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Ischemic Heart DiseasePhase 3ADMIRENCT04005989

Adipose Stromal Cells Injection in the Myocardium for Induction of Revascularization

A Phase 3 study testing Stromal Cells Injection in people with Ischemic Heart Disease and Myocardial Ischemia, run by Hospital do Coracao.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 80 years
What is being tested?
Stromal Cells Injection
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
0 participants
Where
No sites listed yet
Study dates
1 Dec 2021to 20 Dec 2022
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

  • 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
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  • 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)

About this study

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

Read the 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.

Being tested
Stromal Cells Injection
Keywords
STROMAL CELLS, ADIPOSE STROMAL CELLS, REVASCULARIZATION, MYOCARDIUM REVASCULARIZATION, CARDIAC SURGERY, CORONARY ARTERY DISEASE
Medical subject headings
Myocardial Ischemia, Coronary Artery Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Stromal Cells InjectionBiological

    Adipose stromal cell

Study groups in NCT04005989
Study groupRoleWhat they receive
PLACEBO GROUPPlacebo comparatorinjection of saline solution
Receives: Biological: Stromal Cells Injection
Low dose groupActive comparatorhASC injection (1x10e6 / kg body weight)
Receives: Biological: Stromal Cells Injection
Intermediate DoseActive comparatorinjection of hASC (2x10e6 / kg of body weight)
Receives: Biological: Stromal Cells Injection
High dose groupActive comparatorinjection of hASC (4x10e6 / kg body weight)
Receives: Biological: Stromal Cells Injection

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Cardiovascular Death

    Death due to stroke, myocardial infarction or other cardiovascular causes

    Measured: 12 months

  2. Unstable angina

    Occurence of angina requiring hospitalization

    Measured: 12 months

  3. Acute myocardial infarction

    Occurence of acute myocardial infarction (with or without ST segment elevation)

    Measured: 12 months after procedure

  4. Unplanned myocardial revascularization surgery

    Need for urgent surgical myocardial revascularization

    Measured: 12 months

  5. Unplanned myocardial revascularization through angioplasty

    Need for urgent non-surgical myocardial revascularization

    Measured: 12 months

Secondary outcomes (10)

  1. All cause mortality

    Measured: 12 months

  2. Stroke

    Measured: 12 months

  3. Cardiogenic shock

    Measured: 12 months

  4. Occurence of complex ventricular arrhythmia

    Measured: 12 months

  5. New onset atrial fibrilation

    Measured: 12 months

  6. Occurence of acute pulmonary edema

    Measured: 12 months

  7. Pulmonary embolism

    Measured: 12 months

  8. Acute respiratory failure of any cause

    Measured: 12 months

  9. Septic shock

    Disseminated infection requiring vasopressors

    Measured: 12 months

  10. New onset cancer

    Diagnosis of any cancer at any stage during study period

    Measured: 12 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Jul 2019
  2. Study start1 Dec 2021 (estimated)
  3. Primary completion30 Nov 2022 (estimated)
  4. Study completion20 Dec 2022 (estimated)

Why it stopped: Due to logistic issues during COVID-19 pandemic

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
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 blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04005989
Sponsor's protocol ID
ADMIRE
Acronym
ADMIRE
Status last verified
Jul 2021
First submitted
13 Jun 2019
Last updated
22 Sep 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Stromal Cells Injection in people with Ischemic Heart Disease and Myocardial Ischemia, run by Hospital do Coracao.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 22 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cardiovascular Death (time frame: 12 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04005989.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2022.

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