Actively Recruiting

Phase 2
Age: 18Years +
All Genders
ID05711849

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

Led by Barts & The London NHS Trust · Updated on 2026-01-07

110

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating whether using a patient's own stem cells can improve angina symptoms and quality of life for people with refractory angina, a condition where chest pain persists despite standard treatments. This phase II, randomised, double-blind clinical trial compares the effects of intracoronary administration of autologous bone marrow-derived cells to a placebo sham treatment. The study involves 110 symptomatic patients and aims to assess changes in angina severity and other health outcomes. Participants are randomly assigned to either the treatment group, which receives bone marrow aspiration from the hip followed by infusion of stem cells into the heart's arteries, or the sham group, which undergoes similar procedures without actual stem cell collection or infusion. Both groups experience local anaesthetic procedures with measures to maintain blinding, such as wearing blindfolds and noise-cancelling headphones. Follow-up includes phone calls at 1 and 12 months and a clinic visit at 6 months. During the study, patients will have evaluations of their angina symptoms using the Canadian Cardiovascular Society score, quality of life assessments, exercise tolerance tests, and imaging to measure heart blood flow. Safety is monitored through adverse event tracking and major cardiovascular event assessments. The main outcome measure is the change in angina score from baseline to 6 months after treatment. The total participation duration includes these follow-up points, ensuring careful monitoring of treatment effects and safety.

CONDITIONS

Brief Title

Assessing the Safety and Effectiveness of Intracoronary Stem Cells in Patients With Refractory Angina

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Subject is older than 18 years of age
  • Symptomatic coronary artery disease with at least 90 days of refractory angina classified as CCS Grade III or IV despite maximum medical therapy
  • Tried maximum tolerated doses of at least two approved anti-anginal drug classes for over 2 months, with stable regimen for 12 months after randomisation
  • No treatment options or unsuitable/high risk for coronary artery bypass grafting or percutaneous coronary intervention
  • Evidence of reversible ischemia by stress or imaging tests
  • Functional limitation due to angina with exercise tolerance between 2 and 8 minutes on modified Bruce test
  • Left ventricular ejection fraction of 30% or higher within 12 months before procedure
  • Willing and able to provide informed consent and comply with follow-up evaluations
Not Eligible

You will not qualify if you...

  • Recent acute coronary syndrome within 30 days prior to enrolment
  • Successful coronary revascularization within 6 months prior to enrolment
  • Unsuccessful percutaneous coronary intervention within 30 days prior to enrolment
  • Angina mainly caused by breathlessness
  • Other causes of angina such as untreated hyperthyroidism, anemia (hemoglobin <10 g/dL), uncontrolled hypertension, atrial fibrillation with rapid rate, severe aortic stenosis, hypertrophic cardiomyopathy with obstruction
  • NYHA Class III or IV heart failure or recent hospitalization for heart failure
  • Life-threatening or needing future device implantation for heart rhythm disorders
  • Severe chronic obstructive pulmonary disease or need for daytime oxygen or steroids
  • Severe valvular heart disease
  • Moderate or severe right ventricular dysfunction
  • Chronic severe kidney failure (eGFR <30 mL/min/1.73m2)
  • Conditions interfering with trial compliance such as active substance abuse or dementia
  • Currently enrolled in another interfering clinical trial
  • Pregnant or planning pregnancy within 12 months
  • Vulnerable populations unable to give informed consent
  • Unable to tolerate required antiplatelet therapies
  • Life expectancy less than one year due to other illnesses
  • Documented acute infection
  • Use of immunosuppressive medication
  • Unable to understand written and spoken English

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Single day procedure

Participants undergo either bone marrow aspiration and a single intracoronary infusion of autologous bone marrow-derived mononuclear cells or sham procedures under local anaesthetic. Participants are blinded to their treatment assignment.

1 treatment visit (in-person)

Follow-up

Duration - 12 months

Participants are followed up to assess safety and effectiveness, including phone calls and clinic visits to monitor angina symptoms and heart health.

Phone calls at 1 month and 12 months, 1 clinic visit at 6 months

Trial Site Locations

Total: 1 location

1

St Bartholomew's Hospital

London, England, United Kingdom, EC1A 7BE

Actively Recruiting

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Research Team

S

Stem Cell Research Team

A

Alice Reid

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Published Research Related To This Trial

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.

Rohini Ramaseshan, Dhanuka Perera, Alice Reid...

https://pubmed.ncbi.nlm.nih.gov/38862073