Acute Myocardial InfarctionPhase 1/2AMIRSTNCT01536106
Rapid Delivery of Autologous Bone Marrow Derived Stem Cells in Acute Myocardial Infarction Patients.
A Phase 1/2 study testing Autologous Bone marrow mononuclear cells in people with Acute Myocardial Infarction, run by TotipotentRX Cell Therapy Pvt. Ltd. at 3 sites in India.
Trial summary
The primary objective of the study is to determine the feasibility and safety of intracoronary administration of autologous bone marrow derived mononuclear cell product in patients at risk for clinically significant cardiac dysfunction following AMI. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Acute Myocardial Infarction
- What is being tested?
- Autologous Bone marrow mononuclear cells
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 3 sitesIndia
- Study dates
- Dec 2013to Mar 2015
- Phase
- Phase 1/2
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or Female of age 18 - 75 years
- Incidence of first myocardial infarction
- Acute STEMI with LV hypokinesia involving anteroseptal, lateral or inferior walls
- LVEF < 40% pre-intervention
- Successful percutaneous intervention (PCI) within ≤ 24 hours after onset of symptoms (PTCA/stent) or / and Thrombolysed patients having TIMI-3 flow.
- Written informed consent
Who cannot join
- Multi-vessel coronary disease requiring surgical intervention (CABG) or left main coronary artery disease > 50% blockage
- Previous history of CABG
- Pulmonary edema
- Cardiogenic shock
- Myocarditis
- Renal or hepatic dysfunction
Show all 17Show fewer
- Hematologic disease
- General Exclusion Criteria:
- Alcohol or drug dependency, active or uncontrolled acute myocarditis
- HIV, HBV, or HCV infections
- Evidence of malignant or hematological diseases
- Metal implants of any kind
- Claustrophobia
- Renal insufficiency
- History of bleeding disorder
- Anemia (haemoglobin <8.5mg/dl)
- Platelet count <100,000/ml
Trial locations and contacts
3 sites in 1 country.
India3 sites
CARE Hospitals, Banjara Hills
Hyderabad, Hyderabad, 500034
Sreenivas A Kumar, 040-30418126, arramraj@yahoo.com
Sreenivas A Kumar, MD, DM, FACC
Fortis Escorts Heart Institute and Research Centre
New Delhi, New Delhi, 110025
Ashok Seth, FRCS, FSCAI, 911147134232, ashok.seth@fortishealthcare.com
Vinay Sanghi, MD, 911147135000, vinay.sanghi@fortishealthcare.com
Fortis Flt. Lt. Rajan Dhall Hospital
New Delhi, New Delhi, 110070
Upendra Kaul, MD, 911147135000, upendra.kaul@fortishealthcare.com
Tapan Ghose, MD, 911147134232, tapan.ghose@fortishealthcare.com
About this study
Official title: Intracoronary Infusion of Concentrated Autologous Bone Marrow Mononuclear Cells in Acute Myocardial Infarction Patients Utilizing a Novel Point-of-Care Device for Rapid-Delivery of Stem Cells (AMIRST)
The primary objective of the study is to determine the feasibility and safety of intracoronary administration of autologous bone marrow derived mononuclear cell product in patients at risk for clinically significant cardiac dysfunction following AMI.
The secondary objective of the study is to assess the effect on cardiac function and infarct region perfusion. A concurrent placebo control patient group meeting eligibility but not receiving autologous bone marrow derived stem cells will be evaluated similar to the treated group to assess the rate of significant spontaneous improvement in cardiac function.
Read the detailed description
Emerging evidence indicate that progenitor stem cells derived from bone marrow can be used to improve cardiac function in acute myocardial infarction patients. There is a great potential for stem cell therapy, using a variety of cell precursors to contribute to new blood vessel formation and muscle preservation in the myocardial infarct zone. The administration of cells via an infusion through the infarct related artery appears to be feasible and result in a clinical effect in some studies. Across the globe AMI is the leading cause of morbidity and mortality. This cannot be prevented by optimal standard therapies i.e. balloon or stent dilation of the infarct vessels.
The study is a double blind, placebo controlled, randomized, multicenter trial. Male or female patients between 18-75 years with first incidence of Acute Myocardial Infarction(AMI) and LVEF less than or equal to 40% are included in the study. Patients who have undergone successful percutaneous intervention (PCI) within ≤ 24 hours after onset of symptoms (PTCA/stent) or / and Thrombolysed patients having TIMI-3 flow are eligible to take part in the study.
A total of 30 subjects will be recruited and randomly assigned to receive concentrated BMMNC or placebo. All patients will undergo bone marrow aspiration within 3-10 days from the index event(infarction). Bone Marrow(BM) will be processed utilizing point of care technology. Following cell processing, the concentrated BMMNC or placebo control is infused directly into the infarct related artery using the stop flow method. Clinical follow up for all the subjects at 1,30, 60, 90, 180 and 360 days will be performed from the day of the procedure, with primary and secondary end points evaluated for both study arms.
- Conditions
- Acute Myocardial Infarction
- Being tested
- Autologous Bone marrow mononuclear cells, Placebo control
- Keywords
- Cell therapy, Bone marrow stem cells, cardiac cell therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autologous Bone marrow mononuclear cellsOther
Also called BMMNC treatment group
Intracoronary administration of concentrated BMMNC on the same day of BM aspiration using point of care technology.
Placebo controlOther
Also called Placebo control group
Intracoronary infusion of autologous peripheral blood.
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Implantation of bone marrow derived mononuclear cells Receives: Other: Autologous Bone marrow mononuclear cells |
| Placebo Control | Placebo comparator | Infusion of autologous peripheral blood Receives: Other: Placebo control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of adverse events as a measure of safety
Feasibility and safety of Intracoronary infusion of autologous BMMNCs processed through intraoperative point of care technology, freedom from arrhythmia's.
Measured: 12 Months
Secondary outcomes (3)
Changes in the global Left Ventricular Ejection Fraction(LVEF), LV volumes-End Systolic Volume (ESV) and End Diastolic Volume (EDV), infarct size, myocardial mass, myocardial viability and regional wall motion abnormalities.
Changes in the global Left Ventricular Ejection Fraction(LVEF), LV volumes-End Systolic Volume (ESV) and End Diastolic Volume (EDV), infarct size, myocardial mass, myocardial viability and regional wall motion abnormalities measured by Cardiac MRI and assessed by central Core lab.
Measured: 12 Months
Major adverse cardiac events (MACE)
MACE was defined as the composites of any cause of death, myocardial infarction, revascularization of the target vessel, re-hospitalization for heart failure, and life-threatening arrhythmia.
Measured: 12 Months
Quality of life
Quality of life assessment is done using short-form 36, Minnesota living with heart failure questionnaire and Seattle Angina Questionnaire
Measured: 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2012 (estimated)
- Study startDec 2013
- Primary completionJan 2015 (estimated)
- Study completionMar 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- TotipotentRX Cell Therapy Pvt. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- TotipotentRX Corporation
- Responsible party
- Sponsor
- Investigators
- Venkatesh Ponemone, PhD, Study director, TotipotentRX Cell Therapy Pvt. Ltd.Kenneth Harris, MS, Study chair, TotipotentRX Cell Therapy Pvt. Ltd.Ashok Seth, FRCP, FACC, Principal investigator, Fortis Escorts Heart Institute and Research CentreUpendra Kaul, MD,DM, FACC, Principal investigator, Fortis Flt. Lt. Rajan Dhall HospitalSreenivas A Kumar, MD, DM, FACC, Principal investigator, CARE Hospitals Hyderabad, India
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01536106
- Sponsor's protocol ID
- TPRX/POC/BMSC/AMIRST/1.0
- Acronym
- AMIRST
- Status last verified
- Sep 2013
- First submitted
- 16 Jul 2011
- Last updated
- 4 Sep 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Roncalli J, Mouquet F, Piot C, Trochu JN, Le Corvoisier P, Neuder Y, Le Tourneau T, Agostini D, Gaxotte V, Sportouch C, Galinier M, Crochet D, Teiger E, Richard MJ, Polge AS, Beregi JP, Manrique A, Carrie D, Susen S, Klein B, Parini A, Lamirault G, Croisille P, Rouard H, Bourin P, Nguyen JM, Delasalle B, Vanzetto G, Van Belle E, Lemarchand P. Intracoronary autologous mononucleated bone marrow cell infusion for acute myocardial infarction: results of the randomized multicenter BONAMI trial. Eur Heart J. 2011 Jul;32(14):1748-57. doi: 10.1093/eurheartj/ehq455. Epub 2010 Dec 2.
PubMed 21127322Strauer BE, Yousef M, Schannwell CM. The acute and long-term effects of intracoronary Stem cell Transplantation in 191 patients with chronic heARt failure: the STAR-heart study. Eur J Heart Fail. 2010 Jul;12(7):721-9. doi: 10.1093/eurjhf/hfq095.
PubMed 20576835Dohmann HF, Silva SA, Sousa AL, Braga AM, Branco RV, Haddad AF, Oliveira MA, Moreira RC, Tuche FA, Peixoto CM, Tura BR, Borojevic R, Ribeiro JP, Nicolau JC, Nobrega AC, Carvalho AC. Multicenter double blind trial of autologous bone marrow mononuclear cell transplantation through intracoronary injection post acute myocardium infarction - MiHeart/AMI study. Trials. 2008 Jul 3;9:41. doi: 10.1186/1745-6215-9-41.
PubMed 18598362
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intracoronary Infusion of Concentrated Autologous Bone Marrow Mononuclear Cells in Acute Myocardial Infarction Patients Utilizing a Novel Point-of-Care Device for Rapid-Delivery of Stem Cells (AMIRST)
- ClinicalTrials.gov ID
- NCT01536106
- Acronym / sponsor ID
- AMIRST / TPRX/POC/BMSC/AMIRST/1.0
- Conditions
- Acute Myocardial Infarction
- Keywords
- Cell therapy, Bone marrow stem cells, cardiac cell therapy
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- TotipotentRX Cell Therapy Pvt. Ltd.Industry (pharma, biotech, devices)
- Collaborators
- TotipotentRX Corporation
- Study start
- Dec 2013
- Primary completion
- Jan 2015 (estimated)
- Study completion
- Mar 2015 (estimated)
- First posted
- 20 Feb 2012 (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 primary objective of the study is to determine the feasibility and safety of intracoronary administration of autologous bone marrow derived mononuclear cell product in patients at risk for clinically significant cardiac dysfunction following AMI.
The secondary objective of the study is to assess the effect on cardiac function and infarct region perfusion. A concurrent placebo control patient group meeting eligibility but not receiving autologous bone marrow derived stem cells will be evaluated similar to the treated group to assess the rate of significant spontaneous improvement in cardiac function.
Detailed description
Emerging evidence indicate that progenitor stem cells derived from bone marrow can be used to improve cardiac function in acute myocardial infarction patients. There is a great potential for stem cell therapy, using a variety of cell precursors to contribute to new blood vessel formation and muscle preservation in the myocardial infarct zone. The administration of cells via an infusion through the infarct related artery appears to be feasible and result in a clinical effect in some studies. Across the globe AMI is the leading cause of morbidity and mortality. This cannot be prevented by optimal standard therapies i.e. balloon or stent dilation of the infarct vessels.
The study is a double blind, placebo controlled, randomized, multicenter trial. Male or female patients between 18-75 years with first incidence of Acute Myocardial Infarction(AMI) and LVEF less than or equal to 40% are included in the study. Patients who have undergone successful percutaneous intervention (PCI) within ≤ 24 hours after onset of symptoms (PTCA/stent) or / and Thrombolysed patients having TIMI-3 flow are eligible to take part in the study.
A total of 30 subjects will be recruited and randomly assigned to receive concentrated BMMNC or placebo. All patients will undergo bone marrow aspiration within 3-10 days from the index event(infarction). Bone Marrow(BM) will be processed utilizing point of care technology. Following cell processing, the concentrated BMMNC or placebo control is infused directly into the infarct related artery using the stop flow method. Clinical follow up for all the subjects at 1,30, 60, 90, 180 and 360 days will be performed from the day of the procedure, with primary and secondary end points evaluated for both study arms.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Other: Autologous Bone marrow mononuclear cellsImplantation of bone marrow derived mononuclear cells |
| Placebo Control | Placebo comparator | Other: Placebo controlInfusion of autologous peripheral blood |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male or Female of age 18 - 75 years
- Incidence of first myocardial infarction
- Acute STEMI with LV hypokinesia involving anteroseptal, lateral or inferior walls
- LVEF < 40% pre-intervention
- Successful percutaneous intervention (PCI) within ≤ 24 hours after onset of symptoms (PTCA/stent) or / and Thrombolysed patients having TIMI-3 flow.
Key exclusion criteria (17 listed)
- Multi-vessel coronary disease requiring surgical intervention (CABG) or left main coronary artery disease > 50% blockage
- Previous history of CABG
- Pulmonary edema
- Cardiogenic shock
- Myocarditis
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 Bone marrow mononuclear cellsAlso: BMMNC treatment groupIntracoronary administration of concentrated BMMNC on the same day of BM aspiration using point of care technology. | Other | Treatment |
| Placebo controlAlso: Placebo control groupIntracoronary infusion of autologous peripheral blood. | Other | Placebo Control |
Primary outcome
Number of adverse events as a measure of safety
Time frame: 12 Months
Feasibility and safety of Intracoronary infusion of autologous BMMNCs processed through intraoperative point of care technology, freedom from arrhythmia's.
3 secondary outcomes
Changes in the global Left Ventricular Ejection Fraction(LVEF), LV volumes-End Systolic Volume (ESV) and End Diastolic Volume (EDV), infarct size, myocardial mass, myocardial viability and regional wall motion abnormalities.
Time frame: 12 Months
Major adverse cardiac events (MACE)
Time frame: 12 Months
Quality of life
Time frame: 12 Months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2013.
- Results publication: PubMed 21127322Roncalli J, Mouquet F, Piot C, Trochu JN, Le Corvoisier P, Neuder Y, Le Tourneau T, Agostini D, Gaxotte V, Sportouch C, Galinier M, Crochet D, Teiger E, Richard MJ, Polge AS, Beregi JP, Manrique A, Carrie D, Susen S, Klein B, Parini A, Lamirault G, Croisille P, Rouard H, Bourin P, Nguyen JM, Delasalle B, Vanzetto G, Van Belle E, Lemarchand P. Intracoronary autologous mononucleated bone marrow cell infusion for acute myocardial infarction: results of the randomized multicenter BONAMI trial. Eur Heart J. 2011 Jul;32(14):1748-57. doi: 10.1093/eurheartj/ehq455. Epub 2010 Dec 2.
- Results publication: PubMed 20576835Strauer BE, Yousef M, Schannwell CM. The acute and long-term effects of intracoronary Stem cell Transplantation in 191 patients with chronic heARt failure: the STAR-heart study. Eur J Heart Fail. 2010 Jul;12(7):721-9. doi: 10.1093/eurjhf/hfq095.
- Results publication: PubMed 18598362Dohmann HF, Silva SA, Sousa AL, Braga AM, Branco RV, Haddad AF, Oliveira MA, Moreira RC, Tuche FA, Peixoto CM, Tura BR, Borojevic R, Ribeiro JP, Nicolau JC, Nobrega AC, Carvalho AC. Multicenter double blind trial of autologous bone marrow mononuclear cell transplantation through intracoronary injection post acute myocardium infarction - MiHeart/AMI study. Trials. 2008 Jul 3;9:41. doi: 10.1186/1745-6215-9-41.
Related trials for Acute Myocardial Infarction
Not yet recruitingObservational study
Elicit Drugs in Myocardial Infarction
Young Patients With Acute Myocardial Infarction
Recruiting
CT Stress Myocardial Perfusion, Fractional Flow Reserve and Angiography in Patients With Stable Chest Pain Syndromes
Coronary Artery Disease, Chest Syndrome
RecruitingPhase 4
Early Single Antiplatelet Therapy After IVUS-Guided PCI in Acute Coronary Syndrome
Acute Coronary Syndromes, STEMI
Recruiting
Heart@Home Safety and Efficacy of Hospital-at-Home Care Versus Standard Hospitalization in Cardiac Patients
Myocardial Infarction, Myocarditis Acute
Enrolling by invitationPhase 3
Selatogrel Outcome Study in Suspected Acute Myocardial Infarction
Acute Myocardial Infarction
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.
Venkatesh Ponemone, PhD study director
TotipotentRX Cell Therapy Pvt. Ltd.
Kenneth Harris, MS study chair
TotipotentRX Cell Therapy Pvt. Ltd.
Ashok Seth, FRCP, FACC principal investigator
Fortis Escorts Heart Institute and Research Centre
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Autologous Bone marrow mononuclear cells in people with Acute Myocardial Infarction, run by TotipotentRX Cell Therapy Pvt. Ltd. at 3 sites in India.
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 17 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 4 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in India. 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Kenneth Harris, MS (13234207766, ken.harris@totipotentrx.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of adverse events as a measure of safety (time frame: 12 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 NCT01536106, which also lists 3 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 4 Sep 2013.