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IMMUNOSORBENT DEVICE FOR LDL REMOVAL FROM WHOLE BLOOD

Award Information

Agency:
Department of Health and Human Services
Branch:
N/A
Award ID:
7328
Program Year/Program:
1988 / SBIR
Agency Tracking Number:
7328
Solicitation Year:
N/A
Solicitation Topic Code:
N/A
Solicitation Number:
N/A
Small Business Information
Invitron Corp
4649 Le Bourget Dr Saint Louis, MO 63134
View profile »
Woman-Owned: No
Minority-Owned: No
HUBZone-Owned: No
 
Phase 2
Fiscal Year: 1988
Title: IMMUNOSORBENT DEVICE FOR LDL REMOVAL FROM WHOLE BLOOD
Agency: HHS
Contract: N/A
Award Amount: $381,000.00
 

Abstract:

HIGH BLOOD LEVELS OF LDL HAVE BEEN ESTABLISHED AS CAUSATIVE FOR ATHEROSCLEROSIS AND CORONARY HEART DISEASE. FOR SELECTED PATIENTS, EXTRACORPOREAL LDL REMOVAL IS THE MOST EFFECTIVE THERAPY. THE GOAL OF THIS PROJECT IS TO DEVELOP AMONOCLONAL ANTIBODY-BASED IMMUNOADSORPTION DEVICE CAPABLE OF REMOVING LOW-DENSITY LIPOPROTEIN (LDL) FROM HYPERCHOLESTEROLEMIC WHOLE BLOOD CIRCULATED IN A LOW-PRESSURE EXTRACORPOREAL VENOUS SHUNT. PHASE I WILL EXTEND PREVIOUS STUDIES DEMONSTRATING SAFETY AND EFFICACY OF GOAT POLYCLONAL ANTIBODY-BASED IMMUNOSORBENTS FOR REMOVAL OF LDL FROM WHOLE BLOOD IN VITRO TO THE EXTRACORPOREAL REMOVAL OF LDL FROM WHOLE BLOOD OF EXPERIMENTAL ANIMALS. IN ADDITION, MOUSE ANTI-LDL MONOCLONAL ANTIBODIES WILL BE TESTED FOR THEIR SUITABILITY IN THE LDL-IMMUNOSORBENT DEVICE. METHODS OF CHEMICAL STERILIZATION, IMMUNOSORBENT REGENERATION, AND STORAGE BETWEEN USES WILL ALSO BE STUDIED. DURING PHASE II, ADVANCED MEMBRANE TECHNOLOGY, SORBENT CONFIGURATION, AND COUPLING CHEMISTRY WILL BE EVALUATED FOR IMPROVED IMMUNOSORBENT EFFICACY AND CAPACITY. EXTENDED HUMAN TRIALS WILL BEGIN WITH THE IDENTIFICATION OF A SAFE AND EFFICACIOUS LDL-IMMUNOSORBENT DEVICE PROTOTYPE. DURING THE COURSE OF THESE STUDIES, NEW TECHNOLOGY WILL BE DEVELOPED IN THREE AREAS: (1) DESIGN OF WHOLE-BLOOD IMMUNOSORBENTS, (2) STERILIZATION OF IMMUNOSORBENTS, AND (3) APPLICATION OF MONOCLONAL ANTIBODIES TO CLINICAL IMMUNOSORBENTS.

Principal Investigator:

Laura H Silberstein Phd
3144265000

Business Contact:

Small Business Information at Submission:

Invitron Corp.
4649 Le Bourget St Louis, MO 63134

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