Acute Myocardial InfarctionPhase 1NCT00268307
Bone Marrow Stem Cell Infusion Following a Heart Attack
A Phase 1 study testing Autologous, Unfractionated Bone Marrow Mononuclear Cells in people with Acute Myocardial Infarction, run by Minneapolis Heart Institute Foundation at 1 site in United States.
Trial summary
The goal of this study is to determine the safety of giving a patient's own bone marrow-derived stem cells delivered with a catheter (tube) into the coronary arteries (blood vessels of the heart). Stem cells are simple cells produced by the bone marrow that can develop into many types of cells. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Acute Myocardial Infarction
- What is being tested?
- Autologous, Unfractionated Bone Marrow Mononuclear Cells
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2005to Sep 2010
- Phase
- Phase 1
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients age at least 21 years of age
- Patients with an acute anterior myocardial infarction limited to the proximal or mid-LAD with an artery diameter of at least 2.5 mm.
- Ability to undergo cell therapy procedure within 2 to 7 days following acute MI and PTCA/stenting.
- Ejection fraction following reperfusion with PTCA/stenting is between 30% and 50% as assessed by left-ventriculography or echocardiography.
- Consent to protocol and agree to comply with all follow-up visits and studies.
Who cannot join
- History of sustained ventricular arrhythmias not related to their acute myocardial infarction who do not have an ICD.
- Require coronary artery bypass surgery or percutaneous revascularization due to the presence of residual coronary stenosis > 70% luminal obstruction in the non-infarct related vessel.
- History of malignancy within the past 5 years excluding non-melanoma skin cancer or cervical cancer in-situ.
- History of anemia (Hb < 9.0 mg/dl).
- History of thrombocytosis.
- PT or PTT greater than the upper limits of normal.
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- Life expectancy less than one year.
- Patients on chronic dialysis.
- History of untreated alcohol or drug abuse.
- Currently enrolled in another Investigational drug or device trial.
- History of stroke or TIA within the past 6 months.
- History of severe valvular heart disease (aortic valve area < 1.0 cm2 or > 3+ mitral regurgitation.
- Pregnancy
- Subjects who are HIV, hepatitis B or C positive.
- Patients with active inflammatory or autoimmune disease on chronic immunosuppressive therapy.
- Contraindications to cardiac MRI
Trial locations and contacts
1 site in 1 country.
United States1 site
Minneapolis Heart Institute Foundation
Minneapolis, Minnesota, 55407
About this study
Official title: Cellular Transplantation of Autologous Bone Marrow-Derived Stem Cells Following Myocardial Infarction
The goal of this study is to determine the safety of giving a patient's own bone marrow-derived stem cells delivered with a catheter (tube) into the coronary arteries (blood vessels of the heart). Stem cells are simple cells produced by the bone marrow that can develop into many types of cells. It is possible that these cells will decrease the size of damage caused to the heart from a heart attack and increase the pumping efficiency of the heart; which can be decreased due to a heart attack. The stem cells will be taken from bone marrow and then given back into the heart vessels.
Read the detailed description
This protocol will test the hypothesis that an intracoronary infusion of autologous, unfractionated, bone marrow mononuclear cells will attenuate infarct size and improve left-ventricular function in 60 patients following an acute anterior myocardial infarction who have undergone successful revascularization with PTCA/stenting.
- Conditions
- Acute Myocardial Infarction
- Being tested
- Autologous, Unfractionated Bone Marrow Mononuclear Cells
- Keywords
- Cell therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autologous, Unfractionated Bone Marrow Mononuclear CellsDrug
Intracoronary infusion of Autologous, Unfractionated Bone Marrow Mononuclear Cells. Dose is 100,000,000 cells. One time infusion over 20 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Cell therapy | Experimental | Intracoronary, one time infusion of autologous, unfractionated bone marrow mononuclear cells. Receives: Drug: Autologous, Unfractionated Bone Marrow Mononuclear Cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety as measured by holter monitor, laboratory assessments, and cardiac MRI
Measured: 6 months
Secondary outcomes (1)
Improvement of left ventricular function as assessed by serial measurements of infarct size and LV function by cardiac MRI in the active treatment group versus placebo.
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 posted22 Dec 2005 (estimated)
- Study startDec 2005
- Primary completionJan 2010
- Study completionSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Minneapolis Heart Institute Foundation
- Sponsor type
- University, hospital or other
- Collaborators
- Allina Health System
- Responsible party
- Sponsor
- Investigators
- Jay Traverse, MD, Principal investigator, Minneapolis Heart Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00268307
- Sponsor's protocol ID
- opt001
- Status last verified
- Dec 2013
- First submitted
- 20 Dec 2005
- Last updated
- 5 Dec 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Traverse JH, McKenna DH, Harvey K, Jorgenso BC, Olson RE, Bostrom N, Kadidlo D, Lesser JR, Jagadeesan V, Garberich R, Henry TD. Results of a phase 1, randomized, double-blind, placebo-controlled trial of bone marrow mononuclear stem cell administration in patients following ST-elevation myocardial infarction. Am Heart J. 2010 Sep;160(3):428-34. doi: 10.1016/j.ahj.2010.06.009.
PubMed 20826249
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cellular Transplantation of Autologous Bone Marrow-Derived Stem Cells Following Myocardial Infarction
- ClinicalTrials.gov ID
- NCT00268307
- Acronym / sponsor ID
- opt001
- Conditions
- Acute Myocardial Infarction
- Keywords
- Cell therapy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Minneapolis Heart Institute FoundationUniversity, hospital or other
- Collaborators
- Allina Health System
- Study start
- Dec 2005
- Primary completion
- Jan 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 22 Dec 2005 (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.
The goal of this study is to determine the safety of giving a patient's own bone marrow-derived stem cells delivered with a catheter (tube) into the coronary arteries (blood vessels of the heart). Stem cells are simple cells produced by the bone marrow that can develop into many types of cells. It is possible that these cells will decrease the size of damage caused to the heart from a heart attack and increase the pumping efficiency of the heart; which can be decreased due to a heart attack. The stem cells will be taken from bone marrow and then given back into the heart vessels.
Detailed description
This protocol will test the hypothesis that an intracoronary infusion of autologous, unfractionated, bone marrow mononuclear cells will attenuate infarct size and improve left-ventricular function in 60 patients following an acute anterior myocardial infarction who have undergone successful revascularization with PTCA/stenting.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cell therapy | Experimental | Drug: Autologous, Unfractionated Bone Marrow Mononuclear CellsIntracoronary, one time infusion of autologous, unfractionated bone marrow mononuclear cells. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients age at least 21 years of age
- Patients with an acute anterior myocardial infarction limited to the proximal or mid-LAD with an artery diameter of at least 2.5 mm.
- Ability to undergo cell therapy procedure within 2 to 7 days following acute MI and PTCA/stenting.
- Ejection fraction following reperfusion with PTCA/stenting is between 30% and 50% as assessed by left-ventriculography or echocardiography.
- Consent to protocol and agree to comply with all follow-up visits and studies.
Key exclusion criteria (16 listed)
- History of sustained ventricular arrhythmias not related to their acute myocardial infarction who do not have an ICD.
- Require coronary artery bypass surgery or percutaneous revascularization due to the presence of residual coronary stenosis > 70% luminal obstruction in the non-infarct related vessel.
- History of malignancy within the past 5 years excluding non-melanoma skin cancer or cervical cancer in-situ.
- History of anemia (Hb < 9.0 mg/dl).
- History of thrombocytosis.
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 |
|---|---|---|
| Autologous, Unfractionated Bone Marrow Mononuclear CellsIntracoronary infusion of Autologous, Unfractionated Bone Marrow Mononuclear Cells. Dose is 100,000,000 cells. One time infusion over 20 minutes. | Drug | Cell therapy |
Primary outcome
Safety as measured by holter monitor, laboratory assessments, and cardiac MRI
Time frame: 6 months
1 secondary outcome
Improvement of left ventricular function as assessed by serial measurements of infarct size and LV function by cardiac MRI in the active treatment group versus placebo.
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 5 Dec 2013.
- Results publication: PubMed 20826249Traverse JH, McKenna DH, Harvey K, Jorgenso BC, Olson RE, Bostrom N, Kadidlo D, Lesser JR, Jagadeesan V, Garberich R, Henry TD. Results of a phase 1, randomized, double-blind, placebo-controlled trial of bone marrow mononuclear stem cell administration in patients following ST-elevation myocardial infarction. Am Heart J. 2010 Sep;160(3):428-34. doi: 10.1016/j.ahj.2010.06.009.
- click here for more information on this studyLink provided by the sponsor.
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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.
Jay Traverse, MD principal investigator
Minneapolis Heart Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Autologous, Unfractionated Bone Marrow Mononuclear Cells in people with Acute Myocardial Infarction, run by Minneapolis Heart Institute Foundation at 1 site in United States.
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 16 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 5 Dec 2013. 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 United States. 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 phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Safety as measured by holter monitor, laboratory assessments, and cardiac MRI (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 NCT00268307, which also lists 1 linked publication.
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 5 Dec 2013.