- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03169231
Phase IIb Trial to Evaluate Longeveron Mesenchymal Stem Cells to Treat Aging Frailty
March 4, 2022 updated by: Longeveron Inc.
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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).
Study Type
Interventional
Enrollment (Actual)
150
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Florida
-
Aventura, Florida, United States, 33180
- Soffer Health Institute
-
Coral Gables, Florida, United States, 33134
- Clinical Research of South Florida
-
Fort Myers, Florida, United States, 33912
- Clinical Physiology Associates
-
Miami, Florida, United States, 33125
- Miami VA Healthcare System
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Miami, Florida, United States, 33176
- Vista Health Research
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Miami Lakes, Florida, United States, 33014
- Panax Clinical Research
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Naples, Florida, United States, 34102
- Advanced Research for Health Improvement, LLC
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
68 years to 83 years (Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
- 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
a. 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Study Group A
Single peripheral IV infusion of 25 million Longeveron Mesenchymal Stem Cells (LMSCs)
|
Intravenously delivered
|
Experimental: Study Group B
Single peripheral IV infusion of 50 million Longeveron Mesenchymal Stem Cells (LMSCs)
|
Intravenously delivered
|
Experimental: Study Group C
Single peripheral IV infusion of 100 million Longeveron Mesenchymal Stem Cells (LMSCs)
|
Intravenously delivered
|
Experimental: Study Group D
Single peripheral IV infusion of 200 million Longeveron Mesenchymal Stem Cells (LMSCs)
|
Intravenously delivered
|
Placebo Comparator: Study Group E
Single peripheral IV infusion of placebo.
|
Intravenously delivered
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from baseline in 6 Minute Walk Test (6MWT) compared to placebo
Time Frame: Baseline and 180 days post-infusion
|
Change from baseline in 6MWT compared to placebo at 180 days post-infusion
|
Baseline and 180 days post-infusion
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in patient reported outcome of overall physical function capacity using the PROMIS-Physical Function-Short Form 20a compared to placebo
Time Frame: 180 days post-infusion
|
Change from baseline in physical function will be measured to assess Patient-Reported Outcome Measurement compared to placebo at 180 days post infusion.
|
180 days post-infusion
|
Change in TNF-alpha compared to placebo
Time Frame: 180 days post-infusion
|
Change in serum TNF-alpha compared to placebo
|
180 days post-infusion
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 6, 2017
Primary Completion (Actual)
September 30, 2021
Study Completion (Actual)
September 30, 2021
Study Registration Dates
First Submitted
May 24, 2017
First Submitted That Met QC Criteria
May 25, 2017
First Posted (Actual)
May 30, 2017
Study Record Updates
Last Update Posted (Actual)
March 7, 2022
Last Update Submitted That Met QC Criteria
March 4, 2022
Last Verified
March 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 001-03
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Aging Frailty
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University of AlbertaAlberta Health services; Glenrose FoundationActive, not recruitingHealthy | Frail Elderly Syndrome | Frailty | Healthy Aging | Frailty Syndrome | Aging Problems | Aging Disorder | Pre-FrailtyCanada
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The Opole University of TechnologyRecruitingPrevalence, Determinants and Natural History of Frailty and Pre-frailty in Elderly People (FRAILPOL)Frail Elderly Syndrome | Frailty | Aging | Frailty Syndrome | Aging Problems | Fragility | Aging Well | Aging DisorderPoland
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Longeveron Inc.CompletedAging FrailtyUnited States
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Shanghai East HospitalCompleted
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University of PennsylvaniaCompleted
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University of SouthamptonTameside Hospital NHS Foundation Trust; Bournemouth University; Southern Health...Active, not recruitingOlder People | Frailty in AgingUnited Kingdom
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Haukeland University HospitalNot yet recruitingFrail Elderly Syndrome | Frailty | Aging | Frailty SyndromeNorway
-
Chinese Academy of Medical Sciences, Fuwai HospitalNot yet recruiting
-
Wake Forest University Health SciencesActive, not recruiting
Clinical Trials on Longeveron Mesenchymal Stem Cells (LMSCs)
-
Longeveron Inc.Active, not recruiting
-
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Longeveron Inc.CompletedAging FrailtyUnited States
-
Longeveron Inc.CompletedAlzheimer's DiseaseUnited States
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Guangzhou General Hospital of Guangzhou Military...UnknownSpinal Cord InjuryChina
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Guangzhou General Hospital of Guangzhou Military...Guangzhou Municipal Twelfth People's Hospital; Guangdong Prevention and Treatment...Unknown
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Guangzhou General Hospital of Guangzhou Military...UnknownParkinson's DiseaseChina
-
Hospital ZnojmoUnknown
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National Research Center for Hematology, RussiaUnknownRelapse | Graft-versus-host DiseaseRussian Federation
-
University College, LondonUnknownTendinopathy | Achilles Tendinitis | Achilles Degeneration | Achilles Tendinitis, Right Leg | Achilles Tendon Thickening | Achilles Tendinitis, Left LegUnited Kingdom