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 |
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Ischemic Heart Disease Myocardial Ischemia Coronary Artery Disease | Biological: Stromal Cells Injection | Phase 3 |
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 |
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Placebo Comparator: PLACEBO GROUP
injection of saline solution
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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
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Active Comparator: Intermediate Dose
injection of hASC (2x10e6 / kg of body weight)
|
Biological: Stromal Cells Injection
Adipose stromal cell
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Active Comparator: High dose group
injection of hASC (4x10e6 / kg body weight)
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Biological: Stromal Cells Injection
Adipose stromal cell
|
Ages Eligible for Study: | 18 Years to 80 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
do not meet ALL criteria for inclusion
Contact: Jose Eduardo Krieger, MD | 551130536611 ext 8201 | jkrieger@hcor.com.br | |
Contact: Karina Negrelli | 551130536611 ext 8233 | knegrelli@hcor.com.br |
Tracking Information | |||||||||
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First Submitted Date ICMJE | June 13, 2019 | ||||||||
First Posted Date ICMJE | July 2, 2019 | ||||||||
Last Update Posted Date | July 2, 2019 | ||||||||
Estimated Study Start Date ICMJE | December 1, 2019 | ||||||||
Estimated Primary Completion Date | November 30, 2021 (Final data collection date for primary outcome measure) | ||||||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE | Same as current | ||||||||
Change History | No Changes Posted | ||||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
Descriptive Information | |||||||||
Brief Title ICMJE | Adipose Stromal Cells Injection in the Myocardium for Induction of Revascularization | ||||||||
Official Title ICMJE | Adipose Stromal Cells Injection in the Myocardium for Induction of Revascularization | ||||||||
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 |
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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 ICMJE | Interventional | ||||||||
Study Phase ICMJE | Phase 3 | ||||||||
Study Design ICMJE | 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 Description: DOUBLE BLIND Primary Purpose: Treatment
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Condition ICMJE |
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Intervention ICMJE | Biological: Stromal Cells Injection
Adipose stromal cell
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Study Arms ICMJE |
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Publications * | Not Provided | ||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||
Recruitment Status ICMJE | Not yet recruiting | ||||||||
Estimated Enrollment ICMJE |
40 | ||||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||||
Estimated Study Completion Date ICMJE | December 20, 2021 | ||||||||
Estimated Primary Completion Date | November 30, 2021 (Final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria: do not meet ALL criteria for inclusion
|
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 80 Years (Adult, Older Adult) | ||||||||
Accepts Healthy Volunteers ICMJE | No | ||||||||
Contacts ICMJE |
|
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Listed Location Countries ICMJE | Not Provided | ||||||||
Removed Location Countries | |||||||||
Administrative Information | |||||||||
NCT Number ICMJE | NCT04005989 | ||||||||
Other Study ID Numbers ICMJE | ADMIRE | ||||||||
Has Data Monitoring Committee | Not Provided | ||||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE | Not Provided | ||||||||
Responsible Party | Hospital do Coracao | ||||||||
Study Sponsor ICMJE | Hospital do Coracao | ||||||||
Collaborators ICMJE | Not Provided | ||||||||
Investigators ICMJE | Not Provided | ||||||||
PRS Account | Hospital do Coracao | ||||||||
Verification Date | July 2019 | ||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |