Acute Myocardial InfarctionPhase 2/3MAGIC Cell-5NCT00501917
MAGIC Cell-5-Combicytokine Trial
A Phase 2/3 study testing G-CSF with/without darbepoetin, peripheral blood stem cell infusion in people with Acute Myocardial Infarction, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
Combination use of darbepoetin and G-CSF will improve left ventricular systolic function in patients with acute myocardial infarction who receive intracoronary infusion of mobilized peripheral blood stem cell in comparison with patient who treated with conventional measures and who received intracoronary infusion of… Read more about this study
- Who is it for?
- Ages 15 to 80 years
- Conditions the study is for
- Acute Myocardial Infarction
- What is being tested?
- G-CSF with/without darbepoetin, peripheral blood stem cell infusion
- Type of treatment
- Injection or infusion
- How many people
- 116 participants
- Where
- 1 siteSouth Korea
- Study dates
- Mar 2007to Feb 2010
- 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 15 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- ST elevation acute myocardial infarction
- < 80years
- successful revascularization of culprit vessel
Who cannot join
- uncontrolled congestive heart failure
- uncontrolled myocardial ischemia
- uncontrolled ventricular arrhythmia
- malignancy
- serious hematologic disease
- chronic renal failure
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Seoul National Univesity Hospital
Seoul
About this study
Official title: Single Center, Prospective, Randomized, Partly-Double Blinded, Controlled Trial to Assess the Safety and Feasibility of Intracoronary Cell Infusion Mobilized With G-CSF and Darbepoetin and Their Effects on Improvement of Cardiac Function in Patients With Myocardial Infarction: Myocardial Regeneration and Angiogenesis in Myocardial Infarction With G-CSF and Erythropoietin Mobilization and Intra-Coronary Cell Infusion -5-Combination Cytokine Therapy Trial
Combination use of darbepoetin and G-CSF will improve left ventricular systolic function in patients with acute myocardial infarction who receive intracoronary infusion of mobilized peripheral blood stem cell in comparison with patient who treated with conventional measures and who received intracoronary infusion of mobilized peripheral blood stem cell by G-CSF alone.
- Conditions
- Acute Myocardial Infarction
- Being tested
- G-CSF with/without darbepoetin, peripheral blood stem cell infusion
- Keywords
- acute myocardial infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
G-CSF with/without darbepoetin, peripheral blood stem cell infusionDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
change of left ventricular ejection fraction measured by cardiac MRI
Measured: 6, 12, and 24month
Secondary outcomes (1)
wall motion score index exercise capacity BNP
Measured: 6,12, 24month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2007 (estimated)
- Study startMar 2007
- Study completionFeb 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Acute Myocardial InfarctionStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- 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
- Double blind
- Enrolment
- 116 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Hyo-Soo Kim, MD PhD, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00501917
- Sponsor's protocol ID
- MAGIC Cell-5
- Acronym
- MAGIC Cell-5
- Status last verified
- Jul 2007
- First submitted
- 13 Jul 2007
- Last updated
- 16 Jul 2007
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Kang HJ, Yoon EJ, Lee EJ, Kim MK, Suh JW, Park KW, Lee HY, Park KU, Cho YS, Koo BK, Chae IH, Choi DJ, Han KS, Kim HS, Park YB. Cotreatment with darbepoetin and granulocyte colony-stimulating factor is efficient to recruit proangiogenic cell populations in patients with acute myocardial infarction. Cell Transplant. 2012;21(5):1055-61. doi: 10.3727/096368911X627499. Epub 2012 Mar 22.
PubMed 22449332Kang HJ, Kim MK, Kim MG, Choi DJ, Yoon JH, Park YB, Kim HS. A multicenter, prospective, randomized, controlled trial evaluating the safety and efficacy of intracoronary cell infusion mobilized with granulocyte colony-stimulating factor and darbepoetin after acute myocardial infarction: study design and rationale of the 'MAGIC cell-5-combination cytokine trial'. Trials. 2011 Feb 7;12:33. doi: 10.1186/1745-6215-12-33.
PubMed 21299845
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single Center, Prospective, Randomized, Partly-Double Blinded, Controlled Trial to Assess the Safety and Feasibility of Intracoronary Cell Infusion Mobilized With G-CSF and Darbepoetin and Their Effects on Improvement of Cardiac Function in Patients With Myocardial Infarction: Myocardial Regeneration and Angiogenesis in Myocardial Infarction With G-CSF and Erythropoietin Mobilization and Intra-Coronary Cell Infusion -5-Combination Cytokine Therapy Trial
- ClinicalTrials.gov ID
- NCT00501917
- Acronym / sponsor ID
- MAGIC Cell-5 / MAGIC Cell-5
- Conditions
- Acute Myocardial Infarction
- Keywords
- acute myocardial infarction
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 116 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Mar 2007
- Study completion
- Feb 2010 (estimated)
- First posted
- 16 Jul 2007 (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.
Combination use of darbepoetin and G-CSF will improve left ventricular systolic function in patients with acute myocardial infarction who receive intracoronary infusion of mobilized peripheral blood stem cell in comparison with patient who treated with conventional measures and who received intracoronary infusion of mobilized peripheral blood stem cell by G-CSF alone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 15 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- ST elevation acute myocardial infarction
- < 80years
- successful revascularization of culprit vessel
Key exclusion criteria (6 listed)
- uncontrolled congestive heart failure
- uncontrolled myocardial ischemia
- uncontrolled ventricular arrhythmia
- malignancy
- serious hematologic disease
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 |
|---|---|---|
| G-CSF with/without darbepoetin, peripheral blood stem cell infusion | Drug | – |
Primary outcome
change of left ventricular ejection fraction measured by cardiac MRI
Time frame: 6, 12, and 24month
1 secondary outcome
wall motion score index exercise capacity BNP
Time frame: 6,12, 24month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2007.
- Derived from this study: PubMed 22449332Kang HJ, Yoon EJ, Lee EJ, Kim MK, Suh JW, Park KW, Lee HY, Park KU, Cho YS, Koo BK, Chae IH, Choi DJ, Han KS, Kim HS, Park YB. Cotreatment with darbepoetin and granulocyte colony-stimulating factor is efficient to recruit proangiogenic cell populations in patients with acute myocardial infarction. Cell Transplant. 2012;21(5):1055-61. doi: 10.3727/096368911X627499. Epub 2012 Mar 22.
- Derived from this study: PubMed 21299845Kang HJ, Kim MK, Kim MG, Choi DJ, Yoon JH, Park YB, Kim HS. A multicenter, prospective, randomized, controlled trial evaluating the safety and efficacy of intracoronary cell infusion mobilized with granulocyte colony-stimulating factor and darbepoetin after acute myocardial infarction: study design and rationale of the 'MAGIC cell-5-combination cytokine trial'. Trials. 2011 Feb 7;12:33. doi: 10.1186/1745-6215-12-33.
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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.
Hyo-Soo Kim, MD PhD principal investigator
Seoul National University Hospital
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 G-CSF with/without darbepoetin, peripheral blood stem cell infusion in people with Acute Myocardial Infarction, run by Seoul National University Hospital at 1 site in South Korea.
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 3 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 16 Jul 2007. 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 South Korea. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hyo-Soo Kim, MD PhD (82-2-2072-2226, hyosoo@snu.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change of left ventricular ejection fraction measured by cardiac MRI (time frame: 6, 12, and 24month). 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 NCT00501917, 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 16 Jul 2007.