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Safety and Potential Bioactivity of CLBS16 in Patients With Coronary Microvascular Dysfunction and Without Obstructive Coronary Artery Disease

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03508609
Recruitment Status : Completed
First Posted : April 26, 2018
Results First Posted : January 8, 2021
Last Update Posted : January 8, 2021
Sponsor:
Collaborators:
National Heart, Lung, and Blood Institute (NHLBI)
Cedars-Sinai Medical Center
Mayo Clinic
Information provided by (Responsible Party):
Caladrius Biosciences, Inc.

Brief Summary:
This clinical trial will explore the safety and effect of GCSF-mobilized autologous ex vivo selected CD34 cells for the treatment of CMD in adults currently experiencing angina and with no obstructive coronary artery disease. Eligible subjects will receive a single intracoronary infusion of CLBS16.

Condition or disease Intervention/treatment Phase
Coronary Microvascular Dysfunction Biological: CLBS16 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label Exploratory Clinical Study to Evaluate the Safety and Potential Bioactivity of CLBS16 in Patients With Coronary Microvascular Dysfunction (CMD) and Without Obstructive Coronary Artery Disease
Actual Study Start Date : April 19, 2018
Actual Primary Completion Date : December 10, 2019
Actual Study Completion Date : May 5, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Autologous CD34 cells
Open label active treatment arm. Subjects receive autologous CD34 cells.
Biological: CLBS16
GCSF-mobilized autologous CD34 cells




Primary Outcome Measures :
  1. Change From Baseline in Coronary Flow Reserve [ Time Frame: Day 180 ]
    Coronary Flow Reserve (CFR) is a measure of coronary microvascular function.


Secondary Outcome Measures :
  1. Change From Baseline in Microvascular Function as Assessed by Intracoronary Administration of Acetylcholine [ Time Frame: Day 180 ]
  2. Change From Baseline in Peripheral Arterial Tonometry [ Time Frame: Day 180 ]
  3. Change in Angina Frequency From Baseline [ Time Frame: 6 months ]
  4. Canadian Cardiovascular Society Angina Class [ Time Frame: 6 months ]

    Canadian Cardiovascular Society angina class grading scale is assessed according to the following scores:

    Grade 1: Ordinary physical activity does not cause angina, such as walking and climbing stairs. Angina with strenuous or rapid or prolonged exertion at work or recreation Grade 2: Slight limitation of ordinary activity. Walking or climbing stairs rapidly, walking uphill, walking or stair climbing after meals, or in cold, or in wind, or under emotional stress, or only during the few hours after awakening. Walking more than two blocks on the level and climbing more than one flight of ordinary stairs at a normal pace and in normal conditions Grade 3: Marked limitation of ordinary physical activity. Walking one or two blocks on the level and climbing one flight of stairs in normal conditions and at normal pace Grade 4: Inability to carry on any physical activity without discomfort, anginal syndrome may be present at rest A higher grade is a worse outcome.


  5. Change From Baseline in Seattle Angina Questionnaire [ Time Frame: 6 months ]
    The SAQ quantifies patients' physical limitations caused by angina, the frequency of and recent changes in their symptoms, their satisfaction with treatment, and the degree to which they perceive their disease to affect their quality of life. Each scale is transformed to a score of 0 to 100, where higher scores indicate better function (eg, less physical limitation, less angina, and better quality of life).

  6. Change From Baseline in SF-36 Scores [ Time Frame: 6 months ]
    The Short Form (36) Health Survey is a 36-item, patient-reported survey of patient health. The SF-36 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 on the assumption that each question carries equal weight. The lower the score the more disability.



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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:

  • Men or women age ≥18
  • History of and currently experiencing angina at least 3 times per week
  • No obstructive coronary artery disease
  • On stable medical therapy for 30 days prior to enrollment
  • Must agree to use a reliable and acceptable method of contraception for the duration of participation
  • Written informed consent

Exclusion Criteria:

  • Myocardial infarction within 90 days
  • Prior evidence of obstructive heart disease including PCI or CABG (or planned PCI or CABG)
  • Diagnosis of other specific cardiac disease
  • Must meet LVEF and GFR requirements
  • Current use of coumadin or DOACs
  • Hypersensitivity to G-CSF, apheresis or study product components
  • Positive for HIV, hepatitis B or hepatitis C
  • Active inflammatory or autoimmune disease, or chronic immunosuppressive state
  • Drug abuse
  • Pregnant or lactating
  • Malignant neoplasm within 5 years
  • History of Sickle Cell Disease
  • Participation in another clinical study within 90 days

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): NCT03508609


Locations
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United States, California
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
United States, Minnesota
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Caladrius Biosciences, Inc.
National Heart, Lung, and Blood Institute (NHLBI)
Cedars-Sinai Medical Center
Mayo Clinic
Investigators
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Study Director: Douglas W. Losordo, MD Chief Medical Officer
  Study Documents (Full-Text)

Documents provided by Caladrius Biosciences, Inc.:
Study Protocol  [PDF] August 26, 2019
Statistical Analysis Plan  [PDF] May 25, 2020

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Responsible Party: Caladrius Biosciences, Inc.
ClinicalTrials.gov Identifier: NCT03508609    
Other Study ID Numbers: CLBS16-P01
1R44HL135889-01 ( U.S. NIH Grant/Contract )
First Posted: April 26, 2018    Key Record Dates
Results First Posted: January 8, 2021
Last Update Posted: January 8, 2021
Last Verified: November 2020
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
Additional relevant MeSH terms:
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Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases