the
clinical study. patient follow up of more than a year has verified no loss of
the augmentation effect provided by the application of the simple and novel
treatment."
Allergy Test: unknown
Longevity: DermaCellagen is reportedly semi permanent. Although
it is a new product that I am interested in learning more about but it is
essentially a bio-catalyst, as far as I know.
Cost: unknown
Available in the United States? DermaCellagen is not approved by the
FDA for use in the US. Nor have I seen any updated information on its
status.
Website: http://www.gerigene.com
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Isolagen:
(technically: cultured
human fibroblasts) This can be considered a self-derived catalyst
so it falls under two categories. This is not even available for general use
yet. It is currently being run through the required clinical trials in
the U.S. as we speak. Its make up is, as said before, primarily from
cultured human fibroblasts. Fibroblasts are connective-tissue cells of
mesenchymal origin that secrete proteins; especially molecular
collagen from which the extracellular fibrillar matrix (I am not even
going to pretend I knew what that meant when I first read it) of connective
tissue forms. Mesenchymal means: loosely organized undifferentiated
mostly messodermal cells that give rise to such structures as connective
tissues, blood, lymphatics, bone and cartilage. Messoderm (as in
Messodermal) is the middle of the three primary germ layers of an embryo and
is the source of many bodily tissues and structures. Broadly, tissues
derived from this germ layer are considered Messodermic. Which, in a
hand basket, is completely Greek to me and I will definitely ask a
doctor on this one.
Basically, and
in English -- it is an injectable cultured (grown in a petri dish, in a lab,
from skin taken from YOUR body) fibroblasts that, when injected into the
body, encourages tissue growth for an undetermined amount of time. The
human fibroblasts are theorized NOT to cause any reaction and be extremely
tolerated, rather, ACCEPTED wholeheartedly, by the body. In addition
to sparking actual tissue growth from the live fibroblast injection.
In a
nutshell, it looks good to me, although I have no idea what the FDA's plans
are for this product or its approval. Supposedly the trials were over and the
debut was due in the Fall of 99.
Update! 11/02/00:
I spoke with a representative/scientist with
(Isolagen Technologies Inc, Paramus, NJ) and although they have completed
"trials", reportedly the FDA wants them to do them all over in
official FDA trials. However I was told the Isolagen should be available
in Japan by January '01.
Update! 10/19/01: Where's
Isolagen?? Some scattered physicians reported that the product did not
work as well as originally thought and well, the website is now nonexistent.
Makes you go, "hmmmm."
Update! 1/18/01:
I received a letter from my contact who once worked with the company:
"For most of 2000 and
2001 activity was focused on raising capital and the company came close
to shutting down permanently. In August 2001 venture capital funded the
company and did a reverse merger into a publicly traded company. It can
be tracked under the symbol ISLG.OB. The new investors moved the company
to Texas and my tenure with the company ended at this point. My guess is
they are very close to getting FDA approval for starting the next
clinical trials. There are only a few press releases out there at this
point. However, I expect that will change as soon as they get the FDA ok
to start the trials."
Update!
6/14/02: My
contact sent me information regarding Isolagen being released from clinical
hold by the FDA. To be released by the FDA from clinical hold you must
have a lab which is functional. Also it was reported that either
Isolagen was approved or the company was approved for building in the UK. I
was told that there are rumors of a distributor in Australia which implies
they are building a lab there as well. A Mexican based-lab is also
rumored to be either under construction or in planning. Also I am
told that Isolagen has the capital it needs to reach build out and offer the
product through private means. Below is the article regarding Isolagen's FDA
Clinical Hold Release:
Tuesday June 4
Press Release
FDA Releases Isolagen From
Clinical Hold
HOUSTON, June 4 /PRNewswire-FirstCall/
-- Isolagen, Inc. (ISLG) today announced that the United States Food and
Drug Administration ("FDA") has released the clinical hold on
its Investigational New Drug Application ("IND") for Autologous
Fibroblasts (human, dermal, Isolagen Technologies, Inc.) Expanded Ex.
Vivo, Administered Intradermally, for the treatment of scars due to acne,
chickenpox or minor trauma.
Michael Avignon, President of
Isolagen, Inc. stated, "Being off clinical hold is a milestone event.
The technology we have developed offers long- lasting correction for
dermal defects due to scars from acne, chickenpox or minor trauma. Unlike
other available treatments, our therapy does not utilize animal collagens
or any foreign substances. This therapy utilizes a patient's own cells
which produce a patient's own collagen. This is the first, truly 'all
natural' solution to aging or scarred skin."
About Isolagen, Inc.
Isolagen, Inc. is the parent
company of Isolagen Technologies, Inc., which was founded in 1995.
Isolagen has focused its efforts in the development of autologous cellular
technology that has specific application in cosmetic dermatology, cosmetic
surgery, periodontal disease, reconstructive dentistry and other health
related markets.
Isolagen is an emerging
biotechnology company specializing in the development and
commercialization of autologous cellular system ("ACS") for hard
and soft tissue regeneration and other therapies. Isolagen currently holds
four patents with one additional patent pending. Representing breakthrough
technology in the overall approach to cosmetic and medical therapy, ACS is
a process whereby a patient's own cells are extracted, reproduced through
Isolagen's proprietary process, and then reintroduced back into the
patient for specific cosmetic and medical applications. Unlike other
collagen development companies, Isolagen utilizes only the patient's
unique, living cells to produce the patient's own collagen. There is no
foreign substance utilized in this treatment protocol. Isolagen's goal is
to become the industry leader in the research, development and
commercialization of ACS tissue regeneration.
Isolagen's corporate
headquarters are located in Houston, TX. For further information, please
see www.isolagen.com .
SOURCE: Isolagen, Inc.
Allergy
test: n/a
Longevity: reportedly
indefinite (forever) although the collagen is susceptible to natural
aging.
Cost: unknown
Available in the United States? Isolagen has not been approved by the
FDA for use in the US as of yet. Please read the above update.
Website: www.isolagen.com
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New-Fill
or New-Fillä: (technically:
polylactic acid (PLA) hydrogel belonging to the family of aliphatic
polyesters) Brought to you by Biotech Industry, this product has become
very popular in the US the last 2 years. There are no animal compounds
and it has been used for over 20 years in orthopedics, plastic and
reconstructive surgery in Europe.
"BIOTECH
INDUSTRY NEW-FILL® is a polylactic acid (PLA) hydrogel. PLA is a
synthetic polymer that is biocompatible, biodegradable, immunologically
inert ; it has been widely researched and used for a range of applications
in medicine and surgery. Its complete safety has been a proven fact for
over twenty years.
The
manufacturing process for NEW-FILL® and the quality assurance system
deployed, which comply with Good Manufacturing Practice and ISO 9000
industrial standards, offer every possible guarantee of safety.
Laboratory and
clinical studies have demonstrated excellent tolerance for NEW-FILL®.
..."New-Fill™
gives way to the formation of new collagen induced by the properties
inherent in the polylactic acid. The process of new collagen formation (
the natural restructuring of the skin )is manifested by the formation of a
fibrous dermal layer which is responsible for the filling action. Once
this tissue restructuring is induced, the process persists despite the
resorption of the microparticles of polylactic acid.
New-Fill™ is
intended for the treatment of fine lines, wrinkles and more marked furrows
or creases, as well as for the augmentation of the tissue volume in
certain areas of the face (cheek-bones, cheek depressions, lips chin, etc
)." http://www.sculptra.com
The injections can be pretty
painful and sting quite a bit during application. You can use a topical
anesthetic like Marcaine or the newer, Anodyne Anesthetic Prescription
Strength (5% Lidocaine, 5% Tetracaine). Alternatively, PLA can also be
mixed with Lidocaine. The appropriate ratio would be 150 mg of powder:2 ml of
sterile water:1 ml of Lidocaine.
Company's
Description:
"The L-PLA
is in the form of microspheres whose diameter is distributed over the range
40 µ to 60 µ, held in suspension in a CMC gel. Microsphere diameter is
greater than 10 µ in order to avoid immediate phagocytosis by macrophages,
greater than 30 µ to avoid intracapillary dispersal, but nevertheless under
100 µ to guarantee ease of use in syringes for injection via fine
intradermal needles, as well as to avoid a granulated appearance. The
product is lyophilized, thus enabling hydrolysis of the polymer to be
avoided, and allowing very good temporal storage stability to be obtained.
Following reconstitution, the product takes the form of a polylactic acid
hydrogel whose viscosity is inversely proportional to temperature." http://www.sculptra.com
Allergy
Test: n/a
Longevity: New-Fill is not permanent, it eventually absorbs into the
body. It is essentially a bio-catalyst and your own collagen will
eventually diminish.
Retail: Ł250 for lip, nose-mouth lines, forehead
Cost: per Two 3 ml bottles; DEM 750,00, that is roughly 375 US dollars
(Thank you Pieter!). In the US, most of our visitors were getting it for
approximately $1,000. US per treatment at first. This price has since
decreased by as much as half!
Available in the United States? New-Fill™ is not approved by the FDA
for typical cosmetic use in the US as of yet Although I know several
patients who have gotten this in various areas of the face -- including the
lips "off label." I also know that there are clinics all over
the US which offer the injections if you have access to the products -- or
order the products for you if you have HIV/Protease induced facial wasting
disorders.
Website:
http://www.sculptra.com
Update!
07/23/01: Several of our visitors have had New-Fill and you may
speak with them on the message
board. Two of them found that it did not last as long as expected
although they did not have the number of treatments suggested.
Update! 12/18/02: Dr.
Gail Humble advised the New-Fill trials are going very well and they have
found exceptional longevity -- especially in the cheek area. You may
contact her for more information or a consultation for New Fill.
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Reviderm
Intra: (technically:
flexible DEXTRAN micro-beads suspended in super-coiled, stabilized hyaluronic
acid of non-animal orgin) Brought to you by Rofil Medical
International, Reviderm Intra is an in injectable implant (flexible
DEXTRAN microbeads -- DEXTRAN is a carbohydrate complex, the liquid form was
once used in the place of saline in breast implants) 40-60 microns in size.
The micro-beads are evenly suspended in a non-animal hyaluronic acid.
"Reviderm Intra is biocompatible and biodegradable, yet long lasting,
because of the stimulation of growth of connective tissue in the dermis."
It is reported that each 1.0 ml of Reviderm Intra contains:
A regional block
may be used and injected deep into the dermis. At 2 to 4 weeks after
injection, 1 or 2 more injections will more than likely be needed to reach
full desired augmentation. Reviderm Intra proliferates fibroblast and
new collagen formation.
Allergy Test:
n/a
Longevity: reportedly 12 to 2 years
Cost: unknown
Available in the United States? Reviderm Intra is not approved by the
FDA for use in the US but may be considered an investigational material
soon.
Website: http://www.rofil.com
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