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| Name | Class |
|---|---|
| Hexal AG | INDUSTRY |
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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.
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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| Measure | Description | Time Frame |
|---|---|---|
| Incidence of drug-related adverse events following mobilization with Sandoz' filgrastim. | The primary objective is to investigate adverse events that are suspected to be related to stem cell mobilization with the Sandoz' filgrastim in healthy unrelated donors. | each patient will be followed for 10 years after mobilization |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy assessment in terms of the CD34+ cell count. | The secondary objective is to investigate the efficacy of stem cell mobilization with the Sandoz' filgrastim in terms of the CD34+ cell count. | CD34+ cells are counted on 1 day immediately preceding apheresis |
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Inclusion Criteria:
Volunteer adult healthy unrelated donors who have received at least one dose of Sandoz' filgrastim for PBPC mobilization
Exclusion Criteria:
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adult, unrelated, healthy volunteers who received at least one dose of Sandoz' filgrastim
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| Name | Affiliation | Role |
|---|---|---|
| Hexal AG | Hexal AG | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| German Red Cross Blood Donor Service Baden-Wuerttemberg-Hessen, Institute for Transfusion medicine und Immunohematology Frankfurt am Main | Frankfurt am Main | Hesse | 60528 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35287672 | Derived | Heyn J, Brauninger S, Dimova-Dobreva M, Mathieson N, Koptelova N, Kolpakova A, Seidl C, Reinhardt P, Tsamadou C, Schrezenmeier H, Nakov R, Seifried E, Bonig H. Superior physical and mental health of healthy volunteers before and five years after mobilized stem cell donation. J Transl Med. 2022 Mar 14;20(1):121. doi: 10.1186/s12967-022-03322-w. |
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| German Red Cross Blood Donor Service Baden-Wuerttemberg-Hessen, Institute for Clinical Transfusion medicine and Immunogenetics Ulm (IKT) | Ulm | 89081 | Germany |