Repetitive Intramyocardial CD34+ Cell Therapy in Dilated Cardiomyopathy (REMEDIUM)

University Medical Centre Ljubljana

Status and phase: Completed; Phase 3; Phase 2

Conditions: Heart Failure; Dilated Cardiomyopathy

Treatments: Biological: Stem cell therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT02248532

REMEDIUM

Details and patient eligibility

About

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.

Enrollment: 66 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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66 participants in 2 patient groups

Group A

Active Comparator group

Description:

Repetitive stem cell administration

Treatment:

Biological: Stem cell therapy

Group B

Active Comparator group

Description:

Single stem cell administration

Treatment:

Biological: Stem cell therapy