Prospective Randomized Study of Mesenchymal Stem Cell Therapy in Patients Undergoing Cardiac Surgery (PROMETHEUS)

This study has been completed.
Sponsor:
Collaborators:
Johns Hopkins University Specialized Center for Cell Based Therapy
The EMMES Corporation
Information provided by (Responsible Party):
Joshua M Hare, University of Miami
ClinicalTrials.gov Identifier:
NCT00587990
First received: January 2, 2008
Last updated: April 1, 2015
Last verified: April 2015
Results First Received: January 30, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Conditions: Stem Cell Transplantation
Ventricular Dysfunction, Left
Interventions: Genetic: Lower dose mesenchymal stem cell (MSC) injection
Genetic: Placebo
Genetic: Higher dose MSC injection

  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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
This trial, which originally was designed to enroll 45 patients, was suspended after 9 patients were enrolled because of slow accrual.

Reporting Groups
  Description
(1) Lower MSC Dose

Participants will receive lower dose mesenchymal stem cell injections for a total of 2 x 107 cells

Lower dose mesenchymal stem cell (MSC) injection: Participants will receive between 10 and 20 intramyocardial injections of 2 million MSCs per 0.25-0.5 cubic centimeter (cc) for a total of 2 x 107 cells. The injections will be administered following completion of CABG surgery.

(2) Higher MSC Dose

Participants will receive higher dose of mesenchymal stem cell injections for a total of 2 x 108 cells

Higher dose MSC injection: Participants will receive between 10 and 20 intramyocardial injections of 20 million MSCs per 0.25-0.5 cc for a total of 2 x 108 cells. The injections will be administered following completion of CABG surgery.

(3) Placebo Injection

Participants will receive placebo injections

Placebo: Participants will receive between 10 and 20 placebo injections that consist of phosphate buffered saline (PBS) and 1% human serum albumin (HSA).


Participant Flow:   Overall Study
    (1) Lower MSC Dose     (2) Higher MSC Dose     (3) Placebo Injection  
STARTED     2     4     3  
COMPLETED     2     4     3  
NOT COMPLETED     0     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
(1) Lower MSC Dose

Participants will receive lower dose mesenchymal stem cell injections for a total of 2 x 107 cells

Lower dose mesenchymal stem cell (MSC) injection: Participants will receive between 10 and 20 intramyocardial injections of 2 million MSCs per 0.25-0.5 cubic centimeter (cc) for a total of 2 x 107 cells. The injections will be administered following completion of CABG surgery.

(2) Higher MSC Dose

Participants will receive higher dose of mesenchymal stem cell injections for a total of 2 x 108 cells

Higher dose MSC injection: Participants will receive between 10 and 20 intramyocardial injections of 20 million MSCs per 0.25-0.5 cc for a total of 2 x 108 cells. The injections will be administered following completion of CABG surgery.

(3) Placebo

Participants will receive placebo injections

Placebo: Participants will receive between 10 and 20 placebo injections that consist of phosphate buffered saline (PBS) and 1% human serum albumin (HSA).

Total Total of all reporting groups

Baseline Measures
    (1) Lower MSC Dose     (2) Higher MSC Dose     (3) Placebo     Total  
Number of Participants  
[units: participants]
  2     4     3     9  
Age  
[units: participants]
       
<=18 years     0     0     0     0  
Between 18 and 65 years     2     4     3     9  
>=65 years     0     0     0     0  
Age  
[units: years]
Mean (Standard Deviation)
  60.3668720  (13.4742319)     51.9240246  (9.1760352)     63.6276523  (2.9733072)     57.7014222  (9.3869460)  
Gender  
[units: participants]
       
Female     0     0     0     0  
Male     2     4     3     9  
Region of Enrollment  
[units: participants]
       
United States     2     4     3     9  



  Outcome Measures

1.  Primary:   Incidence of Serious Adverse Events (SAEs)   [ Time Frame: Measured at Month 6 after surgery ]

2.  Secondary:   MRI and Echocardiographic Measures of Infarct Scar Size (ISS) and Left Regional and Global Ventricular Function   [ Time Frame: Measured over the 6-month follow-up period and at Month 18 follow-up ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

3.  Secondary:   Treatment Emergent Adverse Event Rates   [ Time Frame: Measured over the 6-month follow-up period, at Month 12 follow-up and at Month 18 follow-up ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   Yes

4.  Secondary:   48-hour Ambulatory Electrocardiogram (ECG) Recordings   [ Time Frame: Measured over the 6-month follow-up period, at Month 12 follow-up and at Month 18 follow-up ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   Yes

5.  Secondary:   Hematology, Clinical Chemistry, and Urinalysis Values   [ Time Frame: Measured over the 6-month follow-up period and at Month 18 follow-up ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   Yes

6.  Secondary:   Pulmonary Function - Forced Expiratory Volume in 1 Second (FEV1) Results   [ Time Frame: Measured over the 6-month follow-up period and at Month 18 follow-up ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   Yes

7.  Secondary:   Cardiac Computed Tomography Measures of ISS, Left Ventricular Ejection Fraction, and End Diastolic and End Systolic Volumes   [ Time Frame: Measured over the 6-month follow-up period and at Month 18 follow-up ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

8.  Secondary:   Serial Troponin and Creatine Kinase MB (CK-MB) Values   [ Time Frame: Measured every 12 hours for the first 48 hours after surgery ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   Yes

9.  Secondary:   Peak VO2 (by Treadmill Determination) and 6-minute Walk Test   [ Time Frame: Measured at baseline and Months 6 and 18 follow-ups ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

10.  Secondary:   New York Heart Association (NYHA) Functional Class   [ Time Frame: Measured over the 6-month follow-up period and at Month 18 follow-up ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

11.  Secondary:   Minnesota Living With Heart Failure (MLHF) Questionnaire   [ Time Frame: Measured over the 6-month follow-up period and at Month 18 follow-up ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

12.  Secondary:   Incidence of the Major Adverse Cardiac Events (MACE) Endpoint, Defined as the Composite Incidence of (1) Death, (2) Hospitalization for Heart Failure, or (3) Non-fatal Recurrent Heart Attack   [ Time Frame: Measured over the 6-month follow-up period and at Month 18 follow-up ]
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: Adam Mendizabal
Organization: EMMES Corporation
phone: 301-251-1161 ext 221
e-mail: amendizabal@emmes.com


Publications of Results:

Responsible Party: Joshua M Hare, University of Miami
ClinicalTrials.gov Identifier: NCT00587990     History of Changes
Other Study ID Numbers: 20070598, U54HL081028, U54 HL081028
Study First Received: January 2, 2008
Results First Received: January 30, 2015
Last Updated: April 1, 2015
Health Authority: United States: Food and Drug Administration