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

NCT02022514 | Completed Phase 2

• 1 other identifier: CMMo/OCC/2012
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Coronary Atherosclerosis and Other Heart Disease

Outcome Measures

Primary Outcomes (1)

• The primary endpoint will be the change in ejection fraction measured by magnetic resonance between inclusion and at 6 months follow-up

  6 months

Secondary Outcomes (4)

• Changes of NYHA functional grade comparative manner between the groups.

  6 months

• Possible cardiac events during follow-up (death, myocardial infarction, repeat revascularization).

  6 months

• Need for hospital admission or presence of major arrhythmia

  6 months

• Changes in global and segmental left ventricular function

  6 months

Study Arms (2)

Mononuclear cells from autologous bone marrow

EXPERIMENTAL

Mononuclear bone marrow cells autologous intracoronary

Other: Mononuclear cells from autologous bone marrow

Conventional medical treatment

ACTIVE COMPARATOR

Conventional medical treatment

Drug: Conventional medical treatment

Interventions

Mononuclear cells from autologous bone marrow OTHER

Mononuclear bone marrow cells autologous intracoronary

Mononuclear cells from autologous bone marrow

Conventional medical treatment DRUG

Conventional medical treatment

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Hemogram and coagulation studies were within normal values, defined by:
• Leucocytes ≥ 3000
• Neutrophils ≥ 1500
• Platelets ≥ 100000
• Hemoglobin \> 10g/dl
• Blood pregnancy test with negative results in the case of patients of childbearing age.
• Acceptance by patients (both men and women) of childbearing age to use safe contraceptive methods throughout the study, including the six month follow-up.
• Willingness and ability to implement the program of visits, treatment plan, laboratory tests, and all study procedures.

You may not qualify if:

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

Sponsors & Collaborators

• Andalusian Initiative for Advanced Therapies - Fundación Pública Andaluza Progreso y Salud: lead
• Iniciativa Andaluza en Terapias Avanzadas: collaborator

Study Sites (2)

Dr. Alejandro Gutierrez

Cadiz, 11009, Spain

Location

Hospital U. Reina Sofía

Seville, 14004, Spain

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Mauel Pan Álvarez-Ossorio, MD, PhD

  Hospital Universitario Reina Sofía

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2013
• First Posted: December 27, 2013
• Study Start: November 1, 2013
• Primary Completion: August 1, 2023
• Study Completion: August 1, 2023
• Last Updated: November 8, 2023

Record last verified: 2023-11

Locations

ES (2)