Ensayos clínicos

Inclusion Criteria:

• Weight at least 110 pounds.
• Must be in good health, defined as “feeling well and can perform normal activities.”
• No known heart, lung, kidney disease, or bleeding disorders.
• No history of engaging in high-risk activities for exposure to the AIDS virus including intravenous drug use, unprotected sex with multiple partners, or exposure to unsterile needles such as acupuncture or tattoo needles.
• No history of AIDS or HTLV infection.
• No history Hepatitis B or C seropositivity.
• No history Infectious or Idiopathic hepatitis or unexplained jaundice.
• Female subjects should not be pregnant.
• Adequate antecubital access for repetitive leukapheresis as assessed by a certified Mayo Clinic apheresis nurse.
• No history malaria, tuberculosis, syphillis, Lyme disease, Infectious mononucleosis, Epstein‑Barr syndrome, West Nile virus, clinically evident cytomegalovirus (CMV) infection, T. cruzi infection (Chagas disease), or Creuzfeld-Jacob disease.
• If donor has an eligible chronic condition such as hypertension or psychiatric diagnosis, condition must be under treatment and/or under control in the estimation of the protocol’s physician investigators.
• No history of cancer other than removed non-melanoma skin cancer.
• No history of seizures.
• No history of temperature chronically above 99.5 F.
• No sexual contact or cohabitation with a person who has hepatitis within the past 12 months.
• No detainment or incarceration within a facility (juvenile detention, lockup, jail, or prison) within the past 12 months.
• No non-autologous transfusion of blood products within past 12 months.
• No history of a human bite within past 12 months.
• No history of exposure to HIV-infected fluids within past 12 months.
• Must not be on the following medications within the past year:
  • Clopidogrel (Plavix) or Ticlid (Ticlopidine);
  • Coumadin (warfarin) , heparin or other prescription blood thinners.
• Must never have received human pituitary-derived growth hormone.
• No smoking history within past 3 years.
• No more than moderate ethanol use (less than 8 glasses of beer or wine per week).
• No use of illegal drugs.
• Willingness to disclose current medications.
• Not currently on medications which in the opinion of the P.I. indicate that the donor is unhealthy or in a dynamic state of health (compensated allergies) or immunosuppressed (e.g., on steroids).
• History of any of the following adverse reactions during any previous blood donation or leukapheresis procedure:
  • Anxiety in excess of Grade 2 (i.e., unresponsive to reassurance and medication required);
  • Citrate toxicity in excess of Grade 2 (responds to slowing the rate of the citrate anticoagulant infusion and by administering oral calcium carbonate tablets (Tumsâ) or intravenous calcium gluconate (up to 4 pushes of 1 gm over 15 minutes every 30 minutes;
  • Hyperventilation in excess of Grade 1 (i.e., pausing the procedure did not resolve and calcium gluconate administration was required);
  • Hypotension in excess of Grade 2 (i.e., unresolved by pausing the procedure, recumbency and fluid administration);
  • Vasovagal reaction in excess of Grade 2 (i.e., unresolved by pausing the procedure, recumbency and fluid administration);
  • Chills/Hypothermia in excess of Grade 2 (i.e., unresolved by routine warming procedures);
  • Hematoma in excess of Grade 2 (i.e., progressive resolution failed to occur with local application of pressure);
  • Pain at venous access site in excess of Grade 2 (i.e., pain persisted beyond 48 hours);
  • Hypervolemia: any occurrence unattributable to nursing error;
  • Infection: any occurrence unattributable to nursing error;
  • Air embolism: any occurrence;
  • Allergic reaction: any occurrence where the aggravating factor (i.e., polyethylene tubing) could not be identified and replaced with a non allergenic alternative;
  • Unanticipated adverse events: any occurrence.
• No other health issues which in the opinion of the Principal Investigator render an individual unsuitable for prospective repetitive leukapheresis donations.