Phase 2
N=13
Study Protocol of Intramyocardial Injection of Autologous Bone Marrow Stem Cells for Refractory Angina
Refractory Angina
Bottom Line
View on ClinicalTrials.gov: NCT01966042 ↗Enrolled (actual)
13
Serious AEs
15.4%
Results posted
Jun 2014
Primary outcome: Primary: Angina Class Variation — -2.0; -1.0; -0.5; 4.0 Angina Classification — p=< 0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Local sedation (Procedure); Bone Marrow Aspiration (Procedure); Minithoracotomy (Procedure); Autologous bone marrow mononuclear cells infusion (Biological)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- CellPraxis Bioengenharia Ltda.
- Primary completion
- Nov 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Angina Class Variation |
-2.0; -1.0; -0.5; 4.0 | < 0.001 sig |
| SECONDARY Functional Change Evaluation |
-15; -100 | — |
| SECONDARY Functional Change Evaluation |
-15; -100 | — |
Summary
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT01966042). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.