Coronary Microvascular DysfunctionPhase 2FREEDOMNCT04614467

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

A Phase 2 study testing CLBS16 in people with Coronary Microvascular Dysfunction and Coronary Microvascular Disease, run by Lisata Therapeutics, Inc. at 7 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Coronary Microvascular Dysfunction, Coronary Microvascular Disease, Microvascular Coronary Artery Disease
What is being tested?: CLBS16
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 34 participants
Where: 7 sitesUnited States
Study dates: 29 Oct 2020to 28 Sep 2022
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Show all 14Show fewer

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

Trial locations and contacts

7 sites in 1 country.

City, postcode or hospital

7 sites in 1 country

United States7 sites

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

Other trials in United States

About this study

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

Conditions: Coronary Microvascular Dysfunction, Coronary Microvascular Disease, Microvascular Coronary Artery Disease
Being tested: CLBS16, Placebo
Keywords: angina, CMD, MVD, non-obstructive coronary artery disease
Medical subject headings: Microvascular Angina, Angina Pectoris

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

CLBS16Biological
GCSF-mobilized autologous CD34+ cells
PlaceboBiological
isotonic solution (no CD34+ cells)

Study groups in NCT04614467
Study group	Role	What they receive
GCSF-mobilized autologous CD34+ cells	Experimental	Not described Receives: Biological: CLBS16
Placebo	Placebo comparator	Not described Receives: Biological: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Change From Baseline in Number of Angina Attacks Per Week
Measured: 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
Measured: Baseline to 3 months
Change From Baseline in Total Exercise Time
Measured: 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
Measured: Baseline to 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

29 Oct 202028 Sep 2022

First posted4 Nov 2020
Study start29 Oct 2020
Primary completion28 Sep 2022
Study completion28 Sep 2022

Why it stopped: Sponsor decision

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Coronary Microvascular DysfunctionStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 34 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04614467
Sponsor's protocol ID: CLBS16-P02
Acronym: FREEDOM
Status last verified: Apr 2026
First submitted: 29 Oct 2020
Last updated: 4 May 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No

Publications

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.
PubMed 34066713

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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A Single Center Diagnostic, Cross-sectional Study of Coronary Microvascular Dysfunction
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The Role of CD34+ Stem Cells in the Pathogenesis of Takotsubo Syndrome
Tako Tsubo Cardiomyopathy, Microvascular Dysfunction
Recruiting
Invasive Evaluation and Phenotype-Guided Treatment of ANOCA in Women
ANOCA - Angina With Non-obstructive Coronary Arteries, Coronary Microvascular Dysfunction (CMD)
RecruitingObservational study
Mechanical Dyssynchrony and Microvascular Dysfunction by SPECT
Myocardial Blood Flow Reserve, Mechanical Dyssynchrony
Recruiting
Mental Stress Reactivity in Women With CMD
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All Coronary Microvascular Dysfunction trials

Study at a glance

From the registry record, last updated by the sponsor on 4 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT04614467
Acronym / sponsor ID: FREEDOM / CLBS16-P02
Conditions: Coronary Microvascular Dysfunction, Coronary Microvascular Disease, Microvascular Coronary Artery Disease
Keywords: angina, CMD, MVD, non-obstructive coronary artery disease
Phase: Phase 2
Study type: Interventional
Recruitment status: TerminatedReason stopped: Sponsor decision
Enrolment: 34 participants (actual)
Lead sponsor: Lisata Therapeutics, Inc.Industry (pharma, biotech, devices)
Study start: 29 Oct 2020 (actual)
Primary completion: 28 Sep 2022 (actual)
Study completion: 28 Sep 2022 (actual)
First posted: 4 Nov 2020 (actual)
Results: Posted 4 May 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
GCSF-mobilized autologous CD34+ cells	Experimental	Biological: CLBS16
Placebo	Placebo comparator	Biological: Placebo

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

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

Key exclusion criteria (14 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
CLBS16GCSF-mobilized autologous CD34+ cells	Biological	GCSF-mobilized autologous CD34+ cells
Placeboisotonic solution (no CD34+ cells)	Biological	Placebo

Primary outcome

Change From Baseline in Number of Angina Attacks Per Week
Time frame: Baseline to Month 3
Change From Baseline in CCS Angina Class
Time frame: Baseline to 3 months
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
Change From Baseline in Total Exercise Time
Time frame: Baseline to 6 months
Change From Baseline in Health-related Quality of Life (HRQoL)
Time frame: Baseline to 3 months
Seattle Angina Questionnaire (SAQ) Scoring is 0 to 100 with higher numbers better

Results and safety

Results posted to the registry on 4 May 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
GCSF-mobilized Autologous CD34+ Cells	20	20
Placebo	14	14

Primary outcome: Change From Baseline in Number of Angina Attacks Per Week

Time frame: Baseline to Month 3. Mean (Standard Deviation). Unit: angina attacks per week

Measure	GCSF-mobilized Autologous CD34+ Cells n = 13	Placebo n = 12
Value	1.2346 (0.98934)	1.4821 (1.33670)

Population analysed: Note that the number of subjects here may be less than in the participant flow module due to missing data.

Primary outcome: Change From Baseline in CCS Angina Class

Time frame: Baseline to 3 months. Mean (Standard Deviation). Unit: units on a scale

Measure	GCSF-mobilized Autologous CD34+ Cells n = 18	Placebo n = 13
Value	-1.2 (1.11)	-0.8 (0.73)

Population analysed: Note that the number of subjects here may be less than in the participant flow module due to missing data.

Primary outcome: Change From Baseline in Total Exercise Time

Time frame: Baseline to 6 months. Mean (Standard Deviation). Unit: minutes

Measure	GCSF-mobilized Autologous CD34+ Cells n = 12	Placebo n = 11
Value	15.67 (84.985)	29.82 (103.375)

Population analysed: Note that the number of subjects here may be less than in the participant flow module due to missing data.

Primary outcome: Change From Baseline in Health-related Quality of Life (HRQoL)

Time frame: Baseline to 3 months. Mean (Standard Deviation). Unit: units on a scale

Measure	GCSF-mobilized Autologous CD34+ Cells n = 15	Placebo n = 11
Value	15.648 (22.1382)	7.323 (16.3523)

Population analysed: Note that the number of subjects here may be less than in the participant flow module due to missing data.

Adverse events

Time frame: Adverse events were collected throughout the trial and the time frame differed depending on how long each patient was in the trial. The longest period of observation was 12 months.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
GCSF-mobilized Autologous CD34+ Cells	7 of 20 (35%)	20 of 20 (100%)	0 of 20
Placebo	2 of 14 (14.3%)	14 of 14 (100%)	0 of 14

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 34066713Rai 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.

Related trials for Coronary Microvascular Dysfunction

Active, not recruiting
A Single Center Diagnostic, Cross-sectional Study of Coronary Microvascular Dysfunction
Coronary Microvascular Disease, Ischemic Heart Disease
Active, not recruitingObservational study
The Role of CD34+ Stem Cells in the Pathogenesis of Takotsubo Syndrome
Tako Tsubo Cardiomyopathy, Microvascular Dysfunction
Recruiting
Invasive Evaluation and Phenotype-Guided Treatment of ANOCA in Women
ANOCA - Angina With Non-obstructive Coronary Arteries, Coronary Microvascular Dysfunction (CMD)
RecruitingObservational study
Mechanical Dyssynchrony and Microvascular Dysfunction by SPECT
Myocardial Blood Flow Reserve, Mechanical Dyssynchrony
Recruiting
Mental Stress Reactivity in Women With CMD
Post-menopause

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Kristen K Buck, MD study director

Lisata Therapeutics, Inc.

7 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing CLBS16 in people with Coronary Microvascular Dysfunction and Coronary Microvascular Disease, run by Lisata Therapeutics, Inc. at 7 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 4 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 4 May 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in Number of Angina Attacks Per Week (time frame: Baseline to Month 3). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04614467, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2026.