Safety Study of ECO Conversion System For Red Blood Cells.

Anemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00261274
• Other study ID #: 152-1001
• Status: Completed
• Phase: Phase 1
• Start date: November 2005

Study information

• Verified date: May 2020
• Source: Velico Medical
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. primary completion date: January 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Anemia

Intervention

Biological:
• A-ECO

• Saline

Locations

Country	Name	City	State
United States	TriCore Reference Laboratories	Albuquerque	New Mexico
United States	Hoxworth Blood Center	Cincinnati	Ohio
United States	University of Minnesota	Minneapolis	Minnesota
United States	Yale New Haven Hospital	New Haven	Connecticut
United States	American Red Cross	Norfolk	Virginia
United States	American Red Cross Blood Services-Penn Jersey Region	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Velico Medical

Country where clinical trial is conducted

United States, 

References & Publications (8)

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. — View Citation

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

Goldstein J. Preparation of transfusable red cells by enzymatic conversion. Prog Clin Biol Res. 1984;165:139-57. — View Citation

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. — View Citation

Lenny LL, Goldstein J. The production of group O cells. Biotechnology. 1991;19:75-100. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse events, clinically significant bruising over a period of 10 weeks.
Secondary	Unexpected lab test results over 10 weeks.