MedDataX Logo

Stem Cell Heart Injections During Laser Revascularization Surgery for Treatment of Chronic Ischemic Heart Disease

NCT ID: NCT03043742

Last Updated: 2020-12-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-07-12

Study Completion Date

2020-11-12

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Assess the safety and effectiveness of stem cell application with regard to improvement in regional myocardial function in patients receiving Trans-Myocardial Laser Revascularization (TMR) and stem cells.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Multiple case experiences and studies have been published reviewing clinical experiences with Carbon Dioxide Trans-Myocardial Laser Revascularization (TMR) and autologous bone marrow derived cell application. These experiences have demonstrated perfusion improvements, ejection fraction improvements and improvements in angina or heart failure symptoms. The investigators elected to examine the use of CD133 positive (CD133+) BM-derived stem cells because of their pluripotent nature and the fact that during the CD133 selection process inflammatory cells present in the bone marrow are being discarded. CD133+ is a recently discovered marker for more primitive bone marrow derived multipotent stem and endothelial progenitor cells and is of particular interest in studies directed to therapeutic angiogenesis, as these cells have been shown to differentiate into endothelial and myogenic cell lines. Multiple studies have utilized BM derived cells for myocardial regeneration. Patients who received CD133+ cells showed improved perfusion at injection sites of stem cells leading to a significant increase in volume of left ventricular ejection fraction, regional wall motion in the infarct zone, and a reduction in end systolic left ventricular volume.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Chronic Ischemic Heart Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Phase I Open Label

open label bone marrow derived autologous CD133+ selected stem cell application in patients receiving trans-myocardial laser revascularization to improve regional myocardial function as detailed below:

Drug: CD133+ selected stem cells Dosage: Single injection of 0.1-0.2 ml around each laser channel Frequency: 10-20 channels Duration: Trans-Myocardial Revascularization

Group Type EXPERIMENTAL

Bone Marrow Derived Autologous CD133+ Selected Cell Product

Intervention Type DRUG

Injection of bone marrow derived autologous CD133+ cell product into laser channels during Trans-Myocardial Revascularization

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Bone Marrow Derived Autologous CD133+ Selected Cell Product

Injection of bone marrow derived autologous CD133+ cell product into laser channels during Trans-Myocardial Revascularization

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Stem cell

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Presence of at least two vessel coronary artery disease not amenable to direct revascularization
* Area of interest defined as part of free left ventricular vall with reduced contractility
* Demonstration of reduced perfusion in the area of interest (\>30% of free wall)
* Global ejection fraction 30-45% with symptoms class \>\_ II on the NYHA scale
* Significant refractory angina defined as symptoms class \>\_ III that are refractory to maximal medical and anti-angina therapy
* Expected survival of at least two years

Exclusion Criteria

* Any condition that prevents successful stem cell collection or application, e.g. systemic infection, puncture for stem cell collection impossible
* Any condition that may adversely affect bone marrow such as malignancy or prior irradiation to the pelvic bone
* Mitral valve insufficiency \> moderate grade
* History of ventricular arrhythmias not controlled by medication and/or AICD
* Need for additional heart surgery (i.e. valve replacement)
* Emergency or salvage operation defined as within 48 hours of diagnosis
* Evidence of left ventricular thrombus
* Previous heart surgery within the last 6 months
* Increased Troponin T (\> 3X ULN) in patients with unstable angina at time of intervention
* History of symptomatic carotid disease within the last 3 months prior to study intervention
* Ejection fraction \< 30%
* End stage renal disease
* Untreatable cancer, current or within preceding 5 years
* Severe COPD
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Michael Sekela

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Michael Sekela

Cardiothoracic Surgeon

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Michael Sekela, MD

Role: PRINCIPAL_INVESTIGATOR

University of Kentucky

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of Kentucky Healthcare

Lexington, Kentucky, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

15-1051

Identifier Type: -

Identifier Source: org_study_id