CompletedNCT02930226FDPUpdated Feb 12, 2021Results posted

Ascending Doses of Autologous FDP vs FFP

A Phase 1 interventional study of Autologous Freeze Dried Plasma (FDP) and Fresh Frozen Plasma (FFP) in Freeze Dried Plasma in Healthy Volunteers, sponsored by U.S. Army Medical Research and Development Command. Completed at 1 site in United States. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-02-12.

Sponsored by U.S. Army Medical Research and Development Command · Phase 1, Interventional, and Treatment

Phase: Phase 1
Study type: Interventional
Enrollment: 30
Allocation: Randomized
Ages: 18 Years to 55 Years
Sex: All

Study summary

Assess the safety of single infusions with RePlas FDP product at increasing fixed doses

Read the detailed description

This is a single-site, partial double-blind study in healthy volunteers designed to assess the safety of infusing ascending doses of reconstituted autologous freeze dried plasma (FDP) in 3 fixed-dose cohorts. Beginning with Cohort 1, subjects will receive a single infusion of 1 unit (approximately 270 mL) of either FDP manufactured from fresh frozen plasma (FFP) derived from autologous whole blood (WB) collection(s) that use citrate phosphate dextrose (CPD) as the anticoagulant (FDP-CPD) or FDP manufactured from FFP units from autologous plasmapheresis where acid citrate dextrose (ACD) is used as the anticoagulant (FDP-ACD). Recruitment of subjects for Cohort 2 follows the completion of infusions in Cohort 1. Subjects in Cohort 2 will receive a single infusion of 2 units (approximately 540 mL) of either FDP-CPD or FDP-ACD before recruitment for Cohort 3 is initiated. Subjects enrolled in Cohort 3 will receive the highest study dose, a plasma infusion dose of 3 units (approximately 810 mL) of FDP-ACD at one infusion visit and the same dose of autologous FFP at another infusion visit. Cohort 3 subjects will only be infused with FDP and FFP products sourced from autologous plasmapheresis. Randomization of Cohort 3 subjects to a treatment sequence determines whether they will be infused with 3 units of FDP or 3 units of FFP at their first infusion visit followed by infusion with the alternate product at the second infusion visit. A 2-week interval will be maintained between infusion visits in Cohort 3. Crossover of FDP and FFP enables comparison of infusion safety and select coagulation factor recoveries within the same subjects between FDP and FFP at this higher dose.

Conditions studied

Freeze Dried Plasma in Healthy Volunteers

In context

Lead sponsor

U.S. Army Medical Research and Development Command is the lead sponsor of 151 studies on the registry; 8 are open to participants now.

Of its 23 completed or terminated interventional studies of FDA-regulated products, 16 (70%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 55 Years
Sexes eligible: All
Accepts healthy volunteers: Yes

Inclusion criteria

Males and non-pregnant/non-breastfeeding females;
Minimum weight is 140 pounds, maximum weight is 220 pounds;
Ages 18-55 years;
Self-reports that he or she feels well and healthy;
Scores ≥ 35 on the Duke Activity Status Index;
Able to donate 1 unit of WB based on the AABB donor history questionnaire with modifications indicated. Subjects with history of travel which puts them at risk for Creutzfeldt-Jakob Disease (CJD) or malaria will be eligible to participate;
Has read the educational materials on donating blood and has had his or her questions answered;
Able and willing to provide written informed consent;
Available for the duration of the trial, which is approximately 12 weeks for subjects in Cohort 1 and Cohort 2, Arm 4; approximately 16 weeks for Cohort 2, Arm 3 and Cohort 3 (includes time for collections, product manufacture, and infusions), and able to come to the treatment clinic for scheduled study visits;
Females of childbearing potential should either be surgically sterile (hysterectomy or tubal ligation), or should use a highly effective, medically accepted contraceptive regimen. Highly effective methods of birth control are defined as those which result in a lower failure rate (i.e., less than 1% per year) when used consistently and correctly such as implants, injectables, combined oral contraceptives, some intrauterine devices, sexual abstinence, or vasectomized partner;
All females must have a negative urine pregnancy test prior to enrollment; and
Understands the English language.

Exclusion criteria

Exclusion Criteria:

Known liver, kidney, cardiovascular, neurologic, gastrointestinal, blood, endocrine/metabolic, autoimmune or pulmonary disease, or treated or untreated hypertension;
Cancer of any kind, under treatment or resolved;
Known or past coagulopathy conditions;
Any conditions, medications, etc. on the AABB medical deferral list;
Past history of asthma (defined as use of a prescribed daily asthma controller medication or required asthma medication in the past 2 weeks);
Past diagnosis of stroke, deep vein thrombosis, or transient ischemic attack
Family history of venous or arterial thrombosis before the age of 50 in first-degree relatives (i.e., biological parents, full siblings, or children);
History of abnormal electrocardiogram (EKG);
Current smoker (defined as having smoked within the last 6 months);
Known Human Immunodeficiency Virus (HIV) or Acquired Immunodeficiency Syndrome (AIDS)-related illness or received a positive test result for HIV infection;
Positive test for Hepatitis B Virus (HBV) or Hepatitis C Virus (HCV) or Human T-cell Lymphotropic Virus (HTLV);
History or significant treated or untreated mental health issues;
Female subject who is pregnant, lactating, or with a positive pregnancy test;
Currently taking an antibiotic or another medication for an infection;
Treatment or use of aspirin (or other platelet inhibiting agents) within 14 days of study donation and infusion visits;
Currently using any medications for anticoagulant therapy;
Previous use of clotting factor concentrate(s);
Receipt of blood or blood products within the past 12 months;
In the past week, has had a headache and fever at the same time;
Known intolerance to any excipients (citrate) in the study drug formulation;
Systolic blood pressure greater than 140 mmHg;
Diastolic blood pressure greater than 90 mmHg;
Temperature greater than 100°F;
Known hematocrit less than 38% for both male and female donors;
Positive direct antiglobulin test (DAT);
Treatment with any investigational agent within 1 month before treatment infusion for this trial;
Participation in any phase of any other investigational trials while participating in this trial;
Unwilling or unable to comply with the requirements of this protocol, including the presence of any condition (physical, mental, or social) that is likely to affect the subject's return for follow-up visits on schedule;
Other unspecified reasons that, in the opinion of the PI, make the subject unsuitable for enrollment; or
Institutionalized because of legal or regulatory order.

Study design

Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Triple (Participant, Care provider, Investigator)
Enrollment: 30 participants (actual)

Study arms

Experimental
1 unit FDP-CPD
Subjects are to have sufficient plasma withdrawn during a single WB collection visit to allow re-infusion with 1 unit of autologous FDP-CPD
Biological: Autologous Freeze Dried Plasma (FDP)
Experimental
Reinfusion 1 unit FDP-ACD
Subjects are to have sufficient plasma withdrawn during 1 plasmapheresis collection visit to allow re-infusion with 1 unit of autologous FDP-ACD
Biological: Autologous Freeze Dried Plasma (FDP)
Experimental
Reinfusion 2 units FDP-CPD
Subjects are to have sufficient plasma withdrawn during 2 separate WB collection visits to allow re-infusion with 2 units of autologous FDP-CPD
Biological: Autologous Freeze Dried Plasma (FDP)
Experimental
Reinfusion 2 units FDP-ACD
Subjects are to have sufficient plasma withdrawn during 1 plasmapheresis collection to allow re-infusion with 2 units of autologous FDP-ACD
Biological: Autologous Freeze Dried Plasma (FDP)
Active comparator
Reinfusion 3 units FDP, 3 units FFP (1st)
Subjects plasma withdrawn during 2 or 3 plasmapheresis collections to allow re-infusion with 3 units of autologous FDP-ACD and 3 units of autologous control FFP. Subjects will receive in total 6 units over the course of 2 infusion visits. Subjects are to be randomized to treatment schedule arms that dictate the sequence for infusing FDP-ACD and FFP across the 2 infusion visits
Biological: Autologous Freeze Dried Plasma (FDP) · Biological: Fresh Frozen Plasma (FFP)
Active comparator
Reinfusion 3 units FDP, 3 units FFP (2nd)
Subjects plasma withdrawn during 2 or 3 plasmapheresis collections to allow re-infusion with 3 units of autologous FDP-ACD and 3 units of autologous control FFP. Subjects will receive in total 6 units over the course of 2 infusion visits. Subjects are to be randomized to treatment schedule arms that dictate the sequence for infusing FDP-ACD and FFP across the 2 infusion visits
Biological: Autologous Freeze Dried Plasma (FDP) · Biological: Fresh Frozen Plasma (FFP)

Interventions

BiologicalAutologous Freeze Dried Plasma (FDP)
Safety of Ascending Doses of Autologous Freeze Dried Plasma (FDP) in Healthy Volunteers
BiologicalFresh Frozen Plasma (FFP)
Controlled FFP in cohort 3 only

What researchers measure

Primary outcomes

Safety of Single Infusions of FDP at Increasing Fixed Doses in Normal Healthy Subjects by Evaluating Vital Signs and Laboratory Tests
Assess the safety of single infusions of FDP at increasing fixed doses of either 1 unit, 2 units, or 3 units in normal healthy subjects by evaluating vital signs during and after infusion
Time frame: Follow-up assessments on days 2, 8, 29, and telephone assessments on days 3 and 4

Secondary outcomes

Number of Participants With Treatment-emergent Adverse Events
Assess the safety and tolerability of a fixed-dose infusion of 3 FDP units in comparison to infusion with the same dose of autologous Fresh Frozen Plasma (FFP) in normal healthy subjects by evaluating vital signs and laboratory tests
Time frame: Follow-up assessments on days 2, 8, 16, 22, 43, and telephone assessments on days 3, 4, 17, and 18
Number of Participants With Significant Changes in Specific Coagulation Values
Determine if the changes in specific coagulation values are similar with clinically meaningful levels pre and post infusion in the different arm groups by evaluating laboratory tests. Blood thrombin, Coombs direct test, Fibrin D dimer, and Thrombin-antithrombin III levels are determined through a blood test to check if your blood is clotting normally. Positive tests or any values below or above the normal reference range is considered abnormal.
Time frame: For cohorts 1 and 2, follow-up assessments on days 2, 8 and 29. For cohort 3, follow-up assessments on days 2, 8, 16, 22, and 43.
Number of Participants With Significant Changes in Specific Hematology Values
Determine if the changes in specific hematology values are similar with clinically meaningful levels pre and post infusion in the different arm groups by evaluating laboratory tests. The specific hematology values are determined through a blood test. Any values below or above the normal reference range is considered abnormal.
Time frame: For cohorts 1 and 2, follow-up assessments on days 2, 8 and 29. For cohort 3, follow-up assessments on days 2, 8, 16, 22, and 43.
Number of Participants With Significant Changes in Specific Chemistry Values
Determine if the changes in specific chemistry values are similar with clinically meaningful levels pre and post infusion in the different arm groups by evaluating laboratory tests. Glucose levels and liver function levels, ALT and AST, are determined through a blood test. Any values below or above the normal reference range is considered abnormal.
Time frame: For cohorts 1 and 2, follow-up assessments on days 2, 8 and 29. For cohort 3, follow-up assessments on days 2, 8, 16, 22, and 43.

Results

Posted Apr 24, 2020

Participant flow

Healthy volunteers were recruited at an academic medical center between February 2017 and March 2018. The first participant was enrolled on March 6, 2017 and the last participant was enrolled on April 5, 2018.

Participant flow — Overall Study
Milestone	1 Unit, Single Infusion FDP-CPD	1 Unit, Single Infusion FDP-ACD	2 Units, Single Infusion FDP-CPD	2 Units, Single Infusion FDP-ACD	3 Units Per Crossover Infusion FDP-ACD x FFP	3 Units Per Crossover Infusion FFP x FDP-ACD
Started	4	4	4	4	4	4
Completed	4	4	4	4	3	4
Not completed	0	0	0	0	1	0
Withdrew: Technical problems: leak in plasma bag	0	0	0	0	1	0

Outcome measures

PrimarySafety of Single Infusions of FDP at Increasing Fixed Doses in Normal Healthy Subjects by Evaluating Vital Signs and Laboratory Tests

Assess the safety of single infusions of FDP at increasing fixed doses of either 1 unit, 2 units, or 3 units in normal healthy subjects by evaluating vital signs during and after infusion

Time frame:: Follow-up assessments on days 2, 8, 29, and telephone assessments on days 3 and 4
Reported as:: Count of participants · Participants

Safety of Single Infusions of FDP at Increasing Fixed Doses in Normal Healthy Subjects by Evaluating Vital Signs and Laboratory Tests
Participants	1 Unit, Single Infusion FDP-CPD	1 Unit, Single Infusion FDP-ACD	2 Units, Single Infusion FDP-CPD	2 Units, Single Infusion FDP-ACD	3 Units Per Crossover Infusion FDP-ACD x FFP	3 Units Per Crossover Infusion FFP x FDP-ACD
Safety of Single Infusions of FDP at Increasing Fixed Doses in Normal Healthy Subjects by Evaluating Vital Signs and Laboratory Tests	4	4	4	4	4	4

SecondaryNumber of Participants With Treatment-emergent Adverse Events

Assess the safety and tolerability of a fixed-dose infusion of 3 FDP units in comparison to infusion with the same dose of autologous Fresh Frozen Plasma (FFP) in normal healthy subjects by evaluating vital signs and laboratory tests

Time frame:: Follow-up assessments on days 2, 8, 16, 22, 43, and telephone assessments on days 3, 4, 17, and 18
Reported as:: Count of participants · Participants

Number of Participants With Treatment-emergent Adverse Events
Participants	3 Units Per Crossover Infusion FDP-ACD x FFP	3 Units Per Crossover Infusion FFP x FDP-ACD
Number of Participants With Treatment-emergent Adverse Events	3	1

SecondaryNumber of Participants With Significant Changes in Specific Coagulation Values

Determine if the changes in specific coagulation values are similar with clinically meaningful levels pre and post infusion in the different arm groups by evaluating laboratory tests. Blood thrombin, Coombs direct test, Fibrin D dimer, and Thrombin-antithrombin III levels are determined through a blood test to check if your blood is clotting normally. Positive tests or any values below or above the normal reference range is considered abnormal.

Time frame:: For cohorts 1 and 2, follow-up assessments on days 2, 8 and 29. For cohort 3, follow-up assessments on days 2, 8, 16, 22, and 43.
Reported as:: Count of participants · Participants

Number of Participants With Significant Changes in Specific Coagulation Values
Participants	1 Unit, Single Infusion FDP-CPD	3 Units Per Crossover Infusion FDP-ACD x FFP	3 Units Per Crossover Infusion FFP x FDP-ACD
Blood thrombin increased	0	1	0
Coombs direct test positive	1	0	0
Fibrin D dimer increased	0	0	1
Thrombin-antithrombin III increased	0	1	0

SecondaryNumber of Participants With Significant Changes in Specific Hematology Values

Determine if the changes in specific hematology values are similar with clinically meaningful levels pre and post infusion in the different arm groups by evaluating laboratory tests. The specific hematology values are determined through a blood test. Any values below or above the normal reference range is considered abnormal.

Time frame:: For cohorts 1 and 2, follow-up assessments on days 2, 8 and 29. For cohort 3, follow-up assessments on days 2, 8, 16, 22, and 43.
Reported as:: Count of participants · Participants

Number of Participants With Significant Changes in Specific Hematology Values
Participants	1 Unit, Single Infusion FDP-CPD	1 Unit, Single Infusion FDP-ACD	2 Units, Single Infusion FDP-CPD	2 Units, Single Infusion FDP-ACD	3 Units Per Crossover Infusion FDP-ACD x FFP	3 Units Per Crossover Infusion FFP x FDP-ACD
Number of Participants With Significant Changes in Specific Hematology Values	0	0	0	0	0	0

SecondaryNumber of Participants With Significant Changes in Specific Chemistry Values

Determine if the changes in specific chemistry values are similar with clinically meaningful levels pre and post infusion in the different arm groups by evaluating laboratory tests. Glucose levels and liver function levels, ALT and AST, are determined through a blood test. Any values below or above the normal reference range is considered abnormal.

Time frame:: For cohorts 1 and 2, follow-up assessments on days 2, 8 and 29. For cohort 3, follow-up assessments on days 2, 8, 16, 22, and 43.
Reported as:: Count of participants · Participants

Number of Participants With Significant Changes in Specific Chemistry Values
Participants	1 Unit, Single Infusion FDP-CPD	1 Unit, Single Infusion FDP-ACD	2 Units, Single Infusion FDP-CPD	2 Units, Single Infusion FDP-ACD	3 Units Per Crossover Infusion FDP-ACD x FFP	3 Units Per Crossover Infusion FFP x FDP-ACD
ALT increased	0	1	0	0	0	0
AST increased	0	1	0	0	0	0
Glucose increased	0	1	0	0	0	0

Adverse events

Collected over 11.1 to 25.4 weeks. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
1 Unit, Single Infusion FDP-CPD	0/4 (0%)	0/4 (0%)	2/4 (50%)
1 Unit, Single Infusion FDP-ACD	0/4 (0%)	0/4 (0%)	2/4 (50%)
2 Units, Single Infusion FDP-CPD	0/4 (0%)	0/4 (0%)	0/4 (0%)
2 Units, Single Infusion FDP-ACD	0/4 (0%)	0/4 (0%)	0/4 (0%)
3 Units Per Crossover Infusion FDP-ACD x FFP	0/4 (0%)	0/4 (0%)	4/4 (100%)
3 Units Per Crossover Infusion FFP x FDP-ACD	0/4 (0%)	0/4 (0%)	1/4 (25%)

Most frequent other events

Showing 10 of 16

Most frequent other events
Event	1 Unit, Single Infusion FDP-CPD	1 Unit, Single Infusion FDP-ACD	2 Units, Single Infusion FDP-CPD	2 Units, Single Infusion FDP-ACD	3 Units Per Crossover Infusion FDP-ACD x FFP	3 Units Per Crossover Infusion FFP x FDP-ACD
Nasal CongestionRespiratory, thoracic and mediastinal disorders	1/4	0/4	0/4	0/4	0/4	0/4
Temperature regulation disorderGeneral disorders	1/4	0/4	0/4	0/4	0/4	0/4
Coombs direct test positiveInvestigations	1/4	0/4	0/4	0/4	0/4	0/4
HyperglycaemiaMetabolism and nutrition disorders	0/4	1/4	0/4	0/4	0/4	0/4
GlycosuriaRenal and urinary disorders	0/4	1/4	0/4	0/4	0/4	0/4
Drug-induced liver injuryHepatobiliary disorders	0/4	1/4	0/4	0/4	0/4	0/4
DysgeusiaNervous system disorders	0/4	0/4	0/4	0/4	1/4	0/4
Oropharyngeal painRespiratory, thoracic and mediastinal disorders	0/4	0/4	0/4	0/4	1/4	0/4
Pulmonary congestionRespiratory, thoracic and mediastinal disorders	0/4	0/4	0/4	0/4	1/4	0/4
RhinorrhoeaRespiratory, thoracic and mediastinal disorders	0/4	0/4	0/4	0/4	1/4	0/4

Baseline characteristics

Age, Continuous
Age, Continuous(years)	1 Unit, Single Infusion FDP-CPD	1 Unit, Single Infusion FDP-ACD	2 Units, Single Infusion FDP-CPD	2 Units, Single Infusion FDP-ACD	3 Units Per Crossover Infusion FDP-ACD x FFP	3 Units Per Crossover Infusion FFP x FDP-ACD	Total
Mean	34.8 ± 7.0	34.3 ± 9.9	33.5 ± 4.8	33.8 ± 17.9	35.8 ± 6.1	32.0 ± 10.7	34.03 ± 10.30

Sex: Female, Male
Sex: Female, Male(Participants)	1 Unit, Single Infusion FDP-CPD	1 Unit, Single Infusion FDP-ACD	2 Units, Single Infusion FDP-CPD	2 Units, Single Infusion FDP-ACD	3 Units Per Crossover Infusion FDP-ACD x FFP	3 Units Per Crossover Infusion FFP x FDP-ACD	Total
Female	2	0	0	0	0	1	3
Male	2	4	4	4	4	3	21

Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)	1 Unit, Single Infusion FDP-CPD	1 Unit, Single Infusion FDP-ACD	2 Units, Single Infusion FDP-CPD	2 Units, Single Infusion FDP-ACD	3 Units Per Crossover Infusion FDP-ACD x FFP	3 Units Per Crossover Infusion FFP x FDP-ACD	Total
Hispanic or Latino	0	0	0	0	0	0	0
Not Hispanic or Latino	4	4	4	4	4	4	24
Unknown or Not Reported	0	0	0	0	0	0	0

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	1 Unit, Single Infusion FDP-CPD	1 Unit, Single Infusion FDP-ACD	2 Units, Single Infusion FDP-CPD	2 Units, Single Infusion FDP-ACD	3 Units Per Crossover Infusion FDP-ACD x FFP	3 Units Per Crossover Infusion FFP x FDP-ACD	Total
American Indian or Alaska Native	0	0	0	0	0	0	0
Asian	0	0	0	0	0	0	0
Native Hawaiian or Other Pacific Islander	0	0	0	0	0	0	0
Black or African American	0	0	0	0	0	1	1
White	4	4	4	4	4	3	23
More than one race	0	0	0	0	0	0	0
Unknown or Not Reported	0	0	0	0	0	0	0

Region of Enrollment
Region of Enrollment(participants)	1 Unit, Single Infusion FDP-CPD	1 Unit, Single Infusion FDP-ACD	2 Units, Single Infusion FDP-CPD	2 Units, Single Infusion FDP-ACD	3 Units Per Crossover Infusion FDP-ACD x FFP	3 Units Per Crossover Infusion FFP x FDP-ACD	Total
United States	4	4	4	4	4	4	24

Body Mass Index (BMI)
Body Mass Index (BMI)(kg/m^2)	1 Unit, Single Infusion FDP-CPD	1 Unit, Single Infusion FDP-ACD	2 Units, Single Infusion FDP-CPD	2 Units, Single Infusion FDP-ACD	3 Units Per Crossover Infusion FDP-ACD x FFP	3 Units Per Crossover Infusion FFP x FDP-ACD	Total
Mean	27.0 ± 4.1	27.4 ± 1.3	26.2 ± 4.8	26.3 ± 4.2	28.8 ± 3.6	27.8 ± 2.3	27.25 ± 3.57

Height
Height(cm)	1 Unit, Single Infusion FDP-CPD	1 Unit, Single Infusion FDP-ACD	2 Units, Single Infusion FDP-CPD	2 Units, Single Infusion FDP-ACD	3 Units Per Crossover Infusion FDP-ACD x FFP	3 Units Per Crossover Infusion FFP x FDP-ACD	Total
Mean	172.7 ± 7.5	185.4 ± 5.5	187.3 ± 8.4	177.8 ± 3.6	180.4 ± 3.6	182.2 ± 11.8	180.97 ± 7.34

Weight
Weight(Kg)	1 Unit, Single Infusion FDP-CPD	1 Unit, Single Infusion FDP-ACD	2 Units, Single Infusion FDP-CPD	2 Units, Single Infusion FDP-ACD	3 Units Per Crossover Infusion FDP-ACD x FFP	3 Units Per Crossover Infusion FFP x FDP-ACD	Total
Mean	80.2 ± 10.3	94.1 ± 7.1	91.6 ± 15.2	83.1 ± 13.4	93.4 ± 8.3	92.2 ± 8.9	89.1 ± 10.86

4 further baseline measures are reported on the registry.

Study locations

1 site

Hoxworth Blood Center
Cincinnati, Ohio 45267, United States

References and documents

Study documents

Study protocol · Apr 19, 2018
Statistical analysis plan · Jul 11, 2018

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Feb 12, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT02930226
Lead sponsor: U.S. Army Medical Research and Development Command
Responsible party: Sponsor
First posted: Oct 12, 2016
Start date: Feb 13, 2017
Primary completion: Aug 2, 2018
Completion: Aug 2, 2018
Results posted: Apr 24, 2020
Last update: Feb 12, 2021

Study contacts

Jose A Cancelas, MD, PhD

principal investigator · Hoxworth Blood Center

Oversight

Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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