IntelliCell BioSciences Announces FDA Listing For Human Cells,
Tissues, and Cellular Based Products
NEW YORK, Nov. 8, 2012 /PRNewswire/ -- IntelliCell
BioSciences, Inc. ("Company") (SVFC) announced today that it has
been notified according to the FDA validation registration number
3009842420, that its new facility located at 460 Park Avenue,
New York, NY 10022 is now
registered to recover, process, package, store, and label human
cells and tissue products (HCT/P's) such as the IntelliCell
autologous stromal vascular fraction cellular product. In the
registration notification, FDA acknowledged that the IntelliCell
process is to be covered under regulations for tissue
products. The HCT/P regulations are described in 21 CFR
section 1271.10.
IntelliCell's Chairman and CEO, Dr. Steven Victor, stated "Our Company is very
pleased to announce today that our new cellular processing facility
has now been registered to process an individual's own tissue for
the purpose of acquiring their stem and regenerative cells for use
in regenerative medicine. The IntelliCell processing
technology is designed to allow physicians to treat their patients
during a same day and same procedure basis much the same way that
bone marrow transplants and IVF treatments are performed
today. This is a significant step for the Company as it
continues its mission to be a leading regenerative medicine
company. We look forward to continuing to work with FDA as we
prepare a number of clinical studies for disease states with high
unmet clinical needs."
Robert Sexauer, EVP of Clinical
Development stated "We can now begin to move forward with our plans
for in-human clinical studies such as lower limb ischemia by
applying to Institutional Review Boards (IRB's) with study
protocols and laboratory processes that will be compliant with the
federal and state regulations. By operating under regulations
for 21 CFR 1271.10 regulations, similar to autologous tissue
transplants, we may be able to prepare a number of regenerative
medicine projects and we look forward to working with FDA to meet
any and all requirements."
About IntelliCell BioSciences
IntelliCell BioSciences is a Regenerative Medicine company
developing novel technologies that address the regenerative,
curative, and preventative conditions of disease states with high
unmet clinical needs. The Company has several patent pending
applications including an industry unique method of obtaining
autologous stromal vascular fraction cells (SVF) from the
vasculature surrounding adipose tissue containing adult stem cells
and a robust population of regenerative healing cells. The
Company is also pioneering the development of autologous and
allogeneic cells from living and non-living tissue donors for
research purposes. IntelliCell is planning a series of
in-human clinical studies with top tier universities for the
treatment of osteoarthritis, multiple sclerosis, lower limb
ischemic wounds, and gum regeneration in the oral cavity as well as
medical aesthetics. The Company has developed a first in
class cGTP cellular processing facility in New York City, purpose built and designed to
be fully integrated into its ambulatory surgery center.
Forward-Looking Statements
Certain statements set forth in this press release constitute
"forward-looking statements." Forward-looking statements include,
without limitation, any statement that may predict, forecast,
indicate, or imply future results, performance or achievements, and
may contain the words "estimate," "project," "intend," "forecast,"
"anticipate," "plan," "planning," "expect," "believe," "will
likely," "will reach," "will change," "will soon," "should,"
"could," "would," "may," "can" or words or expressions of similar
meaning. Such statements are not guarantees of future performance
and are subject to risks and uncertainties that could cause the
company's actual results and financial position to differ
materially from those included within the forward-looking
statements. Forward-looking statements involve risks and
uncertainties, including those relating to the Company's ability to
grow its business. Actual results may differ materially from the
results predicted and reported results should not be considered as
an indication of future performance. The potential risks and
uncertainties include, among others, the Company's limited
operating history, the limited financial resources, domestic or
global economic conditions, activities of competitors and the
presence of new or additional competition, and changes in Federal
or State laws. More information about the potential factors that
could affect the Company's business and financial results is
included in the Company's filings, available via the United States
Securities and Exchange Commission.
Contacts:
IntelliCell BioSciences, Inc.
Angela Metelitsa
Email Contact: Ametelitsa@intellicellbiosciences.com
(646) 576-8708
SOURCE IntelliCell BioSciences, Inc.