Donation of Whole Blood by Healthy Volunteers After Mobilisation by Haematopoietic Growth Factor (Rhu-G-CSF = Granocyte)
Recruiting
Phase 1Interventional Study
Healthy Volunteers
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
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Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 60
Sex
Male
Trial phase
Phase 1
Study type
Interventional
Purpose
Other
Participants needed
40 (estimated)
Sponsor
CellProthera · Industry
Who this trial is looking for
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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
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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 pressu…
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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