Anemia
Conditions
Keywords
transfusion; red blood cells
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.
Interventions
BIOLOGICALA-ECO
BIOLOGICALSaline
Sponsors
Velico Medical
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse events, clinically significant bruising over a period of 10 weeks. | — |
Secondary
| Measure | Time frame |
|---|---|
| Unexpected lab test results over 10 weeks. | — |
Countries
United States
Outcome results
None listed