Intracoronary Infusion of Mononuclear Cells Autologous Bone Marrow in Patients With Chronic Coronary Occlusion and Ventricular Dysfunction, Previously Revascularized.

• Status: Recruiting
• Trial end date: 2023-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Andalusian Initiative for Advanced Therapies - Fundación Pública Andaluza Progreso y Salud
• Collaborator: Iniciativa Andaluza en Terapias Avanzadas

Criteria

Inclusion Criteria:

1. Patients who give their informed consent to participate in this clinical trial.

2. 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.

3. Aged between 18 and 80 years.

4. Magnetic resonance performed at least 3 months of recanalization, the ejection fraction patient should remain below or iqual to 45%.

5. Normal renal function or mild renal insufficiency with serum creatinine exceeding 2.5 mg / dl.

6. Normal hepatic transaminases values function < 2,5 times the upper limit of the normal range.

7. Hemogram and coagulation studies were within normal values, defined by:

• Leucocytes ≥ 3000

• Neutrophils ≥ 1500

• Platelets ≥ 100000

• Hemoglobin > 10g/dl

8. Blood pregnancy test with negative results in the case of patients of childbearing age.

9. Acceptance by patients (both men and women) of childbearing age to use safe contraceptive methods throughout the study, including the six month follow-up.

10. Willingness and ability to implement the program of visits, treatment plan, laboratory tests, and all study procedures.

Exclusion Criteria:

1. Patients with chronic occlusions that recanalization were not achieved successfully.

2. Patients with ejection fractions upper to 45% after 3 months of recanalization.

3. Positive serology for HIV, HCV or HBV.

4. Coexistence of other serious systemic diseases or contraindication for double antiaggregation (clopidogrel and aspirin).

5. Coexistence of any type of hematological disease.

6. 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.

7. 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.

8. Patients with malignant or pre-malignant tumors.

9. Patients in whom an MRI cannot be performed because they carry devices incompatible with the MRI (prostheses, defibrillators, pacemakers, etc).