Safety and Efficacy Trial Using Allogeneic Human Mesenchymal Stem Cells: The SIRONA Trial (SIRONA)

February 14, 2023 updated by: Longeveron Inc.

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

45 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: LMSCs 10 million IV
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.
Biological: Peripheral Intravenous (IV) infusion of LMSCs
Peripheral Intravenous (IV) infusion of LMSCs
Other Names:
  • Biological
  • LMSCs
Placebo Comparator: Placebo (Plasmalyte A,HSA) IV
10 subjects will receive: A single peripheral intravenous (IV) infusion of Plasmalyte A containing human serum albumin (HSA) to be administered on day 1.
Biological: Peripheral Intravenous (IV) infusion of LMSCs
Peripheral Intravenous (IV) infusion of LMSCs
Other Names:
  • Biological
  • LMSCs
Experimental: LMSCs 20 million IV
10 subjects will receive: A single peripheral intravenous (IV) infusion of 20x10^6 (20 million) LMSCs to be administered on day 1.
Biological: Peripheral Intravenous (IV) infusion of LMSCs
Peripheral Intravenous (IV) infusion of LMSCs
Other Names:
  • Biological
  • LMSCs
Experimental: LMSCs100 million IV
10 subjects will receive: A single peripheral intravenous (IV) infusion of 100x10^6 (100 million) LMSCs to be administered on day 1.
Biological: Peripheral Intravenous (IV) infusion of LMSCs
Peripheral Intravenous (IV) infusion of LMSCs
Other Names:
  • Biological
  • LMSCs

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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 month post infusion

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Difference in rate of change in the metabolic syndrome as defined by the following:
Time Frame: Baseline, 3 month, 6 month and 12 months.
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).
Baseline, 3 month, 6 month and 12 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Longeveron Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Anthony Oliva, PhD, Longeveron Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2023

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2023

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 23, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 23, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 27, 2015

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 16, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 14, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 00-0000-02

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings