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SuspendedNCT00790764Updated May 9, 2014

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

A Phase 2 interventional study of MESENDO and placebo in Heart Disease, Blocked Arteries and Coronary Ischemia, sponsored by TCA Cellular Therapy. Suspended at 1 site in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2014-05-09.

Sponsored by TCA Cellular Therapy · Phase 2, Interventional, and Treatment

Why this study was suspended
Suspended due to lack of funding.
Phase
Phase 2
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study 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 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).

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
02

Conditions studied

  • Heart Disease
  • Blocked Arteries
  • Coronary Ischemia
  • Coronary Disease
  • Coronary Artery Disease
  • Coronary Atherosclerosis
03

In context

Coronary Artery Disease

5,598 studies on the registry are indexed under Coronary Artery Disease; 957 are open to participants now.

This study's planned enrollment of 60 is below the median of 124 across 3,436 interventional studies indexed under Coronary Artery Disease.

Browse Coronary Artery Disease studies →

Lead sponsor

TCA Cellular Therapy is the lead sponsor of 7 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
  • 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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
60 participants (estimated)

Study arms

  • Placebo comparator
    Placebo

    20 individuals will receive placebo.

    Other: placebo

  • Experimental
    MESENDO

    Active combination autologous stem cell therapy. 40 individuals will receive MESENDO in either the "high" or "low" dose treatment groups.

    Biological: MESENDO

Interventions

  • BiologicalMESENDO

    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.

  • Otherplacebo

    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

06

What researchers measure

Primary outcomes

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

    Time frame: 2 weeks

Secondary outcomes

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

    Time frame: 6 months

07

Study locations

1 site
  • TCA Cellular Therapy
    Covington, Louisiana 70433, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 9, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00790764
Lead sponsor
TCA Cellular Therapy
Responsible party
Sponsor
First posted
Nov 13, 2008
Start date
Nov 2008
Primary completion
May 2014 (estimated)
Completion
May 2014 (estimated)
Last update
May 9, 2014

Study contacts

Gabriel P. Lasala, MD
principal investigator · TCA Cellular Therapy

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is suspended, as verified in Apr 2011. You cannot join it, but the record below documents what was studied.

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