Safety Study of the Aethlon Hemopurifier

This will be a single-arm, sequential, controlled feasibility/safety study in which each
subject will serve as his/her own control. The control period will be the week immediately
preceding the use of the investigational device during which eligible subjects will undergo
and be monitored during three standard intermittent dialysis sessions. Vital signs, blood
chemistries, hematology, liver function and adverse events will be measured. On weeks two
and three, patients will receive treatment with the Hemopurifier® three times per week
coincident with their ongoing standard intermittent hemodialysis treatments. During these
two weeks, subjects will be assessed for the same clinical parameters but with the addition
of viral load determination by quantitative PCR before and after each treatment with the
Hemopurifier®. Viral load will also be measured at follow-up prior to the start of a given
subject's hemodialysis treatment.

Inclusion Criteria:

1. Males or females 18 years of age and older.

2. Positive test for HCV infection (any genotype).

3. End-stage-renal disease (ESRD) requiring dialysis - already established on HD.

4. The arteriovenous fistula, graft or central venous catheter must have been
functioning adequately for at least 1 month before entry into study showing no signs
of infection or blockage.

5. Have recovered from the toxicity of any prior systemic therapy.

6. Ability to tolerate blood volume losses of up to 150 ml per week, i.e. 50 ml each.

7. Stable clinical condition, including stable hemoglobin which has not fluctuated more
than 1.5 -2.0 gm/dl within 28 days prior to enrollment into study.

8. Must have the following minimum hematologic, biochemical, and serologic criteria
documented within 28 days prior to enrollment into study:

1. Hemoglobin values of ≥ 9.5 gm/dL for males and females

2. Platelet count > 100,000/mm3

3. Bilirubin < 4 mg/dL

4. Albumin stable and not less than 3.5 g/dl.

9. Women of child-bearing potential must be practicing barrier or oral contraception for
the duration of the study or documented as surgically sterile or one year
post-menopausal.

10. If female, be non-nursing, non-pregnant and have a negative serum or urine pregnancy
test within two weeks of starting study.

11. The subject must be informed of the investigational nature of this study and written
informed consent obtained prior to enrollment in this study.

12. The subject must be able to comprehend the study description and its nature as only a
feasibility study.

Exclusion Criteria:

1. Administration of Pegasys-ribavirin or ANY anti-viral drug therapy within 90 days
prior to enrollment into study.

2. Administration of any other investigational drugs within 90 days prior to enrollment
into study.

3. Clinically significant infection, other than HCV, defined as any acute or chronic
viral, bacterial, or fungal infection, which requires specific therapy
(Anti-infectious therapy must have been completed at least 14-days before entry into
study) in order to make entry into the study possible.

4. Patient infected with human immunodeficiency virus or has AIDS.

5. A history of hypotensive episodes during dialysis which lead to early termination of
the treatment in the 2 treatments prior to the start of study treatments.

6. Patients who have received an ACE (angiotensin converting enzyme) inhibitor within
the last 24 hours should not be treated. Patients receiving an ACE inhibitor may
experience an anaphylactoid-like reaction, including hypotension associated with
flushing, dyspnea, and bradycardia. Such reactions, if left untreated, may be
life-threatening. The administration of ACE inhibitors also has been associated with
the occurrence of tachycardia. Risk of an anaphylactoid-like reaction or tachycardia
may be minimized by the temporary cessation of the administration of ACE inhibitors
for 6 days or longer before initiating the treatment protocol.

7. Any known pre-existing medical condition that could interfere with the subject's
participation in the entire protocol, including serious psychiatric disorders, CNS
trauma or active seizure disorders requiring medication, poorly-controlled diabetes
mellitus as indicated by an Hb-A1c > 8% within the two weeks prior to protocol
initiation, significant cardiovascular dysfunction within the past 6 months (e.g.,
angina, congestive heart failure, recent myocardial infarction, severe interdialytic
hypotension, or significant arrhythmia).

8. Subjects with ECG showing clinically significant abnormalities.

9. Dementia or other cognitively-limiting disease processes which would make it
difficult for the patient to articulate their clinical status.

10. Prior blood transfusion for any reason within 3 months prior to enrollment into
study.

11. Recent history of bleeding or bleeding disorders that would likely require the
restriction in use of heparin during study treatments.

12. Active immunologically mediated disease (e.g., inflammatory bowel disease [Crohn's
disease, ulcerative colitis], rheumatoid arthritis, idiopathic thrombocytopenia
purpura, systemic lupus erythematosus, autoimmune or inherited hemolytic anemia,
scleroderma, severe psoriasis).

13. Any medical condition requiring, or likely to require during the course of the study,
chronic systemic administration of steroids or other immunoregulatory medications.

14. Substance abuse, such as alcohol (~80 gm/day), IV drugs, and inhaled drugs (If the
subject has a history of substance abuse, to be considered for inclusion into the
protocol, the subject must have abstained from using the abused substance for at
least 2 months. Subjects receiving methadone within the past year are also excluded.)

15. Any cancer requiring systemic chemotherapy or radiotherapy.

16. Any other condition that, in the opinion of the Principal Investigators, would make
the subject unsuitable for enrollment, or could interfere with the subject
participating in and completing the protocol.