Safety Study of ECO Conversion System For Red Blood Cells. - Full Text View

Sponsor:	ZymeQuest
Information provided by:	ZymeQuest
ClinicalTrials.gov Identifier:	NCT00261274

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 I

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety Study
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:

MedlinePlus related topics: Anemia

U.S. FDA Resources

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

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:

Goldstein J. Conversion of ABO blood groups. Transfus Med Rev. 1989 Jul;3(3):206-12. Review.

Goldstein J, Siviglia G, Hurst R, Lenny L, Reich L. Group B erythrocytes enzymatically converted to group O survive normally in A, B, and O individuals. Science. 1982 Jan 8;215(4529):168-70.

Goldstein J. Preparation of transfusable red cells by enzymatic conversion. Prog Clin Biol Res. 1984;165:139-57. No abstract available.

Lenny LL, Hurst R, Zhu A, Goldstein J, Galbraith RA. Multiple-unit and second transfusions of red cells enzymatically converted from group B to group O: report on the end of phase 1 trials. Transfusion. 1995 Nov-Dec;35(11):899-902.

Lenny LL, Hurst R, Goldstein J, Benjamin LJ, Jones RL. Single-unit transfusions of RBC enzymatically converted from group B to group O to A and O normal volunteers. Blood. 1991 Mar 15;77(6):1383-8.

Lenny LL, Goldstein J. The production of group O cells. In: Goldstein J, ed. Biotechnology of Blood. Boston: Butterworth; 1991: 75-100.

Lenny LL, Hurst R, Goldstein J, Galbraith RA. Transfusions to group O subjects of 2 units of red cells enzymatically converted from group B to group O. Transfusion. 1994 Mar;34(3):209-14.

Kruskall MS, AuBuchon JP, Anthony KY, Herschel L, Pickard C, Biehl R, Horowitz M, Brambilla DJ, Popovsky MA. Transfusion to blood group A and O patients of group B RBCs that have been enzymatically converted to group O. Transfusion. 2000 Nov;40(11):1290-8.

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

Keywords provided by ZymeQuest:

transfusion; red blood cells

ClinicalTrials.gov processed this record on February 08, 2010