NCT00968487

The Safety of Autologous Lyophilized Plasma Versus Fresh Frozen Plasma in Healthy Volunteers

A Clinical Study of the Safety of Ascending Doses of Autologous Lyophilized Plasma Versus Fresh Frozen Plasma in Normal Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: HemCon Medical Technologies, Inc · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

A single-site, single-blind study of ascending doses of Lyophilized Plasma in normal healthy volunteers.

Detailed description

This "first-in-human" Phase I, single-center, dose escalation study (using 3 dose levels) is proposed to assess the safety of infusing reconstituted lyophilized human plasma (LyP). The study design incorporates plasmapheresis-derived autologous plasma (FFP) for infusion(s) to eliminate variables and events known to be related to allogenic transfusion. Subjects will be enrolled at a blood center and provide autologous FFP that will be shipped to the sponsor site and used as the starting material to manufacture LyP. Once manufacturing is complete, the LyP (autologous) will be returned to the blood center for reconstitution and infusion into subjects. Maximum dosage within this study will approach "massive transfusion" (1 liter in Cohort 3) to obtain a preliminary assessment of safety. One half of the FFP obtained from subjects in Cohort 3 (only) will be shipped to the sponsor and returned to the site (but not manufactured into LyP) to serve as the control (autologous FFP).

Conditions

• Healthy

Interventions

Type	Name	Description
BIOLOGICAL	Lyophilized Plasma	Lyophilized Plasma is serves as a source of plasma proteins for subjects who are deficient in plasma proteins. The donor and recipient are the same person, therefore the process is autologous. HemCon's lyophilized plasma originates from FFP from screened individual donors to significantly reduce the risk of bloodborne disease transmission and undesired transfusion-associated reactions. Each single-donor unit is tested (per required of the blood supply) to reduce the risk of transmission of infectious agents and hence, maximize subject safety.
OTHER	Fresh Frozen Plasma	The fluid portion of one unit of human blood that has been centrifuged, separated, and frozen solid at -18 °C (-0.4 °F) (or colder) within 6 hours of collection.

Timeline

• Start date: 2010-06-01
• Primary completion: 2011-12-01
• Completion: 2011-12-01
• First posted: 2009-08-31
• Last updated: 2012-02-24

Locations

1 site across 1 country: United States