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Safety and Potential Bioactivity of CLBS14 in Patients With Coronary Microvascular Dysfunction and Without Obstructive Coronary Artery Disease

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ClinicalTrials.gov Identifier: NCT03508609
Recruitment Status : Recruiting
First Posted : April 26, 2018
Last Update Posted : January 30, 2019
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 CLBS14.

Condition or disease Intervention/treatment Phase
Coronary Microvascular Dysfunction Biological: CLBS14 Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
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 CLBS14 in Patients With Coronary Microvascular Dysfunction (CMD) and Without Obstructive Coronary Artery Disease
Actual Study Start Date : April 19, 2018
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : April 2020

Resource links provided by the National Library of Medicine



Intervention Details:
  • Biological: CLBS14
    GCSF-mobilized autologous CD34 cells


Primary Outcome Measures :
  1. Change from baseline in coronary flow reserve [ Time Frame: Day 180 ]

Secondary Outcome Measures :
  1. Change from baseline in microvascular function as assessed by intracoronary administration of acetylcholine and nitroglycerin [ Time Frame: Day 180 ]
  2. Change from baseline in peripheral arterial tonometry [ Time Frame: Day 180 ]
  3. Proportion of subjects with adverse events [ Time Frame: Day 365 ]


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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


Contacts
Contact: Chrissy Kotynski (908) 842-0093 ckotynski@caladrius.com
Contact: Scott Volk (949) 346-8784 svolk@caladrius.com

Locations
United States, California
Cedars-Sinai Medical Center Recruiting
Los Angeles, California, United States, 90048
Contact: Sandy Joung    310-423-9666    sandy.joung@cshs.org   
Contact: Tracey Early    310-423-1231    Tracey.Early@cshs.org   
Principal Investigator: Timothy Henry, MD         
Principal Investigator: C. Noel Bairey Merz, MD         
United States, Minnesota
Mayo Clinic in Rochester Recruiting
Rochester, Minnesota, United States, 55905
Contact: Diana Albers    507-255-6884    albers.diana2@mayo.edu   
Principal Investigator: Amir Lerman, MD         
Sponsors and Collaborators
Caladrius Biosciences, Inc.
National Heart, Lung, and Blood Institute (NHLBI)
Cedars-Sinai Medical Center
Mayo Clinic
Investigators
Study Director: Douglas W. Losordo, MD Chief Medical Officer

Responsible Party: Caladrius Biosciences, Inc.
ClinicalTrials.gov Identifier: NCT03508609     History of Changes
Other Study ID Numbers: CLBS14-P01
1R44HL135889-01 ( U.S. NIH Grant/Contract )
First Posted: April 26, 2018    Key Record Dates
Last Update Posted: January 30, 2019
Last Verified: January 2019
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

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases