Ignite Creation Date:
2025-12-25 @ 2:18 AM
Ignite Modification Date:
2026-01-03 @ 3:26 PM
Study NCT ID:
NCT04418934
Status:
WITHDRAWN
Last Update Posted:
2020-08-03
First Post:
2020-05-26
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Investigation to Evaluate the Hemanext® Red Blood Cell Processing System for Extended Storage of Leukoreduced Red Blood Cells
Sponsor:
Hemanext
Organization:
Study Overview
Official Title:
Clinical Investigation to Evaluate the Hemanext® Red Blood Cell Processing System for Extended Storage of Leukoreduced Red Blood Cells With CP2D Anticoagulant and AS-3 Additive - Pivotal Trial
Status:
WITHDRAWN
Status Verified Date:
2020-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Grant application for study was rejected
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The primary goal of Hemanext Inc. is to improve the safety and efficacy of transfusion therapy through novel storage methods potentially improving their quality across the storage cycle. Based on our review of the pertinent literature, there is substantial evidence suggesting that prolonged exposure to oxygen during storage results in oxidative damage to the red blood cells (RBC) over the course of storage leading to decreased therapeutic potential. Therefore, removal of oxygen from red blood cell products prior to storage has potential to preserve the cells in a more physiologically relevant state and improve the clinical outcomes of patients that receive blood transfusions in a variety of therapeutic realms1.
Currently, Hemanext Inc. has focused on the design and development of a dual compartment bag system designated as the Hemanext Red Blood Cell Processing System (Hemanext). After standard processing of donated whole blood units into leukoreduced packed red blood cells (LR-RBCs) in AS-3 additive solution, the LR-RBCs would then be placed in the oxygen reduction bag (ORB) processing bag which allows for the rapid diffusion of oxygen out of the blood, through a sterile, oxygen-permeable membrane, and into iron-based oxygen sorbents. After processing, the blood is transferred again from the ORB into the Hemanext Storage Bag (HSB) which will preserve the hypoxic state of the LR-RBC product for the duration of cold storage.
The COVID-19 crisis has placed unprecedented pressure on the US blood supply security. The pandemic has caused blood supplies to fall precipitously, placing all transfusion recipients at acute risk. Hemanext has developed a technology over 12 years with support from 6 NIH grants and contracts that can substantially mitigate the damage done to the blood supply by this COVID-19 crisis and strengthen the ability of the US blood supply to withstand the effects of future crises. Limited shelf life is a key component in exacerbating the current blood supply crisis. Successful completion of this project will allow earliest possible availability (within 9-12 months) of the high quality Hemanext RBC with significantly extended shelf life. Even without shelf life extension, the higher quality Hemanext RBC showed a reduction of \>50% of blood volume required for resuscitation from hemorrhage in a pre-clinical rodent model. Further enhancement of the quality of Hemanext RBC is expected to improve still further the efficacy of Hemanext blood and further to reduce the transfusion volume needed to achieve treatment objectives. In addition, extending the shelf life of the Hemanext RBC will provide greater inventory flexibility to avoid the devastating impact of major blood shortages due to reduced donor activity during threats to blood security such a COVID-19 pandemics and other crises.
Currently, Hemanext Inc. has focused on the design and development of a dual compartment bag system designated as the Hemanext Red Blood Cell Processing System (Hemanext). After standard processing of donated whole blood units into leukoreduced packed red blood cells (LR-RBCs) in AS-3 additive solution, the LR-RBCs would then be placed in the oxygen reduction bag (ORB) processing bag which allows for the rapid diffusion of oxygen out of the blood, through a sterile, oxygen-permeable membrane, and into iron-based oxygen sorbents. After processing, the blood is transferred again from the ORB into the Hemanext Storage Bag (HSB) which will preserve the hypoxic state of the LR-RBC product for the duration of cold storage.
The COVID-19 crisis has placed unprecedented pressure on the US blood supply security. The pandemic has caused blood supplies to fall precipitously, placing all transfusion recipients at acute risk. Hemanext has developed a technology over 12 years with support from 6 NIH grants and contracts that can substantially mitigate the damage done to the blood supply by this COVID-19 crisis and strengthen the ability of the US blood supply to withstand the effects of future crises. Limited shelf life is a key component in exacerbating the current blood supply crisis. Successful completion of this project will allow earliest possible availability (within 9-12 months) of the high quality Hemanext RBC with significantly extended shelf life. Even without shelf life extension, the higher quality Hemanext RBC showed a reduction of \>50% of blood volume required for resuscitation from hemorrhage in a pre-clinical rodent model. Further enhancement of the quality of Hemanext RBC is expected to improve still further the efficacy of Hemanext blood and further to reduce the transfusion volume needed to achieve treatment objectives. In addition, extending the shelf life of the Hemanext RBC will provide greater inventory flexibility to avoid the devastating impact of major blood shortages due to reduced donor activity during threats to blood security such a COVID-19 pandemics and other crises.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: