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Aging FrailtyPhase 2NCT03169231

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

A Phase 2 study testing Longeveron Mesenchymal Stem Cells (LMSCs) in people with Aging Frailty, run by Longeveron Inc. at 7 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a randomized, placebo-controlled, double-blind, parallel arm, multi-center Phase 2b study. Read more about this study

Who is it for?
Ages 70 to 85 years
Conditions the study is for
Aging Frailty
What is being tested?
Longeveron Mesenchymal Stem Cells (LMSCs)
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
150 participants
Where
7 sitesUnited States
Study dates
6 Jul 2017to 30 Sep 2021
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 70 to 85 years
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • Be willing and able to provide written informed consent and comply with all procedures required by the Protocol.
  • Be >70 and < 85 years of age at the time of signing the Informed Consent Form.
  • Have a Canadian Study on Health and Aging (CSHA) Clinical Frailty Scale score of 5 "mildly frail" or 6 "moderately frail".
  • Have a 6 minute walk distance of > 200m and < 400 m. Distances of two 6MWTs are to be within 15% of each other.
  • Have a serum TNF-alpha level > 2.5 pg/mL

Who cannot join

  • Be unwilling or unable to perform any of the assessments required by the protocol.
  • Have a diagnosis of any disabling neurologic disorder, including, but not limited to, Parkinson's disease, Amyotrophic Lateral Sclerosis, multiple sclerosis, cerebrovascular accident with residual deficits (e.g., muscle weakness or gait disorder), or diagnosis of dementia.
  • Have a score of 24 or lower on the Mini Mental State Examination (MMSE)
  • Have poorly controlled blood glucose levels (HbA1c >8.0%).
  • Have a clinical history of malignancy within 2.5 years (i.e., subjects with prior malignancy must be cancer free for 2.5 years) except curatively-treated basal cell carcinoma, melanoma in situ or cervical carcinoma.
  • Have any condition that in the opinion of the Principal Investigator limits lifespan to < 1 year.
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  • Have autoimmune disease (e.g. rheumatoid arthritis, systemic lupus erythematosus).
  • Be using chronic immunosuppressant therapy such as high-dose corticosteroids or TNF-alpha antagonists (prednisone use at doses of < 5 mg daily is allowed).
  • Test positive for hepatitis B virus
  • If the subject tests positive for anti-hepatitis B core antigen (HBc) or anti-HBs, they must be currently receiving treatment for Hepatitis B prior to infusion and remain on treatment throughout the study.
  • Test positive for verimic Hepatitis C virus, HIV1/2, or syphilis
  • Have a resting blood oxygen saturation of <93% (measured by pulse oximetry).
  • Known or suspected alcohol or drug abuse within three years preceding Screening
  • Have a known hypersensitivity to dimethyl sulfoxide (DMSO).
  • Be an organ transplant recipient (other than transplantation for corneal, bone, skin, ligament, or tendon).
  • Be actively listed (or expected future listing) for transplant of any organ (other than corneal transplant).
  • Have any clinically important abnormal screening laboratory values, including, but not limited to:
  • Hemoglobin <10.0 g/dL,
  • White blood cell <2,500/ul, or platelet count <100,000/ul
  • Liver dysfunction evidenced by enzymes (AST and ALT) > 3 times the upper limit of normal (ULN)
  • Coagulopathy (INR>1.3) not due to a reversible cause (e.g. warfarin and/or Factor Xa inhibitors).
  • Uncontrolled hypertension (resting systolic blood pressure >180 mm Hg or diastolic blood pressure of > 110 mm Hg at Screening)
  • Have unstable angina pectoris, uncontrolled or severe peripheral artery disease within the previous 3 months.
  • Have congestive heart failure defined by NYHS (New York Heart Association) Class III or IV, or an ejection fraction of <25%.
  • Have a coronary artery bypass surgery, angioplasty, or peripheral vascular disease revasculation or a myocardial infarction within previous 3 months.
  • Have severe pulmonary dysfunction: acute exacerbation of chronic obstructive lung disease stage III or IV (Gold classification), and/or PaO2 levels <60 mmHg.
  • Have a partial ileal gastric bypass, or other significant intestinal malabsorption.
  • Have advanced liver or renal disease
  • Have cognitive or language barriers that prohibit obtaining informed consent or any study elements.
  • Be currently hospitalized, or living in an assisted living facility or a long-term care facility.
  • Be currently participating (or participated within the previous 30 days of consent) in an investigational therapeutic or device trial.
  • Have a history or current evidence of any condition, therapy, laboratory abnormality, or other circumstance that might confound the results of the study, or interfere with the patient's participation for the full duration of the study.

Trial locations and contacts

7 sites in 1 country.

7 sites in 1 country

United States7 sites

  • Soffer Health Institute

    Aventura, Florida, 33180

  • Clinical Research of South Florida

    Coral Gables, Florida, 33134

  • Clinical Physiology Associates

    Fort Myers, Florida, 33912

  • Miami VA Healthcare System

    Miami, Florida, 33125

  • Vista Health Research

    Miami, Florida, 33176

  • Panax Clinical Research

    Miami Lakes, Florida, 33014

  • Advanced Research for Health Improvement, LLC

    Naples, Florida, 34102

Other trials in United States

About this study

Official title: A Phase 2b, Randomized, Blinded and Placebo-Controlled Trial to Evaluate the Safety and Efficacy of Longeveron Allogenic Human Mesenchymal Stem Cells Infusion in Patients With Aging Frailty

This is a randomized, placebo-controlled, double-blind, parallel arm, multi-center Phase 2b study.

Read the detailed 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).

Conditions
Aging Frailty
Being tested
Longeveron Mesenchymal Stem Cells (LMSCs), Placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Longeveron Mesenchymal Stem Cells (LMSCs)Biological

    Intravenously delivered

  • PlaceboOther

    Intravenously delivered

Study groups in NCT03169231
Study groupRoleWhat they receive
Study Group AExperimentalSingle peripheral IV infusion of 25 million Longeveron Mesenchymal Stem Cells (LMSCs)
Receives: Biological: Longeveron Mesenchymal Stem Cells (LMSCs)
Study Group BExperimentalSingle peripheral IV infusion of 50 million Longeveron Mesenchymal Stem Cells (LMSCs)
Receives: Biological: Longeveron Mesenchymal Stem Cells (LMSCs)
Study Group CExperimentalSingle peripheral IV infusion of 100 million Longeveron Mesenchymal Stem Cells (LMSCs)
Receives: Biological: Longeveron Mesenchymal Stem Cells (LMSCs)
Study Group DExperimentalSingle peripheral IV infusion of 200 million Longeveron Mesenchymal Stem Cells (LMSCs)
Receives: Biological: Longeveron Mesenchymal Stem Cells (LMSCs)
Study Group EPlacebo comparatorSingle peripheral IV infusion of placebo.
Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change from baseline in 6 Minute Walk Test (6MWT) compared to placebo

    Change from baseline in 6MWT compared to placebo at 180 days post-infusion

    Measured: Baseline and 180 days post-infusion

Secondary outcomes (2)

  1. Change in patient reported outcome of overall physical function capacity using the PROMIS-Physical Function-Short Form 20a compared to placebo

    Change from baseline in physical function will be measured to assess Patient-Reported Outcome Measurement compared to placebo at 180 days post infusion.

    Measured: 180 days post-infusion

  2. Change in TNF-alpha compared to placebo

    Change in serum TNF-alpha compared to placebo

    Measured: 180 days post-infusion

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 May 2017
  2. Study start6 Jul 2017
  3. Primary completion30 Sep 2021
  4. Study completion30 Sep 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
150 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03169231
Sponsor's protocol ID
001-03
Status last verified
Mar 2022
First submitted
24 May 2017
Last updated
7 Mar 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Ruiz JG, Oliva AA Jr, Ramdas KN, Javier J, Rosen J, Perry R, Blanco A, Ylisastigui P, Walston J, Arai H, Volpi E, Newman AB, Varnado B, McClain-Moss L, Naioti E, Mehranfard D, Gincel D, Wang C, Mintzer MJ, Danisi J, Green GA, Botbyl J, Zainul Z, Rash BG, Hare JM. Randomized phase 2b dose-escalation trial of stem cell therapy with laromestrocel for aging frailty. Cell Stem Cell. 2026 Mar 5;33(3):393-404.e4. doi: 10.1016/j.stem.2026.01.017. Epub 2026 Feb 25.

    PubMed 41747733

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Longeveron Mesenchymal Stem Cells (LMSCs) in people with Aging Frailty, run by Longeveron Inc. at 7 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 32 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from baseline in 6 Minute Walk Test (6MWT) compared to placebo (time frame: Baseline and 180 days post-infusion). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03169231, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2022.

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