New Health Sciences


Hemanext Anaerobic Storage Platform

The Hemanext Anaerobic Storage Platform (HASP) is a novel technology used to deliver red blood cells (RBCs) of higher efficacy for transfusion therapy, and at the same time, extend the shelf life of refrigerated RBCs.

With HASP, RBCs are stored in a modified additive solution under oxygen-depleted (anaerobic) conditions. Anaerobically stored RBCs are characterized by higher efficacy as well as extended shelf life (9 weeks or more) as compared to same-aged blood stored by conventional methods.

Stored RBCs, even if transfused within the current 6-week storage limit, deteriorate in a variety of significant ways – including hemolysis (red cell destruction), low survival rate of transfused red cells in recipients, reduced deformability (inability to reach capillary beds), inability to release oxygen at tissue, and inability to dilate arterioles to increase perfusion. Numerous Phase I studies, including a recent clinical trial funded by a SBIR Phase I grant, have shown repeatedly that RBCs stored using HASP have higher ATP and 2,3-DPG levels, lower hemolysis, and higher post-transfusion recovery compared to conventionally stored cells, as well as a 50-100% extension in shelf life. These results have been presented in professional meetings as well as published in prominent peer reviewed journals, including Transfusion and Vox Sanguinis. This improved efficacy, while beneficial in all circumstances, will particularly benefit subjects who require chronic transfusion therapy (e.g., sickle cell disease or beta-thalassemia) by reducing transfusion frequency, time-averaged blood transfusion volume, and total iron burden. Additionally, an extended shelf-life will improve the logistics of general blood banking, help alleviate periodic blood shortages, and enhance the utility of pre-operative autologous blood collection.

Research into HASP started in the early 1990s at Los Alamos National Laboratory by two scientists, Mark W. Bitensky M.D. and Tatsuro Yoshida Ph.D. The project was transferred to Boston University with both scientists in 1996, and continued until 2006. During that time numerous small-scale clinical trials using experimental storage protocols were conducted under FDA guidance.

RBC Storage

There are currently three main issues involved in the storage of refrigerated blood:

  • 1. Red cells stored for extended periods become less effective and potentially toxic.
  • a. Up to 25% of red cells are destroyed by the body soon after transfusion.
  • b. Destroyed cells cause iron overload in chronically transfused patients.
  • c. Transfusion does not achieve intended outcome of increased delivery of oxygen to organs.
  • d. Transfusing red cells stored for longer periods result in higher morbidity and longer hospital stays compared to fresher red cells.
  • 2. Refrigerated red cells can be stored for only 6 weeks.
  • a. 3.3% of stored blood is discarded as out-of-date.
  • b. Periodic blood shortages occur around summer and holidays (also results in idled surgical suites).
  • c. Requires high costs in maintaining just-in-time infrastructure.
  • d. Causes logistical problems at remote locations and small hospital blood banks.
  • e. Places limits on quantity and usefulness of pre-operative autologous blood collection.
  • 3. There are no practical alternatives for refrigerated blood.
  • a. Frozen blood has a shelf life that exceeds 10 years. However, the procedure is too cumbersome and expensive for routine use.
  • b. Artificial blood substitutes (chemical or cross-linked hemoglobins) have long shelf lives, but they cannot be used for general transfusion therapies.


“The [HASP] anaerobic storage approach has the potential to enhance the quality of RBC storage and transfusion therapy and will help us to improve and optimise the care of patients in the near future.”

Blood Transfusion 2010;8: DOI 10.2450/2010.0060-10 by:

James AuBuchon, M.D., President & CEO, Puget Sound Blood Center Professor of Medicine & Laboratory Medicine, University of Washington, and

Giancarlo Maria Liumbruno M.D., Research and Clinical Immunohaematology, Transfusion Medicine and Clinical Pathology at the Hospital Fatebenfratelli, Isola, Tiberina.


HASP Technology

The HASP system uses the following components:

  • 1. An additive solution;
  • 2. An oxygen / carbon dioxide sorbant;
  • 3. A membrane with high oxygen permeability in contact with a red cell suspension enclosing oxygen sorbant;
  • 4. An carbon dioxide /oxygen depletion device (OCDD) to remove oxygen from RBCs before they are placed in storage; and
  • 5. A RBC storage bag that can maintain an anaerobic state throughout the extended storage duration.

HVA

HASP: A single use plastic disposable set comprised of an O2/CO2 depletion device (OCDD), a custom blood storage outer bag, interconnection tubing, labels and packaging.


SBIR Funding Overview

In June 2008, the Company clearly established proof of concept in humans following completion of a Phase I clinical trial funded by a $134,000 SBIR Phase I grant from the National Heart, Lung, and Blood Institute (NHLBI). Following this success, the NHSi applied for and NHLBI awarded a $1.9 million a Phase II SBIR grant The primary objective of the Phase II grant is to design and fabricate an anaerobic RBC storage system that can be readily accommodated by current blood banking practices without incurring major alteration in procedures or equipment.

Phase 1 Accomplishments

In the SBIR-funded Phase I trial, a dual arm study conducted at Dartmouth-Hitchcock Medical Center, eight subjects were transfused with RBCs stored under HASP and conventional methods. Anaerobic storage demonstrated a superior 24-hour recovery compared to conventionally stored RBCs after 6 weeks of storage, and equivalent 24-hour recovery after 9 weeks.

Additional Phase 1 trials have shown:
  • Extended shelf life of refrigerated RBCs to 9 weeks using additive solution currently in wide use.
  • Extended shelf life of refrigerated RBCs to 12 weeks using advanced additive solution coupled with metabolic supplementation during storage.
  • Extended shelf life of refrigerated RBCs to 9 weeks using advanced additive solution.

These promising results, reported in Transfusion and Vox Sanguinis induced the NIH to award a Phase II SBIR grant.

Phase II SBIR Project

The anaerobic storage of RBCs has repeatedly been shown to improve metabolic status as well as to extend the shelf life. However, in all preliminary trials, a gas exchange process was used as a means to deplete oxygen prior to storage, and RBCs were kept in an anaerobic chamber during storage. To introduce this technology to the market and test its benefits in large-scale trials, a simple, self-contained blood collection/storage bag set is needed that does not require materially higher costs or major alterations in manufacturing infrastructure or operating procedures of blood banks. Primary design specifications include:

  • 1. functional capabilities that replicate or exceed blood quality and shelf life results achieved in the Phase I trial;
  • 2. maximum design and production engineering compatibility with existing blood collection technology; and
  • 3. minimal incremental RBC unit costs.

NHSi has utilized the SBIR Phase II grant funds to:

  • 1. Successfully complete development of a prototype of the disposable HASP device;
  • 2. Launch in vitro testing of the prototype device at Dartmouth-Hitchcock Medical Center
  • 3. Complete and submit an Investigational New Device (IND) filing with the US Food and Drug Administration.

  • Upon receipt of FDA’s approval of the IND application (anticipated by November 2010), NHSi will commence in vivo trials of the prototype device, again at Dartmouth-Hitchcock Medical Center.

    The in vivo trial is designed to demonstrate that, after 3 and 6 weeks of storage, a significantly higher 24 hour post-transfusion recovery can be achieved compared to conventionally stored blood; and that such RBCs can achieve a 9-week shelf life.

    In April 2011, NHSi plans to use preliminary results from the in vivo trial to support a NIH SBIR Phase IIb application. The Phase IIb funds, if awarded, will be used to fund the pivotal trial required to support an FDA application for approval to market HASP in the United States.

    In addition to demonstrating the improved quality characteristics of anaerobically stored blood, small samples of the red cells collected and stored anaerobically during the in vivo trial will be shared with four other institutions – University of Tuscia (Italy), Puget Sound Blood Center, Mayo Clinic and Tulane University – who are studying the effects of storage (with and without HASP) on the therapeutic quality of red cells. The data generated by wide range of biochemical and biophysical measurements will be correlated with the 24-hour post-transfusion recovery measured in the in vivo trial.

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