NCT01337011

Brief Summary

This is a pilot study comparing the effect of intra-coronary versus intramyocardial application of enriched CD133pos autologous bone marrow derived stem cells for improving left ventricular function in chronic ischemic cardiomyopathy.

Trial Health

57
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable heart-failure

Timeline
Completed

Started Jul 2011

Longer than P75 for not_applicable heart-failure

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 14, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 18, 2011

Completed
2 months until next milestone

Study Start

First participant enrolled

July 1, 2011

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 2, 2016

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 17, 2017

Completed
Last Updated

August 24, 2021

Status Verified

August 1, 2021

Enrollment Period

4.7 years

First QC Date

April 14, 2011

Last Update Submit

August 20, 2021

Conditions

Heart Failure

Keywords

Chronic Ischemic Cardiomyopathy

Outcome Measures

Primary Outcomes (1)

  • LVEF

    Improvement of global left ventricular function as well as global strain rate as assessed by echocardiography. Transthoracic echocardiography will be performed at baseline and after 6 and 12 month. Images are acquired in the standard parasternal and apical views.

    after 6 to 12 months

Study Arms (2)

intra-coronary administration

EXPERIMENTAL

Application of stem cells using the intra-coronary route.

Other: autologous CD133pos stem cell application

intra-myocardial administration

EXPERIMENTAL

Application of stem cells using the intra-myocardial route.

Other: autologous CD133pos stem cell application

Interventions

autologous CD133pos stem cell applicationOTHER

The study aims to show efficacy of both intra-myocardial autologous CD133pos bone marrow cell application as well as intra-coronary CD133pos cell application in patients with symptomatic ischemic heart disease. In addition, efficacy between the two delivery routes will be compared.

intra-coronary administrationintra-myocardial administration

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients 18 to 80 years old
  • Of female and male gender
  • Patient has reduced ejection fraction as evaluated by routine clinical angiogram, echocardiography or MRI (≤45%) due to ischemic heart disease
  • symptomatic heart failure NYHA ≥ II on optimal therapy
  • coronary artery in the target region that can be used for cell infusion
  • Patient has been informed of the nature of the clinical trial and agrees to its provision and has provided written informed consent

You may not qualify if:

  • planned or performed CABG surgery or PCI within 4 weeks of study entry
  • recent myocardial infarction (\< 6 months)
  • TIMI flow \< II in the coronary artery selected for infusion
  • cardiogenic shock requiring mechanical ventilation or intra-aortic balloon pump
  • progressive tumor disease
  • primary disease of bone marrow including mal-function of components of the coagulation system
  • women of child-bearing age premenopausal
  • LV wall thickness \< 5mm at planned site of injection
  • ventricular wall thrombus
  • severe aortic valvular heart disease
  • severe atrial or ventricular tachycardia unresponsive to intravenous or oral drug therapy
  • aneurysm of the anterior wall
  • history of stroke
  • know diseases of the liver resulting in reduced plasmatic coagulation with spontaneous INR \>2
  • patients with chronic infectious diseases (HBV, HCV, HIV, seropositivity for Treponema pallidum)
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ASKLEPIOS Klinik St. Georg

Hamburg, 20099, Germany

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Martin Bergmann, PD Dr.

    Asklepios Kliniken Hamburg GmbH

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Comparison of the effect of CD133pos. bone marrow derived stem cells using the intra-myocardial vs. the intra-coronary route of administration for improving left ventricular function in patients with chronic ischemic cardiomopathy.
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 14, 2011

First Posted

April 18, 2011

Study Start

July 1, 2011

Primary Completion

March 2, 2016

Study Completion

July 17, 2017

Last Updated

August 24, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)