Red cell recovery/survival analysis of untreated and INTERCEPT treated RBC concomitantly

Red Cell Survival in Healthy Volunteers

Red cell survival in INTERCEPT treated red cells

Hoxworth Blood Center

Recovery and Lifespan of Red Blood Cells From Pathogen-reduced, Stored Blood Units

Measurement of the Recovery and Lifespan of Red Blood Cells From Pathogen-Reduced, Stored Blood Units Using Cellular Biotinylation

Jose Cancelas

Professor, Research Division Director, Hoxworth Blood Center

University of Cincinnati

Cerus Corporation

Biomedical Advanced Research and Development Authority

Subjects receive biotin labelled autologous red blood cells.

Anemia

Autologous red blood cells are biotin labelled and transfused to the subject. Survival of these red blood cells is tracked through examination of blood samples until no biotin labelled red blood cells remain.

biotin labelled RBCs

University of Iowa

BioRBC Survival in Adults With Prior Antibody Response to BioRBCs

John A Widness

Professor, Department of Pediatrics

National Heart, Lung, and Blood Institute (NHLBI)

After study enrollment, all subjects started anakinra (Kineret™; Amgen, Thousand Oaks, CA, USA) as a subcutaneous daily injection. Subjects weighing >25 kg at the time of enrollment received 100 mg daily, whereas those weighing <25 kg received 50 mg daily. Anakinra was continued for 28 d with no dose adjustment.

Patients at Children's Medical Center Dallas between ages 6 and 18 years with Type 1 diabetes within one week of diagnosis were eligible.
Diabetes care. At diagnosis, all subjects were placed on a basal-bolus insulin regimen with glargine and either lispro or aspart. For the duration of the study, insulin doses were adjusted per standard clinic protocol with target glucose of 80-140 mg/dL fasting and 80-180 mg/dL before meals. At each study visit, we recorded the subject's current insulin doses and weight to allow calculation of the total daily dose (units/kg/day).
Anakinra. After study enrollment, all subjects started anakinra (Kineret; Amgen, Thousand Oaks, CA) as a subcutaneous daily injection. Subjects weighing more than 25 kg at the time of enrollment received 100 mg daily whereas those weighing 25 kg or less received 50 mg daily. Anakinra was continued for a total of 28 days with no dose adjustment.

Anakinra

Sex: Female, Male

Ethnicity (NIH/OMB)

A1c (Median (IQR))

Beta hydroxybutyrate (mg/dL) (Median (IQR))

Total daily insulin dose at hospital discharge (U/kg/day) (Mean)

Initial IDAA1c (Median (IQR))

Expression data at baseline and after treatment were available on 10 patients who had received anakinra. These were compared to similarly-timed samples from 10 patients from control group B. Several attempts have been made to contact the PI to verify information, but were unsuccessful. Unable to verify if 10 or 12 patients were analyzed.

12 autoantibody positive subjects with newly diagnosed type 1 diabetes who were treated with anakinra

Effect of Anakinra Treatment on PBMC Gene Expression for Patients

Mixed-meal tolerance tests. MMTTs were conducted at the UT Southwestern Clinical Translational Research Center (CTRC). Subjects underwent MMTTs at 3-4 wk after diagnosis and again at 7 months after diagnosis. C-peptide analyses were performed by Dr Philip Raskin (UTSouthwestern MedicalCenter, Dallas, TX,USA). C-peptide AUC was calculated for each MMTT using the trapezoidal method. C-peptide AUC data between groups were rank transformed and then analyzed using a two-way repeated measures analysis of variance (ANOVA).

C-peptide Secretory Capacity

Patients at Children's Medical Center Dallas between ages 6 and 18 yr with type 1 diabetes within 1 wk of diagnosis were eligible. Exclusion criteria included treatment with systemic or inhaled corticosteroids or any other immunomodulatory drug, active infection, history of mycobacterial disease, pregnancy, live vaccine administration within 90 d of enrollment, and severe comorbidities. Patients were excluded if it was uncertain whether they had type 1 or type 2 diabetes.

Overall Study

Perrin White

Type 1 Diabetes Mellitus

Patients will receive daily anakinra therapy for 28 days

biotin/febbre

Recovery and Lifespan of Red Blood Cells From Pathogen-reduced, Stored Blood Units

BioRBC Survival in Adults With Prior Antibody Response to BioRBCs

Anti-inflammatory Therapy With Anakinra in Newly Diagnosed Type 1 Diabetes

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