Refractory Angina PectorisPhase 2RegenCobraNCT05711849
Assessing the Safety and Effectiveness of Intracoronary Stem Cells in Patients With Refractory Angina
A Phase 2 study testing Bone marrow aspiration and a single intracoronary infusion of autologous bone marrow-derived mononuclear cells. in people with Refractory Angina Pectoris and Refractory Angina, run by Barts & The London NHS Trust at 1 site in United Kingdom.
Trial summary
REGENERATE-COBRA will examine whether autologous stem cell treatment can improve angina symptoms and quality of life for patients with refractory angina. Patients will be randomised (randomly allocated with a 50:50 chance) to either the 'treatment' or the 'sham' group - they will not know which group they are in. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Refractory Angina Pectoris, Refractory Angina
- What is being tested?
- Bone marrow aspiration and a single intracoronary infusion of autologous bone marrow-derived mononuclear cells.
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 110 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Mar 2024to 31 Aug 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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
- Subject is older than 18 years of age
- 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
- 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
- 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
- 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.
- 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
Show all 9Show fewer
- 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
- Subject is willing and able to sign informed consent
- Subject is willing to comply with the specified follow-up evaluations
Who cannot join
- Recent (within 30 days prior to enrolment) troponin or CKMB positive acute coronary syndrome (NSTEMI or STEMI).
- Recent successful revascularization by CABG or PCI within six months prior to enrolment
- Recent unsuccessful PCI (e.g., no relief from symptoms, failed attempt to open a chronic total occlusion) within 30 days prior to enrolment
- The predominant manifestation of angina is dyspnoea
- 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.
- NYHA Class III or IV heart failure (HF), decompensated HF or hospitalisation due to HF during the 90 days prior to enrolment
Show all 20Show fewer
- Life threatening rhythm disorders or any rhythm disorders that would require future placement of an internal defibrillator and/or pacemaker
- 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
- Severe valvular heart disease (any valve)
- Moderate or severe RV dysfunction by echocardiography
- Chronic severe renal failure (estimated eGFR less than 30 mL/min/1.73m2 by the MDRD formula)
- 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.)
- 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
- 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)*
- 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.
- 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
- Comorbidities limiting life expectancy to less than one year if recorded in patient's notes
- Documented acute infection in patient's notes
- Immunosuppressive medication
- Inability to understand written and verbal English
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Alice Reid contact
United Kingdom1 site, 1 recruiting
- Recruiting
St Bartholomew's Hospital
London, England, EC1A 7BE
R&D Governance Administrator, +44 (0)20 7882 6826, research.governance@qmul.ac.uk
Ruth Bowles, +44 (0) 20 3765 8704, r.bowles@qmul.ac.uk
About this study
Official title: A Phase II Randomised Sham-controlled Trial Assessing the Safety and Efficacy of Intracoronary Administration of Autologous Bone Marrow Cells in Patients With Refractory Angina
REGENERATE-COBRA will examine whether autologous stem cell treatment can improve angina symptoms and quality of life for patients with refractory angina. Patients will be randomised (randomly allocated with a 50:50 chance) to either the 'treatment' or the 'sham' group - they will not know which group they are in.
In the 'treatment' group:
Read more
- Stem cells will be collected from bone marrow in the patient's hip under local anaesthetic (a bone marrow aspiration).
- Under local anaesthetic, the stem cells will be infused into the arteries that supply blood to the heart through a small tube inserted either in the wrist or the groin.
- The follow-up involves a phone call at 1 month and 12 months and clinic visit at 6 months.
In the 'sham' group:
- A sham bone marrow aspiration is performed - a 3mm nick in the skin will be made under local anaesthetic.
- A sham cell infusion is performed - a small tube is inserted either in the wrist or groin under local anaesthetic.
- The follow-up involves a phone call at 1 month and 12 months and clinic visit at 6 months.
Read the detailed description
REGENERATE-COBRA is a single centre, randomised (1:1) sham-controlled clinical trial taking place at St Bartholomew's Hospital in London, UK.
- It is recruiting 110 symptomatic refractory angina patients.
- All participants will be blinded to their treatment arm. They will wear a blindfold and noise cancelling headphones for the bone marrow aspiration and the infusion procedures.
- Patients allocated to the treatment arm will undergo a bone marrow aspiration. After cell processing, the autologous bone marrow-derived mononuclear cells are infused into the coronary arteries using the stop-flow technique.
- Patients allocated to the sham arm will undergo a sham bone marrow aspiration (a 3mm nick in the skin under local anaesthetic) and a sham cell infusion (a radial or femoral sheath will be inserted under local anaesthetic).
- All patients will be followed up with a phone call at 1 month and 12 months, and a clinic visit at 6 months.
- The primary endpoint is change in Canadian Cardiovascular Society (CCS) angina score at 6 months.
- Conditions
- Refractory Angina Pectoris, Refractory Angina
- Being tested
- Bone marrow aspiration and a single intracoronary infusion of autologous bone marrow-derived mononuclear cells., Sham bone marrow aspiration and sham cell infusion (insertion of vascular access sheath).
- Keywords
- Angina, Autologous stem cells, Stem cells
- Medical subject headings
- Angina Pectoris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bone marrow aspiration and a single intracoronary infusion of autologous bone marrow-derived mononuclear cells.Biological
Bone marrow will be harvested from the posterior superior iliac crest under local anaesthetic, and mononuclear cells will be separated using a Ficoll technique in a certified laboratory. Later that same day, the participant will undergo an intracoronary cell infusion of the mononuclear cells. Participants will be blinded to their treatment arm (they will wear a blindfold and noise cancelling headphones for the bone marrow aspiration and cell infusion).
Sham bone marrow aspiration and sham cell infusion (insertion of vascular access sheath).Procedure or surgery
These participants will have a sham bone marrow aspiration (a 3mm incision in the skin under local anaesthetic) and a sham intracoronary infusion procedure (the insertion of radial or femoral sheath under local anaesthetic). Participants will be blinded to their treatment arm (they will wear a blindfold and noise cancelling headphones for the sham bone marrow aspiration and sham cell infusion).
| Study group | Role | What they receive |
|---|---|---|
| Treatment arm | Experimental | Bone marrow aspiration and a single intracoronary infusion of autologous bone marrow-derived mononuclear cells. Receives: Biological: Bone marrow aspiration and a single intracoronary infusion of autologous bone marrow-derived mononuclear cells. |
| Sham arm | Sham comparator | Sham bone marrow aspiration and sham cell infusion (insertion of vascular access sheath). Receives: Procedure: Sham bone marrow aspiration and sham cell infusion (insertion of vascular access sheath). |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare the effect of an intracoronary administration of autologous bone marrow-derived cells to a placebo sham treatment on Canadian Cardiovascular Society (CCS) angina scores in patients with refractory angina.
The change in Canadian Cardiovascular Society (CCS) angina scores in all participants. Scoring is via Class I-IV where class IV is worse outcome.
Measured: Measured pre procedure (baseline) and at 6 months post procedure
Secondary outcomes (8)
To compare the safety of an intracoronary administration of autologous bone marrow derived cells versus sham as measured by adverse events
Count of number of adverse events occuring in all participants
Measured: Measured at 1 week post procedure, 6 months post procedure and 1 year post procedure
To compare the efficacy of an intracoronary administration of autologous bone marrow-derived cells versus sham on myocardial ischaemic burden as measured by clinically indicated perfusion imaging
The change in myocardial ischaemia as measured by perfusion imaging in all participants
Measured: Measured pre procedure (baseline) and at 6 months post procedure
To compare the efficacy of an intracoronary administration of autologous bone marrow-derived cells versus sham on quality of life as measured by EQ-5D
The change in EQ-5D scores in all participants. Where the higher calculated score indicates a positive outcome.
Measured: Measured pre procedure (baseline) and at 6 months post procedure and 1 year post procedure
To compare the efficacy of an intracoronary administration of autologous bone marrow-derived cells versus sham on quality of life as measured by Seattle Angina Questionnaire (SAQ)
The change in SAQ scores in all participants. Where the higher calculated score indicates a positive outcome.
Measured: Measured pre procedure (baseline) and at 6 months post procedure and 1 year post procedure
To compare the efficacy of an intracoronary administration of autologous bone marrow-derived cells versus sham on total exercise time as measured by a modified Bruce protocol exercise treadmill test
The change in total exercise time obtained by modified Bruce protocol in all participants
Measured: Measured pre procedure (baseline) and at 6 months post procedure
To compare the efficacy of an intracoronary administration of autologous bone marrow-derived cells versus sham as measured by angina frequency
The change in number of episodes of angina occuring in a four week period prior to baseline, 6 months and 1 year visit in all participants
Measured: Measured pre procedure (baseline) and at 6 months post procedure and 1 year post procedure
To compare the safety of an intracoronary administration of autologous bone marrow- derived cells versus sham as measured by major adverse cardiovascular events (MACE; defined as non-fatal stroke, non-fatal myocardial infarction and cardiovascular death)
The number of major adverse events to occur measured at 6 months and 1 year in all participants
Measured: Measured at 6 months post procedure and 1 year post procedure
To compare the efficacy of an intracoronary administration of autologous bone marrow-derived cells versus sham as measured by change in Canadian Cardiovascular Society angina score
The change in the Canadian Cardiovascular Society (CCS) angina scores in all participants. Scoring is via Class I-IV where class IV is worse outcome.
Measured: Measured at 6 months post procedure and 1 year post procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2023
- Study start1 Mar 2024
- Primary completion31 Aug 2026 (estimated)
- Study completion31 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Refractory Angina PectorisStudies 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
- Model description
- Phase II randomised sham-controlled trial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Barts & The London NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anthony Mathur, Principal investigator, Barts & The London NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05711849
- Sponsor's protocol ID
- 1005427
- Acronym
- RegenCobra
- Status last verified
- Jan 2026
- First submitted
- 25 Jan 2023
- Last updated
- 7 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ramaseshan R, Perera D, Reid A, Andiapen M, Ariti C, Kelham M, Jones DA, Mathur A. REGENERATE-COBRA: A phase II randomized sham-controlled trial assessing the safety and efficacy of intracoronary administration of autologous bone marrow-derived cells in patients with refractory angina. Am Heart J. 2024 Sep;275:96-104. doi: 10.1016/j.ahj.2024.06.001. Epub 2024 Jun 9.
PubMed 38862073
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Randomised Sham-controlled Trial Assessing the Safety and Efficacy of Intracoronary Administration of Autologous Bone Marrow Cells in Patients With Refractory Angina
- ClinicalTrials.gov ID
- NCT05711849
- Acronym / sponsor ID
- RegenCobra / 1005427
- Conditions
- Refractory Angina Pectoris, Refractory Angina
- Keywords
- Angina, Autologous stem cells, Stem cells
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Barts & The London NHS TrustUniversity, hospital or other
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 31 Aug 2026 (estimated)
- Study completion
- 31 Aug 2026 (estimated)
- First posted
- 3 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
REGENERATE-COBRA will examine whether autologous stem cell treatment can improve angina symptoms and quality of life for patients with refractory angina. Patients will be randomised (randomly allocated with a 50:50 chance) to either the 'treatment' or the 'sham' group - they will not know which group they are in.
In the 'treatment' group:
- Stem cells will be collected from bone marrow in the patient's hip under local anaesthetic (a bone marrow aspiration).
- Under local anaesthetic, the stem cells will be infused into the arteries that supply blood to the heart through a small tube inserted either in the wrist or the groin.
- The follow-up involves a phone call at 1 month and 12 months and clinic visit at 6 months.
In the 'sham' group:
- A sham bone marrow aspiration is performed - a 3mm nick in the skin will be made under local anaesthetic.
- A sham cell infusion is performed - a small tube is inserted either in the wrist or groin under local anaesthetic.
- The follow-up involves a phone call at 1 month and 12 months and clinic visit at 6 months.
Detailed description
REGENERATE-COBRA is a single centre, randomised (1:1) sham-controlled clinical trial taking place at St Bartholomew's Hospital in London, UK.
- It is recruiting 110 symptomatic refractory angina patients.
- All participants will be blinded to their treatment arm. They will wear a blindfold and noise cancelling headphones for the bone marrow aspiration and the infusion procedures.
- Patients allocated to the treatment arm will undergo a bone marrow aspiration. After cell processing, the autologous bone marrow-derived mononuclear cells are infused into the coronary arteries using the stop-flow technique.
- Patients allocated to the sham arm will undergo a sham bone marrow aspiration (a 3mm nick in the skin under local anaesthetic) and a sham cell infusion (a radial or femoral sheath will be inserted under local anaesthetic).
- All patients will be followed up with a phone call at 1 month and 12 months, and a clinic visit at 6 months.
- The primary endpoint is change in Canadian Cardiovascular Society (CCS) angina score at 6 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Phase II randomised sham-controlled trial
| Arm | Type | Receives |
|---|---|---|
| Treatment arm | Experimental | Biological: Bone marrow aspiration and a single intracoronary infusion of autologous bone marrow-derived mononuclear cells.Bone marrow aspiration and a single intracoronary infusion of autologous bone marrow-derived mononuclear cells. |
| Sham arm | Sham comparator | Procedure: Sham bone marrow aspiration and sham cell infusion (insertion of vascular access sheath).Sham bone marrow aspiration and sham cell infusion (insertion of vascular access sheath). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Subject is older than 18 years of age
- 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
- 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
- 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
- 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.
Key exclusion criteria (20 listed)
- Recent (within 30 days prior to enrolment) troponin or CKMB positive acute coronary syndrome (NSTEMI or STEMI).
- Recent successful revascularization by CABG or PCI within six months prior to enrolment
- Recent unsuccessful PCI (e.g., no relief from symptoms, failed attempt to open a chronic total occlusion) within 30 days prior to enrolment
- The predominant manifestation of angina is dyspnoea
- 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.
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 |
|---|---|---|
| Bone marrow aspiration and a single intracoronary infusion of autologous bone marrow-derived mononuclear cells.Bone marrow will be harvested from the posterior superior iliac crest under local anaesthetic, and mononuclear cells will be separated using a Ficoll technique in a certified laboratory. Later that same day, the participant will undergo an intracoronary cell infusion of the mononuclear cells. Participants will be blinded to their treatment arm (they will wear a blindfold and noise cancelling headphones for the bone marrow aspiration and cell infusion). | Biological | Treatment arm |
| Sham bone marrow aspiration and sham cell infusion (insertion of vascular access sheath).These participants will have a sham bone marrow aspiration (a 3mm incision in the skin under local anaesthetic) and a sham intracoronary infusion procedure (the insertion of radial or femoral sheath under local anaesthetic). Participants will be blinded to their treatment arm (they will wear a blindfold and noise cancelling headphones for the sham bone marrow aspiration and sham cell infusion). | Procedure or surgery | Sham arm |
Primary outcome
To compare the effect of an intracoronary administration of autologous bone marrow-derived cells to a placebo sham treatment on Canadian Cardiovascular Society (CCS) angina scores in patients with refractory angina.
Time frame: Measured pre procedure (baseline) and at 6 months post procedure
The change in Canadian Cardiovascular Society (CCS) angina scores in all participants. Scoring is via Class I-IV where class IV is worse outcome.
8 secondary outcomes
To compare the safety of an intracoronary administration of autologous bone marrow derived cells versus sham as measured by adverse events
Time frame: Measured at 1 week post procedure, 6 months post procedure and 1 year post procedure
To compare the efficacy of an intracoronary administration of autologous bone marrow-derived cells versus sham on myocardial ischaemic burden as measured by clinically indicated perfusion imaging
Time frame: Measured pre procedure (baseline) and at 6 months post procedure
To compare the efficacy of an intracoronary administration of autologous bone marrow-derived cells versus sham on quality of life as measured by EQ-5D
Time frame: Measured pre procedure (baseline) and at 6 months post procedure and 1 year post procedure
To compare the efficacy of an intracoronary administration of autologous bone marrow-derived cells versus sham on quality of life as measured by Seattle Angina Questionnaire (SAQ)
Time frame: Measured pre procedure (baseline) and at 6 months post procedure and 1 year post procedure
To compare the efficacy of an intracoronary administration of autologous bone marrow-derived cells versus sham on total exercise time as measured by a modified Bruce protocol exercise treadmill test
Time frame: Measured pre procedure (baseline) and at 6 months post procedure
To compare the efficacy of an intracoronary administration of autologous bone marrow-derived cells versus sham as measured by angina frequency
Time frame: Measured pre procedure (baseline) and at 6 months post procedure and 1 year post procedure
To compare the safety of an intracoronary administration of autologous bone marrow- derived cells versus sham as measured by major adverse cardiovascular events (MACE; defined as non-fatal stroke, non-fatal myocardial infarction and cardiovascular death)
Time frame: Measured at 6 months post procedure and 1 year post procedure
To compare the efficacy of an intracoronary administration of autologous bone marrow-derived cells versus sham as measured by change in Canadian Cardiovascular Society angina score
Time frame: Measured at 6 months post procedure and 1 year post procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2026.
- Derived from this study: PubMed 38862073Ramaseshan R, Perera D, Reid A, Andiapen M, Ariti C, Kelham M, Jones DA, Mathur A. REGENERATE-COBRA: A phase II randomized sham-controlled trial assessing the safety and efficacy of intracoronary administration of autologous bone marrow-derived cells in patients with refractory angina. Am Heart J. 2024 Sep;275:96-104. doi: 10.1016/j.ahj.2024.06.001. Epub 2024 Jun 9.
- Individual participant dataSharing planned: No
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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.
Alice Reid contact
Anthony Mathur principal investigator
Barts & The London NHS Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Bone marrow aspiration and a single intracoronary infusion of autologous bone marrow-derived mononuclear cells. in people with Refractory Angina Pectoris and Refractory Angina, run by Barts & The London NHS Trust at 1 site in United Kingdom.
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 9 inclusion and 20 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: looking for participants now, as of the sponsor's last update on 7 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Stem Cell Research Team (0203 765 8704, bhnt.stemcells@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To compare the effect of an intracoronary administration of autologous bone marrow-derived cells to a placebo sham treatment on Canadian Cardiovascular Society (CCS) angina scores in patients with refractory angina. (time frame: Measured pre procedure (baseline) and at 6 months post procedure). 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 NCT05711849, 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 7 Jan 2026.