Donation of whole blood by healthy volunteers after treatment with a growth factor
Donation of Whole Blood by Healthy Volunteers After Mobilisation by Haematopoietic Growth Factor for Validation of a Cell Expansion Automaton Allowing the Simultaneous Production of Several Cell Grafts for Therapeutic Use
This study is testing if healthy men can donate blood after taking a growth factor to help create more stem cells for heart treatments.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | Male |
| Sponsor | CellProthera Industry-sponsored |
| Locations | 2 sites (Paris and 1 other locations) |
| Trial ID | NCT05594433 on ClinicalTrials.gov |
What this trial studies
This study involves healthy male volunteers who will donate whole blood after being treated with a haematopoietic growth factor called Lenograstim. The aim is to biologically validate a new cell expansion machine that can produce multiple cell grafts for therapeutic use in cardiac treatments. The study will assess the effectiveness of the cell expansion process and establish the minimum number of stem cells needed for therapeutic efficacy. Participants will undergo medical examinations to ensure they meet health criteria before donation.
Who should consider this trial
Good fit: Ideal candidates for this study are healthy male volunteers aged 18 to 60 who meet specific health criteria.
Not a fit: Patients with cardiopulmonary abnormalities or significant blood work abnormalities will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the production of cell grafts for cardiac therapies, potentially improving treatment outcomes for patients with heart conditions.
How similar studies have performed: Previous studies have shown promising results with similar cell expansion techniques, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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,
Where this trial is running
Paris and 1 other locations
- GHU La Pitié-Salpêtrière — Paris, France (Recruiting)
- CHRU Strasbourg — Strasbourg, France (Recruiting)
Study contacts
- Principal investigator: Catherine Mutter, MD — CHRU Strasbourg
- Study coordinator: Aude Bollinger
- Email: abollinger@cellprothera.com
- Phone: 0369719771
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.