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

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ClinicalTrials.gov Identifier: NCT03169231
Recruitment Status : Recruiting
First Posted : May 30, 2017
Last Update Posted : October 9, 2018
Sponsor:
Information provided by (Responsible Party):
Longeveron LLC

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

Condition or disease Intervention/treatment Phase
Aging Frailty Biological: Longeveron Mesenchymal Stem Cells (LMSCs) Other: Placebo Phase 2

Detailed Description:
The objectives of this study are to assess safety and efficacy of three doses 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-a).

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : July 6, 2017
Estimated Primary Completion Date : June 2, 2019
Estimated Study Completion Date : September 28, 2019

Arm Intervention/treatment
Experimental: Study Group A
Single peripheral IV infusion of 25 million Longeveron Mesenchymal Stem Cells (LMSCs)
Biological: Longeveron Mesenchymal Stem Cells (LMSCs)
Intravenously delivered

Experimental: Study Group B
Single peripheral IV infusion of 50 million Longeveron Mesenchymal Stem Cells (LMSCs)
Biological: Longeveron Mesenchymal Stem Cells (LMSCs)
Intravenously delivered

Experimental: Study Group C
Single peripheral IV infusion of 100 million Longeveron Mesenchymal Stem Cells (LMSCs)
Biological: Longeveron Mesenchymal Stem Cells (LMSCs)
Intravenously delivered

Experimental: Study Group D
Single peripheral IV infusion of placebo
Other: Placebo
Intravenously delivered




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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.

  2. Change in TNF-a compared to placebo [ Time Frame: 180 days post-infusion ]
    Change in serum TNF-a compared to placebo



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Ages Eligible for Study:   70 Years to 85 Years   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  1. Be unwilling or unable to perform any of the assessments required by the protocol.
  2. 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.
  3. Have a score of 24 or lower on the Mini Mental State Examination (MMSE)
  4. Have poorly controlled blood glucose levels (HbA1c >8.0%).
  5. 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.
  6. Have any condition that in the opinion of the Principal Investigator limits lifespan to < 1 year.
  7. Have autoimmune disease (e.g. rheumatoid arthritis, systemic lupus erythematosus).
  8. Be using chronic immunosuppressant therapy such as high-dose corticosteroids or TNF-alpha antagonists (prednisone use at doses of < 5 mg daily is allowed).
  9. 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.

  10. Test positive for verimic Hepatitis C virus, HIV1/2, or syphilis
  11. Have a resting blood oxygen saturation of <93% (measured by pulse oximetry).
  12. Known or suspected alcohol or drug abuse within three years preceding Screening
  13. Have a known hypersensitivity to dimethyl sulfoxide (DMSO).
  14. Be an organ transplant recipient (other than transplantation for corneal, bone, skin, ligament, or tendon).
  15. Be actively listed (or expected future listing) for transplant of any organ (other than corneal transplant).
  16. Have any clinically important abnormal screening laboratory values, including, but not limited to:

    1. Hemoglobin <10.0 g/dL,
    2. White blood cell <2,500/ul, or platelet count <100,000/ul
    3. Liver dysfunction evidenced by enzymes (AST and ALT) > 3 times the upper limit of normal (ULN)
    4. Coagulopathy (INR>1.3) not due to a reversible cause (e.g. warfarin and/or Factor Xa inhibitors).
  17. Uncontrolled hypertension (resting systolic blood pressure >180 mm Hg or diastolic blood pressure of > 110 mm Hg at Screening)
  18. Have unstable angina pectoris, uncontrolled or severe peripheral artery disease within the previous 3 months.
  19. Have congestive heart failure defined by NYHS (New York Heart Association) Class III or IV, or an ejection fraction of <25%.
  20. Have a coronary artery bypass surgery, angioplasty, or peripheral vascular disease revasculation or a myocardial infarction within previous 3 months.
  21. Have severe pulmonary dysfunction: acute exacerbation of chronic obstructive lung disease stage III or IV (Gold classification), and/or PaO2 levels <60 mmHg.
  22. Have a partial ileal gastric bypass, or other significant intestinal malabsorption.
  23. Have advanced liver or renal disease
  24. Have cognitive or language barriers that prohibit obtaining informed consent or any study elements.
  25. Be currently hospitalized, or living in an assisted living facility or a long-term care facility.
  26. Be currently participating (or participated within the previous 30 days of consent) in an investigational therapeutic or device trial.
  27. 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03169231


Contacts
Contact: Suzanne Page, JD 305-909-0850 spage@longeveron.com
Contact: Amy Drouillard 305-909-0843 adrouillard@longeveron.com

Locations
United States, California
University of California, San Diego Not yet recruiting
La Jolla, California, United States, 92093
Contact: Wendy L Davila    858-246-2343    wdavila@ucsd.edu   
Principal Investigator: Anthony N DeMaria, MD         
University of California Los Angeles Not yet recruiting
Los Angeles, California, United States, 90073
Contact: David Segovia    310-268-4658    David.segovia@va.gov   
Principal Investigator: Cathy C Lee, MD         
University of California, Irvine Senior Health Center Recruiting
Orange, California, United States, 92868
Contact: Jinah Chung    949-824-3990    jinahec@uci.edu   
Contact: Carol Baird, RN    949-824-1225    carol.baird@uci.edu   
Principal Investigator: Lisa M Gibbs, MD, AGSF         
Stanford University Recruiting
Stanford, California, United States, 94305
Contact: Hoa Ly, CRC    650-498-6279    hly@stanford.edu   
Principal Investigator: Joseph Wu, MD, PhD         
United States, Florida
Soffer Health Institute Recruiting
Aventura, Florida, United States, 33180
Contact: Cecilia Pernas, ARNP    305-792-0555    cp@sofferhealth.com   
Principal Investigator: Ariel Soffer, MD         
Clinical Research of South Florida Recruiting
Coral Gables, Florida, United States, 33134
Contact: Julio Gomez    305-445-5637 ext 218    julio.gomez@amrllc.com   
Principal Investigator: Jeffrey Rosen, MD         
Clinical Physiology Associates Recruiting
Fort Myers, Florida, United States, 33912
Contact: Tammy Viens    239-908-0504    tviens@amrllc.com   
Contact: Marjorie Gill    239-936-4421    mgill@clinphys.com   
Principal Investigator: Pedro P Ylisastigui, MD         
University of Florida-Institute on Aging Recruiting
Gainesville, Florida, United States, 32610
Contact: Annie Allen, MBA    352-294-5824    asmithbova@ufl.edu   
Principal Investigator: Marco Pahor, MD         
Miami VA Healthcare System Recruiting
Miami, Florida, United States, 33125
Contact: Zubair Rahaman, M.B.B.S    305-575-5287    zubair.rahaman@va.gov   
Principal Investigator: Jorge Ruiz, MD         
Vista Health Research Recruiting
Miami, Florida, United States, 33176
Contact: Jessica Palacio, MHA/ED, CCRC    305-271-7660    jpalacio@vista-health.org   
Principal Investigator: Antonio Blanco, MD         
Advanced Research for Health Improvement, LLC Recruiting
Naples, Florida, United States, 34102
Contact: Kelly Calistri, BS    239-230-2021    kelly.calistri@ARHIUSA.com   
Contact: Juan C Ramos, MS    239-230-2021      
Principal Investigator: Julian J Javier, MD         
Sponsors and Collaborators
Longeveron LLC
Investigators
Principal Investigator: Marco Pahor, MD University of Florida Institute on Aging

Responsible Party: Longeveron LLC
ClinicalTrials.gov Identifier: NCT03169231     History of Changes
Other Study ID Numbers: 001-03
First Posted: May 30, 2017    Key Record Dates
Last Update Posted: October 9, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No