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Terminated NCT05594433

Donation of Whole Blood by Healthy Volunteers After Mobilisation by Haematopoietic Growth Factor (Rhu-G-CSF = Granocyte)

Conditions: Healthy Volunteers

Sex: Male
Ages: 18 Years – 60 Years
Healthy volunteers: Yes
Phase: PHASE1
Enrollment: 40
Sponsor: CellProthera

Location: CHRU Strasbourg Strasbourg France

Summary

Donation of whole blood by healthy volunteers after mobilisation by haematopoietic growth factor (rhu-G-CSF = Granocyte) for biological validation of a cell expansion automaton allowing the simultaneous production of several cell grafts for therapeutic use in the cardiac field - 2nd STAGE

Eligibility Criteria

Inclusion Criteria: * Healthy male volunteers, * Age ≥ 18 years and ≤ 60 years, * Agreeing to the collection of blood products by whole blood donation for scientific research purposes, * Fit for collection by the collecting physician after a medical examination including measurement of blood pressure, heart rate, electrocardiogram and assessment of venous potential, * Minimum weight: 50 kg, * Body mass index (BMI) \< 30, * Haemoglobin level between 13 g/dL and 18 g/dL, * Platelet count between 150.106/mL and 400.106/mL * White blood cell count ≥ 3.9.106/mL with neutrophils ≥ 2.5.106/mL, * Agreement to be registered in the national research file, Exclusion Criteria: * Any cardiopulmonary abnormality on initial clinical and ECG assessment * Clinical measurement of systolic BP ≤ 110 mmHg and/or diastolic BP \< 70 mmHg on initial workup * Any blood work-up abnormality deemed significant by the investigator at the time of the initial work-up, * Previous administration of any haematopoietic growth factor, * Regular use of medication(s) within 8 days prior to the start of the Granocyte mobilisation phase, * Any significant cardiovascular history within the last 2 years * Any history of severe pulmonary disease (including bacterial or viral pneumonia) * Any history of cancer (solid tumours or haematological malignancies) * Anysevere neurological history * Any severe psychiatric history * Renal history (creatinine clearance from stage 1 to stage 5 of the HAS 2012 classification) * Twins with a living twin brother or sister, * Allergy to any of the excipients of Granocyte, * History of severe drug allergy, anaphylactic allergic shock or angioedema * Pre-existing splenomegaly * Obesity (BMI 30), * Autoimmune diseases, * Alcohol and drug abuse, drug abuse * Blood donation within 2 months prior to inclusion * Volunteer registered or wishing to register on the bone marrow donor list, * Sickle cell disease, * Presence of positive virological markers (anti HIV1 and 2, HTLV1 and 2, anti-HCV, anti-HBS, anti-HBC serologies), active syphilis, * Rheumatoid arthritis, * Anticoagulant therapy, * History of cutaneous vasculitis * Phenylketonuria, * Subject on exclusion from another study * Subject under administrative or judicial supervision * Subject who would receive more than 4500 euros in compensation due to participation in other research in the 12 months preceding this study,

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05594433). StuddyBuddy aggregates publicly available trial information.