Study of the Efficacy of Percutaneous Implantation of Autologous Myoblasts in Patients With Old Infarction (PERCUTANEO)
This study is ongoing, but not recruiting participants.
Sponsor:
Clinica Universidad de Navarra, Universidad de Navarra
Collaborator:
Fina Biotech
Information provided by (Responsible Party):
Clinica Universidad de Navarra, Universidad de Navarra
ClinicalTrials.gov Identifier:
NCT00908622
First received: May 25, 2009
Last updated: June 7, 2012
Last verified: June 2012
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Purpose
The purpose of this study is compare the improvement in global and regional cardiac function measured by echocardiography and magnetic resonance in patients with old myocardial infarction subject to cardiac catheterisation with percutaneous endocavity implantation of autologous myoblasts.
| Condition | Intervention | Phase |
|---|---|---|
|
Old Myocardial Infarction |
Procedure: Percutaneous autologous myoblast implantation Procedure: Cardiac revascularization |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | Phase II, Blind, Controlled, Randomised Study of the Efficacy of Percutaneous Implantation of Autologous Myoblasts in Patients With Old Infarction |
Resource links provided by NLM:
Further study details as provided by Clinica Universidad de Navarra, Universidad de Navarra:
Primary Outcome Measures:
- The primary efficacy endpoints will be the ejection fraction and wall motion score index measured with M-mode and echocardiography [ Time Frame: 12 months after surgery ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Secondary efficacy endpoints are wall motion score index, viability and incidence of cardiac arrythmias [ Time Frame: 12 month after surgery ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 50 |
| Study Start Date: | March 2007 |
| Estimated Study Completion Date: | November 2012 |
| Estimated Primary Completion Date: | November 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Skeletal myoblasts
Patients who are receiving skeletal myoblasts
|
Procedure: Percutaneous autologous myoblast implantation
Endocavity implantation of autologous myoblasts
Other Name: Cellular therapy
|
|
Placebo Comparator: No cells
The patients randomised to the control group will receive culture medium without cells
|
Procedure: Cardiac revascularization
Cardiac revascularization
|
Detailed Description:
Ischaemic heart disease is one of the main causes of mortality and morbidity. In particular, myocardial infarction (MI) is of special significance, as the heart muscle cannot regenerate so a region's necrosis leads to the formation of a fibrous scar. In the last few years, new treatments have been developed for the acute phase of myocardial infarction.We have managed to slow down disease progression with these new treatments, but it continues to the development of end stage heart failure. This study tries to determine the benefit of cell cardiomyoplasty with autologous myoblasts in patients with old MI.
Eligibility| Ages Eligible for Study: | 30 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Patients with diagnosis of myocardial infarction, absence of viability.
- Ejection fraction under 40% or 45% in symptomatic patients
- Aged from 30-80 years old.
- Negative pregnancy test (women of childbearing age)
- Informed consent granted
Exclusion Criteria:
- Prior history of tachycardia or ventricular fibrillation (except in the acute phase of MI).
- Myocardial infarction with more than 10 years of evolution.
- Patients positive for HIV, HBV or HCB.
- Patients with organ dysfunction: liver and kidney function
- History of cancer or prior treatment with chemotherapy.
- The patient should not suffer from any concomitant severe and/or uncontrolled medical condition.
- Patients who, due to their geographical, psychiatric or social status, have difficulties in meeting the conditions established in the protocol.
- Pregnant or beast feeding women.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00908622
Locations
| Spain | |
| Clínica Universitaria de Navarra | |
| Pamplona, Navarra, Spain, 31008 | |
| Hospital Gregorio Marañón | |
| Madrid, Spain, 28007 | |
Sponsors and Collaborators
Clinica Universidad de Navarra, Universidad de Navarra
Fina Biotech
Investigators
| Study Director: | Felipe Prósper, MD, Ph.D. | Clínica Universidad de Navarra |
More Information
No publications provided
| Responsible Party: | Clinica Universidad de Navarra, Universidad de Navarra |
| ClinicalTrials.gov Identifier: | NCT00908622 History of Changes |
| Other Study ID Numbers: | MIO/REG/PERCUTÁNEO |
| Study First Received: | May 25, 2009 |
| Last Updated: | June 7, 2012 |
| Health Authority: | Spain: Spanish Agency of Medicines |
Keywords provided by Clinica Universidad de Navarra, Universidad de Navarra:
|
Percutaneous implantation of autologous myoblasts |
Additional relevant MeSH terms:
|
Infarction Myocardial Infarction Ischemia Pathologic Processes Necrosis |
Myocardial Ischemia Heart Diseases Cardiovascular Diseases Vascular Diseases |
ClinicalTrials.gov processed this record on June 17, 2013