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

NCT00790764 | Suspended Phase 2 DMC

• 1 other identifier: 2008--03-II
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Disease; Blocked Arteries; Coronary Ischemia; Coronary Disease; Coronary Artery Disease; Coronary Atherosclerosis

Outcome Measures

Primary Outcomes (1)

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

  2 weeks

Secondary Outcomes (1)

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

  6 months

Study Arms (2)

Placebo

PLACEBO COMPARATOR

20 individuals will receive placebo.

Other: placebo

MESENDO

EXPERIMENTAL

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

Biological: MESENDO

Interventions

MESENDO BIOLOGICAL

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.

MESENDO

placebo OTHER

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

Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• TCA Cellular Therapy: lead

Study Sites (1)

TCA Cellular Therapy

Covington, Louisiana, 70433, United States

Location

MeSH Terms

Conditions

Heart Diseases; Coronary Disease; Coronary Artery Disease

Condition Hierarchy (Ancestors)

Cardiovascular Diseases; Myocardial Ischemia; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases

Study Officials

• Gabriel P. Lasala, MD

  TCA Cellular Therapy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 12, 2008
• First Posted: November 13, 2008
• Study Start: November 1, 2008
• Primary Completion: May 1, 2014
• Study Completion: May 1, 2014
• Last Updated: May 9, 2014

Record last verified: 2011-04

Locations

US (1)