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Ex Vivo Induction of Tolerance for Autoimmune Diabetes

Award Information

Agency:
Department of Health and Human Services
Branch:
N/A
Award ID:
89086
Program Year/Program:
2008 / SBIR
Agency Tracking Number:
DK082122
Solicitation Year:
N/A
Solicitation Topic Code:
N/A
Solicitation Number:
N/A
Small Business Information
XIMEREX, INC.
2614 N. 161 AVE. OMAHA, NE -
View profile »
Woman-Owned: No
Minority-Owned: No
HUBZone-Owned: No
 
Phase 1
Fiscal Year: 2008
Title: Ex Vivo Induction of Tolerance for Autoimmune Diabetes
Agency: HHS
Contract: 1R43DK082122-01
Award Amount: $1,267,089.00
 

Abstract:

DESCRIPTION (provided by applicant): Transplantation of human has proved to be most beneficial for patients with end stage organ failure or loss of critical cells. For example, the transplantation of islets from human cadaveric donors has reversed type 1 diabetes for many recipients, making them insulin independent. Unfortunately, there are not nearly enough human organ donors to satisfy the need. Only about 0.1% of the 1.5 million Americans with T1D receive an islet transplant each year. Furthermore, they must receive chronic immune suppression indefinitely. Pig organs could satisfy this immense unmet need. They can be produced under controlled very clean conditions in a cost effective manner. The physiology is very similar to that of humans. The primar y obstacle to xenotransplantation, however, is the vigorous rejection of pig tissues. Ximerex has developed a technology for avoiding the need for immune suppression. Recipient cells are grown within the donor pig, during fetal development. Later, the c himeric lymphocytes and tissue graft are transplanted back into the recipient. Observations have shown prolonged function of pig islet tissue in diabetic monkeys without immune suppression. The proposal will transform this promising phenomenon into a xe notransplantation system for application in the clinic. The regulatory cells in the chimeric pig will be identified and quantified. A program for bioproduction and purification of the responsible regulatory cells will be developed. The system will be teste d with marrow specimens from human subjects with T1D, where a deficiency of T regulatory cells may contribute to the autoimmune destruction of beta cells. The lessons from the proposed studies would substantially enhance the likelihood that preclinical trials and clinical trials will have successful outcomes. PUBLIC HEALTH RELEVANCE: Type I diabetes (T1D) is due to loss of insulin producing beta cells and effects more than 1.25 million Americans. Ximerex is developing an unlimited source of replaceme nt islets from clean pigs using technology that avoids the need for anti-rejection drugs. This proposal defines the cells that are responsible for long term acceptance, expands and purifies these cells, and determines if such cells are produced from marrow from human subjects with T1D.

Principal Investigator:

William E. Beschorner
4024260660
BESCHORNER@XIMEREX.COM

Business Contact:


beschorner@ximerex.com
Small Business Information at Submission:

XIMEREX, INC.
2614 N. 161 AVE. OMAHA, NE 68116

EIN/Tax ID: 521839842
DUNS: N/A
Number of Employees: N/A
Woman-Owned: No
Minority-Owned: No
HUBZone-Owned: No