SepsisPhase 1CELLULANCT02328612
Randomized, Parallel Group, Placebo Control, Unicentric, Interventional Study to Assess the Effect of Expanded Human Allogeneic Adipose-derived Mesenchymal Adult Stem Cells on the Human Response to Lipopolysaccharyde in Human Volunteers
A Phase 1 study testing Intravenous infusion of cells in people with Sepsis, run by Tigenix S.A.U. at 1 site in Netherlands.
Trial summary
Phase I, randomized, parallel group, placebo control, unicentric, interventional study. Thirty two healthy male volunteers aged between 18-35 years will be randomized into the eASCs or placebo group if they meet all the inclusion criteria at a 3:1 ratio. Read more about this study
- Who is it for?
- Ages 18 to 35 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Sepsis
- What is being tested?
- Intravenous infusion of cells
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteNetherlands
- Study dates
- Oct 2014to Mar 2015
- 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 35 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- A subject will be eligible for inclusion in this study only if all of the following criteria apply:
- Healthy, as determined by a responsible physician, based on a medical evaluation including medical history, physical examination and laboratory tests carried out within 28 days prior to administration of eASCs (if applicable) and LPS. A subject with a clinical abnormality or laboratory parameter outside the reference range may be included only if the investigator judges that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures
- Male aged between 18 and 35 years, inclusive at the time of signing the informed consent
- Male subjects (including those who have had a vasectomy) must agree to use barrier contraception (latex condoms) when engaging in activity in which conception is possible while on study medication and for at least 28 days after taking the last dose of study medication
- Must understand and voluntarily sign an informed consent form prior to the conduct of any study related assessment/procedures. Capable of giving written informed consent and able to comply with the requirements and restrictions listed in the informed consent form.
Who cannot join
- Subjects meeting any of the following exclusion criteria are not to be enrolled in the study:
- Subject has had a major illness in the past 3 months or any significant chronic medical illness that the investigator would deem unfavourable for enrolment, including inflammatory diseases
- Subjects with a history of malignancy
- Significant concurrent, uncontrolled medical condition including, but not limited to, renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, neurological, cerebral psychiatric disease, or evidence of demyelinating disease
- Subject uses tobacco products
- Subject has a history, within 3 years, of drug abuse (including benzodiazepines, opioids, amphetamine, cocaine, THC, methamphetamine)
Show all 19Show fewer
- History of alcoholism and/or drinking more than 5 units of alcohol per day
- Any clinically relevant abnormality noted on the 12-lead ECG as judged by the investigator or an average QTc > 450 msec
- The subject has received an investigational product within three months prior to day 1 of the current study
- Use of prescription or non-prescription drugs and herbal and dietary supplements within 6 months unless in the opinion of the investigator the medication will not interfere with the study procedures or compromise subject safety
- Transfusion of blood or blood products within 6 months prior to the inclusion in the study.
- Subject has difficultly in donating blood or accessibility of a vein in left or right arm.
- Subject has donated more than 350 mL of blood in last 3 months
- Body mass index >28 kg/m2
- Presence of a severe bleeding or thrombotic disorder
- History of known pulmonary embolism or known secondary anti-phospholipid syndrome
- Subjects known or suspected of not being able to comply with a study protocol (e.g. due to alcoholism, drug dependency or psychological disorder)
- Known allergies or hypersensitivity to antibiotics, HSA, DMEM, materials of bovine origin, and Ringer's Lactate Solution
- Any other issue that, in the opinion of the investigator, could be harmful to the subject or compromise interpretation of the data.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase I, Randomized, Parallel Group, Placebo Control, Unicentric, Interventional Study to Assess the Effect of Expanded Human Allogeneic Adipose-derived Mesenchymal Adult Stem Cells on the Human Response to Lipopolysaccharyde in Human Volunteers
Phase I, randomized, parallel group, placebo control, unicentric, interventional study. Thirty two healthy male volunteers aged between 18-35 years will be randomized into the eASCs or placebo group if they meet all the inclusion criteria at a 3:1 ratio.
The treatment administration will be infused intravenously to the following groups after randomization:
- First arm: 250,000 cells/kg
- Second arm: 1 million cells/kg
- Third arm: 4 million cells/kg
- Fourth arm: placebo according to their weight.
An hour after the end of the eASCs administration, all subjects will be given an intravenous dose of LPS. Subjects will be allowed to leave in the evening once deemed clinically stable by the investigator.
Read the detailed description
Medicinal product Suspension of expanded adipose-derived allogeneic adult stem cells (eASCs) at a single dose of 250,000 cells/kg, 1 million cells/kg or 4 million cells/kg by intravenous infusion after suspension in Ringer's lactate solution.
Control Placebo (Ringer's lactate solution) Objectives To investigate the effect of eASCs on the inflammatory response to intravenous LPS in humans.
Design Phase I, randomized, parallel group, placebo control, unicentric, interventional study. Thirty two healthy male volunteers aged between 18-35 years will be randomized into the eASCs or placebo group if they meet all the inclusion criteria at a 3:1 ratio.
The treatment administration will be infused intravenously to the following groups after randomization:
- First arm: 250,000 cells/kg
- Second arm: 1 million cells/kg
- Third arm: 4 million cells/kg
- Fourth arm: placebo according to their weight.
An hour after the end of the eASCs administration, all subjects will be given an intravenous dose of LPS. Subjects will be allowed to leave in the evening once deemed clinically stable by the investigator.
- Conditions
- Sepsis
- Being tested
- Intravenous infusion of cells
- Medical subject headings
- Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravenous infusion of cellsOther
The treatment administration will be infused intravenously to the subjects after randomization:
An hour after the end of the eASCs administration, all subjects will be given an intravenous dose of LPS. Subjects will be allowed to leave in the evening once deemed clinically stable by the investigator.
| Study group | Role | What they receive |
|---|---|---|
| First arm | Experimental | 250,000 cells/kg will be administered via intravenous infusion. Receives: Other: Intravenous infusion of cells |
| Second arm | Experimental | 1,000,000 cells/kg will be administered via intravenous infusion. Receives: Other: Intravenous infusion of cells |
| Third arm | Experimental | 4,000,000 cells/kg will be administered via intravenous infusion. Receives: Other: Intravenous infusion of cells |
| Fourth arm | Placebo comparator | Placebo (Ringer's lactate solution) volume according to subject's weight. Receives: Other: Intravenous infusion of cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inflammatory response as measured by laboratory measurements and functional assays of innate immunology
To investigate the effect of eASCs on the inflammatory response to intravenous LPS in humans.
Measured: Change from baseline markers up to 10 hours after LPS injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2014 (estimated)
- Study startOct 2014
- Primary completionMar 2015
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SepsisStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tigenix S.A.U.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02328612
- Sponsor's protocol ID
- Cx611-0102
- Acronym
- CELLULA
- Status last verified
- Apr 2015
- First submitted
- 11 Dec 2014
- Last updated
- 3 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Perlee D, van Vught LA, Scicluna BP, Maag A, Lutter R, Kemper EM, van 't Veer C, Punchard MA, Gonzalez J, Richard MP, Dalemans W, Lombardo E, de Vos AF, van der Poll T. Intravenous Infusion of Human Adipose Mesenchymal Stem Cells Modifies the Host Response to Lipopolysaccharide in Humans: A Randomized, Single-Blind, Parallel Group, Placebo Controlled Trial. Stem Cells. 2018 Nov;36(11):1778-1788. doi: 10.1002/stem.2891. Epub 2018 Aug 20.
PubMed 30063804
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I, Randomized, Parallel Group, Placebo Control, Unicentric, Interventional Study to Assess the Effect of Expanded Human Allogeneic Adipose-derived Mesenchymal Adult Stem Cells on the Human Response to Lipopolysaccharyde in Human Volunteers
- ClinicalTrials.gov ID
- NCT02328612
- Acronym / sponsor ID
- CELLULA / Cx611-0102
- Conditions
- Sepsis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Tigenix S.A.U.Industry (pharma, biotech, devices)
- Study start
- Oct 2014
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 31 Dec 2014 (estimated)
- 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.
Phase I, randomized, parallel group, placebo control, unicentric, interventional study. Thirty two healthy male volunteers aged between 18-35 years will be randomized into the eASCs or placebo group if they meet all the inclusion criteria at a 3:1 ratio.
The treatment administration will be infused intravenously to the following groups after randomization:
- First arm: 250,000 cells/kg
- Second arm: 1 million cells/kg
- Third arm: 4 million cells/kg
- Fourth arm: placebo according to their weight.
An hour after the end of the eASCs administration, all subjects will be given an intravenous dose of LPS. Subjects will be allowed to leave in the evening once deemed clinically stable by the investigator.
Detailed description
Medicinal product Suspension of expanded adipose-derived allogeneic adult stem cells (eASCs) at a single dose of 250,000 cells/kg, 1 million cells/kg or 4 million cells/kg by intravenous infusion after suspension in Ringer's lactate solution.
Control Placebo (Ringer's lactate solution) Objectives To investigate the effect of eASCs on the inflammatory response to intravenous LPS in humans.
Design Phase I, randomized, parallel group, placebo control, unicentric, interventional study. Thirty two healthy male volunteers aged between 18-35 years will be randomized into the eASCs or placebo group if they meet all the inclusion criteria at a 3:1 ratio.
The treatment administration will be infused intravenously to the following groups after randomization:
- First arm: 250,000 cells/kg
- Second arm: 1 million cells/kg
- Third arm: 4 million cells/kg
- Fourth arm: placebo according to their weight.
An hour after the end of the eASCs administration, all subjects will be given an intravenous dose of LPS. Subjects will be allowed to leave in the evening once deemed clinically stable by the investigator.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| First arm | Experimental | Other: Intravenous infusion of cells250,000 cells/kg will be administered via intravenous infusion. |
| Second arm | Experimental | Other: Intravenous infusion of cells1,000,000 cells/kg will be administered via intravenous infusion. |
| Third arm | Experimental | Other: Intravenous infusion of cells4,000,000 cells/kg will be administered via intravenous infusion. |
| Fourth arm | Placebo comparator | Other: Intravenous infusion of cellsPlacebo (Ringer's lactate solution) volume according to subject's weight. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- A subject will be eligible for inclusion in this study only if all of the following criteria apply:
- Healthy, as determined by a responsible physician, based on a medical evaluation including medical history, physical examination and laboratory tests carried out within 28 days prior to administration of eASCs (if applicable) and LPS. A subject with a clinical abnormality or laboratory parameter outside the reference range may be included only if the investigator judges that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures
- Male aged between 18 and 35 years, inclusive at the time of signing the informed consent
- Male subjects (including those who have had a vasectomy) must agree to use barrier contraception (latex condoms) when engaging in activity in which conception is possible while on study medication and for at least 28 days after taking the last dose of study medication
- Must understand and voluntarily sign an informed consent form prior to the conduct of any study related assessment/procedures. Capable of giving written informed consent and able to comply with the requirements and restrictions listed in the informed consent form.
Key exclusion criteria (19 listed)
- Subjects meeting any of the following exclusion criteria are not to be enrolled in the study:
- Subject has had a major illness in the past 3 months or any significant chronic medical illness that the investigator would deem unfavourable for enrolment, including inflammatory diseases
- Subjects with a history of malignancy
- Significant concurrent, uncontrolled medical condition including, but not limited to, renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, neurological, cerebral psychiatric disease, or evidence of demyelinating disease
- Subject uses tobacco products
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 |
|---|---|---|
| Intravenous infusion of cellsThe treatment administration will be infused intravenously to the subjects after randomization: An hour after the end of the eASCs administration, all subjects will be given an intravenous dose of LPS. Subjects will be allowed to leave in the evening once deemed clinically stable by the investigator. | Other | First arm, Fourth arm, Second arm, Third arm |
Primary outcome
Inflammatory response as measured by laboratory measurements and functional assays of innate immunology
Time frame: Change from baseline markers up to 10 hours after LPS injection
To investigate the effect of eASCs on the inflammatory response to intravenous LPS in humans.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2015.
- Derived from this study: PubMed 30063804Perlee D, van Vught LA, Scicluna BP, Maag A, Lutter R, Kemper EM, van 't Veer C, Punchard MA, Gonzalez J, Richard MP, Dalemans W, Lombardo E, de Vos AF, van der Poll T. Intravenous Infusion of Human Adipose Mesenchymal Stem Cells Modifies the Host Response to Lipopolysaccharide in Humans: A Randomized, Single-Blind, Parallel Group, Placebo Controlled Trial. Stem Cells. 2018 Nov;36(11):1778-1788. doi: 10.1002/stem.2891. Epub 2018 Aug 20.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Intravenous infusion of cells in people with Sepsis, run by Tigenix S.A.U. at 1 site in Netherlands.
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 5 inclusion and 19 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: finished, as of the sponsor's last update on 3 Apr 2015. 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 Netherlands. 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. Some participants in this study may receive a placebo. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Inflammatory response as measured by laboratory measurements and functional assays of innate immunology (time frame: Change from baseline markers up to 10 hours after LPS injection). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02328612, which also lists 1 linked publication.
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 3 Apr 2015.