Safety Study of ECO Conversion System For Red Blood Cells.

Velico Medical

Status and phase

Completed

Phase 1

Conditions

Anemia

Treatments

Biological: A-ECO

Biological: Saline

Study type

Interventional

Funder types

Industry

Identifiers

NCT00261274

152-1001

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

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