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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00629018
Recruitment Status : Completed
First Posted : March 5, 2008
Results First Posted : May 12, 2015
Last Update Posted : May 12, 2015
Sponsor:
Collaborators:
Blood Transfusion Centre of Slovenia
Stanford University
Information provided by (Responsible Party):
Bojan Vrtovec, University Medical Centre Ljubljana

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Treatment
Condition Dilated Cardiomyopathy
Interventions Biological: CD34+ autologous stem cell transplantation
Drug: Bone Marrow Stimulation
Biological: SC therapy
Enrollment 110
Recruitment Details 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 Patients with acute multi-organ failure or history of haematologic neoplasms were not included.
Arm/Group Title SC Group Control Group
Hide Arm/Group Description 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 55 patients were randomized to standard medical therapy, without stem cell injection.
Period Title: Overall Study
Started 55 55
Completed 55 55
Not Completed 0 0
Arm/Group Title SC Group Control Group Total
Hide Arm/Group Description 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 55 patients were randomized to standard medical therapy, without stem cell injection. Total of all reporting groups
Overall Number of Baseline Participants 55 55 110
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 55 participants 55 participants 110 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
53
  96.4%
52
  94.5%
105
  95.5%
>=65 years
2
   3.6%
3
   5.5%
5
   4.5%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 55 participants 55 participants 110 participants
53  (8) 55  (7) 54  (9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 55 participants 55 participants 110 participants
Female
10
  18.2%
11
  20.0%
21
  19.1%
Male
45
  81.8%
44
  80.0%
89
  80.9%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Slovenia Number Analyzed 55 participants 55 participants 110 participants
55 55 110
1.Primary Outcome
Title Heart Failure Mortality
Hide Description [Not Specified]
Time Frame 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
The minimal sample size for the study was calculated using a pre-specified power of 90% and P value of 0.05.
Arm/Group Title SC Group Control Group
Hide Arm/Group Description:
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
55 patients were randomized to standard medical therapy, without stem cell injection.
Overall Number of Participants Analyzed 55 55
Measure Type: Number
Unit of Measure: participants
8 19
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection SC Group, Control Group
Comments The minimal sample size for the study was calculated using a pre-specified power of 90% and P value of 0.05.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.01
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
2.Primary Outcome
Title Changes in Left Ventricular Ejection Fraction
Hide Description Left ventricular ejection fraction measured by echocardiography
Time Frame 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title SC Group Control Group
Hide Arm/Group Description:
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
55 patients were randomized to standard medical therapy, without stem cell injection.
Overall Number of Participants Analyzed 55 55
Mean (Standard Deviation)
Unit of Measure: Percentage of ejection
Baseline 24.3  (6.5) 25.7  (4.1)
5 years 30.0  (5.1) 23.3  (4.2)
3.Secondary Outcome
Title Changes in Exercise Capacity
Hide Description [Not Specified]
Time Frame 5 years
Outcome Measure Data Not Reported
4.Secondary Outcome
Title Changes in Electrophysiologic Properties of Ventricular Myocardium
Hide Description [Not Specified]
Time Frame 6 months
Outcome Measure Data Not Reported
5.Secondary Outcome
Title Changes in Plasma Inflammatory Markers
Hide Description [Not Specified]
Time Frame 6 months
Outcome Measure Data Not Reported
6.Secondary Outcome
Title Changes in Left Ventricular Function
Hide Description [Not Specified]
Time Frame 5 years
Outcome Measure Data Not Reported
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title SC Group Control Group
Hide Arm/Group Description 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 55 patients were randomized to standard medical therapy, without stem cell injection.
All-Cause Mortality
SC Group Control Group
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
SC Group Control Group
Affected / at Risk (%) Affected / at Risk (%)
Total   8/55 (14.55%)   19/55 (34.55%) 
Cardiac disorders     
Death   8/55 (14.55%)  19/55 (34.55%) 
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
SC Group Control Group
Affected / at Risk (%) Affected / at Risk (%)
Total   2/55 (3.64%)   0/55 (0.00%) 
Cardiac disorders     
Non-sustained ventricular tachycardia   2/55 (3.64%)  0/55 (0.00%) 
Indicates events were collected by systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Prof. Dr. Bojan Vrtovec
Organization: UMC Ljubljana
Phone: +3861 522 2844
EMail: bvrtovec@stanford.edu
Layout table for additonal information
Responsible Party: Bojan Vrtovec, University Medical Centre Ljubljana
ClinicalTrials.gov Identifier: NCT00629018     History of Changes
Other Study ID Numbers: DCM-SCT1
First Submitted: February 25, 2008
First Posted: March 5, 2008
Results First Submitted: April 9, 2013
Results First Posted: May 12, 2015
Last Update Posted: May 12, 2015