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

NCT03043742 | Completed Phase 1 DMC

• 1 other identifier: 15-1051
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chronic Ischemic Heart Disease

Outcome Measures

Primary Outcomes (1)

• Occurrence of Treatment-emergent serious adverse events (SAE) and adverse events

  Major adverse cardiac event and adverse events defined in the common toxicity criteria

  Assess from Procedure through 12 months

Secondary Outcomes (9)

• Change in left ventricular ejection fraction compared to baseline

  Assessed at baseline, 6 months, and 12 months

• Change in myocardial regional function compared to baseline

  Assessed at baseline and 6 months

• Change in myocardial regional viability compared to baseline

  Assessed at baseline and 6 months

• Change in distance walked compared to baseline

  Assessed at baseline, 3 months, 6 months, and 12 months

• Change in quality of life associated with heart failure compared to baseline

  Assessed at baseline, 3 months, 6 months, and 12 months

Study Arms (1)

Phase I Open Label

EXPERIMENTAL

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

Drug: Bone Marrow Derived Autologous CD133+ Selected Cell Product

Interventions

Bone Marrow Derived Autologous CD133+ Selected Cell Product DRUG

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

Also known as: Stem cell

Phase I Open Label

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Michael Sekela: lead

Study Sites (1)

University of Kentucky Healthcare

Lexington, Kentucky, 40536, United States

Location

Study Officials

• Michael Sekela, MD

  University of Kentucky

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Cardiothoracic Surgeon

Study Record Dates

• First Submitted: June 17, 2016
• First Posted: February 6, 2017
• Study Start: July 12, 2016
• Primary Completion: November 12, 2020
• Study Completion: November 12, 2020
• Last Updated: December 11, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)