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Safety and Efficacy Study of Stem Cell Transplantation to Treat Dilated Cardiomyopathy

This study has been completed.
Sponsor:
Collaborators:
Blood Transfusion Centre of Slovenia
Stanford University
Information provided by (Responsible Party):
Bojan Vrtovec, University Medical Centre Ljubljana
ClinicalTrials.gov Identifier:
NCT00629018
First received: February 25, 2008
Last updated: April 23, 2015
Last verified: April 2015
Results First Received: April 9, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Outcomes Assessor);   Primary Purpose: Treatment
Condition: Dilated Cardiomyopathy
Interventions: Biological: CD34+ autologous stem cell transplantation
Drug: Bone Marrow Stimulation
Biological: SC therapy

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
This study consisted of an open-label randomized study design conducted at the Advanced Heart Failure and Transplantation Center at University Medical Center Ljubljana in collaboration with the Methodist DeBakey Heart Center and Stanford University.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Patients with acute multi-organ failure or history of haematologic neoplasms were not included.

Reporting Groups
  Description
SC Group 55 patients were randomized to CD34+ cell transplantation (SC group). In the SC group, peripheral CD34+cells were mobilized by G-CSF and collected via apheresis. Patients underwent myocardial scintigraphy and CD34+ cells were injected in the artery supplying the segments with reduced viability
Control Group 55 patients were randomized to standard medical therapy, without stem cell injection.

Participant Flow:   Overall Study
    SC Group   Control Group
STARTED   55   55 
COMPLETED   55   55 
NOT COMPLETED   0   0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
SC Group 55 patients were randomized to CD34+ cell transplantation (SC group). In the SC group, peripheral CD34+cells were mobilized by G-CSF and collected via apheresis. Patients underwent myocardial scintigraphy and CD34+ cells were injected in the artery supplying the segments with reduced viability
Control Group 55 patients were randomized to standard medical therapy, without stem cell injection.
Total Total of all reporting groups

Baseline Measures
   SC Group   Control Group   Total 
Overall Participants Analyzed 
[Units: Participants]
 55   55   110 
Age 
[Units: Participants]
     
<=18 years   0   0   0 
Between 18 and 65 years   53   52   105 
>=65 years   2   3   5 
Age 
[Units: Years]
Mean (Standard Deviation)
 53  (8)   55  (7)   54  (9) 
Gender 
[Units: Participants]
     
Female   10   11   21 
Male   45   44   89 
Region of Enrollment 
[Units: Participants]
     
Slovenia   55   55   110 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Heart Failure Mortality   [ Time Frame: 5 years ]

2.  Primary:   Changes in Left Ventricular Ejection Fraction   [ Time Frame: 5 years ]

3.  Secondary:   Changes in Exercise Capacity   [ Time Frame: 5 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

4.  Secondary:   Changes in Electrophysiologic Properties of Ventricular Myocardium   [ Time Frame: 6 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   Yes

5.  Secondary:   Changes in Plasma Inflammatory Markers   [ Time Frame: 6 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

6.  Secondary:   Changes in Left Ventricular Function   [ Time Frame: 5 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Prof. Dr. Bojan Vrtovec
Organization: UMC Ljubljana
phone: +3861 522 2844
e-mail: bvrtovec@stanford.edu


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Bojan Vrtovec, University Medical Centre Ljubljana
ClinicalTrials.gov Identifier: NCT00629018     History of Changes
Other Study ID Numbers: DCM-SCT1
Study First Received: February 25, 2008
Results First Received: April 9, 2013
Last Updated: April 23, 2015
Health Authority: Slovenia: Ministry of Health