Clinical trial NCT00545610: ACT34-CMI -- Adult Autologous CD34+ Stem Cells (Follow-Up Study)
Official title: A 12-Month Follow-Up Study to Protocol 24779 (A Double-blind, Prospective, Randomized, Placebo-controlled Study to Determine the Tolerability, Efficacy, Safety, and Dose Range of Intramyocardial Injections of G-CSF Mobilized Auto CD34+ Cells for Reduction of Angina Episodes in Patients With Refractory Chronic Myocardial Ischemia [ACT34-CMI])
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Myocardial Ischemia
Lead sponsor: Lisata Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2007-10-17
Enrollment: 150
Sex: ALL
Minimum age (years): 21
Maximum age (years): 81
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Subjects who have received treatment with Auto-CD34+ cells (1 x 10\^5 (+/-10%) CD34+ cells/kg or 5 x 10\^5 (+/-10%) CD34+ cells/kg)or with placebo (saline plus 5% autologous plasma) and who have completed the final study visit (Month 12) of the core therapeutic study 24779

Brief summary: The purpose of this 12-month, observational, follow-up study is to collect additional data (by telephone contact) with which to assess the efficacy, safety, and effects of intramyocardial injections of adult autologous CD34+ cells on quality of life (QoL) in subjects with chronic refractory myocardial ischemia. No treatments will be administered during this study. However, the investigators and other study site personnel and the subjects will remain blinded to the treatment assignments from the core therapeutic study (# 24779) so as to provide a total of 24 months of blinded data.


Eligibility criteria: Inclusion Criteria:

* Subjects who have received treatment with Auto-CD34+ cells or with placebo and who have completed the final study visit (Month 12) of the core therapeutic study 24779
* Subjects who are willing to comply with the specified follow-up evaluations in this study and to provide written informed consent to participate in this study

Primary outcomes:
measure: Long-term safety of intramyocardial injections of Auto-CD34+ cells relative to placebo for reducing the number of angina episodes in subjects with refractory chronic myocardial ischemia over a 12-month follow-up period.
timeFrame: 12 months
Secondary outcomes:
measure: Long-term efficacy of Auto-CD34+ cells relative to placebo for reducing the number of angina episodes in subjects with refractory chronic myocardial ischemia and the effects of this treatment on quality of life (QoL) over a 12-month follow-up period
timeFrame: 12 months
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Cardiology, PC
state: Alabama
city: Phoenix
country: United States
facility: Mayo Clinic Hospital
state: Arizona
city: La Jolla
country: United States
facility: Scripps Green Hospital / Scripps Clinical Hospital
state: California
city: Stanford
country: United States
facility: Stanford University Hospital and Clinics
state: California
city: Washington
country: United States
facility: Washington Hospital Center
state: District of Columbia
city: Fort Lauderdale
country: United States
facility: Holy Cross Hospital
state: Florida
city: Gainesville
country: United States
facility: University of Florida
state: Florida
city: Jacksonville
country: United States
facility: University of Florida Health Science Center
state: Florida
city: Orlando
country: United States
facility: Cardiovascular Institute Florida Hospital
state: Florida
city: Atlanta
country: United States
facility: The Medical Group of St. Joseph´s
state: Georgia
city: Chicago
country: United States
facility: Northwestern University Medical School
state: Illinois
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Iowa City
country: United States
facility: University of Iowa
state: Iowa
city: Boston
country: United States
facility: Caritas St. Elizabeth´s Medical Center
state: Massachusetts
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Minneapolis
country: United States
facility: Minneapolis Heart Institute
state: Minnesota
city: New York
country: United States
facility: Cornell University
state: New York
city: New York
country: United States
facility: New York Presbyterian Hospital
state: New York
city: Cincinnati
country: United States
facility: The Lindner Clinical Trial Center
state: Ohio
city: Cincinnati
country: United States
facility: University of Cincinnati Medical Center
state: Ohio
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
city: Madison
country: United States
facility: University of Wisconsin Medical School
state: Wisconsin
city: Milwaukee
country: United States
facility: Heart Care Associates, LLC
state: Wisconsin
Study officials:
affiliation: Lisata Therapeutics, Inc.
name: Caladrius Study Director
role: STUDY_DIRECTOR
References: