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Autologous Bone Marrow Derived Stem Cells for Acute Myocardial Infarction

Primary Purpose

Myocardial Infarction

Status

Completed

Phase

Phase 3

Locations

Iran, Islamic Republic of

Study Type

Interventional

Intervention

MNC

AC 133

Control

About this trial

This is an interventional treatment trial for Myocardial Infarction focused on measuring Myocardial infarction, Bone marrow stem cells, AC133

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

Royan Institute

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Arm Label

MNC implantation

AC 133 implantation

Control

Arm Description

Implantation of BM derived MNC

Implantation of BM derived AC 133

Injection of cell carrier

Outcomes

Primary Outcome Measures

Left ventricular ejection fraction at rest, measured by gated SPECT

Secondary Outcome Measures

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

changes in LVM index, LVEDV, LVESV

Full Information

NCT ID

NCT01167751

First Posted

July 19, 2010

Last Updated

June 19, 2016

Sponsor

Royan Institute

1. Study Identification

Unique Protocol Identification Number

NCT01167751

Brief Title

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

2. Study Status

Record Verification Date

July 2010

Overall Recruitment Status

Completed

Study Start Date

January 2008 (undefined)

Primary Completion Date

June 2012 (Actual)

Study Completion Date

July 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Royan Institute

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Myocardial Infarction

Keywords

Myocardial infarction, Bone marrow stem cells, AC133

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

90 (Actual)

8. Arms, Groups, and Interventions

Arm Title

MNC implantation

Arm Type

Experimental

Arm Description

Implantation of BM derived MNC

Arm Title

AC 133 implantation

Arm Type

Experimental

Arm Description

Implantation of BM derived AC 133

Arm Title

Control

Arm Type

Placebo Comparator

Arm Description

Injection of cell carrier

Intervention Type

Biological

Intervention Name(s)

MNC

Other Intervention Name(s)

MNC injection

Intervention Description

Implantation of BM derived MNC

Intervention Type

Biological

Intervention Name(s)

AC 133

Other Intervention Name(s)

AC133 injection

Intervention Description

Implantation of BM derived AC133

Intervention Type

Biological

Intervention Name(s)

Control

Other Intervention Name(s)

Placebo

Intervention Description

Injection of cell carrier

Primary Outcome Measure Information:

Title

Left ventricular ejection fraction at rest, measured by gated SPECT

Time Frame

6 months

Secondary Outcome Measure Information:

Title

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

Time Frame

6 months

Title

changes in LVM index, LVEDV, LVESV

Time Frame

6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

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)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Hamid Gourabi, PhD

Organizational Affiliation

Royan Institute

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Hossein Baharvand, PhD

Organizational Affiliation

Royan Institute

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Mohammadhassan Nasseri, MD

Organizational Affiliation

Baghiatollah

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Nasser Aghdami, MD, PhD

Organizational Affiliation

Royan Institute

Official's Role

Study Director

Facility Information:

Facility Name

Royan Institute

City

Tehran

Country

Iran, Islamic Republic of

12. IPD Sharing Statement

Citations:

PubMed Identifier

17691968

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.

Results Reference

background

PubMed Identifier

29633605

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. Erratum In: Cell J. 2018 Oct;20(3):449.

Results Reference

derived

Links:

URL

http://www.royaninstitute.org

Description

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Autologous Bone Marrow Derived Stem Cells for Acute Myocardial Infarction

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