Refractory Angina Clinical Trial
— ReACTOfficial title:
Phase II Study of Intramyocardial Injection of Autologous Bone Marrow Stem Cells for Refractory Angina in Patients With Normal or Slightly Reduced Left Ventricular Function.
Therapeutic neovascularization is an innovative strategy for cardiac tissue recovery due to
chronic, intense ischemia. Thus stem cell therapy has become a promising procedure for the
large number of patients with refractory angina due to coronary disease, despite of the use
of multiple anti-angina medications, remain severely symptomatic with disabling angina.
Stem cell therapy using autologous cells from the patient's bone marrow, has been shown to
be safe and associated with improved myocardial perfusion, reducing the symptoms of advanced
coronary artery disease and increasing the functional capacity of patients whose therapeutic
armamentarium available today has been exhausted.
The study hypothesis was that the infusion of autologous mononuclear cells derived from the
patient's bone marrow and delivered via intramyocardial injection in patients with
refractory angina and normal or slightly depressed ventricular function, promote improvement
in the anginal symptoms and myocardial perfusion by the inducing neoangiogenesis.
Status | Completed |
Enrollment | 13 |
Est. completion date | December 2012 |
Est. primary completion date | November 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 21 Years and older |
Eligibility |
Inclusion Criteria: - Aged above 21 years old; - Documented coronary artery disease by angiography and confirmed ischemia by myocardial perfusion scintigraphy with physical or pharmacological stress; - Class IV angina pectoris (CCSAC) that is unresponsive to optimized dose of at least two anti-anginal medications including nitrates, beta blocker, calcium channel blocker or Ranolazine) as well as aspirin or other anti-platelet agent plus statin therapy; - Considered to not be a candidate for either percutaneous catheter or surgical myocardial revascularization due to either anatomical type, extent of coronary disease in the target vessel, or caliber of the distal vessels; - Ejection fraction of > 45% by Transthoracic echocardiogram with Doppler by the Simpson method; - Myocardial perfusion scintigraphy showing that the areas of myocardial ischemia supply viable tissue. Exclusion Criteria: - Significant Valvular Heart Disease; - Chronic kidney disease requiring renal replacement therapy; - Severe comorbidities associated with the reduction of life expectancy in less than 5 years; - Ongoing abusive use of alcohol or illegal drugs (Based on the Diagnostic and Statistical Manual (DSM) IV - CAGE questionnaire); - Positive Serologic test for HIV, Human T-cell lymphotrophic virus (HTLV), Hepatitis A, B and C; - History of Malignant neoplasia in the last 2 years; - Participation into other studies of cell therapy in the last year; - Pregnancy or Breast-feeding. |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Brazil | Federal University of São Paulo | São Paulo |
Lead Sponsor | Collaborator |
---|---|
CellPraxis Bioengenharia Ltda. | Cryopraxis Criobiologia Ltda., Federal University of São Paulo, University of South Florida |
Brazil,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Life Quality | Analysis of the variation in life quality questionnaire - Short Form Health Survey (SF-36) was performed. Each domain of the questionnaire was evaluated as a quantitative variable and the medians were retrieved before and after the procedure. The SF-36 is a multi-purpose, short-form health survey with only 36 questions. It yields an 8-scale profile of functional health and well-being scores as well as psychometrically-based physical and mental health summary measures and a preference-based health utility index. It consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. One patient was lost before answering the questionnaire post procedure. |
Baseline and 12 months | No |
Primary | Angina Class Variation | It was evaluated in accordance with the percentage of participants that change the functional class of angina according to CCSAC (Canadian Cardiovascular Society Angina Classification - description below), after treatment. The functional class of angina was also analyzed as an ordinal variable and the median of the functional class was calculated before and after the procedure, at the time of interest (3, 6 and 12 months post treatment), in comparison to baseline, ie. value at 3 months minus value at baseline. Screening of Functional Graduation of Stable Angina: I - Angina only occurs after a fast or prolonged and strenuous effort during work or recreation. II - Slight limitation to everyday activities. III - Considerable limitation of common physical activity. IV - Inability to perform any physical activity without discomfort, the symptoms can be present at rest. |
3, 6 and 12 months | No |
Secondary | Functional Change Evaluation | Analysis of Left Ventricular Ejection Fraction (in %), by echocardiogram. | Baseline and 12 months | Yes |
Secondary | Functional Change Evaluation | Analysis of objective improvement in myocardial ischemia (in %), by stress technetium scintigraphy. | Baseline, 6 and 12 months | Yes |
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