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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04005989
Recruitment Status : Not yet recruiting
First Posted : July 2, 2019
Last Update Posted : July 2, 2019
Sponsor:
Information provided by (Responsible Party):
Hospital do Coracao

Brief 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


Condition or disease Intervention/treatment Phase
Ischemic Heart Disease Myocardial Ischemia Coronary Artery Disease Biological: Stromal Cells Injection Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

It is a randomized, prospective, double-blind, placebo-controlled clinical study.

Eligible patients will be randomly divided into 4 groups (one control group and 3 active treatment groups): 10 PATIENTS EACH ARM Control Group - saline injection Low dose group (BD) - hASC injection (1x106 / kg body weight) Intermediate dose group (DI) - injection of hASC (2x106 / kg body weight) High dose group (AD) - hASC injection (4x106 / kg body weight)

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: DOUBLE BLIND
Primary Purpose: Treatment
Official Title: Adipose Stromal Cells Injection in the Myocardium for Induction of Revascularization
Estimated Study Start Date : December 1, 2019
Estimated Primary Completion Date : November 30, 2021
Estimated Study Completion Date : December 20, 2021

Arm Intervention/treatment
Placebo Comparator: PLACEBO GROUP
injection of saline solution
Biological: Stromal Cells Injection
Adipose stromal cell

Active Comparator: Low dose group
hASC injection (1x10e6 / kg body weight)
Biological: Stromal Cells Injection
Adipose stromal cell

Active Comparator: Intermediate Dose
injection of hASC (2x10e6 / kg of body weight)
Biological: Stromal Cells Injection
Adipose stromal cell

Active Comparator: High dose group
injection of hASC (4x10e6 / kg body weight)
Biological: Stromal Cells Injection
Adipose stromal cell




Primary Outcome Measures :
  1. Cardiovascular Death [ Time Frame: 12 months ]
    Death due to stroke, myocardial infarction or other cardiovascular causes

  2. Unstable angina [ Time Frame: 12 months ]
    Occurence of angina requiring hospitalization

  3. Acute myocardial infarction [ Time Frame: 12 months after procedure ]
    Occurence of acute myocardial infarction (with or without ST segment elevation)

  4. Unplanned myocardial revascularization surgery [ Time Frame: 12 months ]
    Need for urgent surgical myocardial revascularization

  5. Unplanned myocardial revascularization through angioplasty [ Time Frame: 12 months ]
    Need for urgent non-surgical myocardial revascularization


Secondary Outcome Measures :
  1. All cause mortality [ Time Frame: 12 months ]
  2. Stroke [ Time Frame: 12 months ]
  3. Cardiogenic shock [ Time Frame: 12 months ]
  4. Occurence of complex ventricular arrhythmia [ Time Frame: 12 months ]
  5. New onset atrial fibrilation [ Time Frame: 12 months ]
  6. Occurence of acute pulmonary edema [ Time Frame: 12 months ]
  7. Pulmonary embolism [ Time Frame: 12 months ]
  8. Acute respiratory failure of any cause [ Time Frame: 12 months ]
  9. Septic shock [ Time Frame: 12 months ]
    Disseminated infection requiring vasopressors

  10. New onset cancer [ Time Frame: 12 month ]
    Diagnosis of any cancer at any stage during study period



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04005989


Contacts
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Contact: Jose Eduardo Krieger, MD 551130536611 ext 8201 jkrieger@hcor.com.br
Contact: Karina Negrelli 551130536611 ext 8233 knegrelli@hcor.com.br

Sponsors and Collaborators
Hospital do Coracao
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Responsible Party: Hospital do Coracao
ClinicalTrials.gov Identifier: NCT04005989    
Other Study ID Numbers: ADMIRE
First Posted: July 2, 2019    Key Record Dates
Last Update Posted: July 2, 2019
Last Verified: July 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hospital do Coracao:
STROMAL CELLS
ADIPOSE STROMAL CELLS
REVASCULARIZATION
MYOCARDIUM REVASCULARIZATION
CARDIAC SURGERY
CORONARY ARTERY DISEASE
Additional relevant MeSH terms:
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Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Ischemia
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Pathologic Processes