Autologous Bone Marrow Derived Stem Cells for Acute Myocardial Infarction
1 other identifier
interventional
90
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Jan 2008
Longer than P75 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2008
CompletedFirst Submitted
Initial submission to the registry
July 19, 2010
CompletedFirst Posted
Study publicly available on registry
July 22, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2012
CompletedJune 21, 2016
July 1, 2010
4.4 years
July 19, 2010
June 19, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Left ventricular ejection fraction at rest, measured by gated SPECT
6 months
Secondary Outcomes (2)
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
6 months
changes in LVM index, LVEDV, LVESV
6 months
Study Arms (3)
MNC implantation
EXPERIMENTALImplantation of BM derived MNC
AC 133 implantation
EXPERIMENTALImplantation of BM derived AC 133
Control
PLACEBO COMPARATORInjection of cell carrier
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Royan Institutelead
Study Sites (1)
Royan Institute
Tehran, Tehran Province, Iran
Related Publications (2)
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.
PMID: 17691968BACKGROUNDNaseri 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.
PMID: 29633605DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Hamid Gourabi, PhD
Royan Institute
- PRINCIPAL INVESTIGATOR
Hossein Baharvand, PhD
Royan Institute
- PRINCIPAL INVESTIGATOR
Mohammadhassan Nasseri, MD
Baghiatollah
- STUDY DIRECTOR
Nasser Aghdami, MD, PhD
Royan Institute
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 19, 2010
First Posted
July 22, 2010
Study Start
January 1, 2008
Primary Completion
June 1, 2012
Study Completion
July 1, 2012
Last Updated
June 21, 2016
Record last verified: 2010-07