Navigation Links
IntelliCell BioSciences Announces FDA Registration for its Cell Processing Facility
Date:11/9/2012

NEW YORK, Nov. 9, 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.
Copyright©2012 PR Newswire.
All rights reserved

Related medicine technology :

1. IntelliCell Announces Dr. Arnold I. Caplan Joins Scientific Advisory Board
2. IntelliCell BioSciences Files Patent Application for a New Mechanical Method to Separate Stromal Vascular Fraction from the Blood Vessels in Adipose Tissue
3. Pressure BioSciences, Inc. and Target Discovery, Inc. Expand Strategic License Agreement and Collaboration Supporting TDIs Planned Offering of Personalized Medicine Clinical Diagnostic Services
4. Neurocrine Biosciences Announces Conference Call and Webcast to Present First Quarter 2012 Financial Results
5. Amarantus BioSciences to Present at the New York Biotechnology Association (NYBA) 21st Annual Meeting on May 2nd, 2012
6. Neurocrine Biosciences Reports First Quarter 2012 Results
7. Pressure BioSciences, Inc. to Discuss First Quarter 2012 Financial Results And Provide Business Update
8. Ambit Biosciences and Teva Announce Clearance of an Investigational New Drug (IND) Application for CEP-32496, A Novel BRAF(V600E) Inhibitor
9. Neurocrine Biosciences to Present at the Jefferies 2012 Global Healthcare Conference
10. 3-V Biosciences To Present at the Seventh Annual JMP Securities Healthcare Conference
11. Sofie Biosciences receives $1M Phase II SBIR grant from the DOE
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:3/23/2017)... Research and Markets has announced the addition ... to their offering. ... The global oxygen therapy devices market to grow at a ... report, Global Oxygen Therapy Devices Market 2017-2021, has been prepared based ... report covers the market landscape and its growth prospects over the ...
(Date:3/23/2017)... 2017 A research report by Mordor ... to reach USD 7.2 billion by the end of 2021 ... a procedure in which a sample is preserved prior to ... procedures since the methods are often allowing repeated testing. The ... most shared procedures in the lab. In many life science ...
(Date:3/23/2017)... -- Newborns are highly vulnerable to infections and ... young immune systems typically mount weak antibody responses. ... strong vaccine responses in newborn animals, including monkeys ... — by adding compounds known as adjuvants that ... they also describe improved adjuvant formulations that could ...
Breaking Medicine Technology:
(Date:3/23/2017)... ... March 23, 2017 , ... Demonstrating their commitment to improving ... health departments have been awarded national accreditation through the Public Health Accreditation ... expanding network of communities across the nation whose health departments meet rigorous national ...
(Date:3/23/2017)... (PRWEB) , ... March 23, 2017 , ... The MBI “Hall of Fame” recognizes the ... acts have had a significant impact on the careers of all others involved. ... Inc. was inducted into the MBI’s Hall of Fame. The induction took place during ...
(Date:3/23/2017)... ... March 23, 2017 , ... Benefits delivery trailblazer, Hodges-Mace, ... and centralized benefits dashboard solving one of the top frustrations in employee benefits ... the first time, employees can access up-to-date information and account balances for all ...
(Date:3/23/2017)... (PRWEB) , ... March 23, 2017 , ... The TouchPoint ... around the world to manage stress and anxiety. , “Buzzies change the way ... inventor and co-founder of Buzzies. , Since its launch date in December 2016, The ...
(Date:3/23/2017)... ... March 23, 2017 , ... ... named The Resource Group as their 2016 Microsoft Dynamics Partner of the Year ... Beach, CA. The award recognizes The Resource Group for their outstanding relationship ...
Breaking Medicine News(10 mins):