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

NCT ID: NCT00545610

Last Updated: 2018-11-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-10-31

Study Completion Date

2010-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Myocardial Ischemia

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Test 1 (n=50)

1 x 10\^5 (+/-10%) CD34+ cells/kg of body weight

No interventions assigned to this group

Test 2 (n=50)

5 x 10\^5 (+/-10%) CD34+ cells/kg of body weight

No interventions assigned to this group

Placebo (n=50)

Saline plus 5% autologous plasma

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Maximum Eligible Age

81 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Lisata Therapeutics, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Caladrius Study Director

Role: STUDY_DIRECTOR

Lisata Therapeutics, Inc.

Locations

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Cardiology, PC

Birmingham, Alabama, United States

Site Status

Mayo Clinic Hospital

Phoenix, Arizona, United States

Site Status

Scripps Green Hospital / Scripps Clinical Hospital

La Jolla, California, United States

Site Status

Stanford University Hospital and Clinics

Stanford, California, United States

Site Status

Washington Hospital Center

Washington D.C., District of Columbia, United States

Site Status

Holy Cross Hospital

Fort Lauderdale, Florida, United States

Site Status

University of Florida

Gainesville, Florida, United States

Site Status

University of Florida Health Science Center

Jacksonville, Florida, United States

Site Status

Cardiovascular Institute Florida Hospital

Orlando, Florida, United States

Site Status

The Medical Group of St. Joseph´s

Atlanta, Georgia, United States

Site Status

Northwestern University Medical School

Chicago, Illinois, United States

Site Status

Rush University Medical Center

Chicago, Illinois, United States

Site Status

University of Iowa

Iowa City, Iowa, United States

Site Status

Caritas St. Elizabeth´s Medical Center

Boston, Massachusetts, United States

Site Status

Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status

Minneapolis Heart Institute

Minneapolis, Minnesota, United States

Site Status

Cornell University

New York, New York, United States

Site Status

New York Presbyterian Hospital

New York, New York, United States

Site Status

The Lindner Clinical Trial Center

Cincinnati, Ohio, United States

Site Status

University of Cincinnati Medical Center

Cincinnati, Ohio, United States

Site Status

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States

Site Status

University of Wisconsin Medical School

Madison, Wisconsin, United States

Site Status

Heart Care Associates, LLC

Milwaukee, Wisconsin, United States

Site Status

Countries

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United States

Other Identifiers

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34976

Identifier Type: -

Identifier Source: org_study_id

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