Brief Title
Repetitive Intramyocardial CD34+ Cell Therapy in Dilated Cardiomyopathy (REMEDIUM)
Official Title
Repetitive Intramyocardial CD34+ Cell Therapy in Dilated Cardiomyopathy
Brief Summary
The goal of REMEDIUM project is to develop personalized stem cell therapy for patients with
chronic heart failure due to dilated cardiomyopathy (DCM). The main focus of the project is
(1) on repetitive administration of cell therapy that would allow for long-lasting
improvements in heart function and outcome in this patient population. In parallel, the
investigators aim to (2) develop a standardized patient-specific stem cell product that could
be cryopreserved and stored in a stem cell bank for prolonged time periods, and used for
therapeutic application when clinically indicated. By using a unique multimodality imaging
platform, the goal of this project is also to (3) define standardized clinical criteria that
would serve as a guideline for evaluation of the effects of stem cell therapy in future
clinical trials and everyday clinical settings. Finally, to improve the clinical
implementation of cell therapy,the investigators aim to (4) develop a stem cell delivery
technique that could be used to treat both left and right and ventricular failure and could
be implemented in a standardized fashion designed for a widespread clinical use.
Study Phase
Phase 2/Phase 3
Study Type
Interventional
Primary Outcome
Change in left ventricular ejection fraction
Secondary Outcome
Changes in regional wall motion
Condition
Dilated Cardiomyopathy
Intervention
Stem cell therapy
Study Arms / Comparison Groups
Group A
Description: Repetitive stem cell administration
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
66
Start Date
January 2014
Completion Date
December 2017
Primary Completion Date
September 2017
Eligibility Criteria
Inclusion Criteria:
- Age 18-70 years old
- Diagnosis of DCM according to European Society of Cardiology position statement
- Left ventricular ejection fraction (LVEF) by echocardiography 20-40%,
- New York Heart Association (NYHA) functional class heart failure II or III for at
least 3 months before referral.
Exclusion Criteria:
- Acute multi-organ failure
- History of any malignant disease within 5 years
- Diminished functional capacity due to non-cardiac co-morbidities (COPD, PAOD, morbid
obesity)
- Pregnancy
Gender
All
Ages
18 Years - 70 Years
Accepts Healthy Volunteers
No
Contacts
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Location Countries
Slovenia
Location Countries
Slovenia
Administrative Informations
NCT ID
NCT02248532
Organization ID
REMEDIUM
Responsible Party
Principal Investigator
Study Sponsor
University Medical Centre Ljubljana
Study Sponsor
, ,
Verification Date
January 2018