Clinical trial NCT01167751: Autologous Bone Marrow Derived Stem Cells for Acute Myocardial Infarction
Official title: Autologous Bone Marrow Derived Ac 133+ and Mono Nuclear Cells In-patient With Acute Myocardial Infarction During Coronary Artery Bypass Grafting (CABG): A Randomized Phase III Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Myocardial Infarction
Keywords: Myocardial infarction
Bone marrow stem cells
AC133
Lead sponsor: Royan Institute
Sponsor class: OTHER_GOV
First posted: 2010-07-22
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: One of the important reasons for human dying is Ischemic heart disease (IHD). The most reason is coronary artery disease. Beside morbidity, IHD induce myocardial infarction and necrosis which due to congestive heart failure.

One therapeutic method is cellular cardiomyoplasty, which is to produce and substitute the cardiac cells with stem cell transplantation. Cell therapy is a potential therapeutic method to prevent ventricular remodeling after acute myocardial infarction. Human and animal studies have shown that stem cell trans plantation to myocardial infarcted zone can improve heart contractile function.

The aim of this study is to comparison the effects of BM-derived AC133 and MNC implantation in patients with myocardial infarction.


Eligibility criteria: Inclusion Criteria:

* CABG candidate
* At least 4 akinetic segments
* First anterior heart attack within in 10 days to 3 month.
* St elevation MI defined by: Post Acute MI LVEF less than 45% as assessed by echocardiography.
* The target lesion had to be located in the left anterior descending (LAD) section.

Exclusion Criteria:

* History of prior anterior myocardial infarction:
* History of prior CABG
* Poor echocardiography window.
* Active infection or history of recurrent infection or positive test for syphilis (RPR), hepatitis B and C (HBSAg/ Anti HBc Anti - Hcv) HIV and HTLV-l
* Documental terminal illness or malignancy.
* Previous bone marrow transplant
* Autoimmune disease (e. g Lupus, Multiple sclerosis)
* Any contraindication for bone - marrow aspiration.
* Positive pregnancy test (in women with child bearing potential)

Primary outcomes:
measure: Left ventricular ejection fraction at rest, measured by gated SPECT
timeFrame: 6 months
Secondary outcomes:
measure: Regional contractility in the AOI / Change in LV dimensions (left ventricular end systolic diameter [LVESD], left ventricular end diastolic diameter [LVEDD]) as assessed by echocardiography
timeFrame: 6 months
measure: changes in LVM index, LVEDV, LVESV
timeFrame: 6 months
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Royan Institute
Study officials:
affiliation: Royan Institute
name: Hamid Gourabi, PhD
role: STUDY_CHAIR
affiliation: Royan Institute
name: Hossein Baharvand, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Baghiatollah
name: Mohammadhassan Nasseri, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Royan Institute
name: Nasser Aghdami, MD, PhD
role: STUDY_DIRECTOR
References:
citation: Ahmadi H, Baharvand H, Ashtiani SK, Soleimani M, Sadeghian H, Ardekani JM, Mehrjerdi NZ, Kouhkan A, Namiri M, Madani-Civi M, Fattahi F, Shahverdi A, Dizaji AV. Safety analysis and improved cardiac function following local autologous transplantation of CD133(+) enriched bone marrow cells after myocardial infarction. Curr Neurovasc Res. 2007 Aug;4(3):153-60. doi: 10.2174/156720207781387141.
citation: Naseri MH, Madani H, Ahmadi Tafti SH, Moshkani Farahani M, Kazemi Saleh D, Hosseinnejad H, Hosseini S, Hekmat S, Hossein Ahmadi Z, Dehghani M, Saadat A, Mardpour S, Hosseini SE, Esmaeilzadeh M, Sadeghian H, Bahoush G, Bassi A, Amin A, Fazeli R, Sharafi Y, Arab L, Movahhed M, Davaran S, Ramezanzadeh N, Kouhkan A, Hezavehei A, Namiri M, Kashfi F, Akhlaghi A, Sotoodehnejadnematalahi F, Vosough Dizaji A, Gourabi H, Syedi N, Shahverdi AH, Baharvand H, Aghdami N. COMPARE CPM-RMI Trial: Intramyocardial Transplantation of Autologous Bone Marrow-Derived CD133+ Cells and MNCs during CABG in Patients with Recent MI: A Phase II/III, Multicenter, Placebo-Controlled, Randomized, Double-Blind Clinical Trial. Cell J. 2018 Jul;20(2):267-277. doi: 10.22074/cellj.2018.5197. Epub 2018 Mar 18.