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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

Tracking Information
First Submitted Date  ICMJE October 23, 2015
First Posted Date  ICMJE October 27, 2015
Last Update Posted Date February 18, 2021
Estimated Study Start Date  ICMJE December 2021
Estimated Primary Completion Date December 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 23, 2015)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 23, 2015)
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).
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Efficacy Trial Using Allogeneic Human Mesenchymal Stem Cells: The SIRONA Trial
Official Title  ICMJE A Randomized, Blinded and Placebo-controlled Trial to Evaluate the Safety and Efficacy of Allogeneic Human Mesenchymal Stem Cells in Patients With Metabolic Syndrome.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Metabolic Disease
  • Endothelial Dysfunction
Intervention  ICMJE Biological: Peripheral Intravenous (IV) infusion of LMSCs
Peripheral Intravenous (IV) infusion of LMSCs
Other Names:
  • LMSCs
  • Biological
Study Arms  ICMJE
  • 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.
    Intervention: Biological: Peripheral Intravenous (IV) infusion of 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.
    Intervention: Biological: Peripheral Intravenous (IV) infusion of 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.
    Intervention: Biological: Peripheral Intravenous (IV) infusion of 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.
    Intervention: Biological: Peripheral Intravenous (IV) infusion of LMSCs
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: October 23, 2015)
40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2022
Estimated Primary Completion Date December 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 45 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Anthony Oliva, PhD (305) 909-0840 aoliva@longeveron.com
Contact: Geoff Green (305) 909-0840 ggreen@longeveron.com
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02587572
Other Study ID Numbers  ICMJE 00-0000-02
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Longeveron LLC
Study Sponsor  ICMJE Longeveron LLC
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Anthony Oliva, PhD Longeveron LLC
PRS Account Longeveron LLC
Verification Date February 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP