AzTrials
AzTrials

Myocardial InfarctionPhase 3NCT00279175

REPAIR-AMI: Intracoronary Progenitor Cells in Acute Myocardial Infarction (AMI)

A Phase 3 study testing Intracoronary infusion of enriched bone marrow-derived progenitor cells in people with Myocardial Infarction, run by A. M. Zeiher at 17 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

Impaired contractile function after a heart attack of the heart is a major cause of "heart failure" limiting quality of life and prognosis, which cannot be prevented even with optimal standard therapy, including immediate balloon/stent dilation of the infarct vessel. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Myocardial Infarction
What is being tested?
Intracoronary infusion of enriched bone marrow-derived progenitor cells
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
204 participants
Where
17 sitesin 2 countries
Study dates
Apr 2004to Dec 2010
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients with acute myocardial infarction (ST elevation in at least 2 leads >= 0.2 mV in V1,V2 or V3 or >= 0.1 mV in other leads), treated by one of the following procedures
  • Either acute PCI with stent implantation within 24 hours after symptom onset or
  • treatment with thrombolysis within 12 hours of symptom onset followed by PCI with stent implantation within 24 hours after thrombolysis.
  • Acute PCI / stent implantation has been successful (residual stenosis visually < 30% and TIMI flow >= 2).
  • At the time of inclusion patient does no longer require i.v. catecholamines or mechanical hemodynamic support (aortic balloon pump)
  • Significant regional wall motion abnormality in LV angiogram at the time of acute PCI (ejection fraction <= 45% on visual estimation).
Show all 9Show fewer
  • Maximal CK elevation >= 400 U/l (measured at 37° C) with significant MB fraction > 6%
  • Age 18 - 80 Years
  • Written informed consent

Who cannot join

  • Regional wall motion abnormality outside the area involved in the index acute myocardial infarction.
  • Need to revascularize additional vessels, outside the infarct artery.
  • Arteriovenous malformations or aneurysms
  • Active infection (CRP > 10 mg/dl) now, or fever or diarrhea within last 4 weeks.
  • Chronic inflammatory disease
  • HIV infection or active hepatitis
Show all 22Show fewer
  • Neoplastic disease without documented remission within the past 5 years.
  • Cerebrovascular insult within 3 months
  • Impaired renal function (creatinine > 2 mg/dl) at the time of cell therapy
  • Significant liver disease (GOT > 2x upper limit) or spontaneous INR > 1,5)
  • Anemia (hemoglobin < 8.5 mg/dl)
  • Platelet count < 100.000/µl
  • Hypersplenism
  • Known allergy or intolerance to clopidogrel, heparin or abciximab.
  • History of bleeding disorder
  • Gastrointestinal bleeding within 3 months
  • Major surgical procedure or traumata within 2 months
  • Uncontrolled hypertension
  • Pregnancy
  • Mental retardation
  • Previously performed stem / progenitor cell therapy
  • Participation in another clinical trial within the last 30 days.

Trial locations and contacts

17 sites in 2 countries.

17 sites in 2 countries

Germany16 sites

  • Zentralklinik Bad Berka

    Bad Berka, 99437

  • Kerckhoff Klinik

    Bad Nauheim, 61231

  • Herz- und Diabeteszentrum NRW

    Bad Oeynhausen, 32545

  • BG Kliniken Bergmannsheil

    Bochum, 44789

  • Klinikum Lippe

    Detmold, 32756

  • Rotes-Kreuz Krankenhaus - Kardiologisches Centrum

    Frankfurt, 60316

  • J. W. Goethe University Hospitals

    Frankfurt, 60590

  • Universitätsklinkum Giessen

    Giessen, 35392

  • Parxis Schofer, Mathey und Partner

    Hamburg, 22763

  • Universitätsklikum Homburg

    Homburg/Saar, 66421

  • Klinikum Kassel

    Kassel, 34125

  • Herzzentrum - Universität Leipzig

    Leipzig, 04289

  • Herzzentrum Ludwigshafen

    Ludwigshafen, 67073

  • Universitätsklinik Mainz

    Mainz, 55131

  • Universitätsklinikum Mannheim

    Mannheim, 68167

  • Zentralklinikum Suhl

    Suhl, 98527

Other trials in Germany

Switzerland1 site

  • Universitätsspital Zürich

    Zurich, 8091

Other trials in Switzerland

About this study

Official title: Reinfusion of Enriched Progenitor Cells And Infarct Remodeling in Acute Myocardial Infarction (REPAIR - AMI)

Impaired contractile function after a heart attack of the heart is a major cause of "heart failure" limiting quality of life and prognosis, which cannot be prevented even with optimal standard therapy, including immediate balloon/stent dilation of the infarct vessel.

The aim of the REPAIR-AMI trial is to investigate whether infusion of progenitor cells into the infarct vessel (after successful reperfusion therapy) may improve left ventricular contractile function compared to placebo therapy. After bone marrow aspiration progenitor cells are enriched via a centrifugation method.

Read the detailed description
  • The study is a double-blind, placebo-controlled, randomized, multicenter trial.
  • Patients after an acute myocardial infarction, undergoing successful reperfusion therapy are included.
  • All patients undergo bone marrow aspiration 3 to 6 days after the infarction.
  • After cell processing, enriched bone marrow-derived progenitor cells or placebo medium is infused direct into the infarct related artery during stop-flow. In addition, a left ventricular angiography is performed.
  • After 4 months left ventricular angiography is repeated. The primary endpoint is the difference in change of left ventricular ejection fraction between the two groups.
Being tested
Intracoronary infusion of enriched bone marrow-derived progenitor cells, Placebo medium supplemented with autologous serum
Keywords
Acute myocardial infarction
Medical subject headings
Myocardial Infarction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Intracoronary infusion of enriched bone marrow-derived progenitor cellsBiological

  • Placebo medium supplemented with autologous serumBiological

Study groups in NCT00279175
Study groupRoleWhat they receive
BMCExperimentalIntracoronary infusion of autologous bone marrow derived cells
Receives: Biological: Intracoronary infusion of enriched bone marrow-derived progenitor cells
PlaceboPlacebo comparatorIntracoronary infusion of Placebo medium
Receives: Biological: Placebo medium supplemented with autologous serum

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in global left ventricular function in quantitative LV angiography after 4 months.

    absolute delta LVEF (%)

    Measured: baseline to 4 months

Secondary outcomes (11)

  1. Primary endpoint in patients without restenosis.

    absolute delta LVEF (%)

    Measured: baseline to 4 months

  2. Improvement of regional wall motion in infarct area

    Measured: baseline to 4 months

  3. Reduction of LV end-systolic volume

    Measured: baseline to 4 months

  4. Major adverse cardiac events (MACE)

    Measured: at 4, 12 and 60 months

  5. Rehospitalization due to heart failure.

    Measured: 4, 12, 60 months

  6. NYHA status after 12 months

    Measured: 12 months

  7. Amendment for extended follow up after 2 and 5 years:

    Measured: 24 and 60 months

  8. outcomes in major adverse cardiac events (MACE)

    Measured: 4, 12, 60 months

  9. Rehospitalization due to heart failure

    Measured: 4, 12, 60 months

  10. NYHA status

    Measured: 4, 12, 60 months

  11. patients in MRI subgroup: improvement in left ventricular function

    Measured: 4, 12, 60 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Jan 2006 (estimated)
  2. Study startApr 2004
  3. Primary completionOct 2005
  4. Study completionDec 2010

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
204 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00279175
Sponsor's protocol ID
2/04
Other IDs
Paul-Ehrlich-Institute 1034/01, EudraCT 2006-000250-43
Status last verified
Sep 2012
First submitted
18 Jan 2006
Last updated
20 Sep 2012
Results posted
No

Publications

  • Schachinger V, Tonn T, Dimmeler S, Zeiher AM. Bone-marrow-derived progenitor cell therapy in need of proof of concept: design of the REPAIR-AMI trial. Nat Clin Pract Cardiovasc Med. 2006 Mar;3 Suppl 1:S23-8. doi: 10.1038/ncpcardio0441.

    PubMed 16501626

  • Schachinger V, Erbs S, Elsasser A, Haberbosch W, Hambrecht R, Holschermann H, Yu J, Corti R, Mathey DG, Hamm CW, Suselbeck T, Assmus B, Tonn T, Dimmeler S, Zeiher AM; REPAIR-AMI Investigators. Intracoronary bone marrow-derived progenitor cells in acute myocardial infarction. N Engl J Med. 2006 Sep 21;355(12):1210-21. doi: 10.1056/NEJMoa060186.

    PubMed 16990384

  • Schachinger V, Erbs S, Elsasser A, Haberbosch W, Hambrecht R, Holschermann H, Yu J, Corti R, Mathey DG, Hamm CW, Suselbeck T, Werner N, Haase J, Neuzner J, Germing A, Mark B, Assmus B, Tonn T, Dimmeler S, Zeiher AM; REPAIR-AMI Investigators. Improved clinical outcome after intracoronary administration of bone-marrow-derived progenitor cells in acute myocardial infarction: final 1-year results of the REPAIR-AMI trial. Eur Heart J. 2006 Dec;27(23):2775-83. doi: 10.1093/eurheartj/ehl388. Epub 2006 Nov 10.

    PubMed 17098754

  • Dill T, Schachinger V, Rolf A, Mollmann S, Thiele H, Tillmanns H, Assmus B, Dimmeler S, Zeiher AM, Hamm C. Intracoronary administration of bone marrow-derived progenitor cells improves left ventricular function in patients at risk for adverse remodeling after acute ST-segment elevation myocardial infarction: results of the Reinfusion of Enriched Progenitor cells And Infarct Remodeling in Acute Myocardial Infarction study (REPAIR-AMI) cardiac magnetic resonance imaging substudy. Am Heart J. 2009 Mar;157(3):541-7. doi: 10.1016/j.ahj.2008.11.011. Epub 2009 Jan 31.

    PubMed 19249426

  • Erbs S, Linke A, Schachinger V, Assmus B, Thiele H, Diederich KW, Hoffmann C, Dimmeler S, Tonn T, Hambrecht R, Zeiher AM, Schuler G. Restoration of microvascular function in the infarct-related artery by intracoronary transplantation of bone marrow progenitor cells in patients with acute myocardial infarction: the Doppler Substudy of the Reinfusion of Enriched Progenitor Cells and Infarct Remodeling in Acute Myocardial Infarction (REPAIR-AMI) trial. Circulation. 2007 Jul 24;116(4):366-74. doi: 10.1161/CIRCULATIONAHA.106.671545. Epub 2007 Jul 9.

    PubMed 17620510

  • Assmus B, Rolf A, Erbs S, Elsasser A, Haberbosch W, Hambrecht R, Tillmanns H, Yu J, Corti R, Mathey DG, Hamm CW, Suselbeck T, Tonn T, Dimmeler S, Dill T, Zeiher AM, Schachinger V; REPAIR-AMI Investigators. Clinical outcome 2 years after intracoronary administration of bone marrow-derived progenitor cells in acute myocardial infarction. Circ Heart Fail. 2010 Jan;3(1):89-96. doi: 10.1161/CIRCHEARTFAILURE.108.843243. Epub 2009 Dec 8.

    PubMed 19996415

  • Rolf A, Assmus B, Schachinger V, Rixe J, Mollmann S, Mollmann H, Dimmeler S, Zeiher AM, Hamm CW, Dill T. Maladaptive hypertrophy after acute myocardial infarction positive effect of bone marrow-derived stem cell therapy on regional remodeling measured by cardiac MRI. Clin Res Cardiol. 2011 Nov;100(11):983-92. doi: 10.1007/s00392-011-0330-3. Epub 2011 Jun 17.

    PubMed 21681619

  • Assmus B, Tonn T, Seeger FH, Yoon CH, Leistner D, Klotsche J, Schachinger V, Seifried E, Zeiher AM, Dimmeler S. Red blood cell contamination of the final cell product impairs the efficacy of autologous bone marrow mononuclear cell therapy. J Am Coll Cardiol. 2010 Mar 30;55(13):1385-94. doi: 10.1016/j.jacc.2009.10.059.

    PubMed 20338501

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Intracoronary infusion of enriched bone marrow-derived progenitor cells in people with Myocardial Infarction, run by A. M. Zeiher at 17 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 17 sites in Germany, Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in global left ventricular function in quantitative LV angiography after 4 months. (time frame: baseline to 4 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00279175, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Sep 2012.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in