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

Primary Purpose

Heart Disease, Blocked Arteries, Coronary Ischemia

Status

Suspended

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

MESENDO

placebo

About this trial

This is an interventional treatment trial for Heart Disease

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

TCA Cellular Therapy

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

MESENDO

Arm Description

20 individuals will receive placebo.

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

Outcomes

Primary Outcome Measures

Safety as measured by laboratory assessments, ecg and temperature.

Secondary Outcome Measures

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

Full Information

NCT ID

NCT00790764

First Posted

November 12, 2008

Last Updated

May 7, 2014

Sponsor

TCA Cellular Therapy

1. Study Identification

Unique Protocol Identification Number

NCT00790764

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2011

Overall Recruitment Status

Suspended

Why Stopped

Suspended due to lack of funding.

Study Start Date

November 2008 (undefined)

Primary Completion Date

May 2014 (Anticipated)

Study Completion Date

May 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

TCA Cellular Therapy

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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: Treatment Group A (30 individuals, including patients and placebo controls) will receive the product by intracoronary infusion, 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: In treatment SubGroup 1, 10 individuals will receive the "low dose" of the cell product and 5 individuals will receive the placebo product. In treatment SubGroup 2, 10 individuals will receive the "high dose" of the cell product and 5 individuals will receive the placebo product

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

20 individuals will receive placebo.

Arm Title

MESENDO

Arm Type

Experimental

Arm Description

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

Intervention Type

Biological

Intervention Name(s)

MESENDO

Intervention Description

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.

Intervention Type

Other

Intervention Name(s)

placebo

Intervention Description

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

Primary Outcome Measure Information:

Title

Safety as measured by laboratory assessments, ecg and temperature.

Time Frame

2 weeks

Secondary Outcome Measure Information:

Title

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

Time Frame

6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Gabriel P. Lasala, MD

Organizational Affiliation

TCA Cellular Therapy

Official's Role

Principal Investigator

Facility Information:

Facility Name

TCA Cellular Therapy

City

Covington

State/Province

Louisiana

ZIP/Postal Code

70433

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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