Study Stopped
Sponsor decision
A Placebo-Controlled Trial of CLBS16 in Subjects With Coronary Microvascular Dysfunction
FREEDOM
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
1 other identifier
interventional
34
1 country
7
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Oct 2020
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 29, 2020
CompletedStudy Start
First participant enrolled
October 29, 2020
CompletedFirst Posted
Study publicly available on registry
November 4, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 28, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
September 28, 2022
CompletedResults Posted
Study results publicly available
May 4, 2026
CompletedMay 4, 2026
April 1, 2026
1.9 years
October 29, 2020
August 25, 2025
April 30, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Change From Baseline in Number of Angina Attacks Per Week
Baseline to Month 3
Change From Baseline in CCS Angina Class
This measure assesses the change in the Canadian Cardiovascular Society angina class scale. CCS angina class was assessed at baseline and again at 3 months and reported as the mean difference. CCS classes are as follows (negative change indicates an improvement): Class 0: No angina with ordinary activity Class I: Angina only with strenuous, prolonged, or rapid exertion Class II: Angina with slight limitations of ordinary activity (e.g., walking uphill, climbing stairs) Class III: Angina with marked limitations of ordinary activity (e.g., walking one to two blocks, climbing one flight of stairs) Class IV: Angina at rest or with minimal exertion
Baseline to 3 months
Change From Baseline in Total Exercise Time
Baseline to 6 months
Change From Baseline in Health-related Quality of Life (HRQoL)
Seattle Angina Questionnaire (SAQ) Scoring is 0 to 100 with higher numbers better
Baseline to 3 months
Study Arms (2)
GCSF-mobilized autologous CD34+ cells
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (7)
Cedars-Sinai Medical Center
Los Angeles, California, 90048, United States
University of Florida - College of Medicine/ div of Cardiovascular Medicine
Gainesville, Florida, 32606, United States
Memorial Regional Hospital
Hollywood, Florida, 33021, United States
Emory University Hospital
Atlanta, Georgia, 30322, United States
Minneapolis Heart Institute at Abbott Northwestern Hospital
Minneapolis, Minnesota, 55407, United States
Mayo Clinic in Rochester
Rochester, Minnesota, 55905, United States
The Christ Hospital
Cincinnati, Ohio, 45219, United States
Related Publications (1)
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.
PMID: 34066713DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Public Relations
- Organization
- Lisata Therapeutics
Study Officials
- STUDY DIRECTOR
Kristen K Buck, MD
Lisata Therapeutics, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 29, 2020
First Posted
November 4, 2020
Study Start
October 29, 2020
Primary Completion
September 28, 2022
Study Completion
September 28, 2022
Last Updated
May 4, 2026
Results First Posted
May 4, 2026
Record last verified: 2026-04