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Efficacy and Safety of Targeted Intramyocardial Delivery of Auto CD34+ Stem Cells for Improving Exercise Capacity in Subjects With Refractory Angina

NCT01508910 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 291

Last updated 2018-12-19

Study results available
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Summary

The purpose of the study is to assess the safety and efficacy of targeted intramyocardial delivery of Auto-CD34+ cells for increasing exercise time and amelioration of anginal symptoms in subjects with refractory angina and chronic myocardial ischemia.

Conditions

  • Chronic Myocardial Ischemia
  • Refractory Angina Pectoris
  • Advanced Coronary Heart Disease

Interventions

BIOLOGICAL

Auto-CD34+ cells

10 intramyocardial injections of 0.2 mL per injection site of Auto-CD34+ cells

BIOLOGICAL

Placebo: Diluent used to suspend Auto-CD34+ cells

10 intramyocardial injections of 0.2 mL per injection site of placebo

OTHER

Standard of care

Standard of care for refractory angina

Sponsors & Collaborators

  • Lisata Therapeutics, Inc.

    lead INDUSTRY

Principal Investigators

  • Caladrius Study Director · Caladrius Biosciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-04-30
Primary Completion
2015-11-30
Completion
2015-11-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01508910 on ClinicalTrials.gov