Intracoronary Infusion of Mononuclear Cells Autologous Bone Marrow in Patients With Chronic Coron… (NCT02022514) | Clinical Trial Compass
CompletedPhase 2/3
Intracoronary Infusion of Mononuclear Cells Autologous Bone Marrow in Patients With Chronic Coronary Occlusion and Ventricular Dysfunction, Previously Revascularized.
Spain28 participantsStarted 2013-11
Plain-language summary
Clinical trial phase III, prospective, controlled, randomized, open.
We hypothesize work that patients with chronic coronary occlusion and poor myocardial viability who failed to recover ventricular function after subjecting coronary revascularization with new techniques of recanalization, could achieve an improvement of ventricular function if given further regenerative treatment with mononuclear cells from autologous bone marrow.
To test this hypothesis we designed a prospective, randomized clinical trial in patients with recanalized chronic occlusions and ventricular dysfunction.
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Patients who give their informed consent to participate in this clinical trial.
. Patients of both sexes with atherosclerotic coronary artery disease and chronic occlusions that recanalization has been achieved successfully implanted medicated stents, and in which nevertheless persists ventricular dysfunction evaluated by magnetic resonance.
. Aged between 18 and 80 years.
. Magnetic resonance performed at least 3 months of recanalization, the ejection fraction patient should remain below or iqual to 45%.
. Normal renal function or mild renal insufficiency with serum creatinine exceeding 2.5 mg / dl.
. Normal hepatic transaminases values function \< 2,5 times the upper limit of the normal range.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The primary endpoint will be the change in ejection fraction measured by magnetic resonance between inclusion and at 6 months follow-up
Timeframe: 6 months
Trial details
NCT IDNCT02022514
SponsorAndalusian Initiative for Advanced Therapies - Fundación Pública Andaluza Progreso y Salud
. Hemogram and coagulation studies were within normal values, defined by:
. Blood pregnancy test with negative results in the case of patients of childbearing age.
Exclusion criteria
. Patients with chronic occlusions that recanalization were not achieved successfully.
. Patients with ejection fractions upper to 45% after 3 months of recanalization.
. Positive serology for HIV, HCV or HBV.
. Coexistence of other serious systemic diseases or contraindication for double antiaggregation (clopidogrel and aspirin).
. Coexistence of any type of hematological disease.
. Pregnant, breast-feeding, or women of childbearing age who are not using effective contraception. A woman of childbearing age is considered to be all women from the age of 18 and up to one year after the last menstruation in the case of menopausal women.
. Patients who are currently participating or have completed their participation in a clinical trial within a period of less than 3 months or who have participated in a clinical trial of Advanced Therapies (cell therapy, gene therapy or tissue engineering) at any time before and has been assigned to an experimental group.
. Patients with malignant or pre-malignant tumors.