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Stem cell shot for stubborn chest pain? early trial cut short

NCT ID NCT04614467

Disease control Sponsor: Lisata Therapeutics, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This phase 2 study tested whether a single infusion of a patient's own blood stem cells (CLBS16) could ease chest pain in people with coronary microvascular dysfunction, a condition where the heart's tiny blood vessels don't work properly. The trial enrolled 34 adults with frequent angina but no blocked arteries. It was terminated early, so we have limited data on whether the treatment works or is safe.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
CLBS16 (a patient's own blood stem cells, called CD34+ cells, collected after a drug to boost their numbers)
What this could lead to
If it worked, this could point toward a new way to reduce chest pain and improve quality of life for people with small-vessel heart disease who don't have blocked arteries.
What could go wrong
This trial was terminated early with only 34 participants, so results are very limited. It is a small, early-phase study, and the treatment may not prove effective or safe in larger groups.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

34 people

The number who actually took part.

Started

Oct 2020

Finished

Sep 2022

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

Angina Pectoris coronary microvascular disorder Microvascular Angina

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Coronary microvascular disease Coronary microvascular dysfunction Microvascular coronary artery disease

Contacts and locations

Locations

  • Cedars-Sinai Medical Center

    Los Angeles, California, 90048, United States

  • Emory University Hospital

    Atlanta, Georgia, 30322, United States

  • Mayo Clinic in Rochester

    Rochester, Minnesota, 55905, United States

  • Memorial Regional Hospital

    Hollywood, Florida, 33021, United States

  • Minneapolis Heart Institute at Abbott Northwestern Hospital

    Minneapolis, Minnesota, 55407, United States

  • The Christ Hospital

    Cincinnati, Ohio, 45219, United States

  • University of Florida - College of Medicine/ div of Cardiovascular Medicine

    Gainesville, Florida, 32606, United States

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