Brief Title
Use of Bone Marrow Derived Stem Cell and G-CSF With Circulatory Assistance in the Treatment of DCM
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
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.
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 Phase
Phase 2
Study Type
Interventional
Primary Outcome
Change in Left Ventricular Ejection Fraction Imaging
Secondary Outcome
Change in Left Ventricular Ejection Fraction
Condition
Dilated Cardiomyopathy
Intervention
Bone marrow derived mononuclear cells and G-CSF
Study Arms / Comparison Groups
BMMNC intervention arm
Description: Bone marrow derived mononuclear cells and G-CSF
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Biological
Estimated Enrollment
20
Start Date
December 24, 2018
Completion Date
July 30, 2021
Primary Completion Date
December 30, 2020
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 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. - 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: - NYHA I-II. - Documented latest ejection fraction >30% (any imaging modality) - 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 catheter 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. - Known active infection at time of randomisation. - Positive virology tests. - 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
Gender
All
Ages
18 Years - 85 Years
Accepts Healthy Volunteers
No
Contacts
Anthony Mathur, 0203 765 8715, [email protected]
Location Countries
United Kingdom
Location Countries
United Kingdom
Administrative Informations
NCT ID
NCT03572660
Organization ID
Reda 012357
Secondary IDs
2018-001063-23
Responsible Party
Sponsor
Study Sponsor
Barts & The London NHS Trust
Study Sponsor
Anthony Mathur, Principal Investigator, Barts & The London NHS Trust
Verification Date
July 2019