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TerminatedNCT00289822Updated Nov 30, 2006

Cell Therapy for Coronary Heart Disease

A Phase 2 interventional study of intracoronary infusion of progenitor cells in Coronary Artery Disease, sponsored by Johann Wolfgang Goethe University Hospital. Terminated at 1 site in Germany. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2006-11-30.

Sponsored by Johann Wolfgang Goethe University Hospital · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
75
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study summary

Impaired contractile function after a heart attack and due to coronary heart disease is a major cause of "heart failure" limiting quality of life and prognosis, which cannot be prevented even with optimal standard therapy.

The aim of the current trial is to investigate whether infusion of progenitor cells into the coronary artery supplying the most dyskinetic left ventricular area may improve left ventricular contractile function, compared to no cell infusion in the control group, in patients with old (>= 3 months) myocardial infarction.

Read the detailed description
  • The study is an open-label, controlled, randomized single-center trial.
  • Patients post myocardial infarction (>= 3 months) with a patent infarct-related artery are included.
  • Bone marrow-derived progenitor cells are aspirated under local anaesthesia, and after cell processing, are infused into the patent infarct-related artery during stop flow within the same day. Blood-derived progenitor cells are isolated out of 250ml peripheral venous blood, and after cell processing and 3 days culture, are infused into the patent infarct-related artery during stop flow. In addition, left ventricular angiography is performed. In the control group coronary angiography and left ventricular angiography without any intracoronary infusion are performed.
  • After 3 months, left ventricular angiography is repeated, and patients of the control group cross-over to active treatment with progenitor cells, whereas patients initially treated with progenitor cells cross-over to the alternate cell type.
  • The primary endpoint is the change in quantitative global left ventricular ejection fraction in LV angiography between the groups.
02

Conditions studied

  • Coronary Artery Disease

Keywords

  • chronic heart failure
  • myocardial infarction
03

In context

Coronary Artery Disease

5,598 studies on the registry are indexed under Coronary Artery Disease; 957 are open to participants now.

This study's enrollment of 75 is below the median of 124 across 3,436 interventional studies indexed under Coronary Artery Disease.

Browse Coronary Artery Disease studies →

Lead sponsor

Johann Wolfgang Goethe University Hospital is the lead sponsor of 158 studies on the registry; 8 are open to participants now.

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

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Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Patients aged 18 to 80
  • Patients post-myocardial infarction (> 3 months old) or with diffuse ischemic CHD
  • Signed informed consent

Exclusion criteria

Exclusion Criteria:

  • Existing neoplastic disease or signs of tumor recurrence within the last 5 years
  • Active infection
  • Active internal bleeding
  • Stroke within the past 2 years
  • Surgery or trauma within the past two months
  • Uncontrolled hypertension over 160/100
  • Arteriovenous malformations or aneurysms
  • HIV infection
  • Signs of significant kidney or liver failure (creatinine > 2.0 mg/dL, GOT > 2 x upper standard value)
  • Thrombopenia (\< 100,000)
  • Anemia (hemoglobin \< 8.5 g/dL)
  • Mental retardation
  • Participation in another clinical study
  • Women of childbearing age
  • Chronic inflammatory disease
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
75 participants

Interventions

  • Drugintracoronary infusion of progenitor cells
06

What researchers measure

Primary outcomes

  1. Change in global left ventricular function (measured by quantitative left ventricular angiography)

Secondary outcomes

  1. Quantitative parameters of regional left ventricular function of the target area

  2. changes in left ventricular volumes

  3. functional status as assessed by NYHA classification

  4. event-free survival after 4 months follow-up

07

Study locations

1 site
  • J. W. Goethe University Hospitals
    Frankfurt, 60590, Germany
08

References and documents

Publications

  • Assmus B, Honold J, Schachinger V, Britten MB, Fischer-Rasokat U, Lehmann R, Teupe C, Pistorius K, Martin H, Abolmaali ND, Tonn T, Dimmeler S, Zeiher AM. Transcoronary transplantation of progenitor cells after myocardial infarction. N Engl J Med. 2006 Sep 21;355(12):1222-32. doi: 10.1056/NEJMoa051779. PubMed 16990385 ↗
  • 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 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 30, 2006, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00289822
Lead sponsor
Johann Wolfgang Goethe University Hospital
First posted
Feb 10, 2006
Start date
Jan 2002
Completion
Jan 2005
Last update
Nov 30, 2006

Study contacts

Andreas M Zeiher, MD
principal investigator · J. W. Goethe University Hospitals
Volker Schaechinger, MD
study director · J. W. Goethe University Hospitals
View the source record on ClinicalTrials.gov ↗

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