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

Evaluating the safety of autologous intra papillary muscle injection of bone marrow stem cell in patients with up to moderate ischemic mitral regurgitation: A Phase II clinical trial

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

IRCT

Registry ID

IRCT201308138860N5

Enrollment

Registered

2013-08-23

Start date

2013-12-22

Completion date

Unknown

Last updated

2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mitral (valve) insufficiency. Mitral (valve) insufficiency

Interventions

Intervention 1: Treatment: All patients will undergo conventional multivessel CABG (complete revascularization).We will inject 10 times (each0.2 ml per single injection and each 0.5 to 1 X MNC cells p

Treatment - Surgery

Treatment: All patients will undergo conventional multivessel CABG (complete revascularization).We will inject 10 times (each0.2 ml per single injection and each 0.5 to 1 X MNC cells per single inject

Control group: All patients will undergo conventional multivessel CABG (complete revascularization)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Mortality. Timepoint: 12 months. Method of measurement: ID.	—

Secondary

Measure	Time frame
Arrhythmia. Timepoint: 40 days, 6 and 12 months after release. Method of measurement: ECG holter.;Papillary muscles viability. Timepoint: 6 month after surgery. Method of measurement: Cardiac MRI.;Cardiac Enzymes. Timepoint: Every 6 hours during admission in the hospital. Method of measurement: Laboratory kit.;CRP. Timepoint: During admission, 40 days, 6 and 12 months after release. Method of measurement: Laboratory kit.;Wall motion Score Index. Timepoint: During admission, 6 and 12 months after release. Method of measurement: Transthoracic Echocardiography.;MR Severity. Timepoint: During admission, 6 and 12 months after release. Method of measurement: Transthoracic Echocardiography.;MRSV. Timepoint: During admission, 6 and 12 months after release. Method of measurement: Transthoracic Echocardiography.;Iso Volumic Relaxation Time (IVRT. Timepoint: During admission, 6 and 12 months after release. Method of measurement: Transthoracic Echocardiography.;Chamber Relaxation velocity)/(Myocard relaxation velocity) (E/e). Timepoint: During admission, 6 and 12 months after release. Method of measurement: Transthoracic Echocardiography.;(IVRT/(QE-Qe. Timepoint: During admission, 6 and 12 months after release. Method of measurement: Transthoracic Echocardiography.;Left ventricular ejection fraction. Timepoint: During admission, 6 and 12 months after release. Method of measurement: Transthoracic Echocardiography.	—

Measure

Time frame

Arrhythmia. Timepoint: 40 days, 6 and 12 months after release. Method of measurement: ECG holter.;Papillary muscles viability. Timepoint: 6 month after surgery. Method of measurement: Cardiac MRI.;Cardiac Enzymes. Timepoint: Every 6 hours during admission in the hospital. Method of measurement: Laboratory kit.;CRP. Timepoint: During admission, 40 days, 6 and 12 months after release. Method of measurement: Laboratory kit.;Wall motion Score Index. Timepoint: During admission, 6 and 12 months after release. Method of measurement: Transthoracic Echocardiography.;MR Severity. Timepoint: During admission, 6 and 12 months after release. Method of measurement: Transthoracic Echocardiography.;MRSV. Timepoint: During admission, 6 and 12 months after release. Method of measurement: Transthoracic Echocardiography.;Iso Volumic Relaxation Time (IVRT. Timepoint: During admission, 6 and 12 months after release. Method of measurement: Transthoracic Echocardiography.;Chamber Relaxation velocity)/(Myocard relaxation velocity) (E/e). Timepoint: During admission, 6 and 12 months after release. Method of measurement: Transthoracic Echocardiography.;(IVRT/(QE-Qe. Timepoint: During admission, 6 and 12 months after release. Method of measurement: Transthoracic Echocardiography.;Left ventricular ejection fraction. Timepoint: During admission, 6 and 12 months after release. Method of measurement: Transthoracic Echocardiography.

—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr. Alireza Alizadeh Ghavidel

Rajaie heart center

AAghavidel@yahoo.com+98 21 2392 2147

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026