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| ID | Type | Description | Link |
|---|---|---|---|
| ERMS#12308001 | Other Grant/Funding Number | Department of Defense |
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| Name | Class |
|---|---|
| U.S. Army Medical Research and Development Command | FED |
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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
This is a feasibility level study conducted to assess the recovery and survival of autologous, radiolabeled leukoreduced packed red blood cells (LR-pRBC) derived from fresh whole blood (WB) units that have been treated with the Mirasol System for Whole Blood (Mirasol System) and stored for 21 days at 1-6°C.1
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Red Blood Cell (RBC) Survival by Product | Assessment of linear & exponential RBC survival and half-life (T50) over 28 days for RBCs derived from Mirasol-treated WB versus RBCs derived from untreated WB. | 28 days |
| Area Under the Curve (AUC) of Red Blood Cell (RBC) Survival |
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Inclusion Criteria:
Inclusion for radiolabeled reinfusion of LR-pRBC on Day 21 (evaluated the day of, prior to, reinfusion):
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Raymond P Goodrich, PhD | TerumoBCT Biotechnologies | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hoxworth Blood Center | Cincinnati | Ohio | 45267 | United States | ||
| Puget Sound Blood Center |
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| ID | Title | Description |
|---|---|---|
| FG000 | Arm 1: Mirasol-treated Whole Blood (WB) Then Untreated WB | Screening Period (14 days); Treatment Period 1 (49 days): Donation of WB treated with Mirasol System for Whole Blood on Day 0, leuko-reduced packed red blood cells (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 |
| FG001 | Arm 2: Untreated WB Then Mirasol-treated WB | 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 |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Adults ≥ 18 yrs; eligible WB donors with normal health status and vital signs by AABB criteria; negative infectious disease and direct/indirect antiglobulin test (DAT/IAAT), and did not meet any exclusion criteria.
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| ID | Title | Description |
|---|---|---|
| BG000 | Arm 1: Mirasol-treated WB Then Untreated WB | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | All subjects who signed an IC form (were enrolled), met eligibility criteria, had no intercurrent illness or notable signs/symptoms during the 24 hours prior to reinfusion, had no evidence of neoantigen formation on stored LR-pRBCs, and had at least 4 blood samples collected during the first 22 min, 30 sec post-infusion in each treatment period. | Posted | Mean | Standard Deviation | % 24-hour RBC Recovery | 24 hours |
|
All AEs collected from the first donation through the end of treatment period 2/study end - SAEs reported from time of 1st WB donation to study exit - TEAEs reported from time of LR-pRBC reinfusion on Day 21 to end of each treatment period
Only Treatment Emergent AEs (TEAE) reported in final results. TEAEs = AEs that occurred following the Day 21 RBC reinfusion (24 total subj).
SAE reporting: from 1st WB donation to study end (29 total subj). Per protocol, subjects were assessed for AEs at each study visit by site staff querying them on their general health since the previous visit
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Mirasol Treated | LR-pRBCs derived from Mirasol-treated WB. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA 17.0 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ray Goodrich, PhD | Terumo BCT Biotechnologies, LLC | (303) 231-4832 |
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|
|
Assessment of AUC of RBC survival over 28 days for RBCs derived from Mirasol-treated Whole Blood (WB) versus RBCs derived from untreated WB. |
| 28 days |
| Spearman's Correlation Coefficients: 24-Hour Red Blood Cell (RBC) Recovery (%) With Hemolysis (%) | Spearman's Correlation Coefficients comparing 24-Hour RBC Recovery (%) with Hemolysis (%) in packed Red Blood Cells (pRBCs) derived from Mirasol-treated whole blood (WB) versus pRBCs derived from untreated WB | 24 hours |
| Spearman's Correlation Coefficients: 24-Hour RBC Recovery (%) With Adenosine Triphosphate (ATP) (µmol/g Hgb) | Spearman's Correlation Coefficients comparing 24-Hour RBC Recovery (%) with ATP (µmol/g Hgb) in packed Red Blood Cells (pRBCs) derived from Mirasol-treated whole blood (WB) versus pRBCs derived from untreated WB | 24 hours |
| Spearman's Correlation Coefficients: 24-Hour RBC Recovery (%) pCO2 (mmHg at 37° C) | Spearman's Correlation Coefficients comparing 24-Hour RBC Recovery (%) with pCO2 (mmHg at 37° C) in packed Red Blood Cells (pRBCs) derived from Mirasol-treated whole blood (WB) versus pRBCs derived from untreated WB | 24 hours |
| Spearman's Correlation Coefficients: Linear T50 (Days) With Hemolysis (%) | Spearman's Correlation Coefficients comparing Linear T50 (Days) with each of Hemolysis (%) in packed Red Blood Cells (pRBCs) derived from Mirasol-treated whole blood (WB) versus pRBCs derived from untreated WB | 28 days |
| Spearman's Correlation Coefficients: Linear T50 (Days) With Adenosine Triphosphate (ATP) (µmol/g Hgb) | Spearman's Correlation Coefficients comparing Linear T50 (Days) with ATP (µmol/g Hgb) in packed Red Blood Cells (pRBCs) derived from Mirasol-treated whole blood (WB) versus pRBCs derived from untreated WB | 28 days |
| Spearman's Correlation Coefficients: Linear T50 (Days) With pCO2 (mmHg at 37° C) | Spearman's Correlation Coefficients comparing Linear T50 (Days) with pCO2 (mmHg at 37° C) in packed Red Blood Cells (pRBCs) derived from Mirasol-treated whole blood (WB) versus pRBCs derived from untreated WB | 28 days |
| Neoantigenicity - Day 21 Direct Antigen Test (DAT) | DAT testing of Red Blood Cells (RBCs) via Anti-immunoglobulin G (Anti-IgG) and Anti Complement Component 3 (Anti-C3) as derived from Mirasol-treated whole blood (WB) versus untreated WB conducted on Day 21 of both Treatment Periods 1 and 2. Number of positive results (indicating a new antigen formation) were recorded. | Day 21 |
| Neoantigenicity - Day 21 Indirect Antigen Test (IAT) | Day 21 IAT testing of RBCs via LISS-15, Anti-IgG and C3 as derived from Mirasol-treated WB versus untreated WB. Number of positive results (indicating antibody formation to a new antigen) were recorded. | Day 21 of Treatment Periods 1 and 2 |
| Neoantigenicity - Day 42 Direct Antigen Test (DAT) | DAT testing of RBCs via Anti-IgG and Anti-C3 as derived from Mirasol-treated WB versus untreated WB. Number of positive results (indicating a new antigen formation) were recorded. | Day 42 of Treatment Periods 1 and 2 |
| Neoantigenicity - Day 42 Indirect Antigen Test (IAT) | IAT testing of RBCs via low ionic strength solution (LISS-15), Anti-IgG and C3 as derived from Mirasol-treated WB versus untreated WB. Number of positive results (indicating antibody formation to a new antigen) were recorded. | Day 42 of Treatment Periods 1 and 2 |
| In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - Hematocrit (%) | Day 0 |
| In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - Hematocrit (%) | Day 21 |
| In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - ATP | Day 0 |
| In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - ATP | Day 21 |
| In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - White Blood Cell (WBC) Count | Day 0 |
| In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - White Blood Cell (WBC) Count | Day 21 |
| In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - Total Hemoglobin | Day 0 |
| In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - Total Hemoglobin | Day 21 |
| In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - pH (at 37° C) | Day 0 |
| In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - pH (at 37° C) | Day 21 |
| In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - pCO2 (mmHg at 37° C) | Day 0 |
| In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - pCO2 (mmHg at 37° C) | Day 21 |
| In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - Potassium | Day 0 |
| In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - Potassium | Day 21 |
| In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - Glucose | Day 0 |
| In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - Glucose | Day 21 |
| In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - Lactate | Day 0 |
| In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - Lactate | Day 21 |
| In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - Supernatant Hgb | Day 0 |
| In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - Supernatant Hgb | Day 21 |
| In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - 2,3-diphosphoglycerate (DPG) | Day 0 |
| In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - 2,3-diphosphoglycerate (DPG) | Day 21 |
| In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - Hemolysis (%) | Day 0 |
| In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - Hemolysis (%) | Day 21 |
| Seattle |
| Washington |
| 98104 |
| United States |
| BG001 | Arm 2: Untreated WB Then Mirasol-treated WB | 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) |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
LR-pRBCs derived from Mirasol-treated WB
| OG001 | Untreated Control | LR-pRBCs derived from untreated WB |
|
|
| Secondary | Red Blood Cell (RBC) Survival by Product | Assessment of linear & exponential RBC survival and half-life (T50) over 28 days for RBCs derived from Mirasol-treated WB versus RBCs derived from untreated WB. | All subjects who signed informed consent,were eligible, had no intercurrent illness or notable signs/symptoms in 24 hrs prior to reinfusion, had no evidence of neoantigen formation on stored LR-pRBCs, and had ≥ 4 blood samples collected within the first 22 min 30 sec post-infusion in each treatment period. | Posted | Mean | Standard Deviation | Days | 28 days |
|
|
|
| Secondary | Area Under the Curve (AUC) of Red Blood Cell (RBC) Survival | Assessment of AUC of RBC survival over 28 days for RBCs derived from Mirasol-treated Whole Blood (WB) versus RBCs derived from untreated WB. | All subjects who signed an IC Form (were enrolled), met eligibility criteria, had no intercurrent illness or notable signs/symptoms during the 24 hours prior to reinfusion, had no evidence of neoantigen formation on stored LR-pRBCs, and had at least 4 blood samples collected within the first 22 min, 30 sec post-infusion in each treatment period. | Posted | Mean | Standard Deviation | Days * Percent Recovery | 28 days |
|
|
|
| Secondary | Spearman's Correlation Coefficients: 24-Hour Red Blood Cell (RBC) Recovery (%) With Hemolysis (%) | Spearman's Correlation Coefficients comparing 24-Hour RBC Recovery (%) with Hemolysis (%) in packed Red Blood Cells (pRBCs) derived from Mirasol-treated whole blood (WB) versus pRBCs derived from untreated WB | All subjects who signed an IC Form (were enrolled), met eligibility criteria, had no intercurrent illness or notable signs/symptoms during the 24 hours prior to reinfusion, had no evidence of neoantigen formation on stored LR-pRBCs, and had at least 4 blood samples collected within the first 22 min, 30 sec post-infusion in each treatment period. | Posted | Number | Spearman's Correlation Coefficient | 24 hours |
|
|
|
| Secondary | Spearman's Correlation Coefficients: 24-Hour RBC Recovery (%) With Adenosine Triphosphate (ATP) (µmol/g Hgb) | Spearman's Correlation Coefficients comparing 24-Hour RBC Recovery (%) with ATP (µmol/g Hgb) in packed Red Blood Cells (pRBCs) derived from Mirasol-treated whole blood (WB) versus pRBCs derived from untreated WB | All subjects who signed an IC Form (were enrolled), met eligibility criteria, had no intercurrent illness or notable signs/symptoms during the 24 hours prior to reinfusion, had no evidence of neoantigen formation on stored LR-pRBCs, and had at least 4 blood samples collected within the first 22 min, 30 sec post-infusion in each treatment period. | Posted | Number | Spearman's Correlation Coefficient | 24 hours |
|
|
|
| Secondary | Spearman's Correlation Coefficients: 24-Hour RBC Recovery (%) pCO2 (mmHg at 37° C) | Spearman's Correlation Coefficients comparing 24-Hour RBC Recovery (%) with pCO2 (mmHg at 37° C) in packed Red Blood Cells (pRBCs) derived from Mirasol-treated whole blood (WB) versus pRBCs derived from untreated WB | All subjects who signed an IC Form (were enrolled), met eligibility criteria, had no intercurrent illness or notable signs/symptoms during the 24 hours prior to reinfusion, had no evidence of neoantigen formation on stored LR-pRBCs, and had at least 4 blood samples collected within the first 22 min, 30 sec post-infusion in each treatment period. | Posted | Number | Spearman's Correlation Coefficient | 24 hours |
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| Secondary | Spearman's Correlation Coefficients: Linear T50 (Days) With Hemolysis (%) | Spearman's Correlation Coefficients comparing Linear T50 (Days) with each of Hemolysis (%) in packed Red Blood Cells (pRBCs) derived from Mirasol-treated whole blood (WB) versus pRBCs derived from untreated WB | All subjects who signed an IC Form (were enrolled), met eligibility criteria, had no intercurrent illness or notable signs/symptoms during the 24 hours prior to reinfusion, had no evidence of neoantigen formation on stored LR-pRBCs, and had at least 4 blood samples collected within the first 22 min, 30 sec post-infusion in each treatment period. | Posted | Number | Spearman's Correlation Coefficient | 28 days |
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| Secondary | Spearman's Correlation Coefficients: Linear T50 (Days) With Adenosine Triphosphate (ATP) (µmol/g Hgb) | Spearman's Correlation Coefficients comparing Linear T50 (Days) with ATP (µmol/g Hgb) in packed Red Blood Cells (pRBCs) derived from Mirasol-treated whole blood (WB) versus pRBCs derived from untreated WB | All subjects who signed an IC Form (were enrolled), met eligibility criteria, had no intercurrent illness or notable signs/symptoms during the 24 hours prior to reinfusion, had no evidence of neoantigen formation on stored LR-pRBCs, and had at least 4 blood samples collected within the first 22 min, 30 sec post-infusion in each treatment period. | Posted | Number | Spearman's Correlation Coefficient | 28 days |
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|
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| Secondary | Spearman's Correlation Coefficients: Linear T50 (Days) With pCO2 (mmHg at 37° C) | Spearman's Correlation Coefficients comparing Linear T50 (Days) with pCO2 (mmHg at 37° C) in packed Red Blood Cells (pRBCs) derived from Mirasol-treated whole blood (WB) versus pRBCs derived from untreated WB | All subjects who signed an IC Form (were enrolled), met eligibility criteria, had no intercurrent illness or notable signs/symptoms during the 24 hours prior to reinfusion, had no evidence of neoantigen formation on stored LR-pRBCs, and had at least 4 blood samples collected within the first 22 min, 30 sec post-infusion in each treatment period. | Posted | Number | Spearman's Correlation Coefficient | 28 days |
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| Secondary | Neoantigenicity - Day 21 Direct Antigen Test (DAT) | DAT testing of Red Blood Cells (RBCs) via Anti-immunoglobulin G (Anti-IgG) and Anti Complement Component 3 (Anti-C3) as derived from Mirasol-treated whole blood (WB) versus untreated WB conducted on Day 21 of both Treatment Periods 1 and 2. Number of positive results (indicating a new antigen formation) were recorded. | All subjects who signed an IC Form (were enrolled), and had samples available for the requested test on Day 21 of both Treatment Periods 1 and 2 | Posted | Number | Positive results | Day 21 |
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| Secondary | Neoantigenicity - Day 21 Indirect Antigen Test (IAT) | Day 21 IAT testing of RBCs via LISS-15, Anti-IgG and C3 as derived from Mirasol-treated WB versus untreated WB. Number of positive results (indicating antibody formation to a new antigen) were recorded. | All subjects who signed an IC Form (were enrolled), and had samples available for the requested test on Day 21 of both Treatment Periods 1 and 2 | Posted | Number | Positive results | Day 21 of Treatment Periods 1 and 2 |
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| Secondary | Neoantigenicity - Day 42 Direct Antigen Test (DAT) | DAT testing of RBCs via Anti-IgG and Anti-C3 as derived from Mirasol-treated WB versus untreated WB. Number of positive results (indicating a new antigen formation) were recorded. | All subjects who signed an IC Form (were enrolled), and had samples available for the requested test | Posted | Number | Positive results | Day 42 of Treatment Periods 1 and 2 |
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| Secondary | Neoantigenicity - Day 42 Indirect Antigen Test (IAT) | IAT testing of RBCs via low ionic strength solution (LISS-15), Anti-IgG and C3 as derived from Mirasol-treated WB versus untreated WB. Number of positive results (indicating antibody formation to a new antigen) were recorded. | All subjects who signed an IC Form (were enrolled), and had samples available for the requested test on Day 42 of both Treatment Periods 1 and 2. | Posted | Number | Positive results | Day 42 of Treatment Periods 1 and 2 |
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| Secondary | In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - Hematocrit (%) | All subjects who signed an IC Form (were enrolled), and had samples available for the requested test | Posted | Mean | Standard Deviation | % of volume | Day 0 |
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| Secondary | In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - Hematocrit (%) | All subjects who signed an IC Form (were enrolled), and had samples available for the requested test | Posted | Mean | Standard Deviation | volume % of red blood cells | Day 21 |
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| Secondary | In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - ATP | All subjects who signed an IC Form (were enrolled), and had samples available for the requested test | Posted | Mean | Standard Deviation | µmol/g Hgb | Day 0 |
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| Secondary | In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - ATP | All subjects who signed an IC Form (were enrolled), and had samples available for the requested test | Posted | Mean | Standard Deviation | µmol/g Hgb | Day 21 |
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| Secondary | In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - White Blood Cell (WBC) Count | All subjects who signed an IC Form (were enrolled), and had samples available for the requested test | Posted | Mean | Standard Deviation | 10E3 cells/µL | Day 0 |
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| Secondary | In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - White Blood Cell (WBC) Count | All subjects who signed an IC Form (were enrolled), and had samples available for the requested test | Posted | Mean | Standard Deviation | 10E3 cells/µL | Day 21 |
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| Secondary | In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - Total Hemoglobin | All subjects who signed an IC Form (were enrolled), and had samples available for the requested test | Posted | Mean | Standard Deviation | g/dL | Day 0 |
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| Secondary | In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - Total Hemoglobin | All subjects who signed an IC Form (were enrolled), and had samples available for the requested test | Posted | Mean | Standard Deviation | g/dL | Day 21 |
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| Secondary | In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - pH (at 37° C) | All subjects who signed an IC Form (were enrolled), and had samples available for the requested test | Posted | Mean | Standard Deviation | pH (at 37° C) | Day 0 |
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| Secondary | In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - pH (at 37° C) | All subjects who signed an IC Form (were enrolled), and had samples available for the requested test | Posted | Mean | Standard Deviation | pH | Day 21 |
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| Secondary | In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - pCO2 (mmHg at 37° C) | All subjects who signed an IC Form (were enrolled), and had samples available for the requested test | Posted | Mean | Standard Deviation | pCO2 (mmHg at 37° C) | Day 0 |
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| Secondary | In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - pCO2 (mmHg at 37° C) | All subjects who signed an IC Form (were enrolled), and had samples available for the requested test | Posted | Mean | Standard Deviation | mmHg at 37° C | Day 21 |
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| Secondary | In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - Potassium | All subjects who signed an IC Form (were enrolled), and had samples available for the requested test | Posted | Mean | Standard Deviation | mEq/L | Day 0 |
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| Secondary | In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - Potassium | All subjects who signed an IC Form (were enrolled), and had samples available for the requested test | Posted | Mean | Standard Deviation | mEq/L | Day 21 |
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| Secondary | In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - Glucose | All subjects who signed an IC Form (were enrolled), and had samples available for the requested test | Posted | Mean | Standard Deviation | mg/dL | Day 0 |
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| Secondary | In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - Glucose | All subjects who signed an IC Form (were enrolled), and had samples available for the requested test | Posted | Mean | Standard Deviation | mg/dL | Day 21 |
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| Secondary | In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - Lactate | All subjects who signed an IC Form (were enrolled), and had samples available for the requested test | Posted | Mean | Standard Deviation | mmol/L | Day 0 |
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| Secondary | In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - Lactate | All subjects who signed an IC Form (were enrolled), and had samples available for the requested test | Posted | Mean | Standard Deviation | mmol/L | Day 21 |
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| Secondary | In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - Supernatant Hgb | All subjects who signed an IC Form (were enrolled), and had samples available for the requested test | Posted | Mean | Standard Deviation | mg/dL | Day 0 |
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| Secondary | In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - Supernatant Hgb | All subjects who signed an IC Form (were enrolled), and had samples available for the requested test | Posted | Mean | Standard Deviation | mg/dL | Day 21 |
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| Secondary | In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - 2,3-diphosphoglycerate (DPG) | All subjects who signed an IC Form (were enrolled), and had samples available for the requested test | Posted | Mean | Standard Deviation | µmol/mL | Day 0 |
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| Secondary | In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - 2,3-diphosphoglycerate (DPG) | All subjects who signed an IC Form (were enrolled), and had samples available for the requested test | Posted | Mean | Standard Deviation | µmol/mL | Day 21 |
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| Secondary | In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - Hemolysis (%) | All subjects who signed an IC Form (were enrolled), and had samples available for the requested test | Posted | Mean | Standard Deviation | % of volume | Day 0 |
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| Secondary | In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - Hemolysis (%) | All subjects who signed an IC Form (were enrolled), and had samples available for the requested test | Posted | Mean | Standard Deviation | % of volume | Day 21 |
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|
|
| 0 |
| 29 |
| 11 |
| 24 |
| EG001 | Untreated Control | LR-pRBCs derived from untreated WB | 0 | 29 | 11 | 24 |
| Nausea | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
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| Vessel puncture site bruise | General disorders | MedDRA 17.0 | Systematic Assessment |
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| Inflammation | General disorders | MedDRA 17.0 | Systematic Assessment |
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| Infusion site bruising | General disorders | MedDRA 17.0 | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
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| Sinusitis | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
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| Cystitis | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
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| Limb injury | Injury, poisoning and procedural complications | MedDRA 17.0 | Systematic Assessment |
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| Muscle strain | Injury, poisoning and procedural complications | MedDRA 17.0 | Systematic Assessment |
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| Haematocrit decreased | Investigations | MedDRA 17.0 | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Systematic Assessment |
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| Sinus headache | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
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| Tension headache | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
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| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Systematic Assessment |
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| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Systematic Assessment |
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| Skin discolouration | Skin and subcutaneous tissue disorders | MedDRA 17.0 | Systematic Assessment |
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| Peripheral coldness | Vascular disorders | MedDRA 17.0 | Systematic Assessment |
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Not provided
| Exponential RBC Survival |
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| Exponential T50 |
|