Adipose Stromal Cells Injection in the Myocardium for Induction of Revascularization

Coronary Artery Disease Clinical Trial

— ADMIRE  

Official title:

Adipose Stromal Cells Injection in the Myocardium for Induction of Revascularization

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04005989
• Other study ID #: ADMIRE
• Status: Withdrawn
• Phase: Phase 3
• Start date: December 1, 2021
• Est. completion date: December 20, 2022

Study information

• Verified date: July 2021
• Source: Hospital do Coracao
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

To test the hypothesis that the implantation of adipose-derived autologous cells derived from adipose tissue (hASCs) combined with coronary artery bypass grafting in patients with coronary artery disease is safe and well tolerated, besides being able to promote regional perfusion increase in the injected segments.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 20, 2022
• Est. primary completion date: November 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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)

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Heart Diseases
• Ischemia
• Ischemic Heart Disease
• Myocardial Ischemia

Intervention

Biological:
• Stromal Cells Injection
Adipose stromal cell

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hospital do Coracao

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cardiovascular Death	Death due to stroke, myocardial infarction or other cardiovascular causes	12 months
Primary	Unstable angina	Occurence of angina requiring hospitalization	12 months
Primary	Acute myocardial infarction	Occurence of acute myocardial infarction (with or without ST segment elevation)	12 months after procedure
Primary	Unplanned myocardial revascularization surgery	Need for urgent surgical myocardial revascularization	12 months
Primary	Unplanned myocardial revascularization through angioplasty	Need for urgent non-surgical myocardial revascularization	12 months
Secondary	All cause mortality		12 months
Secondary	Stroke		12 months
Secondary	Cardiogenic shock		12 months
Secondary	Occurence of complex ventricular arrhythmia		12 months
Secondary	New onset atrial fibrilation		12 months
Secondary	Occurence of acute pulmonary edema		12 months
Secondary	Pulmonary embolism		12 months
Secondary	Acute respiratory failure of any cause		12 months
Secondary	Septic shock	Disseminated infection requiring vasopressors	12 months
Secondary	New onset cancer	Diagnosis of any cancer at any stage during study period	12 month