- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04005989
Adipose Stromal Cells Injection in the Myocardium for Induction of Revascularization (ADMIRE)
Treatment of ischemic myocardium has been the subject of intense research in recent years and stem cell therapy is one of the great promises. The InCor laboratory has studied cells from different backgrounds as candidates for cell therapy in the context of myocardial infarction. Evidence in preclinical studies of the application of stromal (mesenchymal) adipose tissue (hASC) in the ischemic heart by both the InCor group (in the animal model in rodents and pigs) and others in the literature suggest relevant benefits on the decrease of deterioration post-infarction. More recently it has been demonstrated that it arises mainly from the formation of new vessels due to paracrine factors, which are secreted by the injected cells. There are currently no studies in Brazil in which the safety of injecting different doses of hASC cells into the heart has been particularly evaluated. Recently, two studies have demonstrated the clinical applicability of hASC in patients with peripheral ischemic disease and stroke.
Thus, the objective of this work will be to test the hypothesis that the implantation of autologous stromal cells derived from adipose tissue combined with myocardial revascularization surgery in patients with coronary artery disease
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Phase
- Phase 3
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- signing the Informed Consent Form (TCLE)
- the patient must be a patient with obstructive atherosclerotic coronary artery disease
- sex: both men and women are eligible-
- Age: between 18 and 80 years of age
- the patient should present clinical evidence (angina pectoris or angina equivalent) OR imaging (stress echocardiography, myocardial perfusion scintigraphy, cardiac magnetic resonance imaging) of myocardial ischemia, invasively stratified with coronary angiography
- the presence of myocardial ischemia should be confirmed by at least 2 (two) distinct diagnostic methods performed within one year of the patient's inclusion in the study
- the patient is a candidate for myocardial revascularization surgery but coronary obstructive lesions, in their entirety, are NOT amenable for surgical treatment in the opinion of the surgeon (main surgeon), depending on the anatomical type, extent or distal involvement of the lesions OR, even if they can be treated surgically as a whole, an unsatisfactory surgical outcome is anticipated in terms of functional gain (restoration of myocardial perfusion)
Exclusion Criteria:
do not meet ALL criteria for inclusion
- have a concomitant severe disease, at an advanced stage, or with an unquestionable shortening of life expectancy (<1 year), or that prevents complementary examinations and / or attendance at follow-up visits
- have a confirmed diagnosis, previous history and / or past treatment of neoplasia, of any location and staging, in the last 5 years
- being in clinical treatment or awaiting surgical treatment of neoplasia, any location and staging
- present, during the outpatient investigation, unequivocal findings of neoplasia
- have symptoms attributable exclusively to left ventricular dysfunction, although of ischemic etiology, without the evidence of current myocardial ischemia, by at least two (2) methods of evaluation
- presented severe left ventricular dysfunction as defined by transthoracic echocardiography due to the finding of a left ventricular ejection fraction <0.25 (Simpson's method)
- have a history or current diagnosis of severe ventricular arrhythmias such as sustained ventricular tachycardia unless an automatic cardioverter-defibrillator has been implanted previously
- Concurrent heart diseases of other etiologies (valvular, idiopathic, hypertensive, Chagasic, etc.).
- have a history of acute coronary syndrome (unstable angina or acute myocardial infarction) in the last 3 months
- present chronic renal failure in dialysis treatment
- have participated in other cell therapy studies in the past 2 years
- Pregnant women
- patients diagnosed with acquired immunodeficiency syndrome (AIDS)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: PLACEBO GROUP
injection of saline solution
|
Adipose stromal cell
|
Active Comparator: Low dose group
hASC injection (1x10e6 / kg body weight)
|
Adipose stromal cell
|
Active Comparator: Intermediate Dose
injection of hASC (2x10e6 / kg of body weight)
|
Adipose stromal cell
|
Active Comparator: High dose group
injection of hASC (4x10e6 / kg body weight)
|
Adipose stromal cell
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cardiovascular Death
Time Frame: 12 months
|
Death due to stroke, myocardial infarction or other cardiovascular causes
|
12 months
|
Unstable angina
Time Frame: 12 months
|
Occurence of angina requiring hospitalization
|
12 months
|
Acute myocardial infarction
Time Frame: 12 months after procedure
|
Occurence of acute myocardial infarction (with or without ST segment elevation)
|
12 months after procedure
|
Unplanned myocardial revascularization surgery
Time Frame: 12 months
|
Need for urgent surgical myocardial revascularization
|
12 months
|
Unplanned myocardial revascularization through angioplasty
Time Frame: 12 months
|
Need for urgent non-surgical myocardial revascularization
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Stroke
Time Frame: 12 months
|
12 months
|
|
All cause mortality
Time Frame: 12 months
|
12 months
|
|
Cardiogenic shock
Time Frame: 12 months
|
12 months
|
|
Occurence of complex ventricular arrhythmia
Time Frame: 12 months
|
12 months
|
|
New onset atrial fibrilation
Time Frame: 12 months
|
12 months
|
|
Occurence of acute pulmonary edema
Time Frame: 12 months
|
12 months
|
|
Pulmonary embolism
Time Frame: 12 months
|
12 months
|
|
Acute respiratory failure of any cause
Time Frame: 12 months
|
12 months
|
|
Septic shock
Time Frame: 12 months
|
Disseminated infection requiring vasopressors
|
12 months
|
New onset cancer
Time Frame: 12 month
|
Diagnosis of any cancer at any stage during study period
|
12 month
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ADMIRE
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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