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Thrombosomes® in Bleeding Thrombocytopenic Patients

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ClinicalTrials.gov Identifier: NCT03394755
Recruitment Status : Recruiting
First Posted : January 9, 2018
Last Update Posted : January 30, 2019
Sponsor:
Collaborator:
Department of Health and Human Services
Information provided by (Responsible Party):
Cellphire, Inc.

Study Description
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Brief Summary:
This study evaluates in a dose-escalation manner, the safety, and preliminary impact on bleeding, and the preliminary effect on coagulation measures of increasing doses of allogeneic Thrombosomes in thrombocytopenic patients.

Condition or disease Intervention/treatment Phase
Thrombocytopenia Hematologic Diseases Bone Marrow Aplasia Biological: Thrombosomes Phase 1

Detailed Description:
The objectives of this trial, conducted in thrombocytopenic patients with modified World Health Organization (WHO) Grade 1* or 2 bleeding, assessing the safety of infusing increasing doses of allogeneic Thrombosomes in WHO bleeding and measures of coagulation.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
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 : June 18, 2019
Estimated Study Completion Date : June 18, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding

Arms and Interventions
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Arm Intervention/treatment
Experimental: Thrombosomes Biological: Thrombosomes
Freeze-dried platelets


Outcome Measures
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Primary Outcome Measures :
  1. Frequency of adverse events [ Time Frame: 30 days ]

Secondary Outcome Measures :
  1. Changes in WHO Bleeding Grade [ Time Frame: 6 days ]
  2. Changes in Coagulation Measures [ Time Frame: 2 days ]
    Measures of PT/INR, aPTT, d-dimer, fibrinogen, TAT, PF1+2, TEG, TGA


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 68 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adults up to 68 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
Contacts and Locations
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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


Contacts
Contact: Michael Fitzpatrick, PhD 240-268-2473 mfitzpatrick@cellphire.com

Locations
United States, California
City of Hope Recruiting
Duarte, California, United States, 91010
Contact: Vinod Pullarkat, MD         
United States, Michigan
University of Michigan Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Robertson Davenport, MD         
United States, New Hampshire
Dartmouth Hitchcock Medical Center Recruiting
Lebanon, New Hampshire, United States, 03766
Contact: Zbigniew (Ziggy) Szczepiorkowski, MD, PhD         
United States, Ohio
Hoxworth Blood Center Recruiting
Cincinnati, Ohio, United States, 45219
Contact: Jose Cancelas, MD, PhD         
Principal Investigator: Jose Cancelas, MD, PhD         
Sponsors and Collaborators
Cellphire, Inc.
Department of Health and Human Services
Investigators
Study Director: Michael Fitzpatrick Cellphire, Inc.
More Information
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Responsible Party: Cellphire, Inc.
ClinicalTrials.gov Identifier: NCT03394755     History of Changes
Other Study ID Numbers: 2017-1
First Posted: January 9, 2018    Key Record Dates
Last Update Posted: January 30, 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

Keywords provided by Cellphire, Inc.:
thrombocytopenia
bleeding

Additional relevant MeSH terms:
Hemorrhage
Thrombocytopenia
Hematologic Diseases
Anemia, Aplastic
 Pathologic Processes
Blood Platelet Disorders
Anemia
Bone Marrow Diseases