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Myocardial InfarctionPhase 3NCT01167751

Autologous Bone Marrow Derived Stem Cells for Acute Myocardial Infarction

A Phase 3 study testing MNC and AC 133 in people with Myocardial Infarction, run by Royan Institute at 1 site in Iran.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Myocardial Infarction
What is being tested?
MNC and AC 133
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
90 participants
Where
1 siteIran
Study dates
Jan 2008to Jul 2012
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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
Show all 9Show fewer
  • Autoimmune disease (e. g Lupus, Multiple sclerosis)
  • Any contraindication for bone - marrow aspiration.
  • Positive pregnancy test (in women with child bearing potential)

Trial locations and contacts

1 site in 1 country.

Iran1 site

  • Royan Institute

    Tehran, Tehran Province

Other trials in Iran

About this study

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

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.

Being tested
MNC, AC 133, Control
Keywords
Myocardial infarction, Bone marrow stem cells, AC133
Medical subject headings
Myocardial Infarction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MNCBiological

    Also called MNC injection

    Implantation of BM derived MNC

  • AC 133Biological

    Also called AC133 injection

    Implantation of BM derived AC133

  • ControlBiological

    Also called Placebo

    Injection of cell carrier

Study groups in NCT01167751
Study groupRoleWhat they receive
MNC implantationExperimentalImplantation of BM derived MNC
Receives: Biological: MNC
AC 133 implantationExperimentalImplantation of BM derived AC 133
Receives: Biological: AC 133
ControlPlacebo comparatorInjection of cell carrier
Receives: Biological: Control

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Left ventricular ejection fraction at rest, measured by gated SPECT

    Measured: 6 months

Secondary outcomes (2)

  1. 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

    Measured: 6 months

  2. changes in LVM index, LVEDV, LVESV

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Jul 2010 (estimated)
  2. Study startJan 2008
  3. Primary completionJun 2012
  4. Study completionJul 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
90 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01167751
Sponsor's protocol ID
Royan-Heart-001
Status last verified
Jul 2010
First submitted
19 Jul 2010
Last updated
21 Jun 2016
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 17691968

  • 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.

    PubMed 29633605

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing MNC and AC 133 in people with Myocardial Infarction, run by Royan Institute at 1 site in Iran.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Left ventricular ejection fraction at rest, measured by gated SPECT (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01167751, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jun 2016.

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