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Manufacturing Development of Allogeneic Stem Cells in Clinical Settings

Award Information

Agency:
Department of Defense
Branch:
Army
Award ID:
Program Year/Program:
2012 / SBIR
Agency Tracking Number:
A2-4681
Solicitation Year:
2010
Solicitation Topic Code:
A10-117
Solicitation Number:
2010.2
Small Business Information
TECHSHOT, INC.
7200 Highway 150 GREENVILLE, IN 47124-9515
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Woman-Owned: No
Minority-Owned: No
HUBZone-Owned: No
 
Phase 2
Fiscal Year: 2012
Title: Manufacturing Development of Allogeneic Stem Cells in Clinical Settings
Agency / Branch: DOD / ARMY
Contract: W81XWH-11-C-0017
Award Amount: $729,988.00
 

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.

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
Small Business Information at Submission:

Techshot, Inc.
7200 Highway 150 Greenville, IN -

EIN/Tax ID: 351784668
DUNS: N/A
Number of Employees:
Woman-Owned: No
Minority-Owned: No
HUBZone-Owned: No