ACT34-CMI -- Adult Autologous CD34+ Stem Cells (Follow-Up Study)

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])

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.

Study Overview

• Status: Completed
• Conditions: Myocardial Ischemia

• Study Type: Observational
• Enrollment (Anticipated): 150

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States
      • Cardiology, PC
  • Arizona
    • Phoenix, Arizona, United States
      • Mayo Clinic Hospital
  • California
    • La Jolla, California, United States, 92037
      • Scripps Green Hospital / Scripps Clinical Hospital
    • Stanford, California, United States
      • Stanford University Hospital and Clinics
  • District of Columbia
    • Washington, District of Columbia, United States
      • Washington Hospital Center
  • Florida
    • Fort Lauderdale, Florida, United States
      • Holy Cross Hospital
    • Gainesville, Florida, United States
      • University of Florida
    • Jacksonville, Florida, United States
      • University of Florida Health Science Center
    • Orlando, Florida, United States
      • Cardiovascular Institute Florida Hospital
  • Georgia
    • Atlanta, Georgia, United States
      • The Medical Group of St. Joseph´s
  • Illinois
    • Chicago, Illinois, United States
      • Rush University Medical Center
    • Chicago, Illinois, United States
      • Northwestern University Medical School
  • Iowa
    • Iowa City, Iowa, United States
      • University of Iowa
  • Massachusetts
    • Boston, Massachusetts, United States
      • Massachusetts General Hospital
    • Boston, Massachusetts, United States
      • Caritas St. Elizabeth´s Medical Center
  • Minnesota
    • Minneapolis, Minnesota, United States, 55407
      • Minneapolis Heart Institute
  • New York
    • New York, New York, United States
      • Cornell University
    • New York, New York, United States
      • New York Presbyterian Hospital
  • Ohio
    • Cincinnati, Ohio, United States
      • The Lindner Clinical Trial Center
    • Cincinnati, Ohio, United States
      • University of Cincinnati Medical Center
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • University of Pittsburgh Medical Center
  • Wisconsin
    • Madison, Wisconsin, United States
      • University of Wisconsin Medical School
    • Milwaukee, Wisconsin, United States
      • Heart Care Associates, LLC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 81 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
Test 1 (n=50); 1 x 10^5 (+/-10%) CD34+ cells/kg of body weight
Test 2 (n=50); 5 x 10^5 (+/-10%) CD34+ cells/kg of body weight
Placebo (n=50); Saline plus 5% autologous plasma

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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.	12 months

Secondary Outcome Measures

Outcome Measure	Time Frame
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	12 months

Collaborators and Investigators

• Sponsor: Lisata Therapeutics, Inc.
• Investigators: Study Director: Caladrius Study DIrector, Lisata Therapeutics, Inc.

Study record dates

Study Major Dates

• Study Start: October 1, 2007
• Primary Completion (Actual): April 1, 2010
• Study Completion (Actual): June 1, 2010

Study Registration Dates

• First Submitted: October 16, 2007
• First Submitted That Met QC Criteria: October 16, 2007
• First Posted (Estimate): October 17, 2007

Study Record Updates

• Last Update Posted (Actual): November 28, 2018
• Last Update Submitted That Met QC Criteria: November 27, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Coronary Artery Disease; Myocardial Ischemia; Ischemia
• Other Study ID Numbers: 34976