Adipose Stromal Cells Injection in the Myocardium for Induction of Revascularization (ADMIRE)

September 20, 2022 updated by: Hospital do Coracao

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

Detailed 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.

Study Type

Interventional

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

December 1, 2021

Primary Completion (Anticipated)

November 30, 2022

Study Completion (Anticipated)

December 20, 2022

Study Registration Dates

First Submitted

June 13, 2019

First Submitted That Met QC Criteria

July 1, 2019

First Posted (Actual)

July 2, 2019

Study Record Updates

Last Update Posted (Actual)

September 22, 2022

Last Update Submitted That Met QC Criteria

September 20, 2022

Last Verified

July 1, 2021

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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