Pilot Study of Hemospan® in Patients With Chronic Critical Limb Ischemia

Status Completed

Clinical Trial Summary

The purpose of this study is to evaluate the effects of Hemospan infusion on vascular reactivity, regional perfusion and oxygenation of ischemic tissue in patients with chronic critical lower limb ischemia.

Clinical Trial Description

Hemospan® is a novel hemoglobin-based oxygen carrier developed to perfuse and oxygenate tissue at risk for ischemia and hypoxia. Because of its molecular size and oxygen binding characteristics, Hemospan selectively off-loads oxygen in tissues predisposed to low oxygen tension. Preclinical evidence suggests that Hemospan provides volume expansion and enhances tissue perfusion. Hemospan is therefore being developed as an oxygen-carrying plasma expander for patients where tissues are at risk of inadequate perfusion and oxygenation.

In patients with chronic critical lower limb ischemia (CCLI), the primary cause of ischemic symptoms in the leg is insufficient perfusion. As many of the patients suffering from CCLI are elderly and have concomitant disease, surgical procedures may not always be possible. The goal of all treatments is to improve the blood flow in the nutritional vessels of the ischemic areas; one such possibility may be to use an oxygen-carrying plasma expander.

Hemospan has been shown to improve the oxygenation of tissues by preserving functional capillary density. In addition, Hemospan has a high affinity for oxygen - a feature that is specifically designed to target the unloading of oxygen in the microcirculation where local PO2 levels are much lower (e.g., in ischemic regions). Since Hemospan is a cell-free oxygen carrier, it should be able to perfuse capillaries that are so constricted that red blood cells are unable to flow through them. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00633659
Study type	Interventional
Source	Sangart
Contact
Status	Completed
Phase	Phase 2
Start date	September 2007
Completion date	December 2008

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.