Actively Recruiting
Donation of Whole Blood by Healthy Volunteers After Mobilisation by Haematopoietic Growth Factor (Rhu-G-CSF = Granocyte)
Led by CellProthera · Updated on 2024-07-10
40
Participants Needed
2
Research Sites
490 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
Donation of Whole Blood by Healthy Volunteers After Mobilisation by Haematopoietic Growth Factor (Rhu-G-CSF = Granocyte)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Healthy male volunteers
- Aged 18 to 60 years
- Agree to donate blood for scientific research
- Medically fit for blood collection after examination including blood pressure, heart rate, ECG, and vein assessment
- Minimum weight of 50 kg
- Body mass index (BMI) less than 30
- Hemoglobin level between 13 g/dL and 18 g/dL
- Platelet count between 150 x 10^6/mL and 400 x 10^6/mL
- White blood cell count at least 3.9 x 10^6/mL with neutrophils at least 2.5 x 10^6/mL
- Agree to registration in the national research file
You will not qualify if you...
- Any cardiopulmonary abnormality found on initial clinical or ECG assessment
- Systolic blood pressure less than or equal to 110 mmHg or diastolic blood pressure less than 70 mmHg at initial workup
- Significant blood test abnormalities as judged by the investigator
- Prior use of any hematopoietic growth factor
- Regular medication use within 8 days before starting Lenograstim mobilization
- Significant cardiovascular history within the last 2 years
- History of severe pulmonary diseases including pneumonia
- History of cancer, either solid tumors or blood cancers
- Severe neurological or psychiatric history
- Renal disease classified from stage 1 to 5 by HAS 2012
- Being a twin with a living twin brother or sister
- Allergy to any components of Granocyte
- History of severe drug allergies, anaphylactic shock, or angioedema
- Pre-existing enlarged spleen
- Obesity with BMI 30 or higher
- Autoimmune diseases
- Alcohol or drug abuse
- Blood donation within 2 months prior to inclusion
- Registered or wishing to register as a bone marrow donor
- Sickle cell disease
- Positive infectious disease markers including HIV, HTLV, HCV, hepatitis B, or active syphilis
- Rheumatoid arthritis
- Anticoagulant therapy
- History of skin vasculitis
- Phenylketonuria
- Participation in another study that excludes involvement
- Under administrative or judicial supervision
- Receiving over 4500 euros in compensation from other research in the past 12 months
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
GHU La Pitié-Salpêtrière
Paris, France
Actively Recruiting
2
CHRU Strasbourg
Strasbourg, France, 67000
Actively Recruiting
Research Team
A
Aude Bollinger
CONTACT
L
Louise Boudeau, PharmD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
OTHER
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here