Status:
COMPLETED
A Controlled, In Vivo, Pilot Study to Assess the Recovery and Survival of Radiolabeled Autologous INTERCEPT Treated 7-Day Stored Apheresis Platelet Components in 35% Plasma and 65% InterSol and 7-Day Stored Apheresis Platelet Components in 100% Plasma
Lead Sponsor:
Cerus Corporation
Conditions:
Healthy
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The objective of this study is to test the hypothesis that INTERCEPT platelet components stored for 7 days retain sufficient viability for therapeutic efficacy. The post-infusion recovery and lifespan...
Detailed Description
The two stages of this pilot study consist of the following: single or double-dose platelet apheresis collection, pathogen inactivation with INTERCEPT treatment, storage for 7 days, collection of fres...
Eligibility Criteria
Inclusion
- Age-minimum of 18 years, of either gender
- Normal health status (as determined by the Investigator review of medical history and blood donor physical exam)
- Meet FDA and AABB guidelines for autologous apheresis platelet donation
- Complete blood count (CBC) and serum chemistry values within normal limits
- Pre-donation platelet count of more than 150×109 platelets/L
- Negative blood donor screening test panel for HIV, HBV, HCV, HTLV, syphilis, and WNV
- Male and female subjects of childbearing potential must agree to use a medically acceptable method of contraception throughout the study. A barrier method of contraception must be included, regardless of other methods.
- Signed and dated informed consent form
Exclusion
- Clinically significant acute or chronic disease (as determined by the Investigator)
- Pregnant or nursing females
- Male or female subjects of childbearing potential not using effective contraception
- Disease states or conditions that preclude blood donation or apheresis platelet donation per AABB reference standards
- Treatment with aspirin or aspirin containing medications within 7 days of apheresis or treatment with non-steroidal anti-inflammatory drugs (NSAID), anti-platelet agents or other drugs affecting platelet viability within 3 days of apheresis (e.g. ibuprofen or other NSAIDs)
- Smokers using \>10 cigarettes/day for the last 3 months
- Splenectomized subjects
- Prior exposure to amotosalen
- History of known hypersensitivity to indium or chromium
- Participation in another clinical study currently or within the past 28 days
Key Trial Info
Start Date :
December 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2015
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT02310412
Start Date
December 1 2014
End Date
September 1 2015
Last Update
November 8 2017
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