Coronary Artery DiseasePhase 1NCT00548613
Combination Stem Cell (MESENDO) Therapy for Utilization and Rescue of Infarcted Myocardium
A Phase 1 study testing MESENDO in people with Coronary Artery Disease and Coronary Arteriosclerosis, run by TCA Cellular Therapy at 1 site in United States.
Trial summary
The purpose of this research study is to determine if the transplant of a combination of stem cells, obtained from the bone marrow of the same patient, is effective for utilization and rescue of infarcted myocardium. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Coronary Artery Disease, Coronary Arteriosclerosis, Coronary Atherosclerosis
- What is being tested?
- MESENDO
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2007to Mar 2009
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ARM: A -
- Patients with acute myocardial infarction with ST elevation who underwent percutaneous revascularization between 4 and 24 hours after the initiation of symptoms.
- Able to give written informed consent
- Age: 18 to 70 years
- Gender: Male and Female
- Acute myocardial infarction occurring within 4-24 hours after onset of symptoms documented by at least one of the following:
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- ST Segment elevation greater than 2mm in two or more consecutive leads
- New Bundle Branch Block with symptoms consistent of MI
- Troponin I greater than 2.0 ng/ml (Normal Range 0 - 1.5 ng/ml)
- Totally occluded artery as visualized by angiography
- ARM - B
- Patients who are candidates for coronary artery bypass grafting surgery according to ACC/AHA guidelines and have had a myocardial infarction in the past 12 months.
- Able to give written informed consent
- Patients with coronary artery disease who need coronary artery bypass surgery according to ACC/AHA guidelines
- Patients with Left Ventricular Ejection Fraction £ 40%.
- NYHA symptoms Class II (dyspnea with moderate effort)
- Defined region of myocardial dysfunction related to previous myocardial infarction (within the past 12 months) involving the anterior, lateral, posterior or inferior walls by either of the followings: echocardiography, ventriculography, MRI, or SPECT.
- Age: 18 to 70 years
- Gender: Male and Female
Who cannot join
- ARM - A
- Pregnancy
- Previous angiogenic therapy or myocardial laser therapy
- History of cancer within 5 years
- Known sensitivity to gentamycin and/or amphotericin B
- Use or expected use of antineoplastic drugs
Show all 39Show fewer
- No informed consent or unable to provide informed consent.
- Any illness which, in the Investigator's judgment, will interfere with the patient's ability to comply with the protocol, compromise patient's safety, or interfere with the interpretation of the study results.
- Any illness which might affect patient's survival over the study follow-up period
- History of skeletal muscle disease, either primary (i.e., myopathy) or secondary (i.e., ischemic) or any underlying myopathy such as myasthenia gravis, muscular dystrophy, etc.
- Patients with active infectious disease and/or who are known to have tested positive for HIV, HTLV, HBV-sAg, HCV, CMV and/or syphilis
- Cardiogenic shock or severe compromise in left ventricular systolic function defined as ejection fraction lower than 20 %.
- History of intolerance to amiodarone.
- End stage renal disease
- Contraindication for MRI
- Any significant laboratory abnormality which will in the investigator's opinion interfere with the patient's ability to comply with the protocol, compromise the patient's safety, or interfere with the interpretation of the study result.
- Inability to identify the infarct area intra operatively
- ARM - B
- Previous angiogenic therapy or myocardial laser therapy
- History of cancer within 5 years
- Cardiogenic shock or severe compromise in left ventricular systolic function defined as ejection fraction lower than 20 %.
- Left Ventricular Ejection Fraction ≥ 40%.
- Known sensitivity to gentamycin and/or amphotericin B
- Use or expected use of antineoplastic drugs
- No informed consent or unable to provide informed consent
- Any illness which, in the Investigator's judgment, will interfere with the patient's ability to comply with the protocol, compromise patient safety, or interfere with the interpretation of the study results
- Any illness which might affect patient's survival over the study follow-up period
- History of skeletal muscle disease, either primary (i.e., myopathy) or secondary (i.e.,ischemic) or any underlying myopathy such as myasthenia gravis, muscular dystrophy, etc.
- Patients with active infectious disease and/or who are known to have tested positive for HIV, HTLV, HBV-sAg, HCV, CMV and/or syphilis
- Poor candidates for coronary artery bypass surgery
- Patients who are in need of emergency bypass surgery
- History of prior coronary artery bypass surgery
- Patients with severe valvular heart disease
- History of intolerance to amiodarone
- End stage renal disease
- Pregnancy
- Contraindication for MRI
- Any significant laboratory abnormality which will in the investigator's opinion interfere with the patient's ability to comply with the protocol, compromise the patient's safety, or interfere with the interpretation of the study result.
- Inability to identify infarct area intra operatively.
Trial locations and contacts
1 site in 1 country.
United States1 site
TCA Cellular Therapy, LLC
Covington, Louisiana, 70433
About this study
Official title: Phase I Study to Determine the Safety and Feasibility of the Use of a Combination Stem Cell Therapy in Patients With Acute Myocardial Infarction
The purpose of this research study is to determine if the transplant of a combination of stem cells, obtained from the bone marrow of the same patient, is effective for utilization and rescue of infarcted myocardium. End points will be the assessment of development of mature and stable new blood vessels as well as improvement in cardiac function.
This, Phase I, single center, prospective, non-randomized, open-label study will evaluate the safety and feasibility of use of the proposed combination of autologous stem cells. Potential subjects who fulfill clinical and laboratory entry criteria at screening will undergo a process of bone marrow aspiration for preparation of the two types of bone marrow-derived stem /progenitor cells to use. The two bone marrow-derived cell types will be mixed and implanted to patients approximately 2 weeks after bone marrow aspiration. After transplant, patients will be have a 3 month follow-up to evaluate safety as well as functional heart improvement by analysis of symptoms, myocardial perfusion SPECT, and echocardiography.
Read more
Study population will include adult male and female subjects, ages 18-70, presenting with acute myocardial infarction and subjects who have had a recent (within 12 months) myocardial infarction and will undergo coronary artery bypass grafting.
Patients will be divided in two groups:
- the first group will enroll patients with acute myocardial infarction whom percutaneous coronary intervention restored myocardial flow after 4 hours or greater of the initiation of symptoms,
- the second group will enroll patients who are candidates for coronary artery bypass surgery and had a myocardial infarction in the past 12 months.
Patients will receive the cell mixture by intracoronary or intramyocardial infusion, respectively.
The rationale of this clinical study is based on the observation that most attempts using adult stem cells for myocardial regeneration have utilized a source of bone marrow derived progenitor cells with the potential to generate new blood vessel and thus contribute to the revascularization of the ischemic tissue. This therapy seems to be adequate but not sufficient, since it lacks a source of stem cells capable of differentiating and maturing into cardiac muscle cells, thus contributing to the recovery of local contractility. The proposed combination stem/progenitor cell therapy to be used in this protocol is aimed at contributing cell types capable of regenerating both blood vessels and muscle tissues damaged after MI.
- Conditions
- Coronary Artery Disease, Coronary Arteriosclerosis, Coronary Atherosclerosis, Coronary Disease
- Being tested
- MESENDO
- Keywords
- Myocardial Infarction, Heart Attack, Coronary Artery Bypass Grafting
- Medical subject headings
- Coronary Artery Disease, Coronary Disease, Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MESENDOBiological
Intracoronary transplantation of autologous stem cells via balloon catheter
MESENDOBiological
Intracardiac transplantation of autologous stem cells via direct injection
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Patients with documented acute myocardial infarction (heart attack) occurring within 4-24 hours after onset of symptoms Receives: Biological: MESENDO |
| B | Experimental | Candidates for coronary artery bypass grafting that suffered a myocardial infarction (heart attack) within the past 12 months Receives: Biological: MESENDO |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety
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 posted24 Oct 2007 (estimated)
- Study startOct 2007
- Primary completionDec 2008
- Study completionMar 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies 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
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- TCA Cellular Therapy
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Gabriel P. Lasala, M.D., Principal investigator, TCA Cellular Therapy, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00548613
- Sponsor's protocol ID
- 2007-02-I
- Status last verified
- Apr 2011
- First submitted
- 22 Oct 2007
- Last updated
- 28 Apr 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Study to Determine the Safety and Feasibility of the Use of a Combination Stem Cell Therapy in Patients With Acute Myocardial Infarction
- ClinicalTrials.gov ID
- NCT00548613
- Acronym / sponsor ID
- 2007-02-I
- Conditions
- Coronary Artery Disease, Coronary Arteriosclerosis, Coronary Atherosclerosis, Coronary Disease
- Keywords
- Myocardial Infarction, Heart Attack, Coronary Artery Bypass Grafting
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- TCA Cellular TherapyIndustry (pharma, biotech, devices)
- Study start
- Oct 2007
- Primary completion
- Dec 2008 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 24 Oct 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.
The purpose of this research study is to determine if the transplant of a combination of stem cells, obtained from the bone marrow of the same patient, is effective for utilization and rescue of infarcted myocardium. End points will be the assessment of development of mature and stable new blood vessels as well as improvement in cardiac function.
This, Phase I, single center, prospective, non-randomized, open-label study will evaluate the safety and feasibility of use of the proposed combination of autologous stem cells. Potential subjects who fulfill clinical and laboratory entry criteria at screening will undergo a process of bone marrow aspiration for preparation of the two types of bone marrow-derived stem /progenitor cells to use. The two bone marrow-derived cell types will be mixed and implanted to patients approximately 2 weeks after bone marrow aspiration. After transplant, patients will be have a 3 month follow-up to evaluate safety as well as functional heart improvement by analysis of symptoms, myocardial perfusion SPECT, and echocardiography.
Study population will include adult male and female subjects, ages 18-70, presenting with acute myocardial infarction and subjects who have had a recent (within 12 months) myocardial infarction and will undergo coronary artery bypass grafting.
Patients will be divided in two groups:
- the first group will enroll patients with acute myocardial infarction whom percutaneous coronary intervention restored myocardial flow after 4 hours or greater of the initiation of symptoms,
- the second group will enroll patients who are candidates for coronary artery bypass surgery and had a myocardial infarction in the past 12 months.
Patients will receive the cell mixture by intracoronary or intramyocardial infusion, respectively.
The rationale of this clinical study is based on the observation that most attempts using adult stem cells for myocardial regeneration have utilized a source of bone marrow derived progenitor cells with the potential to generate new blood vessel and thus contribute to the revascularization of the ischemic tissue. This therapy seems to be adequate but not sufficient, since it lacks a source of stem cells capable of differentiating and maturing into cardiac muscle cells, thus contributing to the recovery of local contractility. The proposed combination stem/progenitor cell therapy to be used in this protocol is aimed at contributing cell types capable of regenerating both blood vessels and muscle tissues damaged after MI.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Biological: MESENDOPatients with documented acute myocardial infarction (heart attack) occurring within 4-24 hours after onset of symptoms |
| B | Experimental | Biological: MESENDOCandidates for coronary artery bypass grafting that suffered a myocardial infarction (heart attack) within the past 12 months |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- ARM: A -
- Patients with acute myocardial infarction with ST elevation who underwent percutaneous revascularization between 4 and 24 hours after the initiation of symptoms.
- ARM - B
- Patients who are candidates for coronary artery bypass grafting surgery according to ACC/AHA guidelines and have had a myocardial infarction in the past 12 months.
- Able to give written informed consent
Key exclusion criteria (39 listed)
- ARM - A
- Pregnancy
- Previous angiogenic therapy or myocardial laser therapy
- History of cancer within 5 years
- Known sensitivity to gentamycin and/or amphotericin B
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 |
|---|---|---|
| MESENDOIntracoronary transplantation of autologous stem cells via balloon catheter | Biological | A |
| MESENDOIntracardiac transplantation of autologous stem cells via direct injection | Biological | B |
Primary outcome
Safety
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 28 Apr 2011.
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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.
Gabriel P. Lasala, M.D. principal investigator
TCA Cellular Therapy, LLC
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 MESENDO in people with Coronary Artery Disease and Coronary Arteriosclerosis, run by TCA Cellular Therapy 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 19 inclusion and 39 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 28 Apr 2011. 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 (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Apr 2011.