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

Last updated: July 31, 2024
Sponsor: Barts & The London NHS Trust
Overall Status: Active - Not Recruiting

Phase

2

Condition

Cardiac Disease

Cardiomyopathy

Heart Disease

Treatment

Bone marrow derived mononuclear cells and G-CSF

Clinical Study ID

NCT03572660
Reda 012357
2018-001063-23
  • Ages 18-85
  • All Genders

Study Summary

DCM Support is recruiting patients with dilated cardiomyopathy and heart failure symptoms. The goal of this clinical trial is to examine whether treatment with a patient's own stem cells can improve their heart function and alleviate heart failure symptoms.

  • Stem cells will be collected from bone marrow in the patient's hip under local anaesthetic.

  • The stem cells will be infused into the arteries that supply blood to the heart under local anaesthetic.

  • A mini heart pump will be used to take the strain off the heart during the procedure.

  • The follow-up involves a phone call at 1 month and clinic visits at 3 and 12 months

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients with a confirmed diagnosis of dilated cardiomyopathy under the supervisionof a physician or a heart failure nurse specialist.

  • NYHA class ≥ 2 symptoms despite having received optimal medical therapy andappropriate device therapy, as per clinical guidelines for an interval of at least 3months.

  • 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

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 toaccommodate the stem cell infusion & presence of LV thrombus)

  • Weight of patient that exceeds the maximum limit of the cardiac catheterisationlaboratory table / CT scanner.

  • Cardiomyopathy 2o to a reversible cause that has not been treated e.g. thyroiddisease, alcohol abuse, hypophosphataemia, hypocalcaemia, cocaine abuse, seleniumtoxicity & chronic uncontrolled tachycardia.

  • Cardiomyopathy in association with a neuromuscular disorder e.g. Duchenne'sprogressive muscular dystrophy.

  • Previous cardiac surgery.

  • Contra-indication for bone marrow aspiration (thrombocytopaenia - platelet count <80x 10(9)/L or extensive surgical scarring/anatomical deformity at site of bone marrowpuncture).

  • Known active infection on admission as defined by a temperature >37.5°C or on ashort 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 adequatecontraception 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 fromthe trial.

  • Killip Class III or above

Study Design

Total Participants: 20
Treatment Group(s): 1
Primary Treatment: Bone marrow derived mononuclear cells and G-CSF
Phase: 2
Study Start date:
December 24, 2018
Estimated Completion Date:
March 31, 2025

Study Description

DCM SUPPORT is a single centre, single arm clinical trial taking place at St Bartholomew's Hospital in London, UK.

  • It is recruiting patients with dilated cardiomyopathy and ongoing heart failure symptoms

  • All patients undergo a bone marrow aspiration after 5 days of subcutaneous G-CSF injections

  • After cell processing, bone marrow-derived mononuclear cells are infused into the coronary arteries using the stop-flow technique. An intra-procedural Impella CP device is used to support the circulation.

  • The primary endpoint is change in left ventricular ejection fraction at 3 months as measured by cardiac CT.

Connect with a study center

  • St Bartholomew's Hospital

    London, EC1A 7BE
    United Kingdom

    Site Not Available

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