A DB, Randomized, Placebo-controlled Study of the Tolerability, Efficacy, Safety, and Dose Range of Intramyocardial CLBS14 for Reduction of Angina Episodes in Patients With Refractory Chronic Myocardial Ischemia (ACT34-CMI)

Lisata Therapeutics, Inc.25 sites in 1 country321 target enrollmentApril 2006

ConditionsMyocardial Ischemia

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Myocardial Ischemia
Sponsor: Lisata Therapeutics, Inc.
Enrollment: 321
Locations: 25
Primary Endpoint: Number of Angina Episodes Per Week at 6 and 12 Months
Status: Completed
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of intramyocardial injections of CLBS14 in patients with refractory chronic myocardial ischemia.

Detailed Description

This is a double-blind, prospective, randomized, placebo-controlled trial to determine the tolerability, efficacy, safety and dose range of intramyocardial injections of adult autologous CD34+ cells mobilized with granulocyte colony stimulating factor (G-CSF) for the reduction of angina episodes in patients with refractory chronic myocardial ischemia.

Registry

clinicaltrials.gov

Start Date

April 2006

End Date

March 2009

Last Updated

5 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Lisata Therapeutics, Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Canadian Cardiovascular Society (CCS) functional class III or IV chronic refractory angina
•subjects without control of their angina symptoms, in spite of maximal tolerated doses of anti-anginal drugs, must be on optimal therapy for their angina and on a stable anti-anginal medication regimen for at least 1 month prior to entering the screening period of the study
•identified as unsuitable for conventional revascularization
•recent coronary angiogram (within the last 12 months) to document the coronary anatomy and to verify the revascularization procedures
•subjects must have objective evidence of inducible ischemia or viable myocardium in the potential target injection zone
•a left ventricular ejection fraction equal to or greater than 25% by ECHO or single photon emission computed tomography (SPECT) at screening
•subjects must experience at minimum an average of 7 angina or anginal equivalent episodes per week
•subjects must be able to complete a minimum of 3 minutes but nor more than 10 minutes on a treadmill following the Modified Bruce Protocol
•subjects must experience angina or anginal equivalent episodes during the screening exercise treadmill test
•female subjects must either be no longer capable of reproduction or using medically valid contraception to prevent pregnancy during the study

Exclusion Criteria

•predominant congestive heart failure
•myocardial infarction within 60 days of treatment
•successful or partially successful coronary revascularization procedures (any vessel) within 6 months of study enrollment
•placement of a bi-ventricular pacemaker for cardiac resynchronization therapy (CRT) for heart failure in the past 90 days
•documented stroke or transient ischemic attack (TIA) within 60 days of study enrollment
•history of moderate to severe aortic stenosis or severe aortic insufficiency; severe mitral stenosis or severe mitral insufficiency
•prosthetic aortic valve replacement
•evidence of any life-threatening arrhythmia that requires intervention on the 24-hour Holter monitor. Life-threatening arrhythmia that is successfully treated with an implantable cardioverter defibrillator (ICD) is not exclusionary.
•splenomegaly and/or severe co-morbidity associated with a reduction in life expectancy of less than 1 year, such as chronic medical illness (ie, severe chronic obstructive pulmonary disease, renal failure or cancer \[exceptions: in-situ skin cancer or fully removed skin cancer other than melanoma, in-situ cervical cancer, or cancer free for 5 years with no history of a stem cell transplant\])
•sickle cell disease or sickle cell trait

Outcomes

Primary Outcomes

Number of Angina Episodes Per Week at 6 and 12 Months

Time Frame: 6 and 12 months

The number of angina episodes were collected via an electronic subject diary for four weeks at Baseline and at 6 and 12 months. The four-week angina episodes (per week mean) were used as the frequency for each visit. A lower number represents fewer angina episodes. A lower number is better.

Secondary Outcomes

Exercise Treadmill Test According to Modified Bruce Protocol: Mean Change From Baseline in Duration of Exercise(Change from Baseline to 6 months and change from baseline to 12 months after treatment)
Changes From Baseline in Seattle Angina Questionnaire (SAQ) Scores at 6 Months(Baseline to 6 months after treatment)
Change in Anti-anginal Medication (ie, Nitroglycerin) Use(Baseline to 6 months)
Number of Participants With Change in Canadian Cardiovascular Society Anginal Classification Levels(Baseline and 12 months after treatment)
Changes From Baseline to 6 Months in Short Form 36 (SF-36) Parameters(Baseline to 6 months after treatment)