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

Dilated Cardiomyopathy Clinical Trial

— DCM-Support  

Official title:

Phase II Study Assessing the Combined Use of Autologous Bone Marrow Derived Mononuclear Cells and G-csf With Percutaneous Circulatory Assistance in the Treatment of Dilated Cardiomyopathy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03572660
• Other study ID #: Reda 012357
• Secondary ID: 2018-001063-23
• Status: Recruiting
• Phase: Phase 2
• Start date: December 24, 2018
• Est. completion date: March 30, 2025

Study information

• Verified date: March 2023
• Source: Barts & The London NHS Trust
• Contact: Anthony Mathur
• Phone: 0203 765 8704
• Email: a.mathur[@]qmul.ac.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: March 30, 2025
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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 ßHCG 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

Related Conditions & MeSH terms

• Cardiomyopathies
• Cardiomyopathy, Dilated
• Dilated Cardiomyopathy

Intervention

Biological:
• Bone marrow derived mononuclear cells and G-CSF
Intra-coronary infusion

Locations

Country	Name	City	State
United Kingdom	St Bartholomew's Hospital	London

Sponsors (1)

Lead Sponsor	Collaborator
Barts & The London NHS Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in left ventricular ejection fraction	Change in left ventricular ejection fraction as measured by cardiac CT	Baseline to 3 months
Secondary	Change in left ventricular ejection fraction	Change in left ventricular ejection fraction as measured by cardiac CT	Baseline to 12 months
Secondary	Change in exercise capacity	Change in exercise capacity as assessed by a 6-minute walk test	Baseline to 3 and 12 months
Secondary	Change in heart failure symptoms	Change in heart failure symptoms as measured by NYHA classification	Baseline to 3 and 12 months
Secondary	Change in quality of life as assessed by Minnesota Living with Heart Failure Questionnaire scores	Change in quality of life as measured by MLHFQ (The 21-item MLHFQ uses a 6-point Likert scale, where 0 = no, 1= very little and 5= very much. The questions are intended to be representative of the ways heart failure can affect physical and emotional dimensions of quality of life)	Baseline to 3 and 12 months
Secondary	Change in quality of life as measured by EuroQol-5 Dimension 5 Levels questionnaires	Change in quality of life as measured by EQ-5D-5L questionnaires (the scale measures quality of life on a 5-component scale including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression)	Baseline to 3 and 12 months
Secondary	Procedural safety as assessed by in-hospital procedural related morbidity/mortality	Procedural safety as assessed by in-hospital procedural related morbidity/mortality	In-hospital procedural time
Secondary	Change in biochemical markers of heart failure	Change in biochemical markers of heart failure as measured by change in NT-proBNP	Baseline to 3 and 12 months
Secondary	Assessment of rates of MACE (cumulative & individual components)	Rates of MACE (all-cause death, myocardial infarction, hospitalisation for heart failure, major arrhythmias [defined as VT and VF])	3 and 12 months
Secondary	Assessment of rates of stroke	Assessment of rates of stroke	3 and 12 months
Secondary	Assessment of peri-procedural myocardial infarction	Assessment of peri-procedural myocardial infarction as per SCAI definition measured by change in troponin (MI defined by increase in troponin >70 times upper limit of normal from baseline).	Day 0 and Day 6
Secondary	Change in renal function	Change in renal function from baseline at 3 and 12 months as measured by creatinine levels.	Baseline to 3 and 12 months
Secondary	Change in inflammatory markers	Change in inflammatory markers as measured by change in C-reactive protein	Baseline to 3 and 12 months