Inactivation of Whole Blood With Mirasol

NCT01907906 | Completed Phase 1 Results

• 2 other identifiers: CTS-0080ERMS#12308001
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this study is to evaluate radiolabeled recovery and survival of autologous red blood cells (RBC), derived from Mirasol-treated fresh whole blood (WB), stored as leukoreduced packed RBC (LR-pRBC), and re-infused in healthy adult subjects

Conditions

Focus of Study: Radiolabel Recovery and Survival of RBCs

Keywords

Pathogen reduction technology

Outcome Measures

Primary Outcomes (1)

• Red Blood Cell (RBC) 24-Hour Recovery

  To evaluate, as per FDA criteria, the 24-hour post transfusion RBC recovery in healthy adult subjects of leuko-reduced packed red blood cells (LR-pRBC) that have been derived from Mirasol-treated fresh WB units and stored at 1 to 6°C for 21 days. 24-hour RBC Recovery is a measure of the % of RBCs that are still functioning 24 hours after they have been reinfused back into the donor following storage over 21 days.

  24 hours

Secondary Outcomes (36)

• Red Blood Cell (RBC) Survival by Product

  28 days

• Area Under the Curve (AUC) of Red Blood Cell (RBC) Survival

  28 days

• Spearman's Correlation Coefficients: 24-Hour Red Blood Cell (RBC) Recovery (%) With Hemolysis (%)

  24 hours

• Spearman's Correlation Coefficients: 24-Hour RBC Recovery (%) With Adenosine Triphosphate (ATP) (µmol/g Hgb)

  24 hours

• Spearman's Correlation Coefficients: 24-Hour RBC Recovery (%) pCO2 (mmHg at 37° C)

  24 hours

Study Arms (2)

Arm 1: Mirasol-treated WB then untreated WB

EXPERIMENTAL

Screening Period (14 days); Treatment Period 1 (49 days): Donation of WB treated with Mirasol System for Whole Blood on Day 0, LR-pRBCs manufactured \& stored 21 days, radiolabeled RBCs reinfused on Day 21 and samples collected over 28 days (Days 21-49); WB Donation Deferral Period (35-49 days); Treatment Period 2 (49 days): Donation of WB, UNTREATED on Day 0, LR-pRBCs manufactured \& stored 21 days, radiolabeled RBCs reinfused on Day 21 and samples collected over 28 days (Days 21-49) Study Exit on Treatment Period 2, Day 49

Device: Mirasol System for Whole Blood

Arm 2: Untreated WB then Mirasol-treated WB

EXPERIMENTAL

Screening Period (14 days); Treatment Period 1 (49 days): Donation of WB, UNTREATED on Day 0, LR-pRBCs manufactured \& stored 21 days, radiolabeled RBCs reinfused on Day 21 and samples collected over 28 days (Days 21-49); WB Donation Deferral Period (35-49 days); Treatment Period 2 (49 days): Donation of WB treated with Mirasol System for Whole Blood on Day 0, LR-pRBCs manufactured \& stored 21 days, radiolabeled RBCs reinfused on Day 21 and samples collected over 28 days (Days 21-49) Study Exit on Treatment Period 2, Day 49

Device: Mirasol System for Whole Blood

Interventions

Mirasol System for Whole Blood DEVICE

LR-pRBC units derived from WB will be treated with the Mirasol System. Treatment with the Mirasol System requires riboflavin to be mixed into the whole blood unit, which is then exposed to ultra violet (UV) light for a period of time; approximately an hour.

Also known as: Pathogen Reduction Technology

Arm 1: Mirasol-treated WB then untreated WB; Arm 2: Untreated WB then Mirasol-treated WB

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Eligible whole blood donor
• Age ≥ 18 years, of either sex
• Able to commit to the study follow-up schedule
• Subjects must have adequate bilateral antecubital venous access for WB collection and follow-up blood draws
• Negative screening test panel for infectious diseases
• Subjects of child-bearing potential (female or male) must agree to use effective contraceptive during the course of the study per site guidelines
• Subjects must agree to report adverse events (AEs) during the required reporting period
• Negative direct antiglobulin test (DAT) with subject's RBC
• Negative indirect antiglobulin test (IAT) with subject's serum
• Maintenance of healthy status
• Negative direct antiglobulin test (DAT) with subject's RBC (fresh)
• Negative indirect antiglobulin test (IAT) with subject's serum (fresh) versus autologous stored LR-pRBC
• Negative serum or urine pregnancy test in females

You may not qualify if:

• Any serious medical illness and/or therapy, including: abnormal bleeding episodes, clotting or bleeding disorder, evidence of anemia, myocardial infarction, uncontrolled hypertension, heart disease, surgery with bleeding complications, epilepsy or any major surgery (with general or spinal anesthesia) within the last 6 months
• Pregnant or nursing females; For women of childbearing potential, negative serum or urine pregnancy tests at the time of WB donation and before the reinfusion are required
• Unable to give informed consent
• Participation currently, or within the last 12 months, in another investigational trial that would potentially interfere with the analysis of this investigation (e.g., pharmaceutical)
• Have received an accumulated radiation dose that would exclude them from the study according to the local radiation safety limits established by each institution
• Inability to comply with the protocol in the opinion of the investigator

Sponsors & Collaborators

• Terumo BCTbio: lead
• U.S. Army Medical Research and Development Command: collaborator

Study Sites (2)

Hoxworth Blood Center

Cincinnati, Ohio, 45267, United States

Location

Puget Sound Blood Center

Seattle, Washington, 98104, United States

Location

Results Point of Contact

• Title: Ray Goodrich, PhD
• Organization: Terumo BCT Biotechnologies, LLC

(303) 231-4832

Study Officials

• Raymond P Goodrich, PhD

  TerumoBCT Biotechnologies

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 20, 2013
• First Posted: July 25, 2013
• Study Start: June 1, 2013
• Primary Completion: May 1, 2014
• Study Completion: May 1, 2014
• Last Updated: August 18, 2015
• Results First Posted: July 27, 2015

Record last verified: 2015-07

Locations

US (2)