Myocardial InfarctionPhase 2/3NCT01187654
Bone Marrow Derived AC 133+ and Mono-Nuclear Cells (MNC) Implantation in Myocardial Infarction (MI) Patient
A Phase 2/3 study testing AC133 and MNC in people with Myocardial Infarction, run by Royan Institute at 1 site in Iran.
Trial summary
Although a percutaneous coronary intervention (PCI) can be used to open up the blocked artery and restore blood flow to the heart muscle after myocardial infarction, there may be a significant amount of heart tissue that has been irreversibly damaged. 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?
- AC133 and MNC
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteIran
- Study dates
- May 2009to Dec 2012
- Phase
- Phase 2/3
- 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
- BMI> 30
- First acute MI in LAD territory
- St elevation MI
- Ejection fraction: 20-45%
- at least two non - mobile or less mobile segment of left ventricular myocard.
- Successful PCI with stenting
Who cannot join
- Multivessel ceremony artery disease
- Pulmonary edema
- SBP < 80 mmHg
- Thrombocytopenia (PLT < 50, 000)
- INR > 2
- Hepatic failure or dysfunction
Show all 12Show fewer
- Renal failure or dysfunction
- Positive HIV Ab/ HBC Ab/ HCV Ab/ HSV Ag
- Documental terminal illness
- Documental Malignancy
- Patient with sever coronary disease and unstability of vital sign
- History of leukopenia, Anemia, hepatic or renal dysfunction or malignancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison the Therapeutic Outcomes of Bone Marrow Derived AC 133+ and Mono-Nuclear Cells (MNC) Implantation in Patient With Acute Myocardial Infarction Underwent PCI Procedure
Although a percutaneous coronary intervention (PCI) can be used to open up the blocked artery and restore blood flow to the heart muscle after myocardial infarction, there may be a significant amount of heart tissue that has been irreversibly damaged. Recent studies have shown that adult stem cells from bone marrow may be able to improve heart function and prevent from heart remodeling due to heart failure.
This study will evaluate the safety and effectiveness of using adult bone marrow derived stem cells for improving heart function in MI patients with Left Anterior Descending (LAD) involvement.
Read the detailed description
Patient from both gender, who had acute MI within recent 3 Weeks in LAD territory and would underwent PCI are eligible for this study. The bone marrow derived AC 133+ and MNC would be intracoronary injected to the patients during PCI procedure. The control group would be received just serum during PCI. The patient would be followed every month and at the end of 6th and 18thmonth the case and control groups will be evaluated by stress echo and Tc99 scan.
The totality of evidence from trials investigating autologous whole bone marrow infusion into patients following myocardial infarction supports the safety of this approach in terms of efficacy
- Conditions
- Myocardial Infarction
- Being tested
- AC133, MNC, CONTROL
- Keywords
- myocardial infarction, bone marrow stem cell, AC133, mono nuclear cell
- Medical subject headings
- Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AC133Biological
Also called AC133 injection
intra coronary injection of bone marrow derived AC133+ cells
MNCBiological
Also called MNC injection
intra coronary injection of bone marrow derived MNC
CONTROLBiological
Also called placebo injection
autologous serum injection
| Study group | Role | What they receive |
|---|---|---|
| AC133 recipients | Experimental | intra coronary injection of bone marrow derived AC133+ cells Receives: Biological: AC133 |
| MNC recipients | Experimental | intra coronary injection of bone marrow derived MNC Receives: Biological: MNC |
| control | Active comparator | injection of autologous serum Receives: Biological: CONTROL |
What is being measured
The primary outcome is the main question the study is designed to answer.
Increase from baseline in ejection fraction
Measured: 6 months
Secondary outcomes (2)
Decrease LVESV/LVEDV/LVM index
left ventricular end systolic volume (LVESV) left ventricular end diastolic volume (LVEDV) Left Ventricular mass (LVM)
Measured: 6 months
Decrease the number of Non Viable segments from baseline
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2010 (estimated)
- Study startMay 2009
- Primary completionSep 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myocardial InfarctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Royan Institute
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Hamid Gourabi, PhD, Study chair, Royan InstituteMasoud Ghassemi, MD, Principal investigator, Royan InstituteNasser Aghdami, PhD,MD, Study director, Royan InstituteDavood Kazemi saleh, MD, Principal investigator, Royan InstituteHossein Baharvand, PhD, Principal investigator, Royan Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01187654
- Sponsor's protocol ID
- Royan-Heart-002
- Status last verified
- Aug 2010
- First submitted
- 18 Aug 2010
- Last updated
- 27 Dec 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison the Therapeutic Outcomes of Bone Marrow Derived AC 133+ and Mono-Nuclear Cells (MNC) Implantation in Patient With Acute Myocardial Infarction Underwent PCI Procedure
- ClinicalTrials.gov ID
- NCT01187654
- Acronym / sponsor ID
- Royan-Heart-002
- Conditions
- Myocardial Infarction
- Keywords
- myocardial infarction, bone marrow stem cell, AC133, mono nuclear cell
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Royan InstituteOther government
- Study start
- May 2009
- Primary completion
- Sep 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 24 Aug 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Although a percutaneous coronary intervention (PCI) can be used to open up the blocked artery and restore blood flow to the heart muscle after myocardial infarction, there may be a significant amount of heart tissue that has been irreversibly damaged. Recent studies have shown that adult stem cells from bone marrow may be able to improve heart function and prevent from heart remodeling due to heart failure.
This study will evaluate the safety and effectiveness of using adult bone marrow derived stem cells for improving heart function in MI patients with Left Anterior Descending (LAD) involvement.
Detailed description
Patient from both gender, who had acute MI within recent 3 Weeks in LAD territory and would underwent PCI are eligible for this study. The bone marrow derived AC 133+ and MNC would be intracoronary injected to the patients during PCI procedure. The control group would be received just serum during PCI. The patient would be followed every month and at the end of 6th and 18thmonth the case and control groups will be evaluated by stress echo and Tc99 scan.
The totality of evidence from trials investigating autologous whole bone marrow infusion into patients following myocardial infarction supports the safety of this approach in terms of efficacy
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| AC133 recipients | Experimental | Biological: AC133intra coronary injection of bone marrow derived AC133+ cells |
| MNC recipients | Experimental | Biological: MNCintra coronary injection of bone marrow derived MNC |
| control | Active comparator | Biological: CONTROLinjection of autologous serum |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- BMI> 30
- First acute MI in LAD territory
- St elevation MI
- Ejection fraction: 20-45%
- at least two non - mobile or less mobile segment of left ventricular myocard.
Key exclusion criteria (12 listed)
- Multivessel ceremony artery disease
- Pulmonary edema
- SBP < 80 mmHg
- Thrombocytopenia (PLT < 50, 000)
- INR > 2
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AC133Also: AC133 injectionintra coronary injection of bone marrow derived AC133+ cells | Biological | AC133 recipients |
| MNCAlso: MNC injectionintra coronary injection of bone marrow derived MNC | Biological | MNC recipients |
| CONTROLAlso: placebo injectionautologous serum injection | Biological | control |
Primary outcome
Increase from baseline in ejection fraction
Time frame: 6 months
2 secondary outcomes
Decrease LVESV/LVEDV/LVM index
Time frame: 6 months
Decrease the number of Non Viable segments from baseline
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hamid Gourabi, PhD study chair
Royan Institute
Masoud Ghassemi, MD principal investigator
Royan Institute
Nasser Aghdami, PhD,MD study director
Royan Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing AC133 and MNC 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 6 inclusion and 12 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 27 Dec 2012. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Increase from baseline in ejection fraction (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Dec 2012.