A new technique by intra papillary muscle injection of autologous bone marrow stem cell in patients with up to moderate ischemic mitral regurgitatio

Phase 1

• Conditions: Mitral (valve) insufficiency.; Mitral (valve) insufficiency

• Registration Number: IRCT201308138860N5
• Lead Sponsor: Rajaie cardiovascular medical and research center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 22 February 2018

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

1.Recent posterior-inferior MI* (= 2 weeks but = 2 months)
2. Planned complete Revascularization,
3. No evidence of myocardial viability in the infarct area of PM, as shown by a preoperative low-dose dobutamine echocardiography. (Akinetic or dyskinetic segments seen on echocardiography, and lack of myocardial viability on dobutamine echocardiography)
4.Up to moderate Ischemic Mitral Regurgitation
5.LVEF =25 %

Exclusion criteria:
1.Previous myocardial revascularization;
2.Not complete revascularization during CABG
3.Left ventricular aneurysm;
4.Permanent or persistent ventricular arrhythmias;
5.Severe valvular disease;
6.History of any hematological disease, including leucopenia (=3.000 white cells/µL), thrombocytopenia (= 120.000 platelets/µL), or thrombocytosis (= 450.000 platelets/µL);
7. Hepatic or renal dysfunction (serum creatinine = 2 mg/mL, ALT = 2 times of normal value);
8.Positive history of HIV
9. Evidence of malignant diseases or unwillingness to participate.

Exclusion Criteria

Not provided

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mortality. Timepoint: 12 months. Method of measurement: ID.