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

Primary Purpose

Coronary Microvascular Dysfunction, Coronary Microvascular Disease, Microvascular Coronary Artery Disease

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
CLBS16
Placebo
Sponsored by
Lisata Therapeutics, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Microvascular Dysfunction focused on measuring angina, CMD, MVD, non-obstructive coronary artery disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Cedars-Sinai Medical Center
  • University of Florida - College of Medicine/ div of Cardiovascular Medicine
  • Memorial Regional Hospital
  • Emory University Hospital
  • Minneapolis Heart Institute at Abbott Northwestern Hospital
  • Mayo Clinic in Rochester
  • The Christ Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

GCSF-mobilized autologous CD34+ cells

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Change from baseline in angina frequency
Change from baseline in CCS angina class
Change from baseline in total exercise time
Change from baseline in health-related quality of life (HRQoL)

Secondary Outcome Measures

Full Information

First Posted
October 29, 2020
Last Updated
October 9, 2023
Sponsor
Lisata Therapeutics, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04614467
Brief Title
A Placebo-Controlled Trial of CLBS16 in Subjects With Coronary Microvascular Dysfunction
Acronym
FREEDOM
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Terminated
Why Stopped
Sponsor decision
Study Start Date
October 29, 2020 (Actual)
Primary Completion Date
September 28, 2022 (Actual)
Study Completion Date
September 28, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lisata Therapeutics, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Microvascular Dysfunction, Coronary Microvascular Disease, Microvascular Coronary Artery Disease
Keywords
angina, CMD, MVD, non-obstructive coronary artery disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
34 (Actual)

8. Arms, Groups, and Interventions

Arm Title
GCSF-mobilized autologous CD34+ cells
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Biological
Intervention Name(s)
CLBS16
Intervention Description
GCSF-mobilized autologous CD34+ cells
Intervention Type
Biological
Intervention Name(s)
Placebo
Intervention Description
isotonic solution (no CD34+ cells)
Primary Outcome Measure Information:
Title
Change from baseline in angina frequency
Time Frame
Baseline to 3 and 6 months
Title
Change from baseline in CCS angina class
Time Frame
Baseline to 3 and 6 months
Title
Change from baseline in total exercise time
Time Frame
Baseline to 6 months
Title
Change from baseline in health-related quality of life (HRQoL)
Time Frame
Baseline to 3 and 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kristen K Buck, MD
Organizational Affiliation
Lisata Therapeutics, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Cedars-Sinai Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
University of Florida - College of Medicine/ div of Cardiovascular Medicine
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32606
Country
United States
Facility Name
Memorial Regional Hospital
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33021
Country
United States
Facility Name
Emory University Hospital
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Minneapolis Heart Institute at Abbott Northwestern Hospital
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55407
Country
United States
Facility Name
Mayo Clinic in Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
The Christ Hospital
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
34066713
Citation
Rai B, Shukla J, Henry TD, Quesada O. Angiogenic CD34 Stem Cell Therapy in Coronary Microvascular Repair-A Systematic Review. Cells. 2021 May 8;10(5):1137. doi: 10.3390/cells10051137.
Results Reference
derived

Learn more about this trial

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

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