Coronary IschemiaPhase 1CINCT00643981
Combination Stem Cell Therapy for the Treatment of Severe Coronary Ischemia
A Phase 1 study testing MESENDO in people with Coronary Ischemia and Coronary Disease, run by TCA Cellular Therapy at 1 site in United States.
Trial summary
The purpose of this research study is to determine if the infusion of a combination of stem cells obtained from the bone marrow of the same patient will contribute to the formation of new blood vessels in patients with symptomatic severe coronary ischemia. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Coronary Ischemia, Coronary Disease, Coronary Artery Disease
- What is being tested?
- MESENDO
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2008to Feb 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or Female age 18-20
- Angina Pectoris: CCS Class II or IV or angina symptom equivalent
- 70% blockage in at least one epicardial vessel documented within 6 months
- Stable medical therapy
- Reversible perfusion defects by SPECT
- Not a candidate for percutaneous intervention or coronary by-pass surgery
Who cannot join
- Previous angiogenic therapy or myocardial laser therapy
- Severe valvular heart disease
- Recent malignancy or radiation therapy within 6 months
- Renal insufficiency with creatinine greater that 2.7
- White blood count greater than 13,000 or lower than 3,000
- Platelet count lower than 60,000 or higher that 500,000
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- Pregnant or planning to become pregnant
- History of skeletal muscle disease
- AST or ALT greater than two times upper limit of normal
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 See if a of A Combination Stem Cell Therapy is Safe and Feasible for the Treatment of Severe Coronary Ischemia
The purpose of this research study is to determine if the infusion of a combination of stem cells obtained from the bone marrow of the same patient will contribute to the formation of new blood vessels in patients with symptomatic severe coronary ischemia. In this trial we will study the safe use of this therapy and its effects on making new blood vessels will be evaluated.
Coronary ischemia is intractable angina due to severe coronary artery disease which can seriously decrease blood flow to the heart.
Read more
CI needs a comprehensive treatment since the condition will not improve on its own. The overall goal of the treatment is to increase blood flow to the heart and improve symptoms of angina.
The study hypothesis is based on the concept that the process of formation of new blood vessels is complex and requires the participation of several types of stem cells and growth factors. The lack of any of these components will produce vessels which are immature and unable to provide appropriate blood supply to the heart.
Patients eligible to participate in this study are those suffering from severe blockages to the vessels of the heart and are not candidates for percutaneous revascularization or surgical procedures.
Once the final mixture of stem cells is prepared, the cells will be intracoronary infused through a catheter into the blocked vessel of the heart.
Studies will be performed to evaluate if the intracoronary infusion of stem cells is safe, feasible and works.
Patients will be evaluated for 6 months after cell transplant.
- Conditions
- Coronary Ischemia, Coronary Disease, Coronary Artery Disease, Coronary Atherosclerosis, Coronary Arteriosclerosis
- Being tested
- MESENDO
- Medical subject headings
- Coronary Disease, Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MESENDOBiological
2 ml of the "final cell mixture" will be injected through the lumen of an intracoronary percutaneous balloon designed for angioplasty into the ishcemic vessel.
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety as measured by laboratory assessments, ecg, temperature and holter monitor
Measured: 2 weeks
Secondary outcomes (1)
Efficacy as measured by SPECT scan and 2-D Echo
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 posted26 Mar 2008 (estimated)
- Study startFeb 2008
- Primary completionDec 2008
- Study completionFeb 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary IschemiaStudies 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
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- TCA Cellular Therapy
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00643981
- Sponsor's protocol ID
- 2007-03-I
- Acronym
- CI
- Status last verified
- Dec 2008
- First submitted
- 20 Mar 2008
- Last updated
- 28 Apr 2011
- Results posted
- 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 See if a of A Combination Stem Cell Therapy is Safe and Feasible for the Treatment of Severe Coronary Ischemia
- ClinicalTrials.gov ID
- NCT00643981
- Acronym / sponsor ID
- CI / 2007-03-I
- Conditions
- Coronary Ischemia, Coronary Disease, Coronary Artery Disease, Coronary Atherosclerosis, Coronary Arteriosclerosis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- TCA Cellular TherapyIndustry (pharma, biotech, devices)
- Study start
- Feb 2008
- Primary completion
- Dec 2008 (actual)
- Study completion
- Feb 2009 (actual)
- First posted
- 26 Mar 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.
The purpose of this research study is to determine if the infusion of a combination of stem cells obtained from the bone marrow of the same patient will contribute to the formation of new blood vessels in patients with symptomatic severe coronary ischemia. In this trial we will study the safe use of this therapy and its effects on making new blood vessels will be evaluated.
Coronary ischemia is intractable angina due to severe coronary artery disease which can seriously decrease blood flow to the heart.
CI needs a comprehensive treatment since the condition will not improve on its own. The overall goal of the treatment is to increase blood flow to the heart and improve symptoms of angina.
The study hypothesis is based on the concept that the process of formation of new blood vessels is complex and requires the participation of several types of stem cells and growth factors. The lack of any of these components will produce vessels which are immature and unable to provide appropriate blood supply to the heart.
Patients eligible to participate in this study are those suffering from severe blockages to the vessels of the heart and are not candidates for percutaneous revascularization or surgical procedures.
Once the final mixture of stem cells is prepared, the cells will be intracoronary infused through a catheter into the blocked vessel of the heart.
Studies will be performed to evaluate if the intracoronary infusion of stem cells is safe, feasible and works.
Patients will be evaluated for 6 months after cell transplant.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male or Female age 18-20
- Angina Pectoris: CCS Class II or IV or angina symptom equivalent
- 70% blockage in at least one epicardial vessel documented within 6 months
- Stable medical therapy
- Reversible perfusion defects by SPECT
Key exclusion criteria (9 listed)
- Previous angiogenic therapy or myocardial laser therapy
- Severe valvular heart disease
- Recent malignancy or radiation therapy within 6 months
- Renal insufficiency with creatinine greater that 2.7
- White blood count greater than 13,000 or lower than 3,000
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 |
|---|---|---|
| MESENDO2 ml of the "final cell mixture" will be injected through the lumen of an intracoronary percutaneous balloon designed for angioplasty into the ishcemic vessel. | Biological | – |
Primary outcome
Safety as measured by laboratory assessments, ecg, temperature and holter monitor
Time frame: 2 weeks
1 secondary outcome
Efficacy as measured by SPECT scan and 2-D Echo
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Ischemia and Coronary Disease, 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 6 inclusion and 9 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 as measured by laboratory assessments, ecg, temperature and holter monitor (time frame: 2 weeks). 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.