Healthy VolunteersPhase 1CARDIOSTEMNCT05594433
Donation of Whole Blood by Healthy Volunteers After Mobilisation by Haematopoietic Growth Factor (Rhu-G-CSF = Granocyte)
A Phase 1 study testing Lenograstim in people with Healthy Volunteers, run by CellProthera at 2 sites in France.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 60 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Lenograstim
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesFrance
- Study dates
- 10 Sep 2015to 31 Jan 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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,
Show all 10Show fewer
- 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,
Who cannot join
- 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
Show all 29Show fewer
- 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,
Trial locations and contacts
2 sites in 1 country.
France2 sites
GHU La Pitié-Salpêtrière
Paris
CHRU Strasbourg
Strasbourg, France, 67000
About this study
Official title: 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
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
Read the detailed description
The rationale for the MHS002 study is based on the expansion results obtained with the first version of the machine (MHS001):
- Average expansion rate of about 20-fold of CD34+ stem cells observed in a reproducible way on the Mulhouse and Créteil sites,
- No significant difference in phenotypic, immunological or morphological characteristics between the "naive" cells (not multiplied) and the cells after multiplication, nor any chromosomal alteration or hyperploidy: the expansion process developed does not lead to any cellular modification,
- Variability in the number of stem cells obtained after multiplication between healthy volunteers.
Developing a second generation prototype capable of producing 15 grafts per month, it is necessary to proceed with its biological validation, in the same way as the first generation prototype (protocol MHS001) was validated, following the requirements of regulatory agencies. Furthermore, in view of these results, it appeared necessary to define the lower limit of the number of CD34+ stem cells composing the graft, below which the therapeutic efficacy will be reduced or nil. This second stage of the study will make it possible to validate a potency test, i.e. a test making it possible to define the composition and potential effectiveness of the graft before its reinjection.
Given the absence of serious adverse events following the administration of G-CSF in healthy volunteers and in the context of the continued development of the second version of the automaton, validations similar to the first protocol are still necessary. Blood donation from healthy volunteers following stem cell mobilisation by G-CSF administration will allow validation of the second version.
- Conditions
- Healthy Volunteers
- Being tested
- Lenograstim
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LenograstimDrug
Also called Granocyte(R)
Injection sub cutaneous of Lenograstim during 4 days, once per day
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Sub cutaneous injection of Lenograstim with blood donation (450ML) after 4 days of mobilization Receives: Drug: Lenograstim |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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
Confirm that the number of CD34+ cells obtained with the "2nd generation" machine is equivalent to that obtained with the 1st generation machine
Measured: From Day 0 to Day 9 expansion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2022
- Study start10 Sep 2015
- Primary completion31 Dec 2024
- Study completion31 Jan 2025
Why it stopped: Strategic change
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CellProthera
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Catherine Mutter, MD, Principal investigator, CHRU Strasbourg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05594433
- Sponsor's protocol ID
- 2013-A01558-37
- Acronym
- CARDIOSTEM
- Status last verified
- Oct 2026
- First submitted
- 13 Oct 2022
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05594433
- Acronym / sponsor ID
- CARDIOSTEM / 2013-A01558-37
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Strategic change
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- CellProtheraIndustry (pharma, biotech, devices)
- Study start
- 10 Sep 2015 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Jan 2025 (actual)
- First posted
- 26 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
The rationale for the MHS002 study is based on the expansion results obtained with the first version of the machine (MHS001):
- Average expansion rate of about 20-fold of CD34+ stem cells observed in a reproducible way on the Mulhouse and Créteil sites,
- No significant difference in phenotypic, immunological or morphological characteristics between the "naive" cells (not multiplied) and the cells after multiplication, nor any chromosomal alteration or hyperploidy: the expansion process developed does not lead to any cellular modification,
- Variability in the number of stem cells obtained after multiplication between healthy volunteers.
Developing a second generation prototype capable of producing 15 grafts per month, it is necessary to proceed with its biological validation, in the same way as the first generation prototype (protocol MHS001) was validated, following the requirements of regulatory agencies. Furthermore, in view of these results, it appeared necessary to define the lower limit of the number of CD34+ stem cells composing the graft, below which the therapeutic efficacy will be reduced or nil. This second stage of the study will make it possible to validate a potency test, i.e. a test making it possible to define the composition and potential effectiveness of the graft before its reinjection.
Given the absence of serious adverse events following the administration of G-CSF in healthy volunteers and in the context of the continued development of the second version of the automaton, validations similar to the first protocol are still necessary. Blood donation from healthy volunteers following stem cell mobilisation by G-CSF administration will allow validation of the second version.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Drug: LenograstimSub cutaneous injection of Lenograstim with blood donation (450ML) after 4 days of mobilization |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- 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,
Key exclusion criteria (29 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LenograstimAlso: Granocyte(R)Injection sub cutaneous of Lenograstim during 4 days, once per day | Drug | Experimental |
Primary outcome
Number of blood donation of CD34+ stem cells obtained to validate the new automaton
Time frame: From day 0 of mobilization phase to day 5 corresponding to day of blood harvest
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)
1 secondary outcome
Number of CD34+ cells obtained with the second generation machine
Time frame: From Day 0 to Day 9 expansion
Results and safety
The study was stopped early (reason given: Strategic change). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
Related trials for Healthy Volunteers
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Not yet recruitingObservational study
Establishment of Biobank of Nasal Epithelium Samples From Healthy Volunteers
Healthy
RecruitingObservational study
Improved Methods of Cell Selection for Bone Marrow Transplant Alternatives
Graft-Versus-Host Disease, Graft-versus-leukemia
Not yet recruitingObservational study
Screening Protocol
Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Catherine Mutter, MD principal investigator
CHRU Strasbourg
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Lenograstim in people with Healthy Volunteers, run by CellProthera at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Strategic change). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of blood donation of CD34+ stem cells obtained to validate the new automaton (time frame: From day 0 of mobilization phase to day 5 corresponding to day of blood harvest). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2026.