Comparative Analysis of Biotinylated, Irradiated and 51-Chromium Radiolabeled Red Blood Cells for Analysis of Recovery and Survival After Autologous Transfusion

Обзор

This research is being done to compare the red blood circulation survival in healthy adult volunteers between the 51 chromium (51Cr) red blood cell (RBC) labeling method and the Biotin (BioRBC) red blood cell (RBC) labeling method to determine if biotinylated red blood cells (BioRBC) is an acceptable non radioactive alternative to 51 chromium (51Cr) radiolabeling for regulatory pharmacokinetic studies of red blood cell products.

Подробное описание

This is a Phase 1, randomized, controlled, autologous transfusion study in healthy adult volunteers designed to compare biotinylated red blood cells (BioRBC) with 51 chromium (51Cr)-labeled red blood cells for the assessment of red blood cell (RBC) recovery and survival after 42 days of storage, with and without irradiation at Day 0.

Both 51Cr and biotin labeling have been used to measure autologous RBC recovery and survival, but biotin has not yet been accepted by the U.S. Food and Drug Administration (FDA) as a method to determine 24 hour post transfusion recovery and long term survival after storage.

Study procedures include screening, blood samples, testing, labeling and transfusion.

It is expected that about 20 people will take part in this research study.

Вмешательства

• Биопрепарат Biotinylated Red Blood Cells (BioRBC)
  Intravenous infusion
• Биопрепарат Irradiated Biotinylated Red Blood Cells (Irradiated BioRBC)
  Intravenous infusion
• Биопрепарат 51 Chromium Labeled Red Blood Cells (51Cr RBC)
  Intravenous infusion
• Биопрепарат Technetium 99m Labeled Red Blood Cells (99mTc RBC)
  Intravenous infusion

Первичные конечные точки

• 24-hour Post-transfusion Recovery (PTR24) of Irradiated or Non-irradiated biotinylated Red Blood Cells Compared With 51Cr-Labeled Red Blood Cells [Срок оценки: Day 1 after completion of autologous RBC infusion (Day 43 of the study)]
• Lifespan of of Irradiated or Non-irradiated biotinylated Red Blood Cells Compared With 51Cr-Labeled Red Blood Cells [Срок оценки: From immediately post infusion through Day 112 post-infusion (day 154 of the study, at approximately 16 weeks post transfusion).]

Вторичные конечные точки (4)

• T50 of Irradiated or Non-irradiated biotinylated Red Blood Cells Compared With 51Cr-Labeled Red Blood Cells [Срок оценки: From immediately post infusion through Day 112 post-infusion (day 154 of the study, at approximately 16 weeks post transfusion).]
• Area under the curve (AUC) of Irradiated or Non-irradiated biotinylated Red Blood Cells Compared With 51Cr-Labeled Red Blood Cells [Срок оценки: From immediately post infusion through Day 112 post-infusion (day 154 of the study, at approximately 16 weeks post transfusion).]
• Incidence of Adverse Events and Serious Adverse Events Following Infusion of Biotinylated and Irradiated Biotinylated Red Blood Cells [Срок оценки: From Day 42 (infusion day) through Day 154 (approximately 16 weeks post transfusion)]
• Incidence of Antibodies Against Biotinylated Red Blood Cells After Infusion of BioRBC [Срок оценки: From screening (up to 28 days before donation) through Day 112 post infusion (day 154 after red blood cell collection); extended follow up annually if anti BioRBC is detected until it disappears from circulation.]

Критерии участия

Критерии включения

• Signed and dated informed consent form.

• Age ≥18 years, of either gender.
• Normal health status (as determined by Investigators' review of medical history and physical exam).
• Qualifies for a collection; Males: height >5'1" and weight >130 lbs; Females: height >5' 5" and weight > 150 lbs.
• Complete blood count (CBC; including RBC indices MCV, MCH, MCHC, and RDW) and serum chemistry values within normal limits (including calcium, bicarbonate, chloride, inorganic phosphate, potassium, sodium, cholesterol, glucose, total protein, triglycerides, LDH, ALT, AST, total bilirubin, BUN, creatinine, and ferritin). Values outside of normal reference range if considered not to be clinically significant by the site PI may be allowed as per the site PI.
• Hemoglobin levels >13.3 g/dL and hematocrit >40% for both male and female subjects.
• Negative blood donor screening test panel for HIV, HBV, HCV, HTLV, Syphilis, and WNV virus at the time of donation.
• Female subjects of childbearing potential and male subjects must agree to use a medically acceptable method of contraception throughout the study periods. A barrier method of contraception must be included, regardless of other methods.
• Meet or exceed AABB guidelines for blood donation, with the exception of travel deferrals as defined by site-specific SOPs.

Критерии исключения

• Known RBC disorder that could affect RBC survival.

• Treatment with any medication known to affect RBC viability.
• Pregnant or nursing female.
• Male subjects or female subjects of childbearing potential not using medically acceptable contraceptive methods.
• Participation in another clinical study currently or within the past 28 days.
• Subjects not eligible to provide a double RBC donation per AABB guidelines for blood donation.
• Subjects who have received blood transfusion within the previous year.
• Known pre-existing antibody specific to BioRBC.
• Subjects who have received a previous infusion of BioRBC at any time.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Другое

Центры проведения

США · 2 центра

• Hoxworth Blood Center, University of Cincinnati — Cincinnati
• American Red Cross — Norfolk

Идентификаторы

NCT: NCT07446647 · 25-620 · 75A50123C00052

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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