Status:
COMPLETED
Pericardial Matrix With Mesenchymal Stem Cells for the Treatment of Patients With Infarcted Myocardial Tissue
Lead Sponsor:
Fundació Institut Germans Trias i Pujol
Collaborating Sponsors:
Germans Trias i Pujol Hospital
Conditions:
Myocardial Infarction
Eligibility:
All Genders
18-99 years
Phase:
PHASE1
Brief Summary
Myocardial infarction causes necrosis of myocardial cells and reduces cardiac function. Today, there are treatments such as primary angioplasty and thrombolysis that are effective in limiting cell dea...
Detailed Description
Myocardial infarction causes necrosis of myocardial cells and reduces cardiac function. Today there are treatments such as primary angioplasty and thrombolysis that are effective in limiting cell deat...
Eligibility Criteria
Inclusion
- Myocardial infarction of ≥50% of transmurally due to MR
- Candidate for coronary by-pass through that or another territory
- Age ≥18 years
- Signature of informed consent
- Wave Q present in the ECG
- Followed by the cardiology service of Germans Trial i Pujol hospital
Exclusion
- Severe valvular disease with indication of surgical repair
- Candidate for ventricular remodeling
- Contraindication for MR (creatinine clearance less than 30 ml / min / 1.73m2, metallic implant carriers, claustrophobia)
- Extracardiac disease with estimated life expectancy less than 1 year
- Neoplastic disease detected in the last five years or without complete remission
- Severe renal or hepatic insufficiency
- Abnormal laboratory values, not explainable at the time of inclusion, and that at the discretion of the investigator contraindicate the patient's participation in the study
- Patients with a previous cardiac intervention
- Women who are pregnant or breast-feeding.
- Women of childbearing age who are heterosexually active and who do not use an effective contraceptive method from 14 days before the inclusion in the study and at least up to 12 weeks after the end of the study.
- Simultaneous participation in another clinical trial or treatment with another product in investigational phase in the 30 days prior to inclusion in the study.
- Negation of the patient to be followed by a period that exceeds the clinical trial itself (long-term follow-up in the second and third year).
Key Trial Info
Start Date :
May 13 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 6 2022
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT03798353
Start Date
May 13 2019
End Date
October 6 2022
Last Update
December 2 2022
Active Locations (1)
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1
Hospital Universitari Germans Trias i Pujol
Badalona, Barcelona, Spain, 08916