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Allogeneic Mesenchymal Human Stem Cell Infusion Therapy for Endothelial DySfunctiOn in Diabetic Subjects With Symptomatic Ischemic Heart Disease. (ACESO-IHD) (ACESO-IHD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04776239
Recruitment Status : Recruiting
First Posted : March 1, 2021
Last Update Posted : July 11, 2022
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Joshua M Hare, University of Miami

Brief Summary:
The purpose of this study is to test the hypothesis that allogeneic Mesenchymal Stem Cells (MSCs) promote systemic and coronary endothelial repair through rescue of bone marrow progenitors in type 2 diabetic patients with symptomatic IHD compared to placebo.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus Ischemic Heart Disease Drug: 100 million Allogeneic Mesenchymal Human Stem Cells Other: Placebo Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Allogeneic Mesenchymal Human Stem Cell Infusion Therapy for Endothelial DySfunctiOn in Diabetic Subjects With Symptomatic Ischemic Heart Disease.
Actual Study Start Date : August 16, 2021
Estimated Primary Completion Date : July 16, 2024
Estimated Study Completion Date : July 16, 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Group A: Allogeneic Mesenchymal Stem Cells (MSCs) Group
Participants in this group will be receive a single administration of intravenous allogeneic human Mesenchymal Stem Cells (hMSCs) (100 million).
Drug: 100 million Allogeneic Mesenchymal Human Stem Cells
1 single intravenous infusion
Other Names:
  • allo-human Mesenchymal Stem Cells (hMSCs)
  • stem cells

Experimental: Group 2: Placebo Group
Participants in this group will receive a single dose of placebo (Cell-free PlasmaLyte-A medium supplemented with 1% HSA) infusion.
Other: Placebo
Placebo delivered via peripheral intravenous infusion




Primary Outcome Measures :
  1. Post-Percutaneous Coronary Intervention (PCI) coronary artery endothelial function as assessed via CFR [ Time Frame: 6 months (post-infusion) ]
    Coronary Flow Reserve (CFR) as measured via cardiac catheterization angiography

  2. Post-PCI coronary artery endothelial function as assessed via FFR [ Time Frame: 6 months (post infusion) ]
    Fractional Flow Reserve (FFR) as measured via cardiac catheterization angiography


Secondary Outcome Measures :
  1. Target lesion lumen loss [ Time Frame: 6 months (post-infusion) ]
    Target lesion lumen loss as assessed by quantitative coronary angiography (QCA).

  2. Flow Mediated Diameter Percentage (FMD%) [ Time Frame: 6 months post-infusion ]
    FMD% is measured via brachial artery ultrasound

  3. EPC-CFUs levels [ Time Frame: 6 months post-infusion ]
    Endothelial progenitor cells (EPC)-colony forming units (CFUs) will be assessed from blood samples.

  4. Circulating angiogenic factors marker levels [ Time Frame: 6 months post-infusion ]
    Circulating angiogenic marker levels including Protein Kinase B, Stromal Cell Derived Factor 1 (SDF-1), Notch, Vascular Endothelial Growth Factor (VEGF) and Colony Forming Units (CFU) will be assessed from blood samples.

  5. Circulating inflammatory markers [ Time Frame: 6 months post-infusion ]
    Circulating inflammatory markers including Cluster of Differentiation (CD) 3 CD 25 or CD 3 CD 69 will be assessed from blood samples.

  6. Seattle Angina Questionnaire (SAQ) Angina Frequency [ Time Frame: 6 months post-infusion ]
    SAQ is a 7 item questionnaire with a total score ranging from 0-100 with the higher scores indicating less physical limitations, less angina, symptom frequency and better quality of life.

  7. EuroQol(EQ)-5 Dimension (5D) Quality of Life Questionnaire [ Time Frame: 6 months post-infusion ]
    EQ-5D Quality of Life Questionnaire has a total score ranging from 0-10 with higher scores indicating better quality of life.

  8. EQ-5D Quality of life Questionnaire Overall Health Status Question [ Time Frame: 6 months post-infusion ]
    EQ-5D Quality of Life Questionnaire Overall Health Status question has a total score ranging from 0-100 with higher scores indicating better quality of life.

  9. Short Form (SF) 36 Questionnaire Quality of Life Questionnaire [ Time Frame: 6 months post-infusion ]
    SF 36 Quality of Life Questionnaire consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. Lower scores indicate the more disability, and higher scores indicate less disability.

  10. International Index of Erectile Function (IIEF) Questionnaire [ Time Frame: 6 months post-infusion ]
    IIEF is a 15 item questionnaire to be completed by males only, with scores ranging from 0-75. Higher scores indicate better male sexual function/quality of life.

  11. Sexual Quality of Life - Females (SQOL-F) Questionnaire [ Time Frame: 6 months post-infusion ]
    SQOL-F Questionnaire is an 18 item questionnaire in which female participants are asked to record responses on a 6-point Likert scale (completely agree to completely disagree). Total score can range from 18 to 108. Higher scores indicate better female sexual quality of life.

  12. Incidence of Treatment-Emergent Serious Adverse Events (TE-SAE) [ Time Frame: 1 month post infusion ]
    TE-SAEs will be defined as the composite of: death, non-fatal myocardial infarction (MI), stroke, hospitalization for heart failure, sustained ventricular arrhythmias or atrial fibrillation. TE-SAEs will be assessed by treating physician.

  13. Incidence of Major Adverse Cardiac Events (MACE) [ Time Frame: 12 months ]
    Defined as the composite incidence of (1) death, (2) hospitalization for cardiovascular events or (3) non-fatal MI. MACE will be assessed by treating physician.

  14. Rates of Adverse Events [ Time Frame: 12 months ]
    Rates of treatment emergent adverse event (AE) and serious adverse event (SAE) as assessed by treating physician will be reported.

  15. Number of participants with abnormal lab values [ Time Frame: 12 months ]
    Number of participants with clinically significant abnormal serum hematology and clinical chemistry values will be reported. Clinical significance will be assessed by treating physician.

  16. Number of participants with Target Vessel Failure [ Time Frame: 12 months ]
    Number of participants with target vessel failure will be reported. Target vessel failure is defined as any participant that encounters revascularization, death, or MI attributed to the target vessel post-PCI



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Be ≥ 18 years of age (males and females).
  2. Provide written informed consent.
  3. Have a diagnosis of symptomatic ischemic heart disease (IHD) and an indication for standard-of-care coronary angiography.
  4. Have Diabetes Mellitus (DM) type 2 documented by glycated hemoglobin (HbA1C) > 7%, or on medical therapy for diabetes.

Exclusion Criteria:

  1. Be younger than 18 years of age.
  2. Have history of prior myocardial Infarction and revascularization.
  3. Have a baseline glomerular filtration rate (GFR) <30 ml/min 1.73m2 estimated using the Modification of Diet for Renal Disease (MDRD) formula.
  4. Have poorly controlled blood glucose levels with hemoglobin A1C > 8.5% in the previous 3 months.
  5. Have a history of proliferative retinopathy or severe neuropathy requiring medical treatment.
  6. Have an indication for standard-of-care surgical (including valve surgery, placement of left-ventricular assist device) or percutaneous intervention for the treatment of valvular heart disease (including valvuloplasty).
  7. Have known hypersensitivity or contraindication to aspirin; both heparin and bivalirudin; all available P2Y12 inhibitors (clopidogrel, prasugrel, and ticagrelor); or any zotarolimus, cobalt, chromium, nickel, tungsten, acrylic, or fluoropolymers; or hypersensitivity to contrast media that cannot be adequately premedicated.
  8. Have a hematologic abnormality as evidenced by hematocrit < 25%, white blood cell < 2,500/microliter (uL) or platelet values < 100,000/uL without another explanation (per investigator discretion).
  9. Have liver dysfunction, as evidenced by enzymes (AST and ALT) greater than three times the upper limit of normal.
  10. Have a bleeding diathesis or coagulopathy (INR > 1.3), cannot be withdrawn from anticoagulation therapy, or will refuse blood transfusions.
  11. Be an organ transplant recipient or have a history of organ or cell transplant rejection.
  12. Have a clinical history of malignancy within the past 5 years (i.e., subjects with prior malignancy must be disease free for 5 years), except curatively-treated basal cell or squamous cell carcinoma, or cervical carcinoma.
  13. Have a condition that limits lifespan to < 1 year.
  14. Have a history of drug or alcohol abuse within the past 24 months.
  15. Be serum positive for HIV, hepatitis B surface antigen (sAg), or viremic hepatitis C.
  16. Be currently participating (or participated within the previous 30 days) in an investigational therapeutic or device trial.
  17. Be pregnant, nursing, or of childbearing potential and not on contraceptive medications. (May participate if on 2 forms of contraceptives).
  18. Any other condition that in the judgment of the Investigator would be a contraindication to enrollment or follow-up.
  19. Coronary lesions with restenosis or heavy calcification.

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): NCT04776239


Contacts
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Contact: Mauricio G Cohen, MD 305-243-5050 mgcohen@med.miami.edu
Contact: Yvenie Desire, BA 305-243-7273 ydesire@miami.edu

Locations
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United States, Florida
University of Miami Recruiting
Miami, Florida, United States, 33136
Contact: Mauricio G Cohen, MD    305-243-5050    mgcohen@med.miami.edu   
Contact: Yvenie Desire, BA    305-243-7273    ydesire@miami.edu   
Principal Investigator: Mauricio G Cohen, MD         
Sponsors and Collaborators
Joshua M Hare
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
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Principal Investigator: Mauricio G Cohen, MD University of Miami
Additional Information:
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Responsible Party: Joshua M Hare, Professor, University of Miami
ClinicalTrials.gov Identifier: NCT04776239    
Other Study ID Numbers: 20200874
1R01HL134558-01 ( U.S. NIH Grant/Contract )
First Posted: March 1, 2021    Key Record Dates
Last Update Posted: July 11, 2022
Last Verified: July 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Joshua M Hare, University of Miami:
Endothelial dysfunction
Diabetes
Stem cells
Additional relevant MeSH terms:
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Heart Diseases
Myocardial Ischemia
Coronary Artery Disease
Ischemia
Pathologic Processes
Cardiovascular Diseases
Vascular Diseases
Coronary Disease
Arteriosclerosis
Arterial Occlusive Diseases