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AnginaPhase 2NCT01214499

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

A Phase 2 study testing Transmyocardial revascularization (TMR) with Holmium YAG laser and Transmyocardial revascularization (TMR) with Holmium YAG laser plus the patient's own stem cells extracted from bone marrow. in people with Angina and Coronary Disease, run by Fundación de Investigación Biomédica - Hospital Universitario de La Princesa at 1 site in Spain.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Angina, Coronary Disease
What is being tested?
Transmyocardial revascularization (TMR) with Holmium YAG laser and Transmyocardial revascularization (TMR) with Holmium YAG laser plus the patient's own stem cells extracted from bone marrow.
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteSpain
Study dates
Oct 2010to Oct 2012
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Guillermo Reyes Copa, Physician Doctor contact

+34915202268

guillermo_reyes_copa@yahoo.es

Spain1 site, 1 recruiting

  • Hospital Universitario de La Princesa

    Madrid, Madrid, 28006

    Guillermo Reyes Copa, Physician Doctor, +34915202268, guillermo_reyes_copa@yahoo.es

    Guillermo Reyes Copa, Physician Doctor

    Recruiting

Other trials in Spain

About this study

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.

Read more

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.

Being tested
Transmyocardial revascularization (TMR) with Holmium YAG laser, Transmyocardial revascularization (TMR) with Holmium YAG laser plus the patient's own stem cells extracted from bone marrow.
Keywords
Refractory angina, Transmyocardial revascularization, Stem cells, Diffuse coronary disease not amenable to percutaneous coronary intervention, and angina, despite proper medical treatment
Medical subject headings
Angina Pectoris, Coronary Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Transmyocardial revascularization (TMR) with Holmium YAG laserProcedure or surgery

    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.

  • Transmyocardial revascularization (TMR) with Holmium YAG laser plus the patient's own stem cells extracted from bone marrow.Procedure or surgery

    The system called PHOENIXTM consists of a laser probe with Holmium:YAG energy capable of creating transmural channels in the myocardium. Surrounding this fibre 3 needles with side holes are arranged so that the implantation of stem cells is done on the edges of the channel and not on the channel itself. This device is capable of distributing stem cells in those channels created by the laser, carrying out both procedures simultaneously.

Study groups in NCT01214499
Study groupRoleWhat they receive
Treatment ControlActive comparatorTransmyocardial revascularization (TMR) with Holmium YAG (yttrium aluminium garnet) laser, according to habitual clinical practice in the Department of Cardiovascular Surgery.
Receives: Procedure: Transmyocardial revascularization (TMR) with Holmium YAG laser
Experimental TreatmentExperimentalTransmyocardial revascularization (TMR) with Holmium YAG laser plus the patient's own stem cells extracted from bone marrow.
Receives: Procedure: Transmyocardial revascularization (TMR) with Holmium YAG laser plus the patient's own stem cells extracted from bone marrow.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. New York Heart Association (NYHA)classification for angina

    The main variable under study is the percentage of patients achieving a decrease in two levels of the NYHA classification for angina.

    Measured: one year

Secondary outcomes (3)

  1. The demographic, intra and postoperative variables

    The demographic variables and patients' cardiovascular history will be collected. All the intra and postoperative variables will be collected, as well as the data obtained by cytometry (amount of cells injected into each appropriate patient)

    Measured: one year

  2. Tests

    Before surgery and 12 months after it a test of ischemia provocation through isotopes will be carried out in order to measure the percentage of ischemic area (SPECT or Single Photon Emission Computed Tomography) and maximum effort capacity before the occurrence of the angina.

    The ejection fraction, the end-systolic volume and the end-diastolic volume of the left ventricle will be examined through an echocardiogram and a pre- and postoperative cardiac magnetic resonance imaging study.

    Measured: one year

  3. Quality of Life

    The EQ-5D questionnaire (standardised instrument for use as a measure of health outcome)will be completed for the subjective assessment of the quality of life that the patient perceives to have.

    Measured: one year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Oct 2010 (estimated)
  2. Study startOct 2010
  3. Primary completionOct 2012 (estimated)
  4. Study completionOct 2012 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01214499
Sponsor's protocol ID
TMR-SC-02
Status last verified
Nov 2010
First submitted
3 Oct 2010
Last updated
30 Nov 2010
Results posted
No
Data monitoring committee
No

Publications

  • Lopez-Palop R, Moreu J, Fernandez-Vazquez F, Hernandez Antolin R. [Spanish Cardiac Catheterization and Coronary Intervention Registry. 15th official report of the Spanish Society of Cardiology Working Group on Cardiac Catheterization and Interventional Cardiology (1990-2005)]. Rev Esp Cardiol. 2006 Nov;59(11):1146-64. Spanish.

    PubMed 17144990

  • Mukherjee D, Bhatt DL, Roe MT, Patel V, Ellis SG. Direct myocardial revascularization and angiogenesis--how many patients might be eligible? Am J Cardiol. 1999 Sep 1;84(5):598-600, A8. doi: 10.1016/s0002-9149(99)00387-2.

    PubMed 10482164

  • Weintraub WS, Jones EL, Craver JM, Guyton RA. Frequency of repeat coronary bypass or coronary angioplasty after coronary artery bypass surgery using saphenous venous grafts. Am J Cardiol. 1994 Jan 15;73(2):103-12. doi: 10.1016/0002-9149(94)90198-8.

    PubMed 8296729

  • Bridges CR, Horvath KA, Nugent WC, Shahian DM, Haan CK, Shemin RJ, Allen KB, Edwards FH; Society of Thoracic Surgeons. The Society of Thoracic Surgeons practice guideline series: transmyocardial laser revascularization. Ann Thorac Surg. 2004 Apr;77(4):1494-502. doi: 10.1016/j.athoracsur.2004.01.007.

    PubMed 15063304

  • Allen KB, Dowling RD, Angell WW, Gangahar DM, Fudge TL, Richenbacher W, Selinger SL, Petracek MR, Murphy D. Transmyocardial revascularization: 5-year follow-up of a prospective, randomized multicenter trial. Ann Thorac Surg. 2004 Apr;77(4):1228-34. doi: 10.1016/j.athoracsur.2004.01.008.

    PubMed 15063241

  • Allen KB, Dowling RD, Schuch DR, Pfeffer TA, Marra S, Lefrak EA, Fudge TL, Mostovych M, Szentpetery S, Saha SP, Murphy D, Dennis H. Adjunctive transmyocardial revascularization: five-year follow-up of a prospective, randomized trial. Ann Thorac Surg. 2004 Aug;78(2):458-65; discussion 458-65. doi: 10.1016/j.athoracsur.2004.04.049.

    PubMed 15276496

  • Abdel-Latif A, Bolli R, Tleyjeh IM, Montori VM, Perin EC, Hornung CA, Zuba-Surma EK, Al-Mallah M, Dawn B. Adult bone marrow-derived cells for cardiac repair: a systematic review and meta-analysis. Arch Intern Med. 2007 May 28;167(10):989-97. doi: 10.1001/archinte.167.10.989.

    PubMed 17533201

  • Haider HKh. Bone marrow cells for cardiac regeneration and repair: current status and issues. Expert Rev Cardiovasc Ther. 2006 Jul;4(4):557-68. doi: 10.1586/14779072.4.4.557.

    PubMed 16918274

  • Haider HKh, Ashraf M. Bone marrow stem cell transplantation for cardiac repair. Am J Physiol Heart Circ Physiol. 2005 Jun;288(6):H2557-67. doi: 10.1152/ajpheart.01215.2004.

    PubMed 15897328

  • Anversa P, Leri A, Kajstura J, Nadal-Ginard B. Myocyte growth and cardiac repair. J Mol Cell Cardiol. 2002 Feb;34(2):91-105. doi: 10.1006/jmcc.2001.1506.

    PubMed 11851350

  • Klein HM, Ghodsizad A, Borowski A, Saleh A, Draganov J, Poll L, Stoldt V, Feifel N, Piecharczek C, Burchardt ER, Stockschlader M, Gams E. Autologous bone marrow-derived stem cell therapy in combination with TMLR. A novel therapeutic option for endstage coronary heart disease: report on 2 cases. Heart Surg Forum. 2004;7(5):E416-9. doi: 10.1532/HSF98.20041095.

    PubMed 15799915

  • Patel AN, Spadaccio C, Kuzman M, Park E, Fischer DW, Stice SL, Mullangi C, Toma C. Improved cell survival in infarcted myocardium using a novel combination transmyocardial laser and cell delivery system. Cell Transplant. 2007;16(9):899-905. doi: 10.3727/096368907783338253.

    PubMed 18293888

  • Reyes G, Allen KB, Aguado B, Duarte J. Bone marrow laser revascularisation for treating refractory angina due to diffuse coronary heart disease. Eur J Cardiothorac Surg. 2009 Jul;36(1):192-4. doi: 10.1016/j.ejcts.2009.03.022. Epub 2009 Apr 25.

    PubMed 19394846

  • Karch FE, Lasagna L. Toward the operational identification of adverse drug reactions. Clin Pharmacol Ther. 1977 Mar;21(3):247-54. doi: 10.1002/cpt1977213247.

    PubMed 837643

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Transmyocardial revascularization (TMR) with Holmium YAG laser and Transmyocardial revascularization (TMR) with Holmium YAG laser plus the patient's own stem cells extracted from bone marrow. in people with Angina and Coronary Disease, run by Fundación de Investigación Biomédica - Hospital Universitario de La Princesa at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 30 Nov 2010. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Guillermo Reyes Copa, Physician Doctor (+34915202268, guillermo_reyes_copa@yahoo.es), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

New York Heart Association (NYHA)classification for angina (time frame: one year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01214499, which also lists 14 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Nov 2010.

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