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A Placebo-Controlled Trial of CLBS16 in Subjects With Coronary Microvascular Dysfunction (FREEDOM)

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: NCT04614467
Recruitment Status : Recruiting
First Posted : November 4, 2020
Last Update Posted : November 26, 2021
Sponsor:
Information provided by (Responsible Party):
Caladrius Biosciences, Inc.

Brief Summary:
This clinical trial will explore the efficacy and safety of GCSF-mobilized autologous 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 administration of CLBS16 or placebo.

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 105 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Double-Blind, Randomized, Placebo-Controlled Clinical Study to Evaluate the Efficacy and Safety of CLBS16 in Subjects With Coronary Microvascular Dysfunction and Without Obstructive Coronary Artery Disease
Actual Study Start Date : October 28, 2020
Estimated Primary Completion Date : April 2022
Estimated Study Completion Date : October 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: GCSF-mobilized autologous CD34+ cells Biological: CLBS16
GCSF-mobilized autologous CD34+ cells

Placebo Comparator: Placebo Biological: Placebo
isotonic solution (no CD34+ cells)




Primary Outcome Measures :
  1. Change from baseline in peak coronary flow reserve [ Time Frame: Baseline to 6 months ]
  2. Change from baseline in angina frequency [ Time Frame: Baseline to 3 and 6 months ]
  3. Change from baseline in CCS angina class [ Time Frame: Baseline to 3 and 6 months ]
  4. Change from baseline in total exercise time [ Time Frame: Baseline to 6 months ]
  5. Change from baseline in health-related quality of life (HRQoL) [ Time Frame: Baseline to 3 and 6 months ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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
  • Prior diagnosis of CMD based on coronary flow reserve (CFR) ≤ 2.5 or other measures
  • Peak CFR to intracoronary adenosine ≤ 2.5 at screening
  • Canadian Cardiovascular Society (CCS) class II, III or IV chronic refractory angina
  • No obstructive coronary artery disease
  • On stable medical therapy for at least 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 GCSF, 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 prior to informed consent or concurrently with this study
  • Previous treatment with a CD34+ cell based therapy

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): NCT04614467


Contacts
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Contact: Christine Kotynski 9088420093 ckotynski@caladrius.com

Locations
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United States, California
Cedars-Sinai Medical Center Recruiting
Los Angeles, California, United States, 90048
Contact: Odette Chida Ibarra    310-423-9459    odette.chidaibarra@cshs.org   
Principal Investigator: C. Noel Bairey Merz, MD         
Principal Investigator: Janet Wei, MD         
United States, Florida
University of Florida - College of Medicine/ div of Cardiovascular Medicine Recruiting
Gainesville, Florida, United States, 32606
Contact: Nicole Bostick    352-273-8938    Janette.Bostick@medicine.ufl.edu   
Contact: Sarah J Long, RN       Sarah.Long@medicine.ufl.edu   
Principal Investigator: R. David Anderson, MD         
Memorial Regional Hospital Recruiting
Hollywood, Florida, United States, 33021
Contact: Doris Alaby, RN       dalaby@mhs.net   
Principal Investigator: Jonathan Roberts, MD         
United States, Georgia
Emory University Hospital Recruiting
Atlanta, Georgia, United States, 30322
Contact: Kiran Ejaz       Kiran.ejaz@emory.edu   
Principal Investigator: Arshed A Quyyumi, MD         
United States, Minnesota
Minneapolis Heart Institute at Abbott Northwestern Hospital Recruiting
Minneapolis, Minnesota, United States, 55407
Contact: Bethany White, RN    612-863-9312    bethany.white@allina.com   
Principal Investigator: Jay Traverse, MD         
Mayo Clinic in Rochester Recruiting
Rochester, Minnesota, United States, 55905
Contact: Diana Albers       albers.diana2@mayo.edu   
Principal Investigator: Amir Lerman, MD         
United States, Ohio
The Christ Hospital Recruiting
Cincinnati, Ohio, United States, 45219
Contact: Darlene Rock, RN, MBA       darlene.rock@thechristhospital.com   
Principal Investigator: Timothy D. Henry, MD         
Sponsors and Collaborators
Caladrius Biosciences, Inc.
Investigators
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Study Director: Robert Honigberg, MD Caladrius Biosciences, Inc.
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Caladrius Biosciences, Inc.
ClinicalTrials.gov Identifier: NCT04614467    
Other Study ID Numbers: CLBS16-P02
First Posted: November 4, 2020    Key Record Dates
Last Update Posted: November 26, 2021
Last Verified: November 2021

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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 Caladrius Biosciences, Inc.:
angina
CMD
MVD
non-obstructive coronary artery disease
Additional relevant MeSH terms:
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Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Microvascular Angina
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Angina Pectoris