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

NCT02587572 | Withdrawn Phase 2 DMC FDA Drug

• 1 other identifier: 00-0000-02
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Metabolic Disease; Endothelial Dysfunction

Outcome Measures

Primary Outcomes (1)

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

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

  1 month post infusion

Secondary Outcomes (1)

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

  Baseline, 3 month, 6 month and 12 months.

Study Arms (4)

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.

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.

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.

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.

Biological: Peripheral Intravenous (IV) infusion of LMSCs

Interventions

Peripheral Intravenous (IV) infusion of LMSCs BIOLOGICAL

Peripheral Intravenous (IV) infusion of LMSCs

Also known as: LMSCs, Biological

LMSCs 10 million IV; LMSCs 20 million IV; LMSCs100 million IV; Placebo (Plasmalyte A,HSA) IV

Eligibility Criteria

• Age: 45 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Longeveron Inc.: lead

MeSH Terms

Conditions

Metabolic Diseases

Interventions

Biological Products

Condition Hierarchy (Ancestors)

Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Complex Mixtures

Study Officials

• Anthony Oliva, PhD

  Longeveron Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 23, 2015
• First Posted: October 27, 2015
• Study Start: December 1, 2023
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: February 16, 2023

Record last verified: 2023-02