A Phase 2 interventional study of Biotin-Labeled Red Blood Cells in Healthy Volunteers, sponsored by Gladwin, Mark, MD. Terminated at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-04-21.
Sponsored by Gladwin, Mark, MD · Phase 2, Interventional, and Basic science
The purpose of this research is to evaluate the impact of genetic and biologic factors in blood donors on red blood cell storage stability after autologous transfusion over the different range of storage period of 5-7 days and 35-42 days in healthy volunteers.
Gladwin, Mark, MD is the lead sponsor of 13 studies on the registry; none are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 4 (80%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Each participant will receive 2 transfusions of biotin labeled red blood cells.
Biological: Biotin-Labeled Red Blood Cells
We will collect 500 mL of blood. The blood will be processed and split into two bags and labeled with a naturally occurring vitamin, biotin. The blood will then be re-infused back into the same participant at 2 time points (5-7 days and 35-42 days after storage).
Percentage of Biotin Labeled Red Blood Cells
This will be determined using enumeration of biotinylated red blood cells obtained by flow cytometry from blood samples obtained at various time points from subjects with specified genetic mutations, compared with control subjects without the specified mutation. Percentage of Biotin Labeled Red Blood Cells is determined by Biotin Labeled Red Blood Cells in circulation at each time point/baseline Biotin Labeled Red Blood Cells in circulation x 100.
Time frame: 24 hours, 30 days and 60 days after transfusion
The Percentage of Storage Hemolysis
This will be quantified as percent hemolysis, which accounts for the levels of RBC-derived free hemoglobin in response to cold storage. We will define the associations between the primary endpoints and the quantification of storage hemolysis. Quantification of storage hemolysis is based on this equation: (sample hematocrit x levels of free hemoglobin obtained after centrifugation measured in the supernatant / the total amount of sample hemoglobin before centrifugation) x 100.
Time frame: 5-7 days and 35-42 days following blood donation
The Percentage of Red Blood Cell Osmotic Hemolysis
This will be quantified by the evaluation of osmotic stress assays. We will define the associations between the primary endpoints and the quantification of osmotic hemolysis. The percent osmotic hemolysis is determined by this equation: (supernatant cell-free hemoglobin of pink test-treated RBCs / total amount of hemoglobin) x 100.
Time frame: 5-7 days and 35-42 days following blood donation
The Percentage of Red Blood Cell Oxidative Hemolysis
This will be quantified by the evaluation of oxidative stress assays. We will define the associations between the primary endpoints and the quantification of oxidative hemolysis. The percent osmotic hemolysis is determined by this equation: (supernatant cell-free hemoglobin of 2,2'-azobis-2-methyl-propanimidamide, dihydrochloride treated RBCs - supernatant cell-free hemoglobin of untreated red blood cells / total amount of hemoglobin) x 100.
Time frame: 5-7 days and 35-42 days following blood donation
| Milestone | Biotin-Labeled Red Blood Cells Infusion |
|---|---|
| Started | 6 |
| Completed | 4 |
| Not completed | 2 |
| Withdrew: Physician decision | 2 |
This will be determined using enumeration of biotinylated red blood cells obtained by flow cytometry from blood samples obtained at various time points from subjects with specified genetic mutations, compared with control subjects without the specified mutation. Percentage of Biotin Labeled Red Blood Cells is determined by Biotin Labeled Red Blood Cells in circulation at each time point/baseline Biotin Labeled Red Blood Cells in circulation x 100.
| percentage of biotin labeled RBC | Biotin-Labeled Red Blood Cells Infusion |
|---|---|
| Percentage of Fresh Biotin Labeled Red Blood Cells at 24 Hours | 99.2 (99.2 to 99.3) |
| Percentage of Fresh Biotin Labeled Red Blood Cells at Day 30 | 77.2 (74.7 to 79.6) |
| Percentage of Fresh Biotin Labeled Red Blood Cells at Day 60 | 54.3 (49.5 to 59.2) |
| Percentage of Aged Biotin Labeled Red Blood Cells at 24 Hours | 99.2 (99.1 to 99.3) |
| Percentage of Aged Biotin Labeled Red Blood Cells at Day 30 | 75.9 (72.9 to 78.9) |
| Percentage of Aged Biotin Labeled Red Blood Cells at Day 60 | 51.9 (45.9 to 57.8) |
This will be quantified as percent hemolysis, which accounts for the levels of RBC-derived free hemoglobin in response to cold storage. We will define the associations between the primary endpoints and the quantification of storage hemolysis. Quantification of storage hemolysis is based on this equation: (sample hematocrit x levels of free hemoglobin obtained after centrifugation measured in the supernatant / the total amount of sample hemoglobin before centrifugation) x 100.
| percentage of storage hemolysis | Biotin-Labeled Red Blood Cells Infusion |
|---|---|
| 5-7 days | 0.27 ± 0.09 |
| 35-42 days | 0.21 ± 0.14 |
This will be quantified by the evaluation of osmotic stress assays. We will define the associations between the primary endpoints and the quantification of osmotic hemolysis. The percent osmotic hemolysis is determined by this equation: (supernatant cell-free hemoglobin of pink test-treated RBCs / total amount of hemoglobin) x 100.
| percentage of osmotic hemolysis | Biotin-Labeled Red Blood Cells Infusion |
|---|---|
| 5-7 days | 7.4 ± 4.66 |
| 35-42 days | 7.9 ± 6.86 |
This will be quantified by the evaluation of oxidative stress assays. We will define the associations between the primary endpoints and the quantification of oxidative hemolysis. The percent osmotic hemolysis is determined by this equation: (supernatant cell-free hemoglobin of 2,2'-azobis-2-methyl-propanimidamide, dihydrochloride treated RBCs - supernatant cell-free hemoglobin of untreated red blood cells / total amount of hemoglobin) x 100.
| percentage of oxidative hemolysis | Biotin-Labeled Red Blood Cells Infusion |
|---|---|
| 5-7 days | 39.93 ± 12.45 |
| 35-42 days | 46.90 ± 21.92 |
This will be determined using enumeration of biotinylated red blood cells obtained by flow cytometry from blood samples obtained at various time points from subjects.
| days | Biotin-Labeled Red Blood Cells Infusion |
|---|---|
| Fresh Stored Cells | 135 ± 12 |
| Stored Cells | 104 ± 12 |
Collected over Day 125-150 post blood transfusion. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Biotin-Labeled Red Blood Cells Infusion | 0/6 (0%) | 0/6 (0%) | 1/6 (16.7%) |
| Event | Biotin-Labeled Red Blood Cells Infusion |
|---|---|
| Weakly positive antibodiesBlood and lymphatic system disorders | 1/6 |
| Age, Categorical(Participants) | Biotin-Labeled Red Blood Cells Infusion |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 6 |
| >=65 years | 0 |
| Sex: Female, Male(Participants) | Biotin-Labeled Red Blood Cells Infusion |
|---|---|
| Female | 3 |
| Male | 3 |
| Ethnicity (NIH/OMB)(Participants) | Biotin-Labeled Red Blood Cells Infusion |
|---|---|
| Hispanic or Latino | 0 |
| Not Hispanic or Latino | 6 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | Biotin-Labeled Red Blood Cells Infusion |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 3 |
| White | 3 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from Sep 2019 to primary completion in Mar 2021, 17 months.
Results were first posted in Apr 2022, 1 year 1 month after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is terminated, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.
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Gladwin, Mark, MD