Safety Study of ECO Conversion System For Red Blood Cells.

Phase 1

Completed

• Conditions: Anemia
• Interventions: Biological: Saline; Biological: A-ECO

• Registration Number: NCT00261274
• Lead Sponsor: Velico Medical

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.

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 Timeline

• Study Start: 2005-11
• Study First Submitted: 2005-11-30
• Study First Submitted QC: 2005-11-30
• Study First Posted: 2005-12-02
• Primary Completion: 2009-01
• Status Verified: 2020-05
• Last Update Submitted: 2020-05-22
• Last Update Posted: 2020-05-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control Group	Saline	-
Test Group A-ECO	A-ECO	-

Primary Outcome Measures

Name	Time	Method
Adverse events, clinically significant bruising over a period of 10 weeks.

Secondary Outcome Measures

Name	Time	Method
Unexpected lab test results over 10 weeks.

Trial Locations

Locations (6)

TriCore Reference Laboratories; 🇺🇸 Albuquerque, New Mexico, United States

American Red Cross; 🇺🇸 Norfolk, Virginia, United States

Yale New Haven Hospital; 🇺🇸 New Haven, Connecticut, United States

University of Minnesota; 🇺🇸 Minneapolis, Minnesota, United States

Hoxworth Blood Center; 🇺🇸 Cincinnati, Ohio, United States

American Red Cross Blood Services-Penn Jersey Region; 🇺🇸 Philadelphia, Pennsylvania, United States