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NCT Number: NCT00643981

Combination Stem Cell Therapy 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. In this trial we will study the safe use of this therapy and its effects on making new blood vessels will be evaluated.

Coronary ischemia 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 to the vessels of the heart and are not candidates for percutaneous revascularization or surgical procedures.

Once the final mixture of stem cells is prepared, the cells will be intracoronary infused through a catheter into the blocked vessel of the heart.

Studies will be performed to evaluate if the intracoronary infusion of stem cells is safe, feasible and works.

Patients will be evaluated for 6 months after cell transplant.

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Key information

Conditions

Coronary Ischemia Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Arteriosclerosis Coronary Artery Disease Coronary Atherosclerosis Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

TCA Cellular Therapy, LLC

Covington, Louisiana, 70433, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male or Female age 18-20
  • Angina Pectoris: CCS Class II or IV or angina symptom equivalent
  • 70% blockage in at least one epicardial vessel documented within 6 months
  • Stable medical therapy
  • Reversible perfusion defects by SPECT
  • Not a candidate for percutaneous intervention or coronary by-pass surgery

Exclusion criteria

  • Previous angiogenic therapy or myocardial laser therapy
  • Severe valvular heart disease
  • Recent malignancy or radiation therapy within 6 months
  • Renal insufficiency with creatinine greater that 2.7
  • White blood count greater than 13,000 or lower than 3,000
  • Platelet count lower than 60,000 or higher that 500,000
  • Pregnant or planning to become pregnant
  • History of skeletal muscle disease
  • AST or ALT greater than two times upper limit of normal

Treatment and study plan

MESENDO

Biological

2 ml of the "final cell mixture" will be injected through the lumen of an intracoronary percutaneous balloon designed for angioplasty into the ishcemic vessel.

Primary outcomes

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

    Time frame: 2 weeks

Secondary outcomes

  1. Efficacy as measured by SPECT scan and 2-D Echo

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

TCA Cellular Therapy

Industry

Registry information

Official study title

Phase I Study to See if a of A Combination Stem Cell Therapy is Safe and Feasible for the Treatment of Severe Coronary Ischemia

Acronym: CI

Important dates

Study start
2008
Primary completion
2008
Study completion
2009
First posted
Mar 26, 2008
Registry last updated
Apr 28, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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