Safety Study of ECO Conversion System For Red Blood Cells.

This study has been completed.
Sponsor:
Information provided by:
ZymeQuest
ClinicalTrials.gov Identifier:
NCT00261274
First received: November 30, 2005
Last updated: May 22, 2009
Last verified: May 2009
  Purpose

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.


Condition Intervention Phase
Anemia
Procedure: Enzyme converted ECO red blood cells
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Evaluation of the Safety of Repeated Autologous Infusions of Enzyme-Converted A-to-O (A-ECO) Red Cells Into Group A Volunteers.

Resource links provided by NLM:


Further study details as provided by ZymeQuest:

Primary Outcome Measures:
  • Adverse events, clinically significant bruising over a period of 10 weeks.

Secondary Outcome Measures:
  • Unexpected lab test results over 10 weeks.

Estimated Enrollment: 60
Study Start Date: November 2005
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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00261274

Locations
United States, Connecticut
Yale New Haven Hospital
New Haven, Connecticut, United States, 06510-3202
United States, Minnesota
University of Minnesota
Minneapolis, Minnesota, United States, 55455
United States, New Mexico
TriCore Reference Laboratories
Albuquerque, New Mexico, United States, 87102
United States, Ohio
Hoxworth Blood Center
Cincinnati, Ohio, United States, 45267-0055
United States, Pennsylvania
American Red Cross Blood Services-Penn Jersey Region
Philadelphia, Pennsylvania, United States, 19123
United States, Virginia
American Red Cross
Norfolk, Virginia, United States, 23507
Sponsors and Collaborators
ZymeQuest
Investigators
Study Director: Kurt Gunter, MD ZymeQuest, Inc.
  More Information

Publications:
Responsible Party: Doug Clibourn, ZymeQuest, Inc.
ClinicalTrials.gov Identifier: NCT00261274     History of Changes
Other Study ID Numbers: 152-1001
Study First Received: November 30, 2005
Last Updated: May 22, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by ZymeQuest:
transfusion; red blood cells

Additional relevant MeSH terms:
Anemia
Hematologic Diseases

ClinicalTrials.gov processed this record on July 29, 2014