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Register:	EUCTR
Last refreshed on:	21 September 2020
Main ID:	EUCTR2007-004874-14-DE
Date of registration:	04/12/2007
Prospective Registration:	Yes
Primary sponsor:	Cardiology, J. W. Goethe University Frankfurt
Public title:	Doppel-blinde, randomisierte, kontrollierte Studie zur Erfassung des Effektes einer intrakoronaren Applikation von Knochenmark-Progenitorzellen auf die koronare Flußreserve bei Patienten mit akutem Koronarsyndrom (Reinfusion of Enriched Progenitor Cells And Infarct Remodeling in Acute Coronary Syndrome; REPAIR - ACS) - REPAIR-ACS
Scientific title:	Doppel-blinde, randomisierte, kontrollierte Studie zur Erfassung des Effektes einer intrakoronaren Applikation von Knochenmark-Progenitorzellen auf die koronare Flußreserve bei Patienten mit akutem Koronarsyndrom (Reinfusion of Enriched Progenitor Cells And Infarct Remodeling in Acute Coronary Syndrome; REPAIR - ACS) - REPAIR-ACS
Date of first enrolment:	09/06/2008
Target sample size:	100
Recruitment status:	Not Recruiting
URL:	https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2007-004874-14
Study type:	Interventional clinical trial of medicinal product
Study design:	Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no
Phase:	Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no

Countries of recruitment
Germany

Contacts

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Key inclusion & exclusion criteria

Inclusion criteria:
-NSTEMI, treated with sussessful percutaneous coronary intervention and stent implantation
-hemodynamic stability without intravenous catechoamines or mechanical assist within 6 hours after PCI
-age 18 to 80 years
-written informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
- STEMI
- heart failure (ejection fraction <= 30%)
- arteriovenous malformation or aneurysms
- active infection, fever, diarrhoea within 4 weeks
- chronic inflammatory diseases, HIV infection, active hepatitis
- neoplastic disease within 5 years without documented complete remission
- stroke within 3 months
- reduced renal function (creatinine > = 2,5 mg/dl)
- hepatic disease (GOT > 2 xUNL, spontaneous INR > 1,5)
- hematological disorders (anaemia (Hb < 8,5 mg/dl), thrombocytopenia (< 100000), - splenomegaly)
- known allergies to Clopidogrel, Heparin, Abciximab
- bleeding disorders
- GI bleeding within 3 months
- major surgery or trauma within 2 months
- uncontrolled hypertension
- pregnancy
- mental retardation
- participation in other clinical trial within 30 days
- previous stem cell therapy

Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Patients with acute coronary syndrome (NSTEMI) due to coronary artery disease

Intervention(s)

Product Name: autologous bone marrow-derived progenitor cells (BMC)
Pharmaceutical Form: Solution for infusion
Pharmaceutical form of the placebo: Solution for infusion
Route of administration of the placebo: Intracoronary use

Primary Outcome(s)

Main Objective: Myocardial infarction leads to microvascular dysfunction with consecutively reduced coronary flow reserve, which persists after 4 months. Moreover, recent clinical trials have shown that a reduced coronary flow reserve is associated with adverse outcome in the future. Intracoronary infusion of bone marrow-derived progenitor cells lead to complete normalization of coronary blood flow, as demonstrated by the placebo-controlled, double-blind REPAIR-AMI trial, suggesting increased neovascularization by the infused cells .
Therefore, the primary objective of the current trial is to improve coronary flow reserve in patients with NSTEMI by intracoronary infusion of autologous bone marrow-derived mononuclear progenitor cells, compared with a placebo group, in a double-blind way.

Secondary Objective: As secondary endpoints the relative coronary flow reserve, vascular resistences and coronary blood flow will be assessed, as well as cardiovascular events like death, myocardial (re-) infarction, coronary revascularization, and hospitalization for heart failure, and quality of life.

Primary end point(s): Improvement of corornary flow reserve in the infarct artery after 4 months

Secondary Outcome(s)

Secondary ID(s)

2007-08-16 REPAIR-ACS

Source(s) of Monetary Support

Secondary Sponsor(s)

Ethics review

Status: Approved
Approval date: 29/04/2008
Contact:

Results

Results available:
Date Posted:
Date Completed:
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