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New treatment option for Healthy Volunteers
Official title Donation of Whole Blood by Healthy Volunteers After Mobilisation by Haematopoietic Growth Factor (Rhu-G-CSF = Granocyte)
ClinicalTrials.gov ID: NCT05594433
What this study is testing
What is Lenograstim?
Lenograstim is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for healthy volunteers.
Also referred to as Granocyte(R).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 60, men only. Healthy volunteers may be eligible.
You may be able to join if
- 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...
- Minimum weight: 50 kg,
You likely can't join if
- 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
See the full eligibility 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,
- 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,
The study team makes the final eligibility decision.
Where it's taking place
- Paris, France
- Strasbourg, France
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 18 years to 60 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Paris, France; Strasbourg, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.