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

NCT05594433 | Recruiting Phase 1

• 1 other identifier: 2013-A01558-37
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

Brief 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

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

• Number of blood donation of CD34+ stem cells obtained to validate the new automaton

  Validation of the second generation of the automaton able to expend CD34+ stem cells, by collection of 450 mL of blood containing CD34+ stem cells. Blood will be collected after 4 days of mobilization with haematopoietic growth factor (rhu-G-CSF = Granocyte)

  From day 0 of mobilization phase to day 5 corresponding to day of blood harvest

Secondary Outcomes (1)

• Number of CD34+ cells obtained with the second generation machine

  From Day 0 to Day 9 expansion

Study Arms (1)

Experimental

EXPERIMENTAL

Sub cutaneous injection of Lenograstim with blood donation (450ML) after 4 days of mobilization

Drug: Lenograstim

Interventions

Lenograstim DRUG

Injection sub cutaneous of Lenograstim during 4 days, once per day

Also known as: Granocyte(R)

Experimental

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify 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 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,

You may not qualify 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
• 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

Sponsors & Collaborators

• CellProthera: lead

Study Sites (2)

GHU La Pitié-Salpêtrière

Paris, France

RECRUITING

CHRU Strasbourg

Strasbourg, 67000, France

RECRUITING

MeSH Terms

Interventions

Lenograstim

Intervention Hierarchy (Ancestors)

Granulocyte Colony-Stimulating Factor; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Study Officials

• Catherine Mutter, MD

  CHRU Strasbourg

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Aude Bollinger

CONTACT

0369719771; abollinger@cellprothera.com

Louise Boudeau, PharmD

CONTACT

lboudeau@cellprothera.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 13, 2022
• First Posted: October 26, 2022
• Study Start: September 10, 2015
• Primary Completion: December 31, 2024
• Study Completion: January 31, 2025
• Last Updated: July 10, 2024

Record last verified: 2024-07

Locations

FR (2)