Phase IIb Trial to Evaluate Longeveron Mesenchymal Stem Cells to Treat

Clinical Trial Description

The objectives of this study are to assess safety and efficacy of Longeveron Mesenchymal Stem Cells (LMSCs) compared to placebo on 1) functional mobility and exercise tolerance, 2) patient-reported physical function, and 3) the inflammatory cytokine biomarker tumor necrosis factor (TNF-alpha). ;

Study Design

Related Conditions & MeSH terms

See also
Status	Clinical Trial	Phase
Recruiting	`NCT06063590` - A Study to Evaluate Allogenic Bone-Marrow Mesenchymal Stromal Cell Product StromaForte in Aging Frailty Patients	Phase 1/Phase 2
Completed	`NCT02982915` - Lomecel-B on Vaccine-Specific Antibody- Response in Subjects With Aging Frailty	Phase 1/Phase 2
Completed	`NCT03071835` - A Comparative Study of Subjects Past Their Final Follow-ON Visit
Completed	`NCT04314011` - Clinical Study of Umbilical Cord Mesenchymal Stem Cells Infusion for Aging Frailty	Phase 1/Phase 2

See also

Status

Clinical Trial

Phase

Recruiting

NCT06063590 - A Study to Evaluate Allogenic Bone-Marrow Mesenchymal Stromal Cell Product StromaForte in Aging Frailty Patients

Phase 1/Phase 2

Completed

NCT02982915 - Lomecel-B on Vaccine-Specific Antibody- Response in Subjects With Aging Frailty

Phase 1/Phase 2

Completed

NCT03071835 - A Comparative Study of Subjects Past Their Final Follow-ON Visit

Completed

NCT04314011 - Clinical Study of Umbilical Cord Mesenchymal Stem Cells Infusion for Aging Frailty

Phase 1/Phase 2

Interventional studies are often prospective and are specifically tailored to evaluate direct impacts of treatment or preventive measures on disease.

Observational studies are often retrospective and are used to assess potential causation in exposure-outcome relationships and therefore influence preventive methods.

Expanded access is a means by which manufacturers make investigational new drugs available, under certain circumstances, to treat a patient(s) with a serious disease or condition who cannot participate in a controlled clinical trial.

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

NCT number	NCT03169231
Study type	Interventional
Source	Longeveron Inc.
Contact
Status	Completed
Phase	Phase 2
Start date	July 6, 2017
Completion date	September 30, 2021

Phase IIb Trial to Evaluate Longeveron Mesenchymal Stem Cells to Treat Aging Frailty

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms