A Study of Healthy Donor Volunteers to Provide Blood components Via Leukapheresis for In vitro Dendritic Cell Investigations

Overview

About this study

The purpose of this study is to collect blood cells as a healthy donor for use in research studies, which will focus especially on using the immune system’s cells to fight infection and cancer. Blood cells collected as part of participation in this Research Donor Program will be used strictly for laboratory experiments and will not be used for transfusion back into human beings.

 

 

 

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Sandra Gendler, Ph.D.

Open for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20314934

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