Safety Study of ECO Conversion System For Red Blood Cells.

May 22, 2020 updated by: Velico Medical

Evaluation of the Safety of Repeated Autologous Infusions of Enzyme-Converted A-to-O (A-ECO) Red Cells Into Group A Volunteers.

The purpose of this study is to demonstrate that small amounts of a person's own red cells, when treated with an enzyme to make A-ECO Red Blood Cells, can be safely re-infused, repeatedly. Each participant will have some blood drawn, treated with an enzyme, washed and re-infused five times. Additional samples of blood will be drawn for testing and evaluation.

Study Overview

Status

Completed

Conditions

Detailed Description

This study will involve a statistically valid number of subjects so that firm conclusions may be drawn about the safety of small volumes of A-ECO cells. All participants will receive their own (autologous) red cells that have been either: 1) treated with an enzyme to create A-ECO cells (test group); or 2) washed with saline (control group). The test and control groups will be compared for the rate and extent any adverse reactions or unexpected laboratory test results.

Study Type

Interventional

Enrollment

60

Phase

  • 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

    • Connecticut
      • New Haven, Connecticut, United States, 06510-3202
        • Yale New Haven Hospital
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • University of Minnesota
    • New Mexico
      • Albuquerque, New Mexico, United States, 87102
        • TriCore Reference Laboratories
    • Ohio
      • Cincinnati, Ohio, United States, 45267-0055
        • Hoxworth Blood Center
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19123
        • American Red Cross Blood Services-Penn Jersey Region
    • Virginia
      • Norfolk, Virginia, United States, 23507
        • American Red Cross

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 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Healthy volunteer subjects who have no clinically apparent cardiovascular, renal, pulmonary, endocrinological, autoimmune or neurological disorders
  • Blood Group A
  • Available for follow up periodically at varying intervals for twelve weeks
  • Have a clinical presumption of a stable blood volume
  • Between 18 and 65 years of age
  • Able to provide informed consent
  • Practicing contraception, other than oral or systemically delivered contraceptives, while participating in the study (subjects of potential reproductive age).

Exclusion Criteria:

  • Women that are pregnant
  • Persons with documented immune deficiencies
  • Persons found to have abnormal platelet function or anti-platelet antibodies as determined by a pre-study screen
  • Persons with a history of idiopathic thrombocytopenic purpura
  • Persons who are bleeding or undergoing an active hemolytic process
  • Persons who have any history of hemorrhagic tendency
  • Persons who are taking any drug known to interfere with hemostasis, or who take combinations of drugs that have been reported to cause hemostatic problems or interfere with laboratory coagulation and platelet function testing
  • Persons who test positive for von Willebrand's disease
  • Persons taking investigational drugs or using an investigational device
  • Persons with a family history of a bleeding disorder
  • Persons with a history of vasculitis
  • Persons with a history of a dermatological disorder that might be confused with bruising in the judgement of the investigator
  • Persons with medical conditions which represent a contraindication to any study procedure, in the judgement of the investigator
  • Persons with unexplained bruising
  • Persons with abnormal laboratory screening tests

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: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: Control Group
EXPERIMENTAL: Test Group A-ECO

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Adverse events, clinically significant bruising over a period of 10 weeks.

Secondary Outcome Measures

Outcome Measure
Unexpected lab test results over 10 weeks.

Collaborators and Investigators

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

Sponsor

Investigators

  • Study Director: Kurt Gunter, MD, ZymeQuest, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

November 1, 2005

Primary Completion (ACTUAL)

January 1, 2009

Study Registration Dates

First Submitted

November 30, 2005

First Submitted That Met QC Criteria

November 30, 2005

First Posted (ESTIMATE)

December 2, 2005

Study Record Updates

Last Update Posted (ACTUAL)

May 27, 2020

Last Update Submitted That Met QC Criteria

May 22, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • 152-1001

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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