Safety Study of ECO Conversion System For Red Blood Cells.

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Anemia

Intervention / Treatment
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* Biological: A-ECO
* Biological: Saline


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Test Group A-ECO<br> | Biological: A-ECO<br> <br> |
| Placebo Comparator: Control Group<br> | Biological: Saline<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events, clinically significant bruising over a period of 10 weeks. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Unexpected lab test results over 10 weeks. |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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transfusion; red blood cells