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

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ClinicalTrials.gov Identifier: NCT00790764
Recruitment Status : Suspended (Suspended due to lack of funding.)
First Posted : November 13, 2008
Last Update Posted : May 9, 2014
Sponsor:
Information provided by (Responsible Party):
TCA Cellular Therapy

Tracking Information
First Submitted Date  ICMJE November 12, 2008
First Posted Date  ICMJE November 13, 2008
Last Update Posted Date May 9, 2014
Study Start Date  ICMJE November 2008
Estimated Primary Completion Date May 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 12, 2008)
Safety as measured by laboratory assessments, ecg and temperature. [ Time Frame: 2 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 12, 2008)
Efficacy as measured by SPECT scan, MUGA scan and 2D Echogradiogram [ Time Frame: 6 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Phase II Combination Stem Cell Therapy for the Treatment of Severe Coronary Ischemia(CI)
Official Title  ICMJE Phase II Study for the Transfer of Bone Marrow-Derived Mononuclear and Mesenchymal StemCells Into the Myocardium for the Treatment of Severe Coronary Ischemia
Brief 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.

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
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Heart Disease
  • Blocked Arteries
  • Coronary Ischemia
  • Coronary Disease
  • Coronary Artery Disease
  • Coronary Atherosclerosis
Intervention  ICMJE
  • Biological: MESENDO
    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.
  • Other: placebo
    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 Arms  ICMJE
  • Placebo Comparator: Placebo
    20 individuals will receive placebo.
    Intervention: Other: placebo
  • Experimental: MESENDO
    Active combination autologous stem cell therapy. 40 individuals will receive MESENDO in either the "high" or "low" dose treatment groups.
    Intervention: Biological: MESENDO
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Suspended
Estimated Enrollment  ICMJE
 (submitted: November 12, 2008)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 2014
Estimated Primary Completion Date May 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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:

  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00790764
Other Study ID Numbers  ICMJE 2008--03-II
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party TCA Cellular Therapy
Study Sponsor  ICMJE TCA Cellular Therapy
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Gabriel P. Lasala, MD TCA Cellular Therapy
PRS Account TCA Cellular Therapy
Verification Date April 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP