Use of Bone Marrow Derived Stem Cell and G-CSF With Circulatory Assistance in the Treatment of DCM

Launched by BARTS & THE LONDON NHS TRUST · Jun 19, 2018

Keywords

ClinConnect Summary

This clinical trial, called DCM Support, is exploring a new treatment for people with dilated cardiomyopathy (DCM), a condition that affects the heart's ability to pump blood effectively, leading to heart failure symptoms. The study aims to see if using a patient's own stem cells, taken from their bone marrow, can help improve heart function and reduce symptoms. During the procedure, stem cells will be collected from the patient's hip under local anesthesia and then infused into the arteries that supply blood to the heart, with the assistance of a small heart pump to ease the process.

To participate, patients should have a confirmed diagnosis of dilated cardiomyopathy and be experiencing moderate to severe heart failure symptoms despite receiving the best available medical treatment for at least three months. Key eligibility criteria include having a heart function score (measured by left ventricular ejection fraction) of 35% or lower. Participants will have a follow-up check-in via phone one month after the procedure and in-person visits at three and twelve months later to monitor their progress. It's important to note that certain medical conditions or past treatments may make some individuals ineligible for the trial.

Gender

ALL

Eligibility criteria

• 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