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Trial record 19 of 928 for:    stem cells | Studies With Results

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

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: NCT00587990
Recruitment Status : Completed
First Posted : January 8, 2008
Results First Posted : April 2, 2015
Last Update Posted : December 6, 2017
Sponsor:
Collaborators:
National Heart, Lung, and Blood Institute (NHLBI)
Johns Hopkins University Specialized Center for Cell Based Therapy
The Emmes Company, LLC
Information provided by (Responsible Party):
Joshua M Hare, University of Miami

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Conditions Stem Cell Transplantation
Ventricular Dysfunction, Left
Interventions Biological: Lower dose mesenchymal stem cell (MSC) injection
Genetic: Placebo
Biological: Higher dose MSC injection
Enrollment 9
Recruitment Details  
Pre-assignment Details This trial, which originally was designed to enroll 45 patients, was suspended after 9 patients were enrolled because of slow accrual.
Arm/Group Title (1) Lower MSC Dose (2) Higher MSC Dose (3) Placebo Injection
Hide Arm/Group Description

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.

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.

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).

Period Title: Overall Study
Started 2 4 3
Completed 2 4 3
Not Completed 0 0 0
Arm/Group Title (1) Lower MSC Dose (2) Higher MSC Dose (3) Placebo Total
Hide Arm/Group Description

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.

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.

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 of all reporting groups
Overall Number of Baseline Participants 2 4 3 9
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants 4 participants 3 participants 9 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
2
 100.0%
4
 100.0%
3
 100.0%
9
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 2 participants 4 participants 3 participants 9 participants
60.3668720  (13.4742319) 51.9240246  (9.1760352) 63.6276523  (2.9733072) 57.7014222  (9.3869460)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants 4 participants 3 participants 9 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Male
2
 100.0%
4
 100.0%
3
 100.0%
9
 100.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 2 participants 4 participants 3 participants 9 participants
2 4 3 9
1.Primary Outcome
Title Incidence of Serious Adverse Events (SAEs)
Hide Description Incidence of serious adverse events (SAEs), defined as the 6-month post-cardiac surgery for coronary artery bypss grafting CABG SAE proportion of patients experiencing sustained ventricular arrhythmias, ectopic tissue formation, or sudden unexpected death
Time Frame Measured at Month 6 after surgery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title (1) Lower MSC Dose (2) Higher MSC Dose (3) Placebo Injection
Hide Arm/Group Description:

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.

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.

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).

Overall Number of Participants Analyzed 2 4 3
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of patients
0
(0.0 to 84.2)
50
(6.8 to 93.2)
100
(29.2 to 100)
2.Secondary Outcome
Title Treatment Emergent Adverse Event Rates
Hide Description [Not Specified]
Time Frame Measured over the 6-month follow-up period, at Month 12 follow-up and at Month 18 follow-up
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Lower Dose Mesenchymal Stem Cell (MSC) Injection Higher Dose MSC Injection (3) Placebo
Hide Arm/Group Description:

Participants will receive lower dose mesenchymal stem cell injections for a total of 2 x 10^7 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 10^7 cells. The injections will be administered following completion of CABG surgery.

Participants will receive higher dose of mesenchymal stem cell injections for a total of 2 x 10^8 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 10^8 cells. The injections will be administered following completion of CABG surgery.

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).

Overall Number of Participants Analyzed 2 4 0
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
0
3.Secondary Outcome
Title 48-hour Ambulatory Electrocardiogram (ECG) Recordings
Hide Description [Not Specified]
Time Frame Measured over the 6-month follow-up period, at Month 12 follow-up and at Month 18 follow-up
Outcome Measure Data Not Reported
4.Secondary Outcome
Title Hematology, Clinical Chemistry, and Urinalysis Values
Hide Description [Not Specified]
Time Frame Measured over the 6-month follow-up period and at Month 18 follow-up
Outcome Measure Data Not Reported
5.Secondary Outcome
Title Pulmonary Function - Forced Expiratory Volume in 1 Second (FEV1) Results
Hide Description [Not Specified]
Time Frame Measured over the 6-month follow-up period and at Month 18 follow-up
Outcome Measure Data Not Reported
6.Secondary Outcome
Title Cardiac Computed Tomography Measures of ISS, Left Ventricular Ejection Fraction, and End Diastolic and End Systolic Volumes
Hide Description [Not Specified]
Time Frame Measured over the 6-month follow-up period and at Month 18 follow-up
Outcome Measure Data Not Reported
7.Secondary Outcome
Title Serial Troponin and Creatine Kinase MB (CK-MB) Values
Hide Description [Not Specified]
Time Frame Measured every 12 hours for the first 48 hours after surgery
Outcome Measure Data Not Reported
8.Secondary Outcome
Title Peak VO2 (by Treadmill Determination) and 6-minute Walk Test
Hide Description [Not Specified]
Time Frame Measured at baseline and Months 6 and 18 follow-ups
Outcome Measure Data Not Reported
9.Secondary Outcome
Title New York Heart Association (NYHA) Functional Class
Hide Description [Not Specified]
Time Frame Measured over the 6-month follow-up period and at Month 18 follow-up
Outcome Measure Data Not Reported
10.Secondary Outcome
Title Minnesota Living With Heart Failure (MLHF) Questionnaire
Hide Description [Not Specified]
Time Frame Measured over the 6-month follow-up period and at Month 18 follow-up
Outcome Measure Data Not Reported
11.Secondary Outcome
Title 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
Hide Description [Not Specified]
Time Frame Measured over the 6-month follow-up period and at Month 18 follow-up
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Lower Dose Mesenchymal Stem Cell (MSC) Injection Higher Dose MSC Injection (3) Placebo
Hide Arm/Group Description:

Participants will receive lower dose mesenchymal stem cell injections for a total of 2 x 10^7 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 10^7 cells. The injections will be administered following completion of CABG surgery.

Participants will receive higher dose of mesenchymal stem cell injections for a total of 2 x 10^8 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 10^8 cells. The injections will be administered following completion of CABG surgery.

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).

Overall Number of Participants Analyzed 2 4 0
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
0
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title (1) Lower MSC Dose (2) Higher MSC Dose (3) Placebo Injection
Hide Arm/Group Description

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.

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.

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).

All-Cause Mortality
(1) Lower MSC Dose (2) Higher MSC Dose (3) Placebo Injection
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
(1) Lower MSC Dose (2) Higher MSC Dose (3) Placebo Injection
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/2 (0.00%)      2/4 (50.00%)      3/3 (100.00%)    
Cardiac disorders       
Atrioventricular block complete  0/2 (0.00%)  0 1/4 (25.00%)  1 0/3 (0.00%)  0
Ventricular tachycardia  0/2 (0.00%)  0 1/4 (25.00%)  1 1/3 (33.33%)  3
Gastrointestinal disorders       
Large intestine perforation  0/2 (0.00%)  0 0/4 (0.00%)  0 1/3 (33.33%)  1
Immune system disorders       
Hypersensitivity  0/2 (0.00%)  0 0/4 (0.00%)  0 1/3 (33.33%)  1
Injury, poisoning and procedural complications       
Post procedural hemorrhage  0/2 (0.00%)  0 1/4 (25.00%)  1 0/3 (0.00%)  0
Procedural site reaction  0/2 (0.00%)  0 0/4 (0.00%)  0 1/3 (33.33%)  1
Metabolism and nutrition disorders       
Hyperkalemia  0/2 (0.00%)  0 1/4 (25.00%)  1 0/3 (0.00%)  0
Nervous system disorders       
Hypoaesthesia  0/2 (0.00%)  0 1/4 (25.00%)  1 0/3 (0.00%)  0
Transient ischemic attack  0/2 (0.00%)  0 1/4 (25.00%)  1 0/3 (0.00%)  0
Renal and urinary disorders       
Renal failure  0/2 (0.00%)  0 1/4 (25.00%)  1 0/3 (0.00%)  0
Respiratory, thoracic and mediastinal disorders       
Haemothorax  0/2 (0.00%)  0 1/4 (25.00%)  1 0/3 (0.00%)  0
Respiratory arrest  0/2 (0.00%)  0 0/4 (0.00%)  0 1/3 (33.33%)  1
Surgical and medical procedures       
Debridement  0/2 (0.00%)  0 0/4 (0.00%)  0 1/3 (33.33%)  1
Vascular disorders       
Hypotension  0/2 (0.00%)  0 0/4 (0.00%)  0 1/3 (33.33%)  1
Ischemia  0/2 (0.00%)  0 0/4 (0.00%)  0 1/3 (33.33%)  2
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
(1) Lower MSC Dose (2) Higher MSC Dose (3) Placebo Injection
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/2 (100.00%)      4/4 (100.00%)      2/3 (66.67%)    
Blood and lymphatic system disorders       
Anemia  0/2 (0.00%)  0 1/4 (25.00%)  1 0/3 (0.00%)  0
Cardiac disorders       
Arrhythmia  0/2 (0.00%)  0 0/4 (0.00%)  0 1/3 (33.33%)  1
Atrial fibrillation  0/2 (0.00%)  0 2/4 (50.00%)  2 1/3 (33.33%)  1
Bradycardia  0/2 (0.00%)  0 0/4 (0.00%)  0 1/3 (33.33%)  1
Palpitations  0/2 (0.00%)  0 1/4 (25.00%)  1 0/3 (0.00%)  0
Pericardial effusion  1/2 (50.00%)  1 0/4 (0.00%)  0 0/3 (0.00%)  0
Gastrointestinal disorders       
Constipation  1/2 (50.00%)  1 1/4 (25.00%)  1 0/3 (0.00%)  0
Ileus  0/2 (0.00%)  0 1/4 (25.00%)  1 0/3 (0.00%)  0
General disorders       
Chest discomfort  0/2 (0.00%)  0 1/4 (25.00%)  1 0/3 (0.00%)  0
Chest pain  0/2 (0.00%)  0 0/4 (0.00%)  0 1/3 (33.33%)  1
Oedema peripheral  0/2 (0.00%)  0 2/4 (50.00%)  2 0/3 (0.00%)  0
Pyrexia  0/2 (0.00%)  0 2/4 (50.00%)  2 0/3 (0.00%)  0
Tenderness  0/2 (0.00%)  0 0/4 (0.00%)  0 1/3 (33.33%)  1
Infections and infestations       
Nasopharyngitis  0/2 (0.00%)  0 1/4 (25.00%)  2 0/3 (0.00%)  0
Pneumonia  1/2 (50.00%)  1 1/4 (25.00%)  1 0/3 (0.00%)  0
Injury, poisoning and procedural complications       
Back Injury  0/2 (0.00%)  0 1/4 (25.00%)  1 0/3 (0.00%)  0
Procedural pain  0/2 (0.00%)  0 1/4 (25.00%)  1 0/3 (0.00%)  0
Investigations       
Blood triglycerides abnormal  0/2 (0.00%)  0 1/4 (25.00%)  1 0/3 (0.00%)  0
Hematocrit decreased  0/2 (0.00%)  0 1/4 (25.00%)  1 0/3 (0.00%)  0
Hepatic enzyme increased  0/2 (0.00%)  0 1/4 (25.00%)  1 0/3 (0.00%)  0
White blood cell count increased  0/2 (0.00%)  0 1/4 (25.00%)  3 0/3 (0.00%)  0
Metabolism and nutrition disorders       
Acidosis  0/2 (0.00%)  0 1/4 (25.00%)  2 0/3 (0.00%)  0
Fluid overload  0/2 (0.00%)  0 1/4 (25.00%)  1 0/3 (0.00%)  0
Hyperkalemia  0/2 (0.00%)  0 1/4 (25.00%)  1 0/3 (0.00%)  0
Hypokalemia  0/2 (0.00%)  0 1/4 (25.00%)  1 0/3 (0.00%)  0
Musculoskeletal and connective tissue disorders       
Musculoskeletal chest pain  0/2 (0.00%)  0 1/4 (25.00%)  1 0/3 (0.00%)  0
Myalgia  1/2 (50.00%)  1 0/4 (0.00%)  0 0/3 (0.00%)  0
Pain in extremity  1/2 (50.00%)  1 2/4 (50.00%)  2 1/3 (33.33%)  1
Nervous system disorders       
Ageusia  0/2 (0.00%)  0 1/4 (25.00%)  1 0/3 (0.00%)  0
Dizziness  0/2 (0.00%)  0 1/4 (25.00%)  1 0/3 (0.00%)  0
Dizziness postural  0/2 (0.00%)  0 1/4 (25.00%)  1 0/3 (0.00%)  0
Headache  0/2 (0.00%)  0 1/4 (25.00%)  1 0/3 (0.00%)  0
Hypoaesthesia  1/2 (50.00%)  1 1/4 (25.00%)  1 0/3 (0.00%)  0
Neuropathy peripheral  0/2 (0.00%)  0 1/4 (25.00%)  1 0/3 (0.00%)  0
Psychiatric disorders       
Hallucination  0/2 (0.00%)  0 1/4 (25.00%)  1 0/3 (0.00%)  0
Renal and urinary disorders       
Renal failure  0/2 (0.00%)  0 1/4 (25.00%)  1 0/3 (0.00%)  0
Reproductive system and breast disorders       
Erection increased  1/2 (50.00%)  1 0/4 (0.00%)  0 0/3 (0.00%)  0
Respiratory, thoracic and mediastinal disorders       
Atelectasis  0/2 (0.00%)  0 1/4 (25.00%)  1 0/3 (0.00%)  0
Dyspnea  0/2 (0.00%)  0 1/4 (25.00%)  1 0/3 (0.00%)  0
Hypoxia  0/2 (0.00%)  0 1/4 (25.00%)  2 0/3 (0.00%)  0
Pleural effusion  0/2 (0.00%)  0 1/4 (25.00%)  1 0/3 (0.00%)  0
Pneumothorax  0/2 (0.00%)  0 1/4 (25.00%)  2 0/3 (0.00%)  0
Pulmonary congestion  0/2 (0.00%)  0 1/4 (25.00%)  2 0/3 (0.00%)  0
Skin and subcutaneous tissue disorders       
Exfoliative rash  0/2 (0.00%)  0 0/4 (0.00%)  0 1/3 (33.33%)  1
Rash  0/2 (0.00%)  0 1/4 (25.00%)  1 0/3 (0.00%)  0
Surgical and medical procedures       
Hematoma evacuation  1/2 (50.00%)  1 0/4 (0.00%)  0 0/3 (0.00%)  0
Vascular disorders       
Hypotension  0/2 (0.00%)  0 1/4 (25.00%)  1 0/3 (0.00%)  0
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
Responsible Party: Joshua M Hare, University of Miami
ClinicalTrials.gov Identifier: NCT00587990     History of Changes
Other Study ID Numbers: 20070598
U54HL081028 ( U.S. NIH Grant/Contract )
First Submitted: January 2, 2008
First Posted: January 8, 2008
Results First Submitted: January 30, 2015
Results First Posted: April 2, 2015
Last Update Posted: December 6, 2017