DCM-Support: Use of Bone Marrow Derived Stem Cell and G-CSF With Circulatory Assistance in the Treatment of DCM
Study Details
Study Description
Brief Summary
The DCM SUPPORT study is a single centre, single arm study evaluating the change in left ventricular ejection fraction with the combines use of bone marrow derived stem cells and G-CSF with a percutaneous circulatory assistance for the treatment of dilated cardiomyopathy.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Detailed Description
The DCM SUPPORT study is a single centre, single arm, phase II pilot study. The primary endpoint will be a change in LVEF from baseline measured by a CT scan of the heart at 3 months. The secondary endpoints include change in LVEF from baseline measured by a CT scan of the heart at 12 months, in-hospital procedural related morbidity / mortality and assessment of major adverse cardiac events (MACE; death, heart attack, need for repeat heart revascularisation), change in exercise capacity and NYHA class at 3 months and 12 months respectively. The NYHA classification is a quantitative way of assessing a patient's heart failure symptoms. It places patients into one of four categories (I - IV).
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Other: BMMNC intervention arm Bone marrow derived mononuclear cells and G-CSF |
Biological: Bone marrow derived mononuclear cells and G-CSF
Intra-coronary infusion
|
Outcome Measures
Primary Outcome Measures
- Change in Left Ventricular Ejection Fraction Imaging [Baseline to 3 Months]
Change in Left Ventricular Ejection Fraction on Cardiac CT
Secondary Outcome Measures
- Change in Left Ventricular Ejection Fraction [Baseline to 12 months]
Change in Left Ventricular Ejection Fraction on Cardiac CT
- Blood parameters [Baseline to 1,3 and 12 months]
Change in NT-proBNP, troponin, creatine kinase, renal function and CRP
- Clinical outcomes [3 & 12 months]
MACE endpoints
- Change in exercise capacity 6 minutes walk test [Baseline to 3 & 12 months]
Change distance covered measured in meters during a 6 minutes walking test.
- Change in NHYA classfication [Baseline to 3 and 12 months.]
Change in heart failure symptoms as measured on NHYA classification as assessed by physician.
Eligibility Criteria
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 III or IV symptoms despite having received optimal medical therapy and appropriate device therapy, as per clinical guidelines for an interval of at least 3 months.
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No other treatment options available as part of current best standard care.
-
LVEF ≤30% on the cardiac CT scan performed as part of the screening phase.
Exclusion Criteria:
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NYHA I-II.
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Documented latest ejection fraction >30% (any imaging modality)
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Congenital heart disease.
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Clinically significant valvular heart disease.
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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)
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Weight of patient that exceeds the maximum limit of the cardiac catheter laboratory table / CT scanner.
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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.
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Cardiomyopathy in association with a neuromuscular disorder e.g. Duchenne's progressive muscular dystrophy.
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Previous cardiac surgery.
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Contra-indication for bone marrow aspiration.
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Known active infection at time of randomisation.
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Positive virology tests.
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Chronic inflammatory disease requiring on-going medication.
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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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | St Bartholomew's Hospital | London | United Kingdom | EC1A 7BE |
Sponsors and Collaborators
- Barts & The London NHS Trust
Investigators
- Principal Investigator: Anthony Mathur, Barts & The London NHS Trust
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- Reda 012357
- 2018-001063-23