Healthy VolunteersSMART101-HV1NCT05118113
Development of a Cell Culture Process for the Production of Human T-lymphocyte Precursors
A study testing Collection of mobilized hematopoietic stem cells (apheresis products) from healthy volunteers in people with Healthy Volunteers, run by Smart Immune SAS at 1 site in France.
Trial summary
The purpose of this study is to finalise the development of a process for the production of T-cell progenitor cells. Read more about this study
- Who is it for?
- Ages 18 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Collection of mobilized hematopoietic stem cells (apheresis products) from healthy volunteers
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteFrance
- Study dates
- 26 Apr 2022to 31 Aug 2024
- Phase
- Interventional
- 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 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy donors, men aged 18 to 40 years.
- Body weight ≥ 65 kg with a body mass index (BMI) calculated by weight in kg/(height in m)² of 20 to 30 kg/m² at screening.
- Informed consent form signed and dated prior to any study-specific screening procedure.
- Health status judged by the investigator to be compatible with participation in the study based on medical history, results of physical examination, results of biological laboratory tests (cell blood count including RBC, hematocrit, hemoglobin, reticulocytes, WBC, platelet, PT, aPTT, CRP, fasting blood glucose, ionogram (Na+, K+, Cl-, HCO3-), creatinine, creatinine clearance by Cockcroft, albumin, total protein, total bilirubin, AST, ALT, ALP, GGT), vital signs measurements and 12-lead ECG. All results should be normal or, if out of range, clinically insignificant in the judgement of the investigator.
- Venous capital compatible with leukapheresis
- Have a high probability of complying with and completing the study.
- Be affiliated with a Social Security scheme
Who cannot join
- Any cardiovascular (e.g. heart failure), hepatic, renal, respiratory (e.g. asthma), gastrointestinal, endocrine (e.g. diabetes, dyslipidemia), immunological, dermatological, haematological (including hemoglobinopathy), neurological, psychiatric disorder or any history of allergy to a drug.
- State of acute illness (e.g., vomiting, fever, diarrhea) within 7 days prior to the first day of the study.
- History of drug abuse in the year preceding the first day of the study.
- History of alcoholism in the year prior to day 1 defined as consumption of more than 3 standard drinks/day (30 g/day) or 15 standard drinks/week (150 g/week) or less than two non-alcoholic days each week, or more than 5 standard drinks (50 g) on a single occasion.
- Any contra-indication to filgrastim
- Positive serological results for human immunodeficiency virus (HIV) antibodies, hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibodies, syphilis and/or human T-lymphotropic virus (HTLV).
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- Positive urine drug tests (methadone, barbiturates, benzodiazepines, tricyclic antidepressants, cocaine, cannabinoids, morphine, amphetamines and methamphetamines, including 3,4-methylenedioxy-N-methylamphetamine [MDMA]).
- Laboratory workup including blood count, fasting blood glucose, blood ionogram, creatinine, AST, ALT, gamma GT, alkaline phosphatase, total bilirubin, CRP, PT, aPTT incompatible with leukapheresis protocol.
- Use of any experimental drug within 30 days prior to inclusion.
- Use of any prescription or over-the-counter medication within 5 times the elimination half-life prior to inclusion. However, any prescribed medication that may interfere with the study objectives must be discontinued for at least 30 days.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
CIC Paris Est, Hôpital Pitié Salpêtrière
Paris, 75013
For information on study participation, +33 1 42 17 85 31, secretariat.cic.psl@aphp.fr
Joe-Elie Salem, MD, PhD
About this study
The purpose of this study is to finalise the development of a process for the production of T-cell progenitor cells.
- Conditions
- Healthy Volunteers
- Being tested
- Collection of mobilized hematopoietic stem cells (apheresis products) from healthy volunteers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collection of mobilized hematopoietic stem cells (apheresis products) from healthy volunteersProcedure or surgery
Mobilisation of hematopoietic stem cells by injection of filgrastim (authorized auxiliary medicinal product) for 4 consecutive days and leukapheresis on Day 5
| Study group | Role | What they receive |
|---|---|---|
| Healthy donors | Other | Not described Receives: Procedure: Collection of mobilized hematopoietic stem cells (apheresis products) from healthy volunteers |
What is being measured
The primary outcome is the main question the study is designed to answer.
Production of cell therapy products fulfilling the required specifications
Production of cell therapy products fulfilling the required specifications after 7 days of CD34+ cell culture
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2021
- Study start26 Apr 2022
- Primary completion31 Aug 2024 (estimated)
- Study completion31 Aug 2024 (estimated)
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 N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Smart Immune SAS
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Joe-Elie Salem, MD, PhD, Principal investigator, CIC Paris Est, Hôpital Pitié Salpêtrière, Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05118113
- Sponsor's protocol ID
- SI101-HV1
- Acronym
- SMART101-HV1
- Status last verified
- Jul 2023
- First submitted
- 5 Nov 2021
- Last updated
- 21 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Cell Culture Process for the Production of Human T-lymphocyte Precursors
- ClinicalTrials.gov ID
- NCT05118113
- Acronym / sponsor ID
- SMART101-HV1 / SI101-HV1
- Conditions
- Healthy Volunteers
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 14 participants (estimated)
- Lead sponsor
- Smart Immune SASIndustry (pharma, biotech, devices)
- Study start
- 26 Apr 2022 (actual)
- Primary completion
- 31 Aug 2024 (estimated)
- Study completion
- 31 Aug 2024 (estimated)
- First posted
- 11 Nov 2021 (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.
The purpose of this study is to finalise the development of a process for the production of T-cell progenitor cells.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy donors | Other | Procedure: Collection of mobilized hematopoietic stem cells (apheresis products) from healthy volunteers |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Healthy donors, men aged 18 to 40 years.
- Body weight ≥ 65 kg with a body mass index (BMI) calculated by weight in kg/(height in m)² of 20 to 30 kg/m² at screening.
- Informed consent form signed and dated prior to any study-specific screening procedure.
- Health status judged by the investigator to be compatible with participation in the study based on medical history, results of physical examination, results of biological laboratory tests (cell blood count including RBC, hematocrit, hemoglobin, reticulocytes, WBC, platelet, PT, aPTT, CRP, fasting blood glucose, ionogram (Na+, K+, Cl-, HCO3-), creatinine, creatinine clearance by Cockcroft, albumin, total protein, total bilirubin, AST, ALT, ALP, GGT), vital signs measurements and 12-lead ECG. All results should be normal or, if out of range, clinically insignificant in the judgement of the investigator.
- Venous capital compatible with leukapheresis
Key exclusion criteria (10 listed)
- Any cardiovascular (e.g. heart failure), hepatic, renal, respiratory (e.g. asthma), gastrointestinal, endocrine (e.g. diabetes, dyslipidemia), immunological, dermatological, haematological (including hemoglobinopathy), neurological, psychiatric disorder or any history of allergy to a drug.
- State of acute illness (e.g., vomiting, fever, diarrhea) within 7 days prior to the first day of the study.
- History of drug abuse in the year preceding the first day of the study.
- History of alcoholism in the year prior to day 1 defined as consumption of more than 3 standard drinks/day (30 g/day) or 15 standard drinks/week (150 g/week) or less than two non-alcoholic days each week, or more than 5 standard drinks (50 g) on a single occasion.
- Any contra-indication to filgrastim
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 |
|---|---|---|
| Collection of mobilized hematopoietic stem cells (apheresis products) from healthy volunteersMobilisation of hematopoietic stem cells by injection of filgrastim (authorized auxiliary medicinal product) for 4 consecutive days and leukapheresis on Day 5 | Procedure or surgery | Healthy donors |
Primary outcome
Production of cell therapy products fulfilling the required specifications
Time frame: 7 days
Production of cell therapy products fulfilling the required specifications after 7 days of CD34+ cell culture
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2023.
- Individual participant dataSharing planned: No
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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.
Joe-Elie Salem, MD, PhD principal investigator
CIC Paris Est, Hôpital Pitié Salpêtrière, Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Collection of mobilized hematopoietic stem cells (apheresis products) from healthy volunteers in people with Healthy Volunteers, run by Smart Immune SAS at 1 site 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 7 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 21 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Aurelie Bauquet, PhD (+33 (0) 671709793, aurelie.bauquet@smart-immune.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Production of cell therapy products fulfilling the required specifications (time frame: 7 days). 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 21 Nov 2023.