Evaluation of the Safety and Immunogenicity of Autologous Thrombosomes® in Healthy Human Subjects; A Microdose Escalation Study (Cohorts 1 - 4) and Repeat Microdose Immunogenicity Study (Cohort 5)
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ClinicalTrials.gov Identifier: NCT02223117 |
Recruitment Status :
Completed
First Posted : August 22, 2014
Last Update Posted : December 13, 2017
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Healthy | Biological: Thrombosomes Biological: Placebo | Early Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 15 participants |
Allocation: | Randomized |
Intervention Model: | Single Group Assignment |
Masking: | Single (Participant) |
Primary Purpose: | Treatment |
Official Title: | Evaluation of the Safety and Immunogenicity of Autologous Thrombosomes® in Healthy Human Subjects; A Microdose Escalation Study (Cohorts 1 - 4) and Repeat Microdose Immunogenicity Study (Cohort 5) |
Actual Study Start Date : | September 2014 |
Actual Primary Completion Date : | July 21, 2016 |
Actual Study Completion Date : | July 21, 2016 |
Arm | Intervention/treatment |
---|---|
Experimental: Intervention
Thrombosomes
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Biological: Thrombosomes
Freeze-dried platelets |
Placebo Comparator: Placebo
Buffer/placebo Control
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Biological: Placebo
Other Name: Buffer/placebo Control |
- Number of Participants with Adverse Events as a Measure of Safety Evaluation [ Time Frame: 60 days ]
- Standard Hematology, Coagulation and Platelet Immunology Assessment [ Time Frame: 60 Days ]

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Ages Eligible for Study: | 18 Years to 45 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Minimum weight 110 pounds (50 kg)
- Age 18-45 years
- Able and willing to provide informed consent
- Has permanent address and phone/e-mail for contact and notification, and able to come to the research site for scheduled study visits for up to 60 days after their last study infusion
- Understands, speaks and reads standard English language
- Normal healthy subject able to pass the universal blood donor history questionnaire and screen
Exclusion Criteria:
- Breast-feeding female
- At any time, previously pregnant female
- Participation in an experimental drug/device study within the past 30 days.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02223117
United States, Washington | |
Bloodworks Northwest | |
Seattle, Washington, United States, 98104 |
Study Director: | Michael Fitzpatrick, PhD | Cellphire Therapeutics, Inc. | |
Principal Investigator: | Sherrill Slichter, MD | Bloodworks Northwest |
Responsible Party: | Cellphire Therapeutics, Inc. |
ClinicalTrials.gov Identifier: | NCT02223117 |
Other Study ID Numbers: |
2011-1 |
First Posted: | August 22, 2014 Key Record Dates |
Last Update Posted: | December 13, 2017 |
Last Verified: | December 2017 |