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

October 9, 2023 updated by: Lisata Therapeutics, Inc.

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

34

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90048
        • Cedars-Sinai Medical Center
    • Florida
      • Gainesville, Florida, United States, 32606
        • University of Florida - College of Medicine/ div of Cardiovascular Medicine
      • Hollywood, Florida, United States, 33021
        • Memorial Regional Hospital
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Emory University Hospital
    • Minnesota
      • Minneapolis, Minnesota, United States, 55407
        • Minneapolis Heart Institute at Abbott Northwestern Hospital
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic in Rochester
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • The Christ Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Biological: Placebo
isotonic solution (no CD34+ cells)
Experimental: GCSF-mobilized autologous CD34+ cells
Biological: CLBS16
GCSF-mobilized autologous CD34+ cells

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change from baseline in angina frequency
Time Frame: Baseline to 3 and 6 months
Baseline to 3 and 6 months
Change from baseline in CCS angina class
Time Frame: Baseline to 3 and 6 months
Baseline to 3 and 6 months
Change from baseline in total exercise time
Time Frame: Baseline to 6 months
Baseline to 6 months
Change from baseline in health-related quality of life (HRQoL)
Time Frame: Baseline to 3 and 6 months
Baseline to 3 and 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lisata Therapeutics, Inc.

Investigators

  • Study Director: Kristen K Buck, MD, Lisata Therapeutics, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 29, 2020

Primary Completion (Actual)

September 28, 2022

Study Completion (Actual)

September 28, 2022

Study Registration Dates

First Submitted

October 29, 2020

First Submitted That Met QC Criteria

October 29, 2020

First Posted (Actual)

November 4, 2020

Study Record Updates

Last Update Posted (Actual)

October 17, 2023

Last Update Submitted That Met QC Criteria

October 9, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CLBS16-P02

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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