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)

December 11, 2017 updated by: Cellphire Therapeutics, Inc.
This "first-in-human" exploratory IND, single-center study will assess the safety, toxicity, hematology, and immunogenicity of sub-therapeutic "microdoses" of autologous Thrombosomes® in healthy human subjects.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

15

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Washington
      • Seattle, Washington, United States, 98104
        • Bloodworks Northwest

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Minimum weight 110 pounds (50 kg)
  2. Age 18-45 years
  3. Able and willing to provide informed consent
  4. 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
  5. Understands, speaks and reads standard English language
  6. Normal healthy subject able to pass the universal blood donor history questionnaire and screen

Exclusion Criteria:

  1. Breast-feeding female
  2. At any time, previously pregnant female
  3. Participation in an experimental drug/device study within the past 30 days.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention
Thrombosomes
Biological: Thrombosomes
Freeze-dried platelets
Placebo Comparator: Placebo
Buffer/placebo Control
Biological: Placebo
Other Names:
  • Buffer/placebo Control

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of Participants with Adverse Events as a Measure of Safety Evaluation
Time Frame: 60 days
60 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Standard Hematology, Coagulation and Platelet Immunology Assessment
Time Frame: 60 Days
60 Days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cellphire Therapeutics, Inc.

Collaborators

Department of Health and Human Services

Investigators

  • Study Director: Michael Fitzpatrick, PhD, Cellphire Therapeutics, Inc.
  • Principal Investigator: Sherrill Slichter, MD, Bloodworks Northwest

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2014

Primary Completion (Actual)

July 21, 2016

Study Completion (Actual)

July 21, 2016

Study Registration Dates

First Submitted

August 15, 2014

First Submitted That Met QC Criteria

August 21, 2014

First Posted (Estimate)

August 22, 2014

Study Record Updates

Last Update Posted (Actual)

December 13, 2017

Last Update Submitted That Met QC Criteria

December 11, 2017

Last Verified

December 1, 2017

More Information

Terms related to this study

Other Study ID Numbers

  • 2011-1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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