A pivotal trial of safety and efficacy of ADRCs delivered via the intracoronary route in the treatment of patients with ST-elevation acute myocardial infarction â¤* The ADVANCE Trial

Phase 2

Completed

• Conditions: heart attack; 10028593; ST elevated myocardial infarction

• Registration Number: NL-OMON36077
• Lead Sponsor: Cytori Therapeutics Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 40

Inclusion Criteria

* Acute Myocardial Infarction with culprit vessel successfully opened and stented.
* Myocardial Infarction Criteria:
* Ischemic symptoms AND
* Development of pathologic Q waves on the ECG; or
* ECG changes indicative of ischemia (ST segment elevation or depression); or
* New left bundle branch block: AND
* Creatine phosphokinase Isoenzyme (MB Form) > 100 IU/L between admission
and randomization
* Successful revascularization of the culprit lesion in a major epicardial vessel
(defined as the first sustained restoration of TIMI 3 flow) within 150 minutes to
12 hours defined as:
* TIMI 3 flow
* No more than 10% residual stenosis, by on-line QCA or visual assessment
* No dissection/haziness by completion of procedure
* No residual clot
* No MACCE during this hospitalization other than the MI for which the patient
was admitted
* No more than one intracoronary stent placed to treat the non bifurcating target lesion
during the primary PCI, with one additional stent allowed to treat coronary
dissection
* Multi-vessel disease: patients with maximum of one additional, non-target lesion
that must be in an epicardial vessel different from the target vessel can be included
in the study. If the non-target lesion is treated during the PCI for AMI, then both
lesions must meet criteria for successful revascularization in order for the patient to
be eligible. If the non-target lesion is not treated during this procedure, the patient
will be scheduled for treatment of non-target lesion no earlier than 7 months after
the index procedure. Should non-target lesion require ischemia-driven
revascularization, such procedure can be performed as needed, and the
revascularisation will not constitute a MACE or TVF event.
* Area of hypokinesia or akinesia corresponding to the territory of culprit lesion, as
determined by left ventriculogram at the time of primary PCI
* Left ventricular ejection fraction (LVEF) -30% and -45% by 2D TTE
* HgB and serum creatinine WNL between PCI and Liposuction
* Ability to undergo liposuction to obtain a minimum of 220 ml adipose tissue

Exclusion Criteria

More than 24 hours between PCI and start of cell infusion
* More than twelve hours or less than 150 minutes between the onset of first
symptoms of AMI and revascularization defined as restoration of at least TIMI 3
flow
* LVEF <30% or >45% by 2D TTE
* Vascular access site hematoma after PCI and before start of liposuction
* Staged treatment of coronary artery disease beyond 1 single non-target lesion (as
described above)
* Malignant tumor
* Acute or chronic bacterial or viral infectious disease
* Pacemaker, ICD or any other contra-indication for MRI
Moderate or severe COPD
* Current need for mechanical ventilation at the time of planned liposuction
* Cardiogenic shock present post PCI
* Prior MI, cardiomyopathy, or prior hospital admission for congestive heart failure
(CHF)
* Prior ventricular fibrillation, or sustained ventricular tachycardia between hospital
admission and randomization
* Patients with increased bleeding risk including but not limited to:
a. Those who have received any Glycoprotein Inhibitor within seven days
preceding the liposuction
b. Those who have received any anticoagulant within 1 hour prior to liposuction, or
c. Those who have an aPTT result of - 1.8 times the control value prior to
liposuction * Once aPTT returned to documented values below 1.8 UNL, the
investigator can proceed with liposuction
d. Administration of a thrombolytic agent within the previous 24 hours
* Hemodynamic instability within 8 hours prior to randomization, defined as the
presence of any of the following:
* Need for therapeutic doses of inotropic agent greater than 1 hour to maintain
blood pressure above 90 mm Hg before or after PCI
* Systolic blood pressure <90 mmHg for more than 1 hour
* Heart rate >110 bpm for more than 1 hour
* Persistent atrial fibrillation (for MRI quality)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Efficacy parameters will be measured with the following modalities:<br /><br>* MRI (Appendix 3)<br /><br>o MI size (late enhancement)<br /><br>o LVEF<br /><br>o LV-EDV<br /><br>* SPECT (Appendix 5)<br /><br>o Perfusion: Visual Rest Score (VRS) and Total Severity Score (TSS)<br /><br><br /><br>Safety Parameters<br /><br>* Coronary Angiography (Appendix 8)<br /><br>o TIMI flow<br /><br>* Coronary flow reserve (Appendix 4)<br /><br>* Major Ventricular Arrhythmias: 24 hour Holter Monitoring<br /><br>* Adverse Events, Severe Adverse Events, MACCE: AE, SAE, MACCE Criteria below</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>* Re-infarction: Re-infarction Criteria in Appendix 6.<br /><br>* Quality of Life (QOL): Seattle Angina Questionnaire (SAQ) and Euro Qual.<br /><br>score (EQ-5D)<br /><br>* Functional status: NYHA Criteria (Appendix 7) and MV02</p><br>