Safety and Efficacy of ADRCs Delivered Via the Intracoronary Route in the Treatment of Patients With ST-elevation Acute Myocardial Infarction (ADVANCE)
This study is currently recruiting participants.
Verified November 2012 by Cytori Therapeutics
Sponsor:
Cytori Therapeutics
Information provided by (Responsible Party):
Cytori Therapeutics
ClinicalTrials.gov Identifier:
NCT01216995
First received: October 6, 2010
Last updated: November 20, 2012
Last verified: November 2012
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Purpose
Double blind, prospective, randomized, placebo-controlled Safety and Efficacy trial of ADRCs delivered via the intracoronary route in the treatment of patients with ST-elevation acute myocardial infarction (STEMI).
| Condition | Intervention | Phase |
|---|---|---|
|
Acute Myocardial Infarction |
Biological: Dose A Biological: Placebo |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | A Phase II Trial of Safety and Efficacy of ADRCs Delivered Via the Intracoronary Route in the Treatment of Patients With ST-elevation Acute Myocardial Infarction - The ADVANCE Study |
Resource links provided by NLM:
Further study details as provided by Cytori Therapeutics:
Primary Outcome Measures:
- Reduction in Infarct Size [ Time Frame: 6 Months ] [ Designated as safety issue: No ]Reduction in infarct size at 6 months as measured by cardiac MRI
Secondary Outcome Measures:
- MACCE Rates [ Time Frame: Through 36 months ] [ Designated as safety issue: Yes ]Major Adverse Cardiac and Cerebral events (MACCE) is a composite clinical endpoint
| Estimated Enrollment: | 216 |
| Study Start Date: | September 2012 |
| Estimated Study Completion Date: | September 2017 |
| Estimated Primary Completion Date: | September 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Dose A
Dose A
|
Biological: Dose A
ADRC Dose A
Other Name: Adipose-Derived Regenerative Cells
|
|
Placebo Comparator: Placebo
Placebo
|
Biological: Placebo
Placebo Comparator
Other Name: Placebo
|
Detailed Description:
This is a prospective, randomized, two arm, placebo-controlled, double blind, study that will enroll approximately 216 patients at no more than thirty-five (35) international clinical sites. Additional blinding measures will be taken in the assessment of study outcomes. The dose of the test material (ADRCs)is described in the protocol. The study will include two arms.
Eligibility| Ages Eligible for Study: | 20 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Key Inclusion Criteria:
- ST-segment Elevation Myocardial Infarction (STEMI) Criteria:
- Ischemic symptoms AND
- ECG:
- Development of pathologic Q waves on the ECG; or
- ECG changes indicative of severe ischemia (ST segment elevation and/or 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
Key Exclusion Criteria:
- More than 24 hours between PCI and start of liposuction
- Prior myocardial infarction, cardiomyopathy, or a history of congestive heart failure
- Pacemaker, ICD, or any other contra-indication for MRI
- Patients with increased bleeding risk
- Cardiogenic shock present post-index PCI
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01216995
Locations
| Netherlands | |
| Erasmus University Medical Centrum | Not yet recruiting |
| Rotterdam, Netherlands | |
| Contact: Eric Duckers, MD, PhD (010) 704 0 704 | |
| Principal Investigator: Henricus J Duckers, MD, PhD, FESC | |
| Poland | |
| Szpital Uniwersytecki Samodzielna Pracownia Zakladu Hemodynamiki | Recruiting |
| Krakow, Poland, 31501 | |
| Contact: Dariusz Dudek, MD, FESC 48 12 424 71 81 | |
| Principal Investigator: Dariusz Dudek, MD, FESC | |
| Krakowski Szpital Specjalistyczny im. Jana Pawla II Oddzial Kliniczny Chorob Serca i Naczyn | Recruiting |
| Krakow, Poland, 31202 | |
| Contact: Piotr Musialek, MD, PHILD 48 12 614 30 06 | |
| Principal Investigator: Piotr Musialek, MD, PHILD | |
| Samodzielny Publiczny Centralny Szpital Kliniczny Pracownia Kardiologii Inwazyjnej | Recruiting |
| Warsaw, Poland, 02097 | |
| Contact: Janusz Kochman, MD, PhD 48 22 599 1951 | |
| Principal Investigator: Janusz Kochman, MD, PhD | |
Sponsors and Collaborators
Cytori Therapeutics
Investigators
| Study Director: | Bradley S Matsubara, MD | Cytori Therapeutics |
More Information
No publications provided
| Responsible Party: | Cytori Therapeutics |
| ClinicalTrials.gov Identifier: | NCT01216995 History of Changes |
| Other Study ID Numbers: | ADVANCE |
| Study First Received: | October 6, 2010 |
| Last Updated: | November 20, 2012 |
| Health Authority: | Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) |
Keywords provided by Cytori Therapeutics:
|
Heart Attack Regenerative Cells Stem Cells |
Additional relevant MeSH terms:
|
Infarction Myocardial Infarction Ischemia Pathologic Processes Necrosis |
Myocardial Ischemia Heart Diseases Cardiovascular Diseases Vascular Diseases |
ClinicalTrials.gov processed this record on June 18, 2013