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PercutaneOus StEm Cell Injection Delivery Effects On Neomyogenesis in Dilated CardioMyopathy (The POSEIDON-DCM Study) (PoseidonDCM)

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ClinicalTrials.gov Identifier: NCT01392625
Recruitment Status : Completed
First Posted : July 12, 2011
Results First Posted : February 15, 2018
Last Update Posted : February 15, 2018
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Joshua M Hare, University of Miami

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Participant);   Primary Purpose: Treatment
Condition: Non-ischemic Dilated Cardiomyopathy
Interventions: Biological: Autologous hMSCs
Biological: Allogeneic hMSCs

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Autologous hMSCs

Group 1 (18 patients) Eighteen (18) patients will be treated with Auto-hMSCs: 20 million cells/ml delivered in a dose of 0.5 ml per injection x 10 injections for a total of 1 x 108 (100 million) Auto-hMSCs.

Autologous hMSCs: Cells will be administered via the Biosense Webster MyoStar NOGA Injection Catheter System will be tested in 18 patients via transendocardial injection:

Group 1 (18 patients) Eighteen (18) patients will be treated with Auto-hMSCs: 20 million cells/ml delivered in a dose of 0.5 ml per injection x 10 injections for a total of 1 x 108 (100 million) Auto-hMSCs.

Allogeneic hMSCs

Group 2 (18 patients) Eighteen (18) patients will be treated with allogeneic hMSCs (Allo-hMSCs): 20 million cells/ml delivered in a dose of 0.5 ml per injection x 10 injections for a total of 1 x 108 (100 million) Auto-hMSCs.

Allogeneic hMSCs: Cells will be administered via the Biosense Webster MyoStar NOGA Injection Catheter System will be tested in 18 patients via transendocardial injection:

Group 2 (18 patients) Eighteen (18) patients will be treated with Allo-hMSCs: 20 million cells/ml delivered in a dose of 0.5 ml per injection x 10 injections for a total of 1 x 108 (100 million) Auto-hMSCs.


Participant Flow:   Overall Study
    Autologous hMSCs   Allogeneic hMSCs
STARTED   18   19 
COMPLETED   16   18 
NOT COMPLETED   2   1 



  Baseline Characteristics

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
Autologous hMSCs

Group 1 (18 patients) Eighteen (18) patients will be treated with Auto-hMSCs: 20 million cells/ml delivered in a dose of 0.5 ml per injection x 10 injections for a total of 1 x 108 (100 million) Auto-hMSCs.

Autologous hMSCs: Cells will be administered via the Biosense Webster MyoStar NOGA Injection Catheter System will be tested in 18 patients via transendocardial injection:

Group 1 (18 patients) Eighteen (18) patients will be treated with Auto-hMSCs: 20 million cells/ml delivered in a dose of 0.5 ml per injection x 10 injections for a total of 1 x 108 (100 million) Auto-hMSCs.

Allogeneic hMSCs

Group 2 (18 patients) Eighteen (18) patients will be treated with allogeneic hMSCs (Allo-hMSCs): 20 million cells/ml delivered in a dose of 0.5 ml per injection x 10 injections for a total of 1 x 108 (100 million) Auto-hMSCs.

Allogeneic hMSCs: Cells will be administered via the Biosense Webster MyoStar NOGA Injection Catheter System will be tested in 18 patients via transendocardial injection:

Group 2 (18 patients) Eighteen (18) patients will be treated with Allo-hMSCs: 20 million cells/ml delivered in a dose of 0.5 ml per injection x 10 injections for a total of 1 x 108 (100 million) Auto-hMSCs.

Total Total of all reporting groups

Baseline Measures
   Autologous hMSCs   Allogeneic hMSCs   Total 
Overall Participants Analyzed 
[Units: Participants]
 18   19   37 
Age 
[Units: Years]
Mean (Standard Deviation)
     
Participants Analyzed   18   19   37 
   57.4  (11.0)   54.4  (11.5)   55.8  (11.2) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Participants Analyzed   18   19   37 
Female      7  38.9%      5  26.3%      12  32.4% 
Male      11  61.1%      14  73.7%      25  67.6% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
     
Participants Analyzed   18   19   37 
Hispanic or Latino      8  44.4%      4  21.1%      12  32.4% 
Not Hispanic or Latino      10  55.6%      15  78.9%      25  67.6% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
     
Participants Analyzed   18   19   37 
American Indian or Alaska Native      0   0.0%      0   0.0%      0   0.0% 
Asian      0   0.0%      0   0.0%      0   0.0% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      0   0.0% 
Black or African American      1   5.6%      2  10.5%      3   8.1% 
White      16  88.9%      17  89.5%      33  89.2% 
More than one race      0   0.0%      0   0.0%      0   0.0% 
Unknown or Not Reported      1   5.6%      0   0.0%      1   2.7% 
Participants Injection status in the trial 
[Units: Participants]
Count of Participants
     
No       
Participants Analyzed   18   19   37 
No   2   1   3 
Yes       
Participants Analyzed   18   19   37 
Yes   16   18   34 
Participants Ejection Fraction % in the trial 
[Units: Percentage]
Mean (Standard Deviation)
     
Participants Analyzed   18   19   37 
   21.7  (6.2)   22.5  (6.5)   22.1  (6.3) 
Enrollment End Diastolic diameter (CM) 
[Units: Centimeters]
Mean (Standard Deviation)
     
Participants Analyzed   18   19   37 
   7.0  (1.6)   7.2  (1.2)   7.1  (1.4) 
New York Heart Association Class [1] 
[Units: Participants]
Count of Participants
     
Participants Analyzed   16   18   34 
Class I - no limitation      6  37.5%      4  22.2%      10  29.4% 
Class II - Slight Limitation of Physical Activity      8  50.0%      9  50.0%      17  50.0% 
Class III - Marked Limitation of Physical Activity      2  12.5%      5  27.8%      7  20.6% 
Class IV -Inability to carry on physical activity      0   0.0%      0   0.0%      0   0.0% 
[1] 37 participants were randomized to treatment numbers and assignments but 3 did not continue with treatment and not included in the analysis.


  Outcome Measures

1.  Primary:   Incidence of Any Treatment-emergent Serious Adverse Events (TE-SAEs)   [ Time Frame: One month post-catheterization ]

2.  Secondary:   Measurement of Changes in Peak VO2   [ Time Frame: Baseline, 6 month and 12 month ]

3.  Secondary:   Measurement of Changes in 6 Minute Walk   [ Time Frame: Baseline, 6 month and 12 month ]

4.  Secondary:   Measurement of Changes in Global Ejection Fraction   [ Time Frame: Baseline, 6 month and 12 month ]

5.  Secondary:   Measurement of Changes in New York Heart Association (NYHA)   [ Time Frame: Baseline, 6 month and 12 month ]

6.  Secondary:   Measurement of Changes in Minnesota Living With Heart Failure (MLHF) Questionnaire   [ Time Frame: Baseline, 6 month and 12 month ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

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
No text entered.


  More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Joshua M. Hare, MD
Organization: ISCI / University of Miami Miller School of Medicine
phone: 305-243-5579
e-mail: JHare@med.miami.edu


Publications:

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

Responsible Party: Joshua M Hare, University of Miami
ClinicalTrials.gov Identifier: NCT01392625     History of Changes
Other Study ID Numbers: 20100968
1R01HL110737-01 ( U.S. NIH Grant/Contract )
First Submitted: June 29, 2011
First Posted: July 12, 2011
Results First Submitted: August 3, 2017
Results First Posted: February 15, 2018
Last Update Posted: February 15, 2018