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Trial record 2 of 2 for:    clbs16

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04614467
Recruitment Status : Active, not recruiting
First Posted : November 4, 2020
Last Update Posted : July 13, 2022
Sponsor:
Information provided by (Responsible Party):
Lisata Therapeutics, 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 : December 2022
Estimated Study Completion Date : June 2023

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 angina frequency [ Time Frame: Baseline to 3 and 6 months ]
  2. Change from baseline in CCS angina class [ Time Frame: Baseline to 3 and 6 months ]
  3. Change from baseline in total exercise time [ Time Frame: Baseline to 6 months ]
  4. 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

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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
  • 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


Locations
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United States, California
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
United States, Florida
University of Florida - College of Medicine/ div of Cardiovascular Medicine
Gainesville, Florida, United States, 32606
Memorial Regional Hospital
Hollywood, Florida, United States, 33021
United States, Georgia
Emory University Hospital
Atlanta, Georgia, United States, 30322
United States, Minnesota
Minneapolis Heart Institute at Abbott Northwestern Hospital
Minneapolis, Minnesota, United States, 55407
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
United States, Ohio
The Christ Hospital
Cincinnati, Ohio, United States, 45219
Sponsors and Collaborators
Lisata Therapeutics, Inc.
Investigators
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Study Director: Kristen K Buck, MD Lisata Therapeutics, Inc.
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Lisata Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT04614467    
Other Study ID Numbers: CLBS16-P02
First Posted: November 4, 2020    Key Record Dates
Last Update Posted: July 13, 2022
Last Verified: July 2022

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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 Lisata Therapeutics, 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