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Heart DiseasePhase 2NCT00790764

Phase II Combination Stem Cell Therapy for the Treatment of Severe Coronary Ischemia(CI)

A Phase 2 study testing MESENDO in people with Heart Disease and Blocked Arteries, run by TCA Cellular Therapy at 1 site in United States.

Suspended

Paused. Enrolment is on hold for now and may resume.

Official record
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Trial summary

The present investigation will be a Phase II, single center, placebo-controlled, randomized, dose escalation, infusion modality (intracoronary vs transendocardial injection using the Cordis Biosense NOGASTAR TM Mapping Catheter with the Biosense MYOSTAR TM left ventricular injection catheter) transplantation of an… Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Heart Disease, Blocked Arteries, Coronary Ischemia
What is being tested?
MESENDO
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
60 participants
Where
1 siteUnited States
Study dates
Nov 2008to May 2014
Phase
Phase 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 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age 18 to 80
  • Male or female
  • Angina pectoris: Canadian Cardiovascular Society Class III or IV or symptoms consistent with angina equivalent (dyspnea) CCS Class III or IV (Functional Class)
  • Chronic coronary artery disease in at least one epicardial vessel with stenosis > 70% by coronary angiography within the last 6 months
  • Stable medical therapy for at least one month
  • Reversible perfusion defects by SPECT
  • Not a candidate for coronary artery by-pass surgery due to poor targets or small vessels and not a candidate for percutaneous intervention due to small vessels or unreachable coronary lesions due to complicated anatomy

Who cannot join

  • Inability to give written informed consent
  • Previous angiogenic therapy or myocardial laser therapy
  • Recent (< 4 weeks) acute ST-elevation myocardial infarction
  • Patients with severe valvular heart disease
  • Recent malignancy or radiation therapy (< 6 months) and not expected to survive 6 months
  • Known sensitivity to gentamycin and/or amphotericin B
Show all 19Show fewer
  • Use or expected use of antineoplastic drugs
  • Renal insufficiency with creatinine greater than 2.7 unless on dialysis
  • WBC greater than 13,000 or lower than 3,000
  • Hematocrit lower than 30 or higher than 50
  • Platelet counts lower than 60,000 or higher than 500,000
  • Child bearing potential without use of contraceptives
  • Pregnant or planning to become pregnant
  • 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 sturdy 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, AST or ALT > 2 times ULRR
  • Cardiogenic shock
  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • TCA Cellular Therapy

    Covington, Louisiana, 70433

Other trials in United States

About this study

Official title: Phase II Study for the Transfer of Bone Marrow-Derived Mononuclear and Mesenchymal StemCells Into the Myocardium for the Treatment of Severe Coronary Ischemia

The present investigation will be a Phase II, single center, placebo-controlled, randomized, dose escalation, infusion modality (intracoronary vs transendocardial injection using the Cordis Biosense NOGASTAR TM Mapping Catheter with the Biosense MYOSTAR TM left ventricular injection catheter) transplantation of an autologous (your own stem cells) combination of bone marrow-derived stem cells into myocardium 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(CI).

Read more

In this trial we will determine whether the combination stem cell treatment is safe, feasible and results in the development of mature stable and/or collateral vessels and improvement of cardiac function.

Coronary Ischemia (CI) 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 of the vessels of the heart and are not candidates for percutaneous revascularization or surgical procedures.

Read the detailed description

Enrolled individuals (60) will be divided in 2 Treatment groups for the infusion of the cell /placebo product:

  1. Treatment Group A (30 individuals, including patients and placebo controls) will receive the product by intracoronary infusion,
  2. Treatment Group B (30 individuals, including patients and placebo controls) will receive the product by transendocardial injections. In turn, each Treatment Group will consist of 2 subgroups of individuals that will receive the infusion of one of the two doses established of the cell product:
  3. In treatment SubGroup 1, 10 individuals will receive the "low dose" of the cell product and 5 individuals will receive the placebo product.
  4. In treatment SubGroup 2, 10 individuals will receive the "high dose" of the cell product and 5 individuals will receive the placebo product
Being tested
MESENDO, placebo
Medical subject headings
Heart Diseases, 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

    For the cell product, proper aliquots of each cell type will be taken to fulfill the doses established for this protocol. The two aliquots will be mixed and resuspended to a final volume of 3 ml in the 'Final Suspension Medium' which consists of Dulbecco's Phosphate Buffered Saline (DPBS), containing 5% human serum albumin.

  • placeboOther

    For placebo, 3 ml of the 'Final Suspension Medium' which consists of Dulbecco's Phosphate Buffered Saline (DPBS), containing 5% human serum albumin will be transferred to a 5 ml syringe

Study groups in NCT00790764
Study groupRoleWhat they receive
PlaceboPlacebo comparator20 individuals will receive placebo.
Receives: Other: placebo
MESENDOExperimentalActive combination autologous stem cell therapy. 40 individuals will receive MESENDO in either the "high" or "low" dose treatment groups.
Receives: Biological: MESENDO

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Safety as measured by laboratory assessments, ecg and temperature.

    Measured: 2 weeks

Secondary outcomes (1)

  1. Efficacy as measured by SPECT scan, MUGA scan and 2D Echogradiogram

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Nov 2008 (estimated)
  2. Study startNov 2008
  3. Primary completionMay 2014 (estimated)
  4. Study completionMay 2014 (estimated)

Why it stopped: Suspended due to lack of funding.

Resources

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00790764
Sponsor's protocol ID
2008--03-II
Status last verified
Apr 2011
First submitted
12 Nov 2008
Last updated
9 May 2014
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing MESENDO in people with Heart Disease and Blocked Arteries, 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 7 inclusion and 19 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: paused, as of the sponsor's last update on 9 May 2014. 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. 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 phase mean?

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?

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 and temperature. (time frame: 2 weeks). 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 NCT00790764.

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 9 May 2014.

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