Status:
SUSPENDED
Intramyocardial Delivery of Autologous Bone Marrow
Lead Sponsor:
IRCCS San Raffaele
Conditions:
Refractory Angina
Eligibility:
All Genders
21+ years
Phase:
PHASE2
Brief Summary
A randomized study to assess the safety, feasibility and effectiveness of direct intramyocardial percutaneous delivery of autologous bone marrow-derived total mononuclear cells or selected CD34+ cells...
Detailed Description
Primary Endpoint: Incidence of major adverse cardiac events (MACE) at 30 days. MACE is defined as a combined endpoint of death, acute MI (Q-wave and non-Q wave), revascularization procedures (percutan...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Subjects \>21 years old;
- Subjects with functional class (CCS) III or IV angina;
- Subjects with left ventricular (LV) ejection fraction ³ 30%
- Attempted "best" tolerated medical therapy
- Clinical signs and symptoms of myocardial ischemia with reversible ischemia on perfusion imaging;
- Patient deemed to be a poor candidate or at high surgical risk;
- Subject must be able to complete a minimum of 2 minutes but no more than 10 minutes exercise test (Bruce Protocol);
- Subject (or their legal guardian) understands the nature of the procedure and provides written consent prior to the procedure;
- Subject is willing to comply with specified follow-up evaluations;
- Patient must develop angina and a horizontal or down-sloping ST-segment depression of ³ 1 mm during exercise, compared to pre-exercise ST segment, 80 ms from the J point or moderate angina with or without the above ST segment changes.
- Angiographic
- Severe obstruction (lumen diameter stenosis \> 70%) in a coronary or surgical conduit felt to be solely or partially responsible for angina and myocardial ischemia;
- There must be at least one coronary or surgical conduit with \< 70% diameter stenosis
- Poor candidate for percutaneous coronary intervention of treatment zone
- Poor candidates for surgical revascularization procedures, such as inadequate target coronary anatomy or lack of potential surgical conduits.
Exclusion
- Pregnant women;
- Left ventricular ejection fraction \<30% as assessed by either echocardiography or left ventriculography;
- Severe cardiac heart failure with NYHA functional class III-IV symptoms;
- Chronic atrial fibrillation;
- Prosthetic aortic valve;
- Severe (grade III-IV) mitral or aortic insufficiency;
- Wall thickness of \<8 mm (defined by echocardiography) of the proposed target region of myocardium;
- Severe co-morbidity associated with a reduction in life expectancy of \<1 year, such as chronic medical illnesses
- Braunwald class II unstable angina
- Severe peripheral (or aortic) vascular disease which might increase the risk of vascular complications (perforation, dissection or embolization);
- Significant aortic valve pathologic sclerosis or stenosis
- LV thrombus (mobile or mural-based) seen on echocardiography;
- Recent (within 4 weeks) documented myocardial infarction (Q and/or non-Q wave) defined as CK-MB \>3times upper normal level;
- Currently enrolled in another investigational device or drug trial that has not completed the required follow-up period;
- Thrombocytopenia or history of heparin-induced thrombocytopenia or thrombocytosis
- Leukopenia
- Leukocytosis
- Anemia or erythrocytosis
- Active peptic ulcer or active gastrointestinal bleeding;
- Chronic renal failure requiring dialysis;
- Prior or current malignancy
- Other conditions that can significantly affect the bone-marrow
- Evidence of concurrent infection (WBC \>12.000 mm3, temperature \>38.5° C);
- Serological of clinical evidence of HIV
- Immunotherapy
- Abnormal bone-marrow morphology as evident in bone-marrow smear prior to the intervention
- Angiographic/Ventriculographic
Key Trial Info
Start Date :
May 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2018
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT00820586
Start Date
May 1 2007
End Date
December 1 2018
Last Update
February 2 2012
Active Locations (1)
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1
IRCCS S. Raffaele
Milan, Italy, 20132