Metabolic DiseasePhase 2SIRONANCT02587572
Safety and Efficacy Trial Using Allogeneic Human Mesenchymal Stem Cells: The SIRONA Trial
A Phase 2 study testing Peripheral Intravenous (IV) infusion of LMSCs in people with Metabolic Disease and Endothelial Dysfunction, run by Longeveron Inc..
Trial summary
This is a phase 2b, randomized, placebo-controlled clinical trial designed to evaluate the safety and efficacy of Longeveron Mesenchymal Stem Cells (LMSCs) in subjects with metabolic syndrome and to assess the effects of LMSCs on endothelial function using several different doses. Read more about this study
- Who is it for?
- Ages 45 to 85 years
- Conditions the study is for
- Metabolic Disease, Endothelial Dysfunction
- What is being tested?
- Peripheral Intravenous (IV) infusion of LMSCs
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2023to Dec 2023
- Phase
- Phase 2
- 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 45 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Each subject must provide written informed consent.
- Each subject must be ≥45 and ≤ 85 years of age at the time of signing the Informed Consent Form.
- Each subject must have endothelial dysfunction.
- At the time of enrollment, each subject must meet at least 3 out of the 5 criteria under the harmonized definition of the metabolic syndrome, consisting of the following
- Hypertension.
- Elevated triglycerides.
- Reduced high-density lipoprotein (HDL) levels.
- Elevated fasting glucose. --Central obesity.
Who cannot join
- Be unable and/or unwilling to perform any of the assessments required for endpoint analysis.
- Have diabetic retinopathy.
- Sitting or resting systolic blood pressure >180 mm Hg or diastolic blood pressure >110 mm Hg at Screening.
- Have a resting blood oxygen saturation of <93% (measured by pulse oximetry).
- Be hypersensitive to dimethyl sulfoxide (DMSO).
- Have a history of alcohol or drug abuse within the past 24 months.
Show all 15Show fewer
- Have been diagnosed with malignancy within the past 5 years, with the exception of curatively-treated basal cell carcinoma, melanoma in situ or cervical carcinoma.
- Be an organ transplant recipient.
- Be actively listed (or expected to be listed) for transplant of any organ.
- Have a condition that limits life expectancy to < 1 year.
- Be serum positive for HIV, hepatitis B sAG or viremic hepatitis C.
- Be a female who is pregnant, nursing, or of childbearing potential while not practicing effective contraception (female patients must undergo a blood or urine pregnancy test at screening and within 36 hours prior to injection).
- Have any serious comorbid illness or other condition that, in the opinion of the Investigator, may compromise the safety or compliance of the subject or preclude successful completion of the study.
- Be currently participating in an investigational therapeutic or device trial.
- Be currently participating in an investigational therapeutic or device trial, or have participated in an investigational therapeutic or device trial within the previous 30 days, or participate in any other clinical trial for the duration of the time that he or she is actively participating in this trial.
About this study
Official title: A Randomized, Blinded and Placebo-controlled Trial to Evaluate the Safety and Efficacy of Allogeneic Human Mesenchymal Stem Cells in Patients With Metabolic Syndrome.
This is a phase 2b, randomized, placebo-controlled clinical trial designed to evaluate the safety and efficacy of Longeveron Mesenchymal Stem Cells (LMSCs) in subjects with metabolic syndrome and to assess the effects of LMSCs on endothelial function using several different doses.
Read the detailed description
This is a randomized, placebo-controlled clinical trial designed to evaluate the safety and efficacy of Longeveron Mesenchymal Stem Cells (LMSCs) in subjects with metabolic syndrome and to assess the effects of LMSCs on endothelial function using several different doses. Following a successful run-in phase, a total of forty (40) subjects will be randomized (1:1:1:1) to receive one of three different doses of LMSCs or placebo. After randomization, baseline imaging, testing and study product infusion, subjects will be followed up at 24 hours, month 1, month 3, month 6, month 9 and month 12 post study product infusion. All endpoints will be assessed at the 3, 6 and 12 month visits which will occur 90±30 days, 180±30 days, and 365±30 days respectively from the day of the study product infusion (Day 1). For the purposes of the endpoint analysis and safety evaluations, an "intent-to-treat" study population will be utilized.
- Conditions
- Metabolic Disease, Endothelial Dysfunction
- Being tested
- Peripheral Intravenous (IV) infusion of LMSCs
- Medical subject headings
- Metabolic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peripheral Intravenous (IV) infusion of LMSCsBiological
Also called LMSCs, Biological
Peripheral Intravenous (IV) infusion of LMSCs
| Study group | Role | What they receive |
|---|---|---|
| LMSCs 10 million IV | Experimental | A total of 10 subjects will receive: A single peripheral intravenous (IV) infusion of 10 x10^6 (10 million) of LMSCs to be administered on day 1. Receives: Biological: Peripheral Intravenous (IV) infusion of LMSCs |
| Placebo (Plasmalyte A,HSA) IV | Placebo comparator | 10 subjects will receive: A single peripheral intravenous (IV) infusion of Plasmalyte A containing human serum albumin (HSA) to be administered on day 1. Receives: Biological: Peripheral Intravenous (IV) infusion of LMSCs |
| LMSCs 20 million IV | Experimental | 10 subjects will receive: A single peripheral intravenous (IV) infusion of 20x10^6 (20 million) LMSCs to be administered on day 1. Receives: Biological: Peripheral Intravenous (IV) infusion of LMSCs |
| LMSCs100 million IV | Experimental | 10 subjects will receive: A single peripheral intravenous (IV) infusion of 100x10^6 (100 million) LMSCs to be administered on day 1. Receives: Biological: Peripheral Intravenous (IV) infusion of LMSCs |
What is being measured
The primary outcome is the main question the study is designed to answer.
Endothelial function: Changes in endothelial function as assessed by the following:
Flow-mediated vasodilation (FMD). Endothelial progenitor cell (EPC) function.
Measured: 1 month post infusion
Secondary outcomes (1)
Difference in rate of change in the metabolic syndrome as defined by the following:
Endothelial function (FMD, EPC function) Inflammatory markers (CBC with differential, TNFα, CRP, IL-1, IL-6, D-dimer, Fibrinogen) Heart function and structure (Dobutamine Stress Echocardiography) Blood pressure Lipid profile (HDL; LDL; triglycerides; cholesterol) Physical activity (6 minute walk test and CHAMPS questionnaire) Lung function (spirometry) Glycemia (hemoglobin A1c;fasting glucose; urine glucose) Weight Subject quality of life (QOL) (QOL assessments).
Measured: Baseline, 3 month, 6 month and 12 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2015 (estimated)
- Study start1 Dec 2023 (estimated)
- Primary completionDec 2023 (estimated)
- Study completionDec 2023 (estimated)
Why it stopped: Sponsor has made decision not to conduct this clinical trial.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic DiseaseStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Longeveron Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Anthony Oliva, PhD, Study director, Longeveron Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02587572
- Sponsor's protocol ID
- 00-0000-02
- Acronym
- SIRONA
- Status last verified
- Feb 2023
- First submitted
- 23 Oct 2015
- Last updated
- 16 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Blinded and Placebo-controlled Trial to Evaluate the Safety and Efficacy of Allogeneic Human Mesenchymal Stem Cells in Patients With Metabolic Syndrome.
- ClinicalTrials.gov ID
- NCT02587572
- Acronym / sponsor ID
- SIRONA / 00-0000-02
- Conditions
- Metabolic Disease, Endothelial Dysfunction
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Sponsor has made decision not to conduct this clinical trial.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Longeveron Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Dec 2023 (estimated)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 27 Oct 2015 (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.
This is a phase 2b, randomized, placebo-controlled clinical trial designed to evaluate the safety and efficacy of Longeveron Mesenchymal Stem Cells (LMSCs) in subjects with metabolic syndrome and to assess the effects of LMSCs on endothelial function using several different doses.
Detailed description
This is a randomized, placebo-controlled clinical trial designed to evaluate the safety and efficacy of Longeveron Mesenchymal Stem Cells (LMSCs) in subjects with metabolic syndrome and to assess the effects of LMSCs on endothelial function using several different doses. Following a successful run-in phase, a total of forty (40) subjects will be randomized (1:1:1:1) to receive one of three different doses of LMSCs or placebo. After randomization, baseline imaging, testing and study product infusion, subjects will be followed up at 24 hours, month 1, month 3, month 6, month 9 and month 12 post study product infusion. All endpoints will be assessed at the 3, 6 and 12 month visits which will occur 90±30 days, 180±30 days, and 365±30 days respectively from the day of the study product infusion (Day 1). For the purposes of the endpoint analysis and safety evaluations, an "intent-to-treat" study population will be utilized.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| LMSCs 10 million IV | Experimental | Biological: Peripheral Intravenous (IV) infusion of LMSCsA total of 10 subjects will receive: A single peripheral intravenous (IV) infusion of 10 x10^6 (10 million) of LMSCs to be administered on day 1. |
| Placebo (Plasmalyte A,HSA) IV | Placebo comparator | Biological: Peripheral Intravenous (IV) infusion of LMSCs10 subjects will receive: A single peripheral intravenous (IV) infusion of Plasmalyte A containing human serum albumin (HSA) to be administered on day 1. |
| LMSCs 20 million IV | Experimental | Biological: Peripheral Intravenous (IV) infusion of LMSCs10 subjects will receive: A single peripheral intravenous (IV) infusion of 20x10^6 (20 million) LMSCs to be administered on day 1. |
| LMSCs100 million IV | Experimental | Biological: Peripheral Intravenous (IV) infusion of LMSCs10 subjects will receive: A single peripheral intravenous (IV) infusion of 100x10^6 (100 million) LMSCs to be administered on day 1. |
Who may qualify
- Ages
- 45 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Each subject must provide written informed consent.
- Each subject must be ≥45 and ≤ 85 years of age at the time of signing the Informed Consent Form.
- Each subject must have endothelial dysfunction.
- At the time of enrollment, each subject must meet at least 3 out of the 5 criteria under the harmonized definition of the metabolic syndrome, consisting of the following
Key exclusion criteria (15 listed)
- Be unable and/or unwilling to perform any of the assessments required for endpoint analysis.
- Have diabetic retinopathy.
- Sitting or resting systolic blood pressure >180 mm Hg or diastolic blood pressure >110 mm Hg at Screening.
- Have a resting blood oxygen saturation of <93% (measured by pulse oximetry).
- Be hypersensitive to dimethyl sulfoxide (DMSO).
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 |
|---|---|---|
| Peripheral Intravenous (IV) infusion of LMSCsAlso: LMSCs, BiologicalPeripheral Intravenous (IV) infusion of LMSCs | Biological | LMSCs 10 million IV, LMSCs 20 million IV, LMSCs100 million IV, Placebo (Plasmalyte A,HSA) IV |
Primary outcome
Endothelial function: Changes in endothelial function as assessed by the following:
Time frame: 1 month post infusion
Flow-mediated vasodilation (FMD). Endothelial progenitor cell (EPC) function.
1 secondary outcome
Difference in rate of change in the metabolic syndrome as defined by the following:
Time frame: Baseline, 3 month, 6 month and 12 months.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2023.
Related trials for Metabolic Disease
RecruitingObservational study
Clinical and Laboratory Study of Methylmalonic Acidemia
Organic Acidemia, Methylmalonic Acidemia
RecruitingObservational study
Natural History, Physiology, Microbiome and Biochemistry Studies of Propionic Acidemia
Metabolic Disease, Propionic Acidemia
RecruitingObservational study
Long-Term Follow-Up of Survivors of Pediatric Cushing Disease
Cushing Disease
RecruitingObservational study
Natural History of the Human Biological Response to Environmental Exposure and Injury
Inflammation, Normal Controls
Active, not recruiting
Countermeasures to Circadian Misalignment
Circadian Rhythm Sleep Disorder of Shift Work Type, Metabolic Disease
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.
Anthony Oliva, PhD study director
Longeveron Inc.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Peripheral Intravenous (IV) infusion of LMSCs in people with Metabolic Disease and Endothelial Dysfunction, run by Longeveron Inc..
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 8 inclusion and 15 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: withdrawn, as of the sponsor's last update on 16 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 withdrawn before enrolling participants, so there are no results.
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?
Endothelial function: Changes in endothelial function as assessed by the following: (time frame: 1 month post infusion). 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 Feb 2023; AzTrials last refreshed its copy on 30 Oct 2026.