Manufacturing Development of Allogeneic Stem Cells in Clinical Settings

Award Information
Agency:
Department of Defense
Branch
Army
Amount:
$729,988.00
Award Year:
2012
Program:
SBIR
Phase:
Phase II
Contract:
W81XWH-11-C-0017
Award Id:
n/a
Agency Tracking Number:
A2-4681
Solicitation Year:
2010
Solicitation Topic Code:
A10-117
Solicitation Number:
2010.2
Small Business Information
7200 Highway 150, Greenville, IN, -
Hubzone Owned:
N
Minority Owned:
N
Woman Owned:
N
Duns:
621970383
Principal Investigator:
Nathan Thomas
Project Manager/Principal
(812) 923-9591
nthomas@techshot.com
Business Contact:
Mark Deuser
President&CEO
(812) 923-9591
mdeuser@techshot.com
Research Institute:
Stub




Abstract
Cellular therapies are rapidly moving toward widespread clinical application in cancer treatment, autoimmune disease control and trauma recovery. Human adipose tissue, an available waste product from reconstructive and plastic surgery, is becoming a most popular source of adult stem cells, which are already being applied in autotransplant situations. For allogeneic transplants a leap-ahead manufacturing process that isolates desired and eliminates undesired cell types at a high processing rate is required. Techshot, Inc. will work with collaborators at the University of Pittsburgh and IKOTECH, LLC to (1) refine quadrupole magnetic cell sorting (QMS) equipment and supplies for validated manufacture under cGMP rules, (2) prepare for Investigational New Drug (IND) applications by manufacturing at least three clinically acceptable mesenchymal stem cell products from adipose tissue digests using the resulting equipment and single-use kits and Standard Operating Procedures in a clinical setting, and (3) utilize the results to meet FDA requirements for a FDA Device Master File (DMF). Successful conclusion of this project will prepare QMS for use in clinical trials of interest to the Armed Forces Institute for Regenerative Medicine (AFIRM) and will enable new therapies in the high-growth civilian regenerative medicine market.

* information listed above is at the time of submission.

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