ClinicalTrials.gg
Status unknownNCT00962364BMC registryUpdated Feb 26, 2020

Long-term Evaluation of Patients Receiving Bone Marrow-derived Cell Administration for Heart Disease

An observational study in Acute Myocardial Infarction, Ischemic Cardiomyopathy and Dilated Cardiomyopathy, sponsored by Johann Wolfgang Goethe University Hospital. Status unknown at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-02-26.

Sponsored by Johann Wolfgang Goethe University Hospital · Observational

The sponsor has not verified this record recently (last verified Feb 2020), so the status shown — last known as Active, not recruiting — may be out of date.
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
1,500
Ages
18 Years and older
Sex
All
01

Study summary

This study will provide follow-up information and care of patients who have undergone autologous intracoronary bone marrow cell administration at our institution. Patients are monitored for their response to treatment, progression of heart failure and coronary artery disease, and potential later occurring effects of the administered bone marrow cells.

Patients are eligible for this follow-up study if they have received their first intracoronary bone marrow cell administration for the treatment of cardiac disease at our institution from 2001 ongoing.

Participants are generally seen in the clinic at 12 months and 5 years after cell administration, in the meantime regular yearly telephone contacts are performed until 10 years after cell transplantation.

The detailed description contains the planned procedures that are performed during the clinical visits and, if necessary, at additional contacts.

Read the detailed description

In detail, the following procedures are performed during the clinical visits and, if necessary, at additional contacts:

  • periodic physical examination and blood tests
  • non-invasive imaging studies may include echocardiography and magnetic resonance imaging
  • electrocardiogram at rest and during treadmill testing (may include spiroergometry testing)
  • interrogation of implanted defibrillators / pacemakers for monitoring of arrhythmias
02

Conditions studied

  • Acute Myocardial Infarction
  • Ischemic Cardiomyopathy
  • Dilated Cardiomyopathy
  • Heart Failure
03

In context

Cardiomyopathy, Dilated

258 studies on the registry are indexed under Cardiomyopathy, Dilated; 65 are open to participants now.

This study's planned enrollment of 1,500 is above the median of 224 across 99 observational studies indexed under Cardiomyopathy, Dilated.

Browse Cardiomyopathy, Dilated studies →

Lead sponsor

Johann Wolfgang Goethe University Hospital is the lead sponsor of 160 studies on the registry; 8 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients suffering from heart disease with consecutive signs of heart failure, treated in our clinic or being referred for cell therapy

Eligibility criteria

Inclusion Criteria: Clinical diagnosis of heart disease with signs and symptoms of heart failure due to

  • acute myocardial infarction or
  • ischemic cardiomyopathy with or without previous myocardial infarction or
  • dilated cardiomyopathy due to valvular heart disease, hypertensive heart disease, history of myocarditis (no active myocardial infection present)

Exclusion Criteria:

  • none, all patients meeting the inclusion criteria will be eligible.
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
1,500 participants (estimated)
Biospecimen retention
Samples with dna

Groups and cohorts

  • AMI

    Patients with acute myocardial infarction treated with intracoronary administration of bone marrow derived cells

    Biological: autologous bone marrow-derived cells

  • ICM

    Patients with ischemic cardiomyopathy treated with intracoronary administration of bone marrow derived cells

    Biological: autologous bone marrow-derived cells

  • DCM

    Patients with dilated cardiomyopathy treated with intracoronary administration of bone marrow derived cells

    Biological: autologous bone marrow-derived cells

Interventions

  • Biologicalautologous bone marrow-derived cells

    autologous bone marrow-derived cells isolated by density gradient centrifugation from 50 ml bone marrow aspirate obtained under local anesthesia

06

What researchers measure

Primary outcomes

  1. Evaluation of procedural and long-term safety of intracoronary administration of bone marrow cells for the treatment for cardiac disease

    Time frame: 10 years

07

Study locations

1 site
  • Cardiology, Department of Internal Medicine III
    Frankfurt, 60590, Germany
08

References and documents

Publications

  • Assmus B, Fischer-Rasokat U, Honold J, Seeger FH, Fichtlscherer S, Tonn T, Seifried E, Schachinger V, Dimmeler S, Zeiher AM; TOPCARE-CHD Registry. Transcoronary transplantation of functionally competent BMCs is associated with a decrease in natriuretic peptide serum levels and improved survival of patients with chronic postinfarction heart failure: results of the TOPCARE-CHD Registry. Circ Res. 2007 Apr 27;100(8):1234-41. doi: 10.1161/01.RES.0000264508.47717.6b. Epub 2007 Mar 22. PubMed 17379833 ↗
  • Luu B, Leistner DM, Herrmann E, Seeger FH, Honold J, Fichtlscherer S, Zeiher AM, Assmus B. Minute Myocardial Injury as Measured by High-Sensitive Troponin T Serum Levels Predicts the Response to Intracoronary Infusion of Bone Marrow-Derived Mononuclear Cells in Patients With Stable Chronic Post-Infarction Heart Failure: Insights From the TOPCARE-CHD Registry. Circ Res. 2017 Jun 9;120(12):1938-1946. doi: 10.1161/CIRCRESAHA.116.309938. Epub 2017 Mar 28. PubMed 28351842 ↗
  • Honold J, Fischer-Rasokat U, Seeger FH, Leistner D, Lotz S, Dimmeler S, Zeiher AM, Assmus B. Impact of intracoronary reinfusion of bone marrow-derived mononuclear progenitor cells on cardiopulmonary exercise capacity in patients with chronic postinfarction heart failure. Clin Res Cardiol. 2013 Sep;102(9):619-25. doi: 10.1007/s00392-013-0574-1. Epub 2013 Apr 24. PubMed 23612920 ↗
  • De Rosa S, Seeger FH, Honold J, Fischer-Rasokat U, Lehmann R, Fichtlscherer S, Schachinger V, Dimmeler S, Zeiher AM, Assmus B. Procedural safety and predictors of acute outcome of intracoronary administration of progenitor cells in 775 consecutive procedures performed for acute myocardial infarction or chronic heart failure. Circ Cardiovasc Interv. 2013 Feb;6(1):44-51. doi: 10.1161/CIRCINTERVENTIONS.112.971705. Epub 2013 Jan 29. PubMed 23362308 ↗
  • Leistner DM, Seeger FH, Fischer A, Roxe T, Klotsche J, Iekushi K, Seeger T, Assmus B, Honold J, Karakas M, Badenhoop K, Frantz S, Dimmeler S, Zeiher AM. Elevated levels of the mediator of catabolic bone remodeling RANKL in the bone marrow environment link chronic heart failure with osteoporosis. Circ Heart Fail. 2012 Nov;5(6):769-77. doi: 10.1161/CIRCHEARTFAILURE.111.966093. Epub 2012 Aug 30. PubMed 22936827 ↗
  • Xu Q, Seeger FH, Castillo J, Iekushi K, Boon RA, Farcas R, Manavski Y, Li YG, Assmus B, Zeiher AM, Dimmeler S. Micro-RNA-34a contributes to the impaired function of bone marrow-derived mononuclear cells from patients with cardiovascular disease. J Am Coll Cardiol. 2012 Jun 5;59(23):2107-17. doi: 10.1016/j.jacc.2012.02.033. PubMed 22651868 ↗
09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Oct 2001, a primary completion of Dec 2020 and a completion of Dec 2021. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 19, 2009
First posted
Aug 20, 2009
Start
Oct 2001
Primary completionEst.
Dec 2020
CompletionEst.
Dec 2021
Last update
Feb 26, 2020
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 26, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00962364
Responsible party
A. M. Zeiher (Prof. Dr. Andreas M. Zeiher, Johann Wolfgang Goethe University Hospital) — Principal investigator
First posted
Aug 20, 2009
Start date
Oct 2001
Primary completion
Dec 2020 (estimated)
Completion
Dec 2021 (estimated)
Last update
Feb 26, 2020

Study contacts

Andreas M Zeiher, Prof. Dr
principal investigator · Cardiology, Goethe University Frankfurt, Germany

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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