ACT34-CMI -- Adult Autologous CD34+ Cells
CompletedPhase 2NCT00300053
View the official record on ClinicalTrials.gov Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.
This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
The purpose of this study is to evaluate the efficacy and safety of intramyocardial injections of CLBS14 in patients with refractory chronic myocardial ischemia.
Study details
- Official title
- 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)
- Conditions
- Interventions
- Biological: CLBS14 (low-dose)
- Biological: CLBS14 (high-dose)
- Biological: placebo injection
- Sponsor
- Lisata Therapeutics, Inc.
- Start date
- 2006-04
- Primary completion
- 2008-03
- Sex
- All
- Age range
- from 21 Years to 80 Years
- Results posted
- Yes, on ClinicalTrials.gov
- Countries
- United States
- Total sites listed
- 26
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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 * subjects must be willing and able to comply with specified follow-up evaluations 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 ca…
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT00300053