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

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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