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

Primary Purpose

Coronary Atherosclerosis and Other Heart Disease

Status

Active

Phase

Phase 2

Locations

Spain

Study Type

Interventional

Intervention

Mononuclear cells from autologous bone marrow

Conventional medical treatment

About this trial

This is an interventional treatment trial for Coronary Atherosclerosis and Other Heart Disease

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.
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.

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

Sites / Locations

Dr. Alejandro Gutierrez
Hospital U. Reina Sofía

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Mononuclear cells from autologous bone marrow

Conventional medical treatment

Arm Description

Mononuclear bone marrow cells autologous intracoronary

Conventional medical treatment

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Changes of NYHA functional grade comparative manner between the groups.

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

Need for hospital admission or presence of major arrhythmia

Changes in global and segmental left ventricular function

Full Information

NCT ID

NCT02022514

First Posted

December 20, 2013

Last Updated

April 5, 2022

Sponsor

Andalusian Initiative for Advanced Therapies - Fundación Pública Andaluza Progreso y Salud

Collaborators

Iniciativa Andaluza en Terapias Avanzadas

1. Study Identification

Unique Protocol Identification Number

NCT02022514

Brief Title

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

Official Title

Phase III Clinical Trial, Multicentric, Open, Randomized and Controlled to Assess the Effectiveness of Intracoronary Infusion of Mononuclear Cells Autologous Bone Marrow in Patients With Chronic Coronary Occlusion and Ventricular Dysfunction, Previously Revascularized.

Study Type

Interventional

2. Study Status

Record Verification Date

April 2022

Overall Recruitment Status

Active, not recruiting

Study Start Date

November 2013 (Actual)

Primary Completion Date

December 2023 (Anticipated)

Study Completion Date

December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Andalusian Initiative for Advanced Therapies - Fundación Pública Andaluza Progreso y Salud

Collaborators

Iniciativa Andaluza en Terapias Avanzadas

4. Oversight

Data Monitoring Committee

5. Study Description

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.

Detailed Description

This is a randomized, open label prospective clinical trial in which all patients diagnosed with chronic coronary occlusion in the Cardiology Department of Hospital Reina Sofía in Cordoba and Hospital Puerta del Mar in Cadiz, who meet inclusion criteria and none of the exclusion shall include and express their accordance with trial participation by signing the informed consent. 66 patients who did not improve ventricular function measured by Magnetic resonance at least 3 months after revascularization of chronic coronary occlusion will be included . The 66 patients will be randomized in one to one ratio to an intervention group that received bone marrow mononuclear cells by intracoronary autologous (0.5 to 1 x 10 9 total cells) and a control group who receive only conventional medical treatment. The two groups of patients will be followed, in the clinical trial, for 6 months. Once the test is complete, they will follow according to standard clinical practice of Cardiology hospital for at least 24 months. Patients will be assessed by clinical and Magnetic resonance methods. All patients will be medically treated similarly with ACE inhibitors or angiotensine 1 receptor (AT1) receptor antagonists of angiotensin II, beta-blockers and diuretics. The main objective os the study is to determine the efficacy of intracoronary infusion of mononuclear cells from autologous bone marrow in patients with chronic coronary occlusion previously revascularized with stents in terms of improved ventricular function determined by magnetic resonance. Secondary objectives of the study are: To confirm, in view of the obtained results, the suitability of the proved protocol for the treatment of chronic coronary occlusion. To study changes in functional class (I-IV NYHA) of these patients compared with the control group. To evaluate the safety of treatment, the analysis of possible cardiac events during the 6-month follow-up in the clinical trial and 24 months of additional clinical follow-up (death, myocardial infarction, repeat revascularization) compared with the control group.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Coronary Atherosclerosis and Other Heart Disease

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

28 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Mononuclear cells from autologous bone marrow

Arm Type

Experimental

Arm Description

Mononuclear bone marrow cells autologous intracoronary

Arm Title

Conventional medical treatment

Arm Type

Active Comparator

Arm Description

Conventional medical treatment

Intervention Type

Other

Intervention Name(s)

Mononuclear cells from autologous bone marrow

Intervention Description

Mononuclear bone marrow cells autologous intracoronary

Intervention Type

Drug

Intervention Name(s)

Conventional medical treatment

Primary Outcome Measure Information:

Title

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

Time Frame

6 months

Secondary Outcome Measure Information:

Title

Changes of NYHA functional grade comparative manner between the groups.

Time Frame

6 months

Title

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

Time Frame

6 months

Title

Need for hospital admission or presence of major arrhythmia

Time Frame

6 months

Title

Changes in global and segmental left ventricular function

Time Frame

6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Mauel Pan Álvarez-Ossorio, MD, PhD

Organizational Affiliation

Hospital Universitario Reina Sofía

Official's Role

Principal Investigator

Facility Information:

Facility Name

Dr. Alejandro Gutierrez

City

Cadiz

ZIP/Postal Code

11009

Country

Spain

Facility Name

Hospital U. Reina Sofía

City

Sevilla

ZIP/Postal Code

14004

Country

Spain

12. IPD Sharing Statement

Links:

URL

http://www.juntadeandalucia.es/terapiasavanzadas/

Description

Andalusian Initiative for Advanced Therapies

Learn more about this trial

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

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