IMMUNOSORBENT DEVICE FOR LDL REMOVAL FROM WHOLE BLOOD

Award Information
Agency:
Department of Health and Human Services
Branch
n/a
Amount:
$381,000.00
Award Year:
1988
Program:
SBIR
Phase:
Phase II
Contract:
n/a
Award Id:
7328
Agency Tracking Number:
7328
Solicitation Year:
n/a
Solicitation Topic Code:
n/a
Solicitation Number:
n/a
Small Business Information
4649 Le Bourget, St Louis, MO, 63134
Hubzone Owned:
N
Minority Owned:
N
Woman Owned:
N
Duns:
n/a
Principal Investigator:
Laura H Silberstein Phd
(314) 426-5000
Business Contact:
() -
Research Institute:
n/a
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.

* information listed above is at the time of submission.

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