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

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ClinicalTrials.gov Identifier: NCT02587572
Recruitment Status : Not yet recruiting
First Posted : October 27, 2015
Last Update Posted : February 18, 2021
Sponsor:
Information provided by (Responsible Party):
Longeveron LLC

Study Description
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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.

Condition or disease Intervention/treatment Phase
Metabolic Disease Endothelial Dysfunction Biological: Peripheral Intravenous (IV) infusion of LMSCs Phase 2

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
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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.
Estimated Study Start Date : December 2021
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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:
  • LMSCs
  • Biological
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:
  • LMSCs
  • Biological
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:
  • LMSCs
  • Biological
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:
  • LMSCs
  • Biological


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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).


Eligibility Criteria
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Ages Eligible for Study:   45 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02587572


Contacts
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Contact: Anthony Oliva, PhD (305) 909-0840 aoliva@longeveron.com
Contact: Geoff Green (305) 909-0840 ggreen@longeveron.com

Sponsors and Collaborators
Longeveron LLC
Investigators
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Study Director: Anthony Oliva, PhD Longeveron LLC
More Information
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Responsible Party: Longeveron LLC
ClinicalTrials.gov Identifier: NCT02587572    
Other Study ID Numbers: 00-0000-02
First Posted: October 27, 2015    Key Record Dates
Last Update Posted: February 18, 2021
Last Verified: February 2021

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Metabolic Diseases