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Could your own stem cells repair a failing heart?
NCT ID NCT03572660
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 2 times
Summary
This phase 2 trial is testing whether a patient's own bone marrow stem cells can improve heart function and ease symptoms in people with dilated cardiomyopathy and heart failure. Twenty participants will have stem cells collected from their hip and then infused into their heart arteries while a mini heart pump supports the heart. The study will measure changes in heart pumping ability, exercise capacity, and symptoms over 12 months.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- patient's own bone marrow stem cells and G-CSF
- What this could lead to
- If it works, this could point toward a new way to improve heart function and reduce symptoms in people with dilated cardiomyopathy who have few other options.
- What could go wrong
- This is a small, early-phase trial with only 20 participants, so results may not apply to everyone. The procedure carries risks from the mini heart pump and stem cell infusion, and the treatment may not improve heart function.
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
-
About 20 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Dec 2018
- Expected to finish
-
Mar 2030
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 to 85 years
- Sex
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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 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: * Patients with a confirmed diagnosis of dilated cardiomyopathy under the supervision of a physician or a heart failure nurse specialist. * NYHA class ≥ 2 symptoms despite having received optimal medical therapy and appropriate device therapy, as per clinical guidelines for an interval of at least 3 months. * No other treatment options available as part of the current best standard of care. * LVEF ≤35% on any imaging modality performed as part of the screening phase. Exclusion Criteria: * Congenital heart disease. * Clinically significant valvular heart disease. * Patients who are not suitable for a Percutaneous Mechanical Support Device (E.g. unsuitable femoral artery anatomy, unable able to lie flat for prolonged time to accommodate the stem cell infusion \& presence of LV thrombus) * Weight of patient that exceeds the maximum limit of the cardiac catheterisation laboratory table / CT scanner. * Cardiomyopathy 2o to a reversible cause that has not been treated e.g. thyroid disease, alcohol abuse, hypophosphataemia, hypocalcaemia, cocaine abuse, selenium toxicity \& chronic uncontrolled tachycardia. * Cardiomyopathy in association with a neuromuscular disorder e.g. Duchenne's progressive muscular dystrophy. * Previous cardiac surgery. * Contra-indication for bone marrow aspiration (thrombocytopaenia - platelet count \<80 x 10(9)/L or extensive surgical scarring/anatomical deformity at site of bone marrow puncture). * Known active infection on admission as defined by a temperature \>37.5°C or on a short course of antibiotics. * An active infection of hepatitis B, hepatitis C, syphilis or HTLV * Known HIV infection * Chronic inflammatory disease requiring on-going medication. * Concomitant disease with a life expectancy of less than one year * Follow-up impossible (no fixed abode, etc.) * Neoplastic disease without documented remission within the past 5 years. * Patients on renal replacement therapy. * Subjects of childbearing potential unless βHCG negative and are on adequate contraception during the trial. * Patients falling into the vulnerable category or lacking capacity * Patients who are unable to understand or read written English will be excluded from the trial. * Killip Class III or above
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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.
Contacts and locations
Locations
-
St Bartholomew's Hospital
London, EC1A 7BE, United Kingdom
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