NCT00261274

Brief Summary

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P75+ for phase_1

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2005

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

November 30, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 2, 2005

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2009

Completed
Last Updated

May 27, 2020

Status Verified

May 1, 2020

Enrollment Period

3.2 years

First QC Date

November 30, 2005

Last Update Submit

May 22, 2020

Conditions

Anemia

Keywords

transfusion; red blood cells

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (1)

  • Unexpected lab test results over 10 weeks.

Study Arms (2)

Test Group A-ECO

EXPERIMENTAL
Biological: A-ECO

Control Group

PLACEBO COMPARATOR
Biological: Saline

Interventions

A-ECOBIOLOGICAL
Test Group A-ECO
SalineBIOLOGICAL
Control Group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Yale New Haven Hospital

New Haven, Connecticut, 06510-3202, United States

Location

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

TriCore Reference Laboratories

Albuquerque, New Mexico, 87102, United States

Location

Hoxworth Blood Center

Cincinnati, Ohio, 45267-0055, United States

Location

American Red Cross Blood Services-Penn Jersey Region

Philadelphia, Pennsylvania, 19123, United States

Location

American Red Cross

Norfolk, Virginia, 23507, United States

Location

Related Publications (8)

  • Goldstein J. Conversion of ABO blood groups. Transfus Med Rev. 1989 Jul;3(3):206-12. doi: 10.1016/s0887-7963(89)70080-8.

    PMID: 2562478BACKGROUND

  • 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. doi: 10.1126/science.6274021.

    PMID: 6274021BACKGROUND

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

    PMID: 6095313BACKGROUND

  • 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. doi: 10.1046/j.1537-2995.1995.351196110892.x.

    PMID: 8604485BACKGROUND

  • 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.

    PMID: 1848117BACKGROUND

  • Lenny LL, Goldstein J. The production of group O cells. Biotechnology. 1991;19:75-100. doi: 10.1016/b978-0-7506-9120-8.50009-3. No abstract available.

    PMID: 1664756BACKGROUND

  • 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. doi: 10.1046/j.1537-2995.1994.34394196617.x.

    PMID: 8146892BACKGROUND

  • 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. doi: 10.1046/j.1537-2995.2000.40111290.x.

    PMID: 11099655BACKGROUND

MeSH Terms

Conditions

Anemia

Interventions

Sodium Chloride

Condition Hierarchy (Ancestors)

Hematologic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

ChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Officials

  • Kurt Gunter, MD

    ZymeQuest, Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 30, 2005

First Posted

December 2, 2005

Study Start

November 1, 2005

Primary Completion

January 1, 2009

Last Updated

May 27, 2020

Record last verified: 2020-05

Locations

US(6)