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

Sponsor
Caladrius Biosciences, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT00545610
Collaborator
(none)
150
Enrollment
23
Locations
32
Duration (Months)
6.5
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    150 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Prospective
    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 Start Date :
    Oct 1, 2007
    Actual Primary Completion Date :
    Apr 1, 2010
    Actual Study Completion Date :
    Jun 1, 2010

    Arms and Interventions

    Arm Intervention/Treatment
    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

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. 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]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    21 Years to 81 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Cardiology, PC Birmingham Alabama United States
    2 Mayo Clinic Hospital Phoenix Arizona United States
    3 Scripps Green Hospital / Scripps Clinical Hospital La Jolla California United States 92037
    4 Stanford University Hospital and Clinics Stanford California United States
    5 Washington Hospital Center Washington District of Columbia United States
    6 Holy Cross Hospital Fort Lauderdale Florida United States
    7 University of Florida Gainesville Florida United States
    8 University of Florida Health Science Center Jacksonville Florida United States
    9 Cardiovascular Institute Florida Hospital Orlando Florida United States
    10 The Medical Group of St. Joseph´s Atlanta Georgia United States
    11 Northwestern University Medical School Chicago Illinois United States
    12 Rush University Medical Center Chicago Illinois United States
    13 University of Iowa Iowa City Iowa United States
    14 Caritas St. Elizabeth´s Medical Center Boston Massachusetts United States
    15 Massachusetts General Hospital Boston Massachusetts United States
    16 Minneapolis Heart Institute Minneapolis Minnesota United States 55407
    17 Cornell University New York New York United States
    18 New York Presbyterian Hospital New York New York United States
    19 The Lindner Clinical Trial Center Cincinnati Ohio United States
    20 University of Cincinnati Medical Center Cincinnati Ohio United States
    21 University of Pittsburgh Medical Center Pittsburgh Pennsylvania United States 15213
    22 University of Wisconsin Medical School Madison Wisconsin United States
    23 Heart Care Associates, LLC Milwaukee Wisconsin United States

    Sponsors and Collaborators

    • Caladrius Biosciences, Inc.

    Investigators

    • Study Director: Caladrius Study Director, Caladrius Biosciences, Inc.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Caladrius Biosciences, Inc.
    ClinicalTrials.gov Identifier:
    NCT00545610
    Other Study ID Numbers:
    • 34976
    First Posted:
    Oct 17, 2007
    Last Update Posted:
    Nov 28, 2018
    Last Verified:
    Nov 1, 2018
    Additional relevant MeSH terms:
    Myocardial Ischemia
    Coronary Artery Disease
    Ischemia

    Study Results

    No Results Posted as of Nov 28, 2018