Non-interventional, Long-term Safety Data Collection of Zarzio® / Filgrastim HEXAL® in Stem Cell Donors (SMART)
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Data collection on the safety and efficacy of Zarzio® / Filgrastim HEXAL® in adult healthy unrelated stem cell donors undergoing peripheral blood progenitor cell mobilization.
Condition or disease
Hematopoietic Stem Cell Mobilization
This will be a prospective, non-interventional long term data collection study. Adult healthy unrelated stem cell donors receiving Sandoz' filgrastim according to the stem cell mobilization protocols of the respective apheresis centers will be monitored for safety and efficacy during the mobilization period, and a systematic safety data follow-up will be implemented for up to 10 years after mobilization.
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Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
adult, unrelated, healthy volunteers who received at least one dose of Sandoz' filgrastim
Volunteer adult healthy unrelated donors who have received at least one dose of Sandoz' filgrastim for PBPC mobilization
Donors of age <18 years
Related to recipient
Chronic significant organ diseases
Systemic autoimmune diseases
Chronic infectious diseases
History of malignant disease
Pregnant and breastfeeding women
Hypersensitivity to E. coli derived proteins
Hypersensitivity to the active substance or to any of the excipients of Sandoz' filgrastim
Absolute and relative contraindications as specified in the SmPC of Sandoz' filgrastim
Participation in previous stem cell mobilization procedures
Previous or concurrent use of other mobilizing agents, e.g. plerixafor
Informed consent was not signed prior to beginning of documentation.