Could your own bone marrow ease incurable chest pain?
NCT ID NCT05711849
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether a single infusion of a patient's own bone marrow stem cells can reduce chest pain and improve quality of life for people with refractory angina—a severe form of chest pain that doesn't respond to standard treatments. About 110 participants will be randomly assigned to receive either the real stem cell treatment or a sham procedure, and neither they nor their doctors will know which they got. The main goal is to see if angina symptoms improve over six months.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- autologous bone marrow stem cells
- What this could lead to
- If it works, this could offer a new way to reduce chest pain and improve daily life for people with refractory angina who have few other options.
- What could go wrong
- This is a mid-stage trial with only 110 participants, so results may not apply to everyone. The procedure involves bone marrow collection and heart artery infusion, which carry risks like bleeding or infection.
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
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 110 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Mar 2024
- Expected to finish
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Aug 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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: 1. Subject is older than 18 years of age 2. Symptomatic coronary artery disease (CAD) with greater than or equal to 90 days of persistent refractory angina pectoris classified as CCS Grade III or IV despite maximally tolerated guideline directed medical therapy 3. Must have attempted treatment with the maximally tolerated dose of at least two of the four approved classes of anti-anginal agents: long-acting nitrates, calcium channel blockers (either a dihydropyridine or a non-dihydropyridine), beta blockers, and ranolazine. The regimen must be stable for greater than 2 months prior to enrolment, with no intent to change the medical regimen for at least 12 months after randomisation 4. Subject has either no treatment options for revascularization by coronary artery bypass grafting or by percutaneous coronary intervention, or is otherwise unsuitable or high risk for revascularization 5. Evidence of either exercise or pharmacologically induced reversible ischemia severity by stress echo, nuclear study, PET, perfusion MRI, CT perfusion, FFRCT, FFR, iFR, or other non-hyperaemic tests. 6. Functional limitation due to refractory angina as defined by a modified Bruce exercise tolerance test duration of greater than or equal to 2 minutes but less than or equal to 8 minutes 7. Left ventricular ejection fraction (LVEF) greater than or equal to 30% within the 12- months prior to procedure (must be reassessed after any intervening myocardial infarction); the most recent LVEF assessment is used as the qualifying test 8. Subject is willing and able to sign informed consent 9. Subject is willing to comply with the specified follow-up evaluations Exclusion Criteria: 1. Recent (within 30 days prior to enrolment) troponin or CKMB positive acute coronary syndrome (NSTEMI or STEMI). 2. Recent successful revascularization by CABG or PCI within six months prior to enrolment 3. Recent unsuccessful PCI (e.g., no relief from symptoms, failed attempt to open a chronic total occlusion) within 30 days prior to enrolment 4. The predominant manifestation of angina is dyspnoea 5. Has extra-coronary contributory causes of angina - e.g., untreated hyperthyroidism, anaemia (hgb \<10 g/dL), uncontrolled hypertension (systolic blood pressure \>160 mmHg or diastolic blood pressure \>100 mmHg despite medications), atrial fibrillation with rapid ventricular response (consistently \>100 bpm despite medications) or other tachyarrhythmia, severe aortic stenosis, hypertrophic cardiomyopathy with left ventricular outflow tract obstruction or asymmetric septal hypertrophy (concentric left ventricular hypertrophy is not an exclusion criterion), etc. 6. NYHA Class III or IV heart failure (HF), decompensated HF or hospitalisation due to HF during the 90 days prior to enrolment 7. Life threatening rhythm disorders or any rhythm disorders that would require future placement of an internal defibrillator and/or pacemaker 8. Severe chronic obstructive pulmonary disease (COPD) as indicated by a forced expiratory volume in one second (FEV1) that is less than 55% of the predicted value, or need for home daytime oxygen or oral steroids 9. Severe valvular heart disease (any valve) 10. Moderate or severe RV dysfunction by echocardiography 11. Chronic severe renal failure (estimated eGFR less than 30 mL/min/1.73m2 by the MDRD formula) 12. Any clinical condition that might interfere with the trial protocol or the subject's ability to be compliant with the trial protocol (e.g., active alcohol or drug abuse, dementia, etc.) 13. Currently enrolled in another investigational device or drug trial that has not reached its primary endpoint or that might clinically interfere with the current trial endpoints or procedures 14. Pregnant or planning pregnancy within the next 12 months (women of reproductive potential must have a negative pregnancy test within 7 days of the randomisation procedure)\* 15. Subject is part of a vulnerable population who, in the judgment of the investigator, is unable to give Informed Consent for reasons of incapacity, immaturity, adverse personal circumstances or lack of autonomy. This may include individuals with mental disability, persons in nursing homes, children, impoverished persons, persons in emergency situations, homeless persons, nomads, refugees, and those incapable of giving informed consent. Vulnerable populations also may include members of a group with a hierarchical structure such as university students, subordinate hospital and laboratory personnel, employees of the Sponsor, members of the armed forces, and persons kept in detention. 16. Inability to tolerate dual antiplatelet therapy for 1 month if not on a chronic oral anticoagulant, or inability to tolerate a P2Y12 inhibitor for at least 1 month if on a chronic oral anticoagulant 17. Comorbidities limiting life expectancy to less than one year if recorded in patient's notes 18. Documented acute infection in patient's notes 19. Immunosuppressive medication 20. Inability to understand written and verbal English
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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St Bartholomew's Hospital
RECRUITINGLondon, England, EC1A 7BE, United Kingdom
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Other studies related to the condition(s) this trial covers.
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- Could your own stem cells ease incurable chest pain?
- Heart drug trial pulled before it even started
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