A randomized clinical study of stem cells taken from fat tissue in the experimental treatment of patients with myocardial infarction (heart attack)

Conditions: patients with ST-elevation myocardial infarction after PCI with stent
MedDRA version: 14.1Level: LLTClassification code 10028597Term: Myocardial infarction acuteSystem Organ Class: 10007541 - Cardiac disorders
Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

Registration Number: EUCTR2010-022153-42-NL

Lead Sponsor: Cytori Therapeutics, Inc

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 216

Inclusion Criteria

•ST-segment Elevation Myocardial Infarction (STEMI)Criteria:
o Ischemic symptoms AND
oECG:
-Development of pathologic Q waves on the ECG; or

-ECG changes indicative of severe ischemia (ST segment elevation and/or reciprocal depression); or

- New left bundle branch block; AND
- Creatine Phosphokinase Isoenzyme (MB Form) > 100 IU/L, or troponin >5x the upper limit of normal 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 from the time of symptom onset defined as:
-TIMI 3 flow
-No more than 10% residual stenosis, by online 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 revascularization will not constitute a MACCE or target vessel failure (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, or left ventricular wall motion abnormalities (at least 2/18 segments) in the territory of the culprit lesion as assessed by 2D TTE
• Hemoglobin and serum creatinine within normal limits between PCI and liposuction
• Ability to undergo liposuction to obtain a minimum of 300 mL adipose tissue, as assessed by the physician performing the liposuction procedure

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

• More than 24 hours between PCI and start of liposuction
• Clinically significant (greater than TIMI ‘minimal’ bleeding, per Appendix 11) 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
• 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
• Prior ventricular fibrillation, or sustained ventricular tachycardia between hospital admission and randomization
• Patients with increased bleeding risk including but not limited to:
-Those who have received any glycoprotein IIb/IIIa inhibitor within seven days preceding the liposuction
-Those who have received any anticoagulant within 1 hour prior to liposuction, or
-Those who have an aPTT result of = 1.8 times the control value 1 hour prior to liposuction – once aPTT returns to a documented value below 1.8 upper limit of normal, liposuction can start
-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 mmHg 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)
• Any concurrent disease or condition that, in the opinion of the investigator, would make the patient unsuitable for participation in the trial

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To assess safety and efficacy of adipose-derived regenerative cells delivered via the intracoronary (IC) route in the treatment of patients with ST-elevation myocardial infarction (STEMI) ;Secondary Objective: NA;Primary end point(s): The primary efficacy endpoint is absolute improvement in infarct size [expressed as percent of left ventricle infarcted (%LVI)] at 6 months post-index procedure as measured by gadolinium contrast cardiac MRI; i.e., change in 6-Month vs. Day 4 infarct size.;Timepoint(s) of evaluation of this end point: 6 Months

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): • Reduction in Infarct Size at 12 months (MRI) <br>• Major adverse cardiac or cerebral events (MACCE) rates at 1, 6, 12, 24, and 36 months. MACCE is a composite endpoint comprised of the following:<br>-Cardiac death<br>-Myocardial infarction (MI) <br>-Overnight hospitalization for heart failure which requires administration of IV diuretics<br>-Target lesion revascularization (TLR) <br>-Target vessel revascularization (TVR) <br>-Stroke<br>• SPECT assessment of improvement in perfusion defect, LVEDV, LVESV, and LVEF at 6 and 12 months (measured by SPECT); subset of clinical sites as designated by the Sponsor <br>;Timepoint(s) of evaluation of this end point: 1, 6, 12, 24 and 26 months

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