Clinical trial NCT01214499: Prospective, Controlled and Randomized Clinical Trial on Cardiac Cell Regeneration With Laser and Autologous Bone Marrow Stem Cells, in Patients With Coronary Disease and Refractory Angina
Official title: Prospective, Controlled and Randomized Clinical Trial on Cardiac Cell Regeneration With Laser and Autologous Bone Marrow Stem Cells, in Patients With Coronary Disease and Refractory Angina
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Angina
Coronary Disease
Keywords: Refractory angina
Transmyocardial revascularization
Stem cells
Diffuse coronary disease not amenable to percutaneous coronary intervention, and angina, despite proper medical treatment
Lead sponsor: Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
Sponsor class: OTHER
First posted: 2010-10-05
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Coronary disease is one of the most frequent pathology of the modern world and the leading cause of death in the investigators country. In Spain more than 50.000 coronary percutaneous intervention and more than 5.000 coronary artery bypass graft (CABG) procedures are performed every year. Despite this data about 12% of patients have diffuse coronary disease and are not candidates to conventional therapies. Also between 15-25% of patients undergoing coronary bypass grafting receive an incomplete revascularization due to the poor quality of the coronary vessels.

Transmyocardial revascularization (TMR) is a surgical procedure that uses a laser to create channels through the myocardial, so this laser stimulates local angiogenesis and provides blood in the ischemic area. Results of this procedure have shown clear benefits in terms of reduction of angina and increase of survival of patients, compared to medical treatment.

Cell therapy in heart disease is offering in recent years encouraging results despite the methodological difficulties that being able to use this technique sometimes involves. The basis lies in the potential ability of stem cells to differentiate into any type of adult cell. In the case of cardiac cell therapy, stem cells can differentiate into myocardial cells or vascular cells capable of developing angiogenesis. Further studies are needed to draw firm conclusions about the clinical impact that the use of stem cells has on cardiovascular disease.

Recently a system has been developed to create, at the same time and in a simple and effective way, the laser channels and the introduction of stem cells on the edges of these channels. This system called PHOENIX ™ consists of a laser probe capable of creating transmural channels in the myocardium.

Based on the what has just been explained, it is quite possible that the combination of both therapies can increase successful results regarding the reduction in angina these patients need. Initially, and after having some experience with this type of treatment, the results could be analyzed and compared with the results obtained through laser therapy, with the help of a controlled clinical trial, such as the one the investigators are proposing.


Eligibility criteria: Inclusion Criteria:

* Patients over 18 years of age.
* Patients with at least one area of myocardial ischemia or chronic myocardial infarction of the left ventricle demonstrated by any imaging technique not amenable to conventional revascularization and angina refractory to medical treatment.
* Ejection fraction\> 25% measured in the six months prior to the procedure.
* Participants must be mentally competent to give consent for inclusion in the clinical trial

Exclusion Criteria:

* Patients with unstable angina defined as the need for intravenous nitrates at the time of surgery.
* Recent myocardial infarction (within 15 days before the procedure).
* Patients with decompensated heart failure at the time of surgery.
* Severe or life threatening arrhythmia (ventricular tachycardia or fibrillation) in the week before the procedure.
* Patients requiring some type of concomitant valvular surgery.
* Patients with severe obstructive lung disease criteria who are considered as not capable of bearing general anesthesia

Primary outcomes:
measure: New York Heart Association (NYHA)classification for angina
timeFrame: one year
Secondary outcomes:
measure: The demographic, intra and postoperative variables
timeFrame: one year
measure: Tests
timeFrame: one year
measure: Quality of Life
timeFrame: one year
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Hospital Universitario de La Princesa
Study officials:
affiliation: Cardiovascular Surgey Service, Hospital Universitario de La Princesa
name: Guillermo Reyes Copa, Physician Doctor
role: PRINCIPAL_INVESTIGATOR
References:
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