Acute Myocardial InfarctionREGEN-AMINCT00765453
Bone Marrow Derived Adult Stem Cells for Acute Anterior Myocardial Infarction
A study of Acute Myocardial Infarction, run by Barts & The London NHS Trust at 5 sites in 3 countries.
Trial summary
Study hypothesis : The purpose of this study is to determine whether Intracoronary infusion of autologous bone marrow derived progenitor cells to patients undergoing primary angioplasty for acute anterior myocardial infarction will lead to an improvement in cardiac function greater than that seen by placebo alone. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Acute Myocardial Infarction
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 5 sitesin 3 countries
- Study dates
- Mar 2008to Mar 2018
- Phase
- Interventional
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients presenting to the Heart Attack Centre with acute anterior myocardial infarction (ST elevation in at least 2 contiguous anterior leads ≥ 0.2 mV) and treated with acute PCI with stent implantation within 24 hours after symptom onset
- Acute PCI / stent implantation has been successful (residual stenosis visually < 30% and TIMI flow ≥ 2).
- At the time of inclusion patient no longer requires i.v. catecholamines or mechanical hemodynamic support (aortic balloon pump)
- Significant regional wall motion abnormality in LV angiogram at the time of acute PCI in the LAD territory
- Age 18 - 80 Years (primary angioplasty confers an adverse prognosis in those over the age of 80 years)
- Written informed consent in the recruiting centres native language
Who cannot join
- Regional wall motion abnormality outside the area involved in the index acute myocardial infarction
- Need to revascularise additional vessels, outside the infarct artery as a planned procedure (these vessels can be treated at baseline)
- Arteriovenous malformations or aneurysms
- Active infection, or fever or diarrhoea within last 4 weeks
- Chronic inflammatory disease
- Known HIV infection or active hepatitis
Show all 22Show fewer
- Neoplastic disease without documented remission within the past 5 years
- Cerebrovascular insult within 3 months
- Impaired renal function (creatinine > 200mmol) at the time of cell therapy
- Significant liver disease (GOT > 2x upper limit) or spontaneous INR > 1,5)
- Anemia (hemoglobin < 8.5 mg/dl)
- Platelet count < 100.000/µl
- Hypersplenism
- Known allergy or intolerance to clopidogrel, heparin or abciximab
- History of bleeding disorder
- Gastrointestinal bleeding within 3 months
- Major surgical procedure or trauma within 2 months
- Uncontrolled hypertension
- Pregnancy
- Mental retardation leading to inability to obtain informed consent
- Previously performed stem / progenitor cell therapy
- Participation in another clinical trial within the last 30 days
Trial locations and contacts
5 sites in 3 countries.
5 sites in 3 countries
United Kingdom3 sites
London Chest Hospital, Barts and The London NHS Trust
Bethnal Green, London, E2 9JX
The Heart Hosptial, UCLH Foundation Trust
London
The Royal Free Hospital, Royal Free London Foundation Trust
London
About this study
Official title: Randomised Controlled Clinical Trial of the Use of Autologous Bone Marrow Derived Progenitor Cells to Salvage Myocardium in Patients With Acute Anterior Myocardial Infarction
Study hypothesis :
The purpose of this study is to determine whether Intracoronary infusion of autologous bone marrow derived progenitor cells to patients undergoing primary angioplasty for acute anterior myocardial infarction will lead to an improvement in cardiac function greater than that seen by placebo alone.
Read more
Aims
- To demonstrate that it is safe and feasible to deliver autologous bone marrow derived stem cells within hours of the primary angioplasty procedure
- To demonstrate the effects of autologous bone marrow derived stem cells on cardiac function using cardiac MRI (or cardiac CT), echocardiography and left ventriculography.
- To demonstrate the effect of autologous bone marrow derived stem cells in addition to standard care leads to improvement in cardiac function compared to patients saline(placebo) and standard care.
- Conditions
- Acute Myocardial Infarction
- Being tested
- Bone marrow derived progenitor cells or placebo infusion, Placebo infusion
- Keywords
- Heart attack, Anterior Myocardial infarction (MI), adult stem cells, bone marrow progenitor cells, bone marrow stem cells, autologous, left ventricular function, intracoronary injection
- Medical subject headings
- Myocardial Infarction, Anterior Wall Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bone marrow derived progenitor cells or placebo infusionOther
Over-the-wire balloon catheter delivers infusion into coronary vessel using a stop-flow technique
Placebo infusionOther
Placebo infusion
| Study group | Role | What they receive |
|---|---|---|
| Intracoronary | Experimental | Patients will be randomised in a 1:1 ratio to receive intracoronary injections of bone marrow derived stem/progenitor cells or placebo infusion through a percutaneous route Receives: Other: Bone marrow derived progenitor cells or placebo infusion |
| Placebo | Placebo comparator | Placebo infusion Receives: Other: Placebo infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Longitudinal change in left ventricular function (ejection fraction)
Measured: 1 year
Secondary outcomes (7)
Longitudinal change in left ventricular function (ejection fraction), change in left ventricular end systolic volume, and change in infarct size
Measured: 3 months
Longitudinal change in left ventricular function as measured by LV angiography
Measured: 6 months
Longitudinal change in left ventricular function assessed by echocardiography.
Measured: 6 months
Change in left ventricular end systolic volume and change in infarct size.
Measured: 12 months
Longitudinal change in left ventricular function assessed by echocardiography.
Measured: 12 months
MACE
Measured: 12 months
Change in Quality of life
Measured: 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2008 (estimated)
- Study startMar 2008
- Primary completionMar 2014
- Study completionMar 2018
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.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Barts & The London NHS Trust
- Sponsor type
- University, hospital or other
- Collaborators
- University College, London, Queen Mary University of London
- Responsible party
- Principal investigator, Anthony Mathur, Barts & The London NHS Trust
- Investigators
- Anthony Mathur, FRCP FESC Ph, Principal investigator, Barts and the London NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00765453
- Sponsor's protocol ID
- 07/Q0603/76
- Other IDs
- 2007-002-144
- Acronym
- REGEN-AMI
- Status last verified
- Feb 2020
- First submitted
- 2 Oct 2008
- Last updated
- 2 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Choudry F, Hamshere S, Saunders N, Veerapen J, Bavnbek K, Knight C, Pellerin D, Locca D, Westwood M, Rakhit R, Crake T, Kastrup J, Parmar M, Agrawal S, Jones D, Martin J, Mathur A. A randomized double-blind control study of early intra-coronary autologous bone marrow cell infusion in acute myocardial infarction: the REGENERATE-AMI clinical trialdagger. Eur Heart J. 2016 Jan 14;37(3):256-63. doi: 10.1093/eurheartj/ehv493. Epub 2015 Sep 23.
PubMed 26405233Hamshere S, Choudhury T, Jones DA, Locca D, Mills P, Rothman M, Knight C, Parmar M, Agrawal S, Martin J, Mathur A. A randomised double-blind control study of early intracoronary autologous bone marrow cell infusion in acute myocardial infarction (REGENERATE-AMI). BMJ Open. 2014 Feb 18;4(2):e004258. doi: 10.1136/bmjopen-2013-004258.
PubMed 24549163
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised Controlled Clinical Trial of the Use of Autologous Bone Marrow Derived Progenitor Cells to Salvage Myocardium in Patients With Acute Anterior Myocardial Infarction
- ClinicalTrials.gov ID
- NCT00765453
- Acronym / sponsor ID
- REGEN-AMI / 07/Q0603/76
- Conditions
- Acute Myocardial Infarction
- Keywords
- Heart attack, Anterior Myocardial infarction (MI), adult stem cells, bone marrow progenitor cells, bone marrow stem cells, autologous, left ventricular function, intracoronary injection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Barts & The London NHS TrustUniversity, hospital or other
- Collaborators
- University College, London, Queen Mary University of London
- Study start
- Mar 2008
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2018 (actual)
- First posted
- 3 Oct 2008 (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.
Study hypothesis :
The purpose of this study is to determine whether Intracoronary infusion of autologous bone marrow derived progenitor cells to patients undergoing primary angioplasty for acute anterior myocardial infarction will lead to an improvement in cardiac function greater than that seen by placebo alone.
Aims
- To demonstrate that it is safe and feasible to deliver autologous bone marrow derived stem cells within hours of the primary angioplasty procedure
- To demonstrate the effects of autologous bone marrow derived stem cells on cardiac function using cardiac MRI (or cardiac CT), echocardiography and left ventriculography.
- To demonstrate the effect of autologous bone marrow derived stem cells in addition to standard care leads to improvement in cardiac function compared to patients saline(placebo) and standard care.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intracoronary | Experimental | Other: Bone marrow derived progenitor cells or placebo infusionPatients will be randomised in a 1:1 ratio to receive intracoronary injections of bone marrow derived stem/progenitor cells or placebo infusion through a percutaneous route |
| Placebo | Placebo comparator | Other: Placebo infusionPlacebo infusion |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients presenting to the Heart Attack Centre with acute anterior myocardial infarction (ST elevation in at least 2 contiguous anterior leads ≥ 0.2 mV) and treated with acute PCI with stent implantation within 24 hours after symptom onset
- Acute PCI / stent implantation has been successful (residual stenosis visually < 30% and TIMI flow ≥ 2).
- At the time of inclusion patient no longer requires i.v. catecholamines or mechanical hemodynamic support (aortic balloon pump)
- Significant regional wall motion abnormality in LV angiogram at the time of acute PCI in the LAD territory
- Age 18 - 80 Years (primary angioplasty confers an adverse prognosis in those over the age of 80 years)
Key exclusion criteria (22 listed)
- Regional wall motion abnormality outside the area involved in the index acute myocardial infarction
- Need to revascularise additional vessels, outside the infarct artery as a planned procedure (these vessels can be treated at baseline)
- Arteriovenous malformations or aneurysms
- Active infection, or fever or diarrhoea within last 4 weeks
- Chronic inflammatory 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 |
|---|---|---|
| Bone marrow derived progenitor cells or placebo infusionOver-the-wire balloon catheter delivers infusion into coronary vessel using a stop-flow technique | Other | Intracoronary |
| Placebo infusionPlacebo infusion | Other | Placebo |
Primary outcome
Longitudinal change in left ventricular function (ejection fraction)
Time frame: 1 year
7 secondary outcomes
Longitudinal change in left ventricular function (ejection fraction), change in left ventricular end systolic volume, and change in infarct size
Time frame: 3 months
Longitudinal change in left ventricular function as measured by LV angiography
Time frame: 6 months
Longitudinal change in left ventricular function assessed by echocardiography.
Time frame: 6 months
Change in left ventricular end systolic volume and change in infarct size.
Time frame: 12 months
Longitudinal change in left ventricular function assessed by echocardiography.
Time frame: 12 months
MACE
Time frame: 12 months
Change in Quality of life
Time frame: 6 and 12 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 2 Mar 2020.
- Derived from this study: PubMed 26405233Choudry F, Hamshere S, Saunders N, Veerapen J, Bavnbek K, Knight C, Pellerin D, Locca D, Westwood M, Rakhit R, Crake T, Kastrup J, Parmar M, Agrawal S, Jones D, Martin J, Mathur A. A randomized double-blind control study of early intra-coronary autologous bone marrow cell infusion in acute myocardial infarction: the REGENERATE-AMI clinical trialdagger. Eur Heart J. 2016 Jan 14;37(3):256-63. doi: 10.1093/eurheartj/ehv493. Epub 2015 Sep 23.
- Derived from this study: PubMed 24549163Hamshere S, Choudhury T, Jones DA, Locca D, Mills P, Rothman M, Knight C, Parmar M, Agrawal S, Martin J, Mathur A. A randomised double-blind control study of early intracoronary autologous bone marrow cell infusion in acute myocardial infarction (REGENERATE-AMI). BMJ Open. 2014 Feb 18;4(2):e004258. doi: 10.1136/bmjopen-2013-004258.
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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.
Anthony Mathur, FRCP FESC Ph principal investigator
Barts and the London NHS Trust
5 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Acute Myocardial Infarction, run by Barts & The London NHS Trust at 5 sites in 3 countries.
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 22 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 2 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United Kingdom, Denmark, Switzerland. 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.
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?
Longitudinal change in left ventricular function (ejection fraction) (time frame: 1 year). 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 NCT00765453, 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 2 Mar 2020.