NCT03651791

Brief Summary

To evaluate the ability to trace iron oxide-labeled mesenchymal stromal cells with magnetic resonance imaging (MRI) after NOGA-guided injection therapy into the myocardium in patients with ischemic heart disease.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
5

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started May 2013

Longer than P75 for phase_1

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2013

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
3.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2017

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

August 23, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 29, 2018

Completed
Last Updated

August 29, 2018

Status Verified

August 1, 2018

Enrollment Period

1.1 years

First QC Date

August 23, 2018

Last Update Submit

August 27, 2018

Conditions

Ischemic Heart Disease

Outcome Measures

Primary Outcomes (1)

  • MSC identification using MRI in-vivo on day 0

    Being able to identify the iron-oxide labeled mesenchymal stromal cells on day 0 after injection into the myocardium by MRI.

    24 hours

Secondary Outcomes (18)

  • MSC identification using MRI in-vivo on day 1

    1 day

  • MSC identification using MRI in-vivo on day 7

    7 days

  • MSC identification using MRI in-vivo after 2 weeks

    2 weeks

  • MSC identification using MRI in-vivo after 4 weeks

    4 weeks

  • MSC identification using MRI in-vivo after 8 weeks

    8 weeks

  • +13 more secondary outcomes

Study Arms (1)

USPIO labeled MSC injection

EXPERIMENTAL

USPIO labeled MSC injection

Combination Product: USPIO labeled MSC injection

Interventions

USPIO labeled MSC injectionCOMBINATION_PRODUCT

USPIO labeled MSC injection

USPIO labeled MSC injection

Eligibility Criteria

Age30 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age between 30 and 80 years.
  • Signed informed consent.
  • Chronic stable ischemic heart disease
  • New York Heart Association (NYHA) class II-IV or Canadian Cardiovascular Society (CCS) class II-IV
  • Maximal tolerable angina and/or heart failure medication.

You may not qualify if:

  • Pregnant or fertile women.
  • Clinical significant anemia, leukopenia, leukocytosis or thrombocythemia.
  • Diminished functional capacity for other reasons such as: chronic obstructive pulmonary disease (COLD) with Forced Expiratory Volume in 1 second (FEV1)\<1 L/min, moderate to severe claudication or morbid obesity.
  • Patients with reduced immune response or treated with immunosuppressive medication.
  • Moderate to severe valvular disease or valvular disease with option for valvular surgery.
  • Other experimental treatment within 4 weeks of baseline evaluation.
  • Other revascularization treatment within 4 months of treatment.
  • Contraindications for Magnetic Resonance Imaging (MRI) such as: Claustrophobia, pacemaker, Implantable Cardioverter Defibrillator (ICD) unit, metal fragments or metal implants in the cranium

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • Mathiasen AB, Hansen L, Friis T, Thomsen C, Bhakoo K, Kastrup J. Optimal labeling dose, labeling time, and magnetic resonance imaging detection limits of ultrasmall superparamagnetic iron-oxide nanoparticle labeled mesenchymal stromal cells. Stem Cells Int. 2013;2013:353105. doi: 10.1155/2013/353105. Epub 2013 Mar 19.

    PMID: 23577035BACKGROUND

  • Hansen L, Hansen AB, Mathiasen AB, Ng M, Bhakoo K, Ekblond A, Kastrup J, Friis T. Ultrastructural characterization of mesenchymal stromal cells labeled with ultrasmall superparamagnetic iron-oxide nanoparticles for clinical tracking studies. Scand J Clin Lab Invest. 2014 Aug;74(5):437-46. doi: 10.3109/00365513.2014.900698. Epub 2014 Apr 15.

    PMID: 24734781BACKGROUND

  • Mathiasen AB, Qayyum AA, Jorgensen E, Helqvist S, Ekblond A, Ng M, Bhakoo K, Kastrup J. In Vivo MRI Tracking of Mesenchymal Stromal Cells Labeled with Ultrasmall Paramagnetic Iron Oxide Particles after Intramyocardial Transplantation in Patients with Chronic Ischemic Heart Disease. Stem Cells Int. 2019 Nov 14;2019:2754927. doi: 10.1155/2019/2754927. eCollection 2019.

    PMID: 31814830DERIVED

MeSH Terms

Conditions

Myocardial Ischemia

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesVascular Diseases

Study Officials

  • Jens Kastrup, MD DMSc

    The Heart Centre, Rigshospitalet, University of Copenhagen

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 23, 2018

First Posted

August 29, 2018

Study Start

May 1, 2013

Primary Completion

June 1, 2014

Study Completion

October 1, 2017

Last Updated

August 29, 2018

Record last verified: 2018-08