Safety Study of ECO Conversion System For Red Blood Cells.

Completed · Phase 1

Conditions studied: Anemia

In brief

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.

Key facts

Study ID

NCT00261274

Run by

Velico Medical

People needed

60

Starts

2005-11-01

Last updated by the study team

2020-05-27

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

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

Where it is running

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

Full record on ClinicalTrials.gov

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