Combination Stem Cell Therapy for the Treatment of Severe Coronary Ischemia

Coronary Artery Disease Clinical Trial

— CI  

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00643981
• Other study ID #: 2007-03-I
• Status: Completed
• Phase: Phase 1
• First received: March 20, 2008
• Last updated: April 27, 2011
• Start date: February 2008
• Est. completion date: February 2009

Study information

• Verified date: December 2008
• Source: TCA Cellular Therapy
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: February 2009
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arteriosclerosis
• Atherosclerosis
• Coronary Arteriosclerosis
• Coronary Artery Disease
• Coronary Atherosclerosis
• Coronary Disease
• Coronary Ischemia
• Ischemia
• Myocardial Ischemia

Intervention

Biological:
• MESENDO
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.

Locations

Country	Name	City	State
United States	TCA Cellular Therapy, LLC	Covington	Louisiana

Sponsors (1)

Lead Sponsor	Collaborator
TCA Cellular Therapy

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety as measured by laboratory assessments, ecg, temperature and holter monitor		2 weeks	Yes
Secondary	Efficacy as measured by SPECT scan and 2-D Echo		6 months	No