Clinical trial NCT05925608: Clinical Trial of Human Allogenic Culture-expanded Bone Marrow-derived Mesenchymal Stem Cells
Official title: Phase I/II Clinical Trial of Human Allogenic Culture-expanded Bone Marrow-derived Mesenchymal Stem Cells (hMSCs) in Patients With Ischemic Heart Failure With Reduced Ejection Fraction (HFrEF)
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: PHASE1
PHASE2
Conditions: Heart Failure, Systolic
Lead sponsor: BioCardia, Inc.
Sponsor class: INDUSTRY
First posted: 2023-06-29
Enrollment: 39
Sex: ALL
Minimum age (years): 21
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Phase I: Dose escalation, safety study consisting of 3 cell doses of 20million, 100 million and 200 million allogeneic hMSC. Each dose cohort will consist of 3 patients. Phase II: Randomized, controlled trial to evaluate the treatment.
Primary purpose: TREATMENT

Brief summary: This clinical study will utilize allogenic bone marrow-derived culture-expanded MSC that are expanded from mesenchymal stem cells and delivered using the investigational Helix transendocardial delivery catheter as a therapy for ischemic HFrEF with reduced ejection fraction.

Detailed description: Chronic heart failure is in need of new therapies. Over the past few years, cardiovascular regenerative medicine using bone marrow-derived cells has emerged as a new treatment strategy that could have tremendous benefit in treating heart failure. At present, several types of adult bone marrow derived stem cells hold great promise to treat heart failure. Allogenic culture-expanded bone marrow-derived human mesenchymal stem cells (MSC) are the subject of the current study as having potential to provide a safe and effective treatment for patients with ischemic heart failure. Mesenchymal stem cells are multipotent stromal cells that can differentiate into a variety of cell types, including osteoblasts (bone cells), chondrocytes (cartilage cells), myocytes (muscle cells) and adipocytes (fat cells which give rise to marrow adipose tissue). The CardiALLO cell therapy is an allogenic bone marrow-derived cell treatment which is delivered intramyocardially using the investigational Helix delivery catheter. The purpose of this study is to determine the safety, optimal dose and efficacy of CardiALLO cell therapy system in patients with ischemic heart failure with reduced ejection fraction (HFrEF). Phase I is designed to determine effective dose and Phase II is designed to evaluate effectiveness for improving clinical outcomes.

Eligibility criteria: Inclusion Criteria:

* New York Heart Association (NYHA) Class II or III
* Diagnosis of chronic ischemic left ventricular dysfunction secondary to myocardial infarction
* Left ventricular ejection fraction between 20% and 40%
* On stable, guideline-directed medical and device therapy, as appropriate
* NTproBNP level of \>500 pg/ml.
* Have inflammation \> 2 mg/L as measured by high-sensitivity C-reactive protein (hs-CRP) test.

Exclusion Criteria:

* Other cardiovascular or medical history parameters, as appropriate, that may preclude safe administration of the study treatment.

Primary outcomes:
measure: Treatment-emergent serious adverse events
timeFrame: Through 30 days post-procedure.
measure: Composite endpoint consisting of all cause or cardiac death, non-fatal cardiac-related hospitalizations and functional capacity measured using the 6 minute walk distance.
timeFrame: Through Month 12
Secondary outcomes:
measure: Overall survival
timeFrame: Through 12 months
measure: Major Adverse Cardiac Events (MACE)
timeFrame: Through 12 months
measure: Minnesota Living with Heart Failure Questionnaire
timeFrame: Through 12 months
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: University of Florida
state: Florida
Study officials:
affiliation: University of Florida
name: Carl Pepine, MD
role: PRINCIPAL_INVESTIGATOR
References: