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

Primary Purpose

Metabolic Disease, Endothelial Dysfunction

Status

Withdrawn

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

Peripheral Intravenous (IV) infusion of LMSCs

About this trial

This is an interventional treatment trial for Metabolic Disease

Eligibility Criteria

45 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Placebo Comparator

Experimental

Arm Label

LMSCs 10 million IV

Placebo (Plasmalyte A,HSA) IV

LMSCs 20 million IV

LMSCs100 million IV

Arm Description

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.

10 subjects will receive: A single peripheral intravenous (IV) infusion of Plasmalyte A containing human serum albumin (HSA) to be administered on day 1.

10 subjects will receive: A single peripheral intravenous (IV) infusion of 20x10^6 (20 million) LMSCs to be administered on day 1.

10 subjects will receive: A single peripheral intravenous (IV) infusion of 100x10^6 (100 million) LMSCs to be administered on day 1.

Outcomes

Primary Outcome Measures

Endothelial function: Changes in endothelial function as assessed by the following:

Flow-mediated vasodilation (FMD). Endothelial progenitor cell (EPC) function.

Secondary Outcome Measures

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).

Full Information

NCT ID

NCT02587572

First Posted

October 23, 2015

Last Updated

February 14, 2023

Sponsor

Longeveron Inc.

1. Study Identification

Unique Protocol Identification Number

NCT02587572

Brief Title

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

Acronym

SIRONA

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.

Study Type

Interventional

2. Study Status

Record Verification Date

February 2023

Overall Recruitment Status

Withdrawn

Why Stopped

Sponsor has made decision not to conduct this clinical trial.

Study Start Date

December 1, 2023 (Anticipated)

Primary Completion Date

December 2023 (Anticipated)

Study Completion Date

December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Longeveron Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Metabolic Disease, Endothelial Dysfunction

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

LMSCs 10 million IV

Arm Type

Experimental

Arm Description

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.

Arm Title

Placebo (Plasmalyte A,HSA) IV

Arm Type

Placebo Comparator

Arm Description

10 subjects will receive: A single peripheral intravenous (IV) infusion of Plasmalyte A containing human serum albumin (HSA) to be administered on day 1.

Arm Title

LMSCs 20 million IV

Arm Type

Experimental

Arm Description

10 subjects will receive: A single peripheral intravenous (IV) infusion of 20x10^6 (20 million) LMSCs to be administered on day 1.

Arm Title

LMSCs100 million IV

Arm Type

Experimental

Arm Description

10 subjects will receive: A single peripheral intravenous (IV) infusion of 100x10^6 (100 million) LMSCs to be administered on day 1.

Intervention Type

Biological

Intervention Name(s)

Peripheral Intravenous (IV) infusion of LMSCs

Other Intervention Name(s)

LMSCs, Biological

Intervention Description

Peripheral Intravenous (IV) infusion of LMSCs

Primary Outcome Measure Information:

Title

Endothelial function: Changes in endothelial function as assessed by the following:

Description

Flow-mediated vasodilation (FMD). Endothelial progenitor cell (EPC) function.

Time Frame

1 month post infusion

Secondary Outcome Measure Information:

Title

Difference in rate of change in the metabolic syndrome as defined by the following:

Description

Time Frame

Baseline, 3 month, 6 month and 12 months.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

45 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Anthony Oliva, PhD

Organizational Affiliation

Longeveron Inc.

Official's Role

Study Director

12. IPD Sharing Statement

Learn more about this trial

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

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