Myocardial InfarctionPhase 1/2NCT00883727
Ex Vivo Cultured Bone Marrow Derived Allogenic MSCs in AMI
A Phase 1/2 study testing Stem cell and Plasmalyte A in people with Myocardial Infarction, run by Stempeutics Research Pvt Ltd at 4 sites in India.
Trial summary
This clinical trial aims to find out the safety and efficacy of adult mesenchymal stem cells in patients with myocardial infarction. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Myocardial Infarction
- What is being tested?
- Stem cell and Plasmalyte A
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 4 sitesIndia
- Study dates
- Apr 2009to Aug 2012
- 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 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with STEMI aged between 20 and 70 years, either males or females with non-child bearing potential, after 2 days of successful PCI.
- Patient has global left ventricular systolic dysfunction with an ejection fraction of <50% and >30%.
- ECG with sign of acute anterior MI with ST-elevation ≥ 2 mm in at least 2 of the following leads I, AVL, V1-V6, or ECG with sign of acute inferoposterior MI with ST-elevation ≥1 mm on all of the following leads- II, III, V5-V6 or STelevation ≥ 2 mm in at least 2 of the leads.
- The target lesion located in the proximal section of the left anterior descending, left circumflex or right coronary artery.
- Patient with acute myocardial infarction within 10 days prior to IP administration.
- Normal liver and renal function.
- Able to understand study information provided to him.
- Able to give voluntary written consent.
Who cannot join
- History of acute/chronic inflammatory condition or severe aortic stenosis or insufficiency; severe mitral stenosis or severe mitral insufficiency.
- Severe co-morbidity associated with a reduction in life expectancy of less than 1 year.
- Advanced renal dysfunction and creatinine ≥ 2mg%.
- Advanced hepatic dysfunction.
- Have clinically serious and/or unstable intercurrent infection, medical illnesses or conditions that are uncontrolled or whose control, in the opinion of the Investigator, may be jeopardized by participation in this study or by the complications of this therapy
Trial locations and contacts
4 sites in 1 country.
India4 sites
SAL Hospital and Medical Institute
Ahmedabad, Gujarat, 380054
MS Ramaiah Memorial Hospital
Bangalore, Karnataka, 560054
Bhagawan Mahaveer Jain Heart Centre
Bangalore, Karnataka, 5660052
Care Hospital
Hyderabad, Andhra Pradesh, 500034
About this study
Official title: A Randomized, Double Blind, Multicentric, Placebo Controlled, Single Dose, Phase - i/ii Study Assessing the Safety and Efficacy of Intravenous ex Vivo Cultured Adult Allogenic Mesenchymal Stem Cells in Patients With st Elevated Acute Myocardial Infarction (Stemi)
This clinical trial aims to find out the safety and efficacy of adult mesenchymal stem cells in patients with myocardial infarction.
- Conditions
- Myocardial Infarction
- Being tested
- Stem cell, Plasmalyte A
- Keywords
- mesenchymal stem cells, myocardial infarction
- Medical subject headings
- Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stem cellDrug
IV infusion of stem cells
Plasmalyte ADrug
IV infusion
| Study group | Role | What they receive |
|---|---|---|
| stem cells | Experimental | Not described Receives: Drug: Stem cell |
| Placebo | Placebo comparator | Not described Receives: Drug: Plasmalyte A |
What is being measured
The primary outcome is the main question the study is designed to answer.
AE and ECG parameters
Measured: 6 months
Secondary outcomes (1)
Regional myocardial perfusion and infarct size
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 posted20 Apr 2009 (estimated)
- Study startApr 2009
- Primary completionMay 2010
- Study completionAug 2012
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 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stempeutics Research Pvt Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sreenivas Kumar, MD, DM, Principal investigator, Care Hospital, HyderabadSatya Gupta, Principal investigator, SAL Hospital, AhmedabadR Keshava, MD, DM, Principal investigator, Bhagwan Mahaveer JAin Hospital, BangalorePrakash VS, MD., DM, Principal investigator, MS Ramaiah Memorial Hospital, Bangalore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00883727
- Sponsor's protocol ID
- SRPL/AMI/07-08/001
- Status last verified
- Mar 2013
- First submitted
- 17 Apr 2009
- Last updated
- 5 Mar 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Chullikana A, Majumdar AS, Gottipamula S, Krishnamurthy S, Kumar AS, Prakash VS, Gupta PK. Randomized, double-blind, phase I/II study of intravenous allogeneic mesenchymal stromal cells in acute myocardial infarction. Cytotherapy. 2015 Mar;17(3):250-61. doi: 10.1016/j.jcyt.2014.10.009. Epub 2014 Dec 4.
PubMed 25484310
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double Blind, Multicentric, Placebo Controlled, Single Dose, Phase - i/ii Study Assessing the Safety and Efficacy of Intravenous ex Vivo Cultured Adult Allogenic Mesenchymal Stem Cells in Patients With st Elevated Acute Myocardial Infarction (Stemi)
- ClinicalTrials.gov ID
- NCT00883727
- Acronym / sponsor ID
- SRPL/AMI/07-08/001
- Conditions
- Myocardial Infarction
- Keywords
- mesenchymal stem cells, myocardial infarction
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Stempeutics Research Pvt LtdIndustry (pharma, biotech, devices)
- Study start
- Apr 2009
- Primary completion
- May 2010 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 20 Apr 2009 (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.
This clinical trial aims to find out the safety and efficacy of adult mesenchymal stem cells in patients with myocardial infarction.
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 |
|---|---|---|
| stem cells | Experimental | Drug: Stem cell |
| Placebo | Placebo comparator | Drug: Plasmalyte A |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patients with STEMI aged between 20 and 70 years, either males or females with non-child bearing potential, after 2 days of successful PCI.
- Patient has global left ventricular systolic dysfunction with an ejection fraction of <50% and >30%.
- ECG with sign of acute anterior MI with ST-elevation ≥ 2 mm in at least 2 of the following leads I, AVL, V1-V6, or ECG with sign of acute inferoposterior MI with ST-elevation ≥1 mm on all of the following leads- II, III, V5-V6 or STelevation ≥ 2 mm in at least 2 of the leads.
- The target lesion located in the proximal section of the left anterior descending, left circumflex or right coronary artery.
- Patient with acute myocardial infarction within 10 days prior to IP administration.
Key exclusion criteria (5 listed)
- History of acute/chronic inflammatory condition or severe aortic stenosis or insufficiency; severe mitral stenosis or severe mitral insufficiency.
- Severe co-morbidity associated with a reduction in life expectancy of less than 1 year.
- Advanced renal dysfunction and creatinine ≥ 2mg%.
- Advanced hepatic dysfunction.
- Have clinically serious and/or unstable intercurrent infection, medical illnesses or conditions that are uncontrolled or whose control, in the opinion of the Investigator, may be jeopardized by participation in this study or by the complications of this therapy
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 |
|---|---|---|
| Stem cellIV infusion of stem cells | Drug | stem cells |
| Plasmalyte AIV infusion | Drug | Placebo |
Primary outcome
AE and ECG parameters
Time frame: 6 months
1 secondary outcome
Regional myocardial perfusion and infarct size
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 Mar 2013.
- Derived from this study: PubMed 25484310Chullikana A, Majumdar AS, Gottipamula S, Krishnamurthy S, Kumar AS, Prakash VS, Gupta PK. Randomized, double-blind, phase I/II study of intravenous allogeneic mesenchymal stromal cells in acute myocardial infarction. Cytotherapy. 2015 Mar;17(3):250-61. doi: 10.1016/j.jcyt.2014.10.009. Epub 2014 Dec 4.
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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.
Sreenivas Kumar, MD, DM principal investigator
Care Hospital, Hyderabad
Satya Gupta principal investigator
SAL Hospital, Ahmedabad
R Keshava, MD, DM principal investigator
Bhagwan Mahaveer JAin Hospital, Bangalore
4 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 Stem cell and Plasmalyte A in people with Myocardial Infarction, run by Stempeutics Research Pvt Ltd at 4 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 8 inclusion and 5 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 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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?
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?
AE and ECG parameters (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 NCT00883727, 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 Mar 2013.