Vi riposto l'intervista alla Responsabile di Histogen, parla chiaramente di aumento della conta dei capelli del 15% a quattro settimane, ed aumento del peso del 20% del capello.
Guardate il famoso PDF di Histogen si parla di conta di capelli in maniera chiara, c'è anche l'immagine con i capelli contrassegnati in rosso e dopo 12 settimane in verde, mi sembra molto eloquente, è comunque roba vecchia del 2008.
http://www.histogeninc.com/downloads/stem_cell_summit.pdf
Interview with Gail Naughton, PhD, CEO, Chairman of the
Board, Histogen Inc.
1. How did your company Histogen get involved in hair
therapy?
In the course of studies on culture medium conditioned
by fi broblasts, we noted reports in the literature that hair
formation was the result of an interaction between epithelial
cells (which form the hair) and a fi broblast-derived
population (that directs them to do so) and that proteins
called wnt were involved in the process. We wondered
whether our fi broblast-conditioned medium, which is
gained by growing the cells under unique embryonic-like
conditions of low oxygen and low gravity, might contain
wnt protein and so we performed experiments in mice.
The experiments involved injecting derivatives of the conditioned
medium into the backs of mice, which had been
shaved so that new hair growth (entry into anagen) during
the telogen stage of the hair cycle would be evident. We
obtained preliminary evidence that this might be so, and
pursued the project.
2. What is the basis of your hair regeneration product and
how is it produced?
The hair regeneration product, which we are currently
referring to as HSC (Hair Stimulating Complex), is derived
from fi broblasts grown under controlled conditions, on beads
and in a subatmospheric oxygen tension. These conditions
duplicate the environment of the body more closely than
do other culture systems. Under these conditions, the cells
increase their production of wnt proteins, specifi cally wnt
7a, and other hair-regeneration-related proteins (such as
follistatin) and release them into the medium. During the
production of wnt proteins, the cells also secrete a variety of
wound healing growth factors, such as KGF and VEGF, which
have also been shown to play a role in hair growth. To our
knowledge, Histogen is the only company currently capable
of producing naturally-secreted, active wnt proteins.
3. Where do the embryonic fi broblasts come from that you
use?
The fi broblasts are derived from neonatal foreskins following
routine circumcision. We establish cell banks that
are tested for all known pathogens and viruses as per the
Center for Biologics Evaluation and Research’s (CBER) Points
to Consider. From one donor foreskin we establish enough
tested cells for years of manufacturing. (The CBER is the
center within the U.S. Food and Drug Administration [FDA]
that regulates biological products for human use. Points to
Consider are guidelines from the FDA on cell lines used in
biological products.)
4. What is the main responsible component of your solution
that appears to increase hair growth: wnt, other growth
factors, antioxidants…?
We believe that wnt proteins play an important role in the
hair regenerative properties of the conditioned medium. It is
known that wnt proteins are involved in both the initial induction
of the hair follicle and also in the regenerative phase
of the hair cycle. However, the formation and maintenance of
the hair is a complex process and many other proteins are
known to be involved. These include sonic hedgehog, activin,
and bone morphogenetic protein-2, which are involved in
a complex manner with the maintenance of stem cells and
the development of the cells into hair. The process also involves
inhibitors of these growth factors, such as follistatin,
which inhibits activin and is produced in large quantities by
fi broblasts in our manufacturing system.
5. How is the treatment administered (e.g., topical/injectible)
and how often?
At this point, the treatment is administered by 0.1cc
injection into the mid dermis. In our initial human trial,
these injections were done at the baseline time point with
evaluations performed at subsequent visits. We will look at
different concentrations or injections at multiple time points,
to determine a dose ranging within future studies. In addition,
we are working with formulations that will allow us to
test topical application of the product.
6. What component of the hair follicle seems to be the
target: the dermal papillae, the bulge stem cells, other
non-bulge stem cells?
It is one of the advantages of the approach taken here that
the target is at several levels. As discussed above, the hair cycle
is a complex process and requires the coordinated activity of
many components. This includes the activation of stem cells
to generate transit amplifying cells, and the expansion of the
transit amplifying population and their differentiation into the
cells that die to form the hair shaft. The conditioned medium
contains proteins that affect all these processes. For instance,
bone morphogenetic protein (BMP) and activin are involved
both in the maintenance of stem cells and also in the differentiation
of transit amplifying cells. In the reactivation of the
growth phase of the hair cycle, stem cells have to be induced
to make transit amplifying cells, which involves a reduction
in BMP and activin, and then they have to differentiate, which
involves an increase in BMP and activin. Hence the importance
of inhibitors of these factors, such as follistatin. However, most
of these processes are initiated in the hair bulb.
7. Do you have an animal model for the current clinical
trials?
Yes. For efficacy, HSC has been tested using a standard
hair growth model in C57 Bl mice. In addition, a preclinical
safety study was performed prior to initiation of the human
clinical study to evaluate the potential toxicity resulting from
a single subcutaneous injection of the HSC formulation in
an established experimental model of acute toxicity in rats.
The study was performed by a third-party contract research
organization in a manner consistent with standards of GLPs
(Good Laboratory Practices) and applicable regulatory and
animal welfare compliance. Toxicity was assessed during the
8-day study by clinical observations of the injection sites,
general morbidity, hematology and clinical chemistry determinations,
and evaluation of the post-mortem macroscopic
and microscopic pathology. No adverse clinical events were
noted in any treatment groups. It was concluded that the
HSC formulation did not produce significant toxicity when
administered as a single subcutaneous injection to Sprague
Dawley rats.
8. You have elected to conduct these trials outside the United
States. Why is this and is there any particular reason to
choose Honduras?
Trials in foreign countries provide the same information
as those performed in this country and conform to the
same standards of patient protection and quality of results.
However, they may be less expensive and entail less burden
of regulations than in this country and, in some cases,
may provide a particularly suitable patient population. In
our study all subjects signed an informed consent and our
principal investigators, Dr. Craig Ziering and Dr. David Perez-
Meza, travelled to Honduras for patient treatment. In addition
to the cost savings involved with the clinical study itself,
we were able to minimize costs by manufacturing product
under GMP-like conditions without undertaking the large
expense of establishing GMP (Good Manufacturing Practice)
manufacturing, a requirement for even phase I testing in the
United States. (GMP involves regulating the manufacturing
and laboratory testing environment. It involves documentation
of every aspect of the process, activities, and operations
involved with drug an
Comunque sembra veramente molto interessante e promettente ma non in sto 20-30 % di capelli in piu ci stanno anche i propri miniaturizzati che tornano a essere terminali oppure no ? Non ho ben capito se si o no! O_O