Clinical trial
A PILOT TRIAL OF CELL THERAPY IN HEART FAILURE WITH PRESERVED EJECTION FRACTION
Name
CELLpEF
Description
The primary objective of the study is to investigate safety and efficacy of transendocardial CD34+ cell therapy in patients with HFpEF by evaluating changes in myocardial structure and function, patient exercise capacity and clinical outcome.
The safety end-points include serious adverse events (SAEs), defined as any serious event that may result in persistent or significant disability or incapacity and included death, heart transplantation, sustained ventricular arrhythmia (ventricular tachycardia or ventricular fibrillation), and heart failure exacerbation requiring hospitalization.
Trial arms
Trial start
2016-01-01
Estimated PCD
2022-01-01
Trial end
2022-03-01
Status
Completed
Phase
Early phase I
Treatment
Cell Therapy
Electro-anatomical mapping will be performed using the Biosense NOGA system (Biosense-Webster, Diamond Bar, California). Local diastolic function will be assessed by a novel algorhithm that allows for the measuring local ventricular relaxation times at each of the sampling points. Target areas for cell delivery will be defined as the myocardial segments with the evidence of local diastolic dysfunction and myocardial hibernation. Transendocardial delivery of cell suspension in the SC Group will be performed with MyoStar® (Biosense Webster) injection catheter. Each patient will receive 20 injections of 0.3 mL of stem cell suspension.
Arms:
SC Group
Size
30
Primary endpoint
Change in left ventricular filling pressures (E/e') assessed by echocardiography
Baseline, 6 months and 1 year
Eligibility criteria
Inclusion Criteria:
* Preserved left ventricular systolic function on echocardiography (LVEF\>50%)
* Evidence of diastolic dysfunction by echocardiography (E/e'\>15)
* Symptoms of heart failure
* NT-proBNP levels \>300 pg/ml
* absence of permanent atrial fibrillation
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SEQUENTIAL', 'interventionModelDescription': 'The study is designed in a prospective crossover fashion. In Phase 1 of the study, all patients are treated with optimization of medical therapy for 6 months. Thereafter, all patients cross over to Phase 2 of the study, where they receive transendocardial CD34+ cell therapy. Follow-up of Phase 2 lasts for 6 months. At the time of enrollment (6 months before cell therapy), at time of cell therapy, and 6 months thereafter we will perform detailed clinical evaluation, laboratory assays, echocardiography, 6-minute walk test, and measure plasma levels of N-terminal pro B-type natriuretic peptide (NT-proBNP).', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'The echocardiographer will be blinded for the timing of echocardiographic recordings.'}}, 'enrollmentInfo': {'count': 30, 'type': 'ACTUAL'}}
Updated at
2023-05-10
1 organization
1 product
1 indication
Organization
University Medical Centre LjubljanaProduct
Cell Therapy