Cell Therapy and Myocardial Recovery in Heart Failure Patients Undergoing Left Ventricular Assist Device Support

NCT06154044 | Recruiting Phase 2

• 1 other identifier: UMC 1
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of CELL-VAD Pilot trial is to investigate a personalized stem cell therapy approach for patients with advanced non-ischemic chronic heart failure (NICM) who are supported by LVAD. In the clinical trial, the investigators aim to enroll 10 patients with NICM, scheduled for LVAD implantation. After successful LVAD implantation, patients will be enrolled and followed for 2 months to allow for postoperative rehabilitation and heart failure medical therapy and LVAD support optimization. All patients will then undergo autologous CD34+ cell therapy which will be intracoronaryly delivered to the target myocardium using NOGA electromechanical mapping system. All patients will be followed for 6 months after cell therapy. At baseline, and at 1, 3, and 6 months after cell therapy, the investigators will perform comprehensive clinical evaluation.

Conditions

Heart Failure; Mechanical Circulatory Support

Keywords

heart failure; mechanical circulatory support; stem cells

Outcome Measures

Primary Outcomes (9)

• change in left ventricular ejection fraction (LVEF)

  change in left ventricular ejection fraction (LVEF), measured by transthoracic echocardiography using Simpson's rule between the time of stem cell therapy and 6 months.

  Baseline to 6 months

• Changes in left ventricular end-systolic and end-diastolic dimensions

  Changes in left ventricular end-systolic (LVESd) and end-diastolic dimensions (LVEDd) measured by transthoracic echocardiography in parasternal longitudinal axis with expected change \> 10%.

  Baseline to 3 and 6 months

• Changes in left ventricular longitudinal and circumferential strains

  Changes in left ventricular longitudinal and circumferential strains will be measured using transthoracic echocardiography and segmental wall motion analysis with expected change \> 10%.

  Baseline to 3 and 6 months

• Changes in right ventricular size

  Changes in right ventricular size (RVIDd) will be measured using transthoracic echocardiography with expected change \> 10%.

  Baseline to 3 and 6 months

• Change in serum neurohumoral activation

  Change in serum neurohumoral activation will be assessed measuring NT-proBNP serum levels, with expected decrease \> 30%.

  Baseline to 3 and 6 months

• Changes in serum markers of fibrosis and angiogenesis

  Changes in serum markers of fibrosis and angiogenesis will be assessed by measuring biomarkers of fibrosis and angiogenesis using Luminex commercially available kits (Human XL Cytokine Luminex® Performance Assay 46-plex); any detectable change will be considered a positive response.

  Baseline to 3 and 6 months

• Change in 6-minute walk test

  Change in 6-minute walk test with expected increase \> 30 m

  Baseline to 3 and 6 months

• Change in quality of life questionnaire score

  Change in quality of life KCCQ questionnaire score with expected decrease of ≥ 5 points

  Baseline to 3 and 6 months

• Change in heart failure-related hospitalization

  Change in heart failure-related hospitalization; any decrease will be considered

  Baseline to 3 and 6 months

Study Arms (1)

Treatment Arm

EXPERIMENTAL

After successful LVAD implantation, patients will be enrolled and followed for 2 months to allow for postoperative rehabilitation and heart failure medical therapy and LVAD support optimization. All patients will then undergo autologous CD34+ cell therapy which will be delivered via intracoronary route. All patients will be followed for 6 months after cell therapy. At baseline, and at 1, 3 and 6 months after cell therapy, we will perform comprehensive clinical evaluation. Clinical, biochemical, biomarker-related, imaging and myocardial histology data will be transferred to a secured central database.

Biological: CD34+ stem cell therapy

Interventions

CD34+ stem cell therapy BIOLOGICAL

After 5-days GCSF stimulation all patients will undergo apheresis to obtain CD34+ cell which will subsequently be injected in the target coronary artery using microcatheter.

Treatment Arm

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• non-ischemic dilated cardiomyopathy
• patient accepted for LVAD support
• optimal (or maximal tolerable therapy) heart failure ≥ 2 months
• age 18-65 years
• ability to provide informed consent

You may not qualify if:

• ischemic cardiomyopathy
• Cardiomyopathy with 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.
• ongoing or recent (less than 1 month) infection
• acute multi-organ failure
• clinically significant anemia (Hb \< 10 g/dL)
• clinically significant leukopenia (L \< 2 x 109/L) or leukocytosis (L \> 14 x 109/L)
• clinically significant thrombocytopenia (TRC \< 50 x 109/L)
• known disorders of hemostasis that can not be corrected
• history of any thromboembolic complications
• chronic kidney disease (higher than stage III)
• chronic liver disease (Child B or C)
• diminished functional capacity for other reasons such as COPD, moderate or severe claudications, severe musculosceletal system pain or morbid obesity (BMI \> 35 kg/m2)
• aortic stenosis (AVA \< 1.3 cm2) or ocluded aortic valve
• artificial (mechanical or biological) aortic valve

Sponsors & Collaborators

• University Medical Centre Ljubljana: lead

Study Sites (1)

University Medical Center Ljubljana

Ljubljana, 1000, Slovenia

RECRUITING

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Bojan Vrtovec, MD, PhD

  UMC Ljubljana

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mateja Lani

CONTACT

+38615221163; mateja.lani@kclj.si

Gregor Poglajen, MD, PhD

CONTACT

+38615228671; gregor.poglajen@kclj.si

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Masking Details: Imaging core lab employees will be blinded to the patient's status (before or after cell therapy)
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 6, 2023
• First Posted: December 1, 2023
• Study Start: May 1, 2022
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): March 1, 2029
• Last Updated: January 26, 2026

Record last verified: 2026-01

Locations

SL (1)