ISRCTN42886452进行中（未招募）1 期
A single centre, randomised, controlled, single-blind Phase I cross-over trial in healthy volunteers to assess the safety and survival of a mini-dose of red blood cells derived from CD34+ cells isolated from adult blood vs standard donated red blood cells
HS Blood and Transplant R&D Office0 个研究点目标入组 15 人开始时间: 2019年7月4日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 15
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •Participant Inclusion Criteria (blood donors)
- •Blood donors must satisfy all the following criteria to be eligible for the study:
- •1. Born after 1st January 1996
- •2. Able to donate whole blood
- •3. Fulfil all requirements to donate whole blood for transfusion according to UK Blood Services definition at the time of donation
- •4. Previous successful whole blood donation
- •5. Willing to consent to their blood donations being used for the trial, including scheduling donation appointments to suit the needs of the trial
- •Participant Inclusion Criteria (recipients)
- •The participants (recipients) must satisfy all the following criteria to be eligible for the study:
- •1. Over 18 years of age
- •2. In good general health
- •3. Female and of no child-bearing potential (sterilised, post-hysterectomy or post-menopausal) or male
- •4. Has a blood group profile that is compatible with one of the donors who will donate units of blood for the study
- •5. Willing to accept that participation in the trial will prevent them from becoming a blood donor or donating blood in the future, as is the case for individuals who have received a blood transfusion. Willing to accept that participation in the trial may affect their ability to donate organs or tissues in the future.
- •6. Able and willing to keep to the trial schedule
- •7. Able and willing to provide informed consent to participate
- •8. Female participants will need to have a negative pregnancy test on the day of infusion, even though they will have confirmed they have no child-bearing potential. Based on the dose of radiation received, there is no requirement for male participants to use contraception or for any recipients to avoid proximity with pregnant women
排除标准
- •Current exclusion criteria as of 13/02/2024:
- •Participant Exclusion Criteria (blood donors)
- •Blood donors may not donate for the study if ANY of the following apply:
- •1. Confirmed positive for any microbiological tests performed on blood donors on a sample tested at the time of donation (Hepatitis B (HBV), Hepatitis C (HCV), Hepatitis E (HEV), Human Immunodeficiency Virus (HIV), Human T-cell Lymphotropic Virus (HTLV), syphilis)
- •2. A positive direct antiglobulin test (DAT)
- •3. The presence of Sickle Cell Trait (HbAS), glucose-6-phosphate dehydrogenase (G6PD) deficiency, pseudohyperkalaemia
- •4. Have plans to travel in regions that would justify their deferral as a blood donor at the time of donation
- •5. Within 30 days of participating in another clinical trial, at the CI’s discretion
- •6. Unable to use videoconferencing for study visits, at the CI's discretion
- •Participant Exclusion Criteria (recipients)
- •Potential participants (recipients) may not enter the study if ANY of the following apply:
- •screening tests.
- •2. Previous splenectomy.
- •3. Participation in another clinical trial within the last 30 days or currently participating in another clinical trial.
- •4. Receipt of radio-isotopes within the last 12 months, unless given as part of the RESTORE trial.
- •5. Past or present occupational exposure to radiation that necessitates or necessitated the wearing of a monitoring badge
- •6. Known allergy to Cr-51
- •7. Known allergies warranting the use of adrenaline (EpiPen)
- •8. Positive for clinically significant red cell alloantibodies, as detected by routine serological methods, including 3 cell screen.
- •9. Positive for any other cross-match reactivity on screening.
- •10. Positive pregnancy test
- •11. Females that are breastfeeding
- •12. Surgery planned for the period of study participation unless the CI/screening physician deems the risk of the participant experiencing substantial blood loss during that surgery as very low and unlikely to require a blood transfusion.
- •13. Subject to enhanced COVID-19 restrictions at the time of recruitment, due to clinical status, at the physician’s discretion (e.g. shielding” or clinically vulnerable”).
- •14. Unable to use videoconferencing for study visits, at the CI/trial physician’s discretion.
- •Previous exclusion criteria:
- •Participant Exclusion Criteria (blood donors)
- •Blood donors may not donate for the study if ANY of the following apply:
- •1. Confirmed positive for any microbiological tests performed on blood donors on a sample tested at the time of donation (Hepatitis B (HBV), Hepatitis C (HCV), Hepatitis E (HEV), Human Immunodeficiency Virus (HIV), Human T-cell Lymphotropic Virus (HTLV), syphilis)
- •2. A positive direct antiglobulin test (DAT)
- •3. The presence of Sickle Cell Trait (HbAS), glucose-6-phosphate dehydrogenase (G6PD) deficiency, pseudohyperkalaemia
- •4. Have plans to travel in regions that would justify their deferral as a blood donor at the time of donation
- •5. Within 30 days of participating in another clinical trial, at the CI’s discretion
- •Participant Exclusion Criteria (recipients)
- •Potential participants (recipients) may not enter the study if ANY of the following apply:
- •1. Any clinically relevant abnormality on history, physical examination or laboratory screening tests
- •2. Previous splenectomy
- •3. Participation in another clinical trial within the last 30 days or currently participating in another clinical trial
- •4. Receipt of radio-isotopes within the last 12 months
- •5. Past or present occupational exposure to radiation
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