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Safety and Efficacy of Autologous Cardiopoietic Cells for Treatment of Ischemic Heart Failure.

NCT01768702 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 315

Last updated 2018-06-01

No results posted yet for this study

Summary

Evaluation the safety and efficacy of C3BS-CQR-1 by comparing the overall response to standard of care and C3BS-CQR-1 relative to standard of care and a sham procedure.

Conditions

Interventions

BIOLOGICAL

Injection of C3BS-CQR-1

Injection of the C3BS-CQR-1 using the C-Cath® injection catheter.

BIOLOGICAL

Sham, no injection

Mimic the injection procedure trough insertion of a sham catheter. No injection actually performed

Sponsors & Collaborators

  • Celyad Oncology SA

    lead INDUSTRY

Principal Investigators

  • André Terzic, MD · Mayo Clinic, Division of Cardiovascular Diseases, Rochester (MN, USA)

  • Jozef Bartunek, MD · OLV Ziekenhuis Aalst (Belgium)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2012-11-30
Primary Completion
2017-08-31
Completion
2017-08-31

Countries

  • Belgium
  • Bulgaria
  • Hungary
  • Israel
  • Italy
  • Poland
  • Serbia
  • Spain
  • Switzerland

Study Locations

More Related Trials

Entities

Diseases

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 NCT01768702 on ClinicalTrials.gov