Thrombosomes® in Bleeding Thrombocytopenic Patients
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT03394755 |
Recruitment Status : Unknown
Verified January 2019 by Cellphire, Inc..
Recruitment status was: Active, not recruiting
First Posted : January 9, 2018
Last Update Posted : July 11, 2019
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Thrombocytopenia Hematologic Diseases Bone Marrow Aplasia | Biological: Thrombosomes | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 24 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Phase I, Multi-Center, Open-Label, Dose Escalation Study of Thrombosomes® in Bleeding Thrombocytopenic Patients in Three Cohorts |
Actual Study Start Date : | March 19, 2018 |
Estimated Primary Completion Date : | August 3, 2019 |
Estimated Study Completion Date : | October 18, 2019 |
Arm | Intervention/treatment |
---|---|
Experimental: Thrombosomes |
Biological: Thrombosomes
Freeze-dried platelets |
- Frequency of adverse events [ Time Frame: 30 days ]
- Changes in WHO Bleeding Grade [ Time Frame: 6 days ]
- Changes in Coagulation Measures [ Time Frame: 2 days ]Measures of PT/INR, aPTT, d-dimer, fibrinogen, TAT, PF1+2, TEG, TGA

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 74 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Adults up to 74 y/o with any of following: acute leukemia (ALL or AML), myelodysplasia, aplasia, and/or therapy (chemotherapy or radiation) induced bone marrow aplasia or hypoplasia with thrombocytopenia (platelet count ≥ 5,000 and ≤ 70,000/μL) for a minimum of 2 days. May include bone marrow transplant or peripheral or cord blood stem cell recipients, but not subjects with Graft-vs-Host disease.
- Hospitalized patients (or willing to be hospitalized for 24 hours after Rx) with Modified WHO Grade 1 (subset) or Grade 2 Bleeding Score or at risk for same within 4 weeks of screening. The Grade 1 subset includes patients who have either epistaxis, hematuria, oral petechiae, or bleeding at invasive or other wound sites.
- No platelet inhibitor drugs within 5 days prior to infusion and during the immediate study 6 Day follow-up period.
Exclusion Criteria:
- Hx or condition related to thrombosis, embolism or vascular occlusion/ischemia, including but not limited to: TIA, stroke, MI, stent placement, valve replacement and/or repair
- Currently with an active acute infection, or suspected infection, a single oral temperature of ≥ 101° F or a temperature of ≥ 100.4°F sustained over a 1 h period in past 24 h. Subjects on prophylactic antibiotics are not excluded from study
- Coagulopathy or receiving anticoagulants that result in PT or aPTT values greater than 1.3 X upper limit of normal or elevated D-dimer of decreased fibrinogen
- History of any inherited coagulation or platelet function, disorder or ITP, TTP, or HUS
- Receipt of tranexamic acid or other antifibrinolytics within 48 hrs prior to infusion
- Rx with an investigational drug w/in 1 month of infusion, other than for treatment of their underlying disease

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): NCT03394755
United States, California | |
City of Hope | |
Duarte, California, United States, 91010 | |
United States, District of Columbia | |
Georgetown University Hospital | |
Washington, District of Columbia, United States, 20016 | |
United States, Illinois | |
Loyola University Medical Center | |
Chicago, Illinois, United States, 60130 | |
United States, Michigan | |
University of Michigan | |
Ann Arbor, Michigan, United States, 48109 | |
United States, New Hampshire | |
Dartmouth Hitchcock Medical Center | |
Lebanon, New Hampshire, United States, 03766 | |
United States, Ohio | |
Hoxworth Blood Center | |
Cincinnati, Ohio, United States, 45219 | |
United States, Texas | |
MD Anderson Cancer Center | |
Houston, Texas, United States, 77092 | |
Norway | |
Haukeland University Hospital | |
Bergen, Norway |
Study Director: | Michael Fitzpatrick | Cellphire, Inc. |
Responsible Party: | Cellphire, Inc. |
ClinicalTrials.gov Identifier: | NCT03394755 |
Other Study ID Numbers: |
2017-1 |
First Posted: | January 9, 2018 Key Record Dates |
Last Update Posted: | July 11, 2019 |
Last Verified: | January 2019 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
thrombocytopenia bleeding |
Thrombocytopenia Hematologic Diseases Anemia, Aplastic Hemorrhage |
Pathologic Processes Blood Platelet Disorders Anemia Bone Marrow Diseases |