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Safety Study of Allogeneic Mesenchymal Precursor Cell Infusion in Myocardial Infarction (AMICI)

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: NCT01781390
Recruitment Status : Completed
First Posted : February 1, 2013
Results First Posted : January 18, 2022
Last Update Posted : June 23, 2022
Sponsor:
Information provided by (Responsible Party):
Mesoblast, Ltd. ( Mesoblast, Inc. )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Acute Myocardial Infarction
Interventions Other: Placebo
Biological: Mesenchymal Precursor Cells (MPC) 12.5 M
Biological: Mesenchymal Precursor Cells (MPC) 25 M
Enrollment 106
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Placebo Mesenchymal Precursor Cells (MPC) 12.5 M Mesenchymal Precursor Cells (MPC) 25 M
Hide Arm/Group Description Participants received matching-placebo solution 2 milliliter per minute (mL/min) infused Intracoronary for 60 min including line flush [0 Mesenchymal Precursor Cells (MPCs)/min] on Day 0. Participants received MPC 12.5 solution 2 mL/min infused Intracoronary for 60 min including line flush (2.5x10^5 MPCs/min) on Day 0. Participants received MPC 12.5 solution 2 mL/min infused Intracoronary for 60 min including line flush (5.0x10^5 MPCs/min) on Day 0.
Period Title: Overall Study
Started 35 35 36
Completed 32 28 32
Not Completed 3 7 4
Reason Not Completed
Withdrawal of Consent             0             3             1
Lost to Follow-up             1             1             1
Adverse Event             1             2             1
Participants who were Randomized and Not Treated             1             1             1
Arm/Group Title Placebo Mesenchymal Precursor Cells (MPC) 12.5 M Mesenchymal Precursor Cells (MPC) 25 M Total
Hide Arm/Group Description Participants received matching-placebo solution 2 mL/min infused Intracoronary for 60 min including line flush [0 Mesenchymal Precursor Cells (MPCs)/min] on Day 0. Participants received MPC 12.5 solution 2 mL/min infused Intracoronary for 60 min including line flush (2.5x10^5 MPCs/min) on Day 0. Participants received MPC 12.5 solution 2 mL/min infused Intracoronary for 60 min including line flush (5.0x10^5 MPCs/min) on Day 0. Total of all reporting groups
Overall Number of Baseline Participants 34 34 35 103
Hide Baseline Analysis Population Description
Full analysis population included all participants who were randomized, underwent percutaneous coronary intervention (PCI) and had infusion of study agent (mesenchymal precursor cells [MPCs] or placebo) initiated.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 34 participants 34 participants 35 participants 103 participants
61.3  (9.79) 60.7  (13.11) 57.6  (12.12) 59.8  (11.76)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 34 participants 34 participants 35 participants 103 participants
Female
7
  20.6%
2
   5.9%
8
  22.9%
17
  16.5%
Male
27
  79.4%
32
  94.1%
27
  77.1%
86
  83.5%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 34 participants 34 participants 35 participants 103 participants
Hispanic or Latino
1
   2.9%
1
   2.9%
0
   0.0%
2
   1.9%
Not Hispanic or Latino
33
  97.1%
33
  97.1%
35
 100.0%
101
  98.1%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 34 participants 34 participants 35 participants 103 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
1
   2.9%
0
   0.0%
0
   0.0%
1
   1.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
White
33
  97.1%
33
  97.1%
34
  97.1%
100
  97.1%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
1
   2.9%
1
   2.9%
2
   1.9%
Left Ventricular (LV) End-systolic Volume (LVESV) as Assessed by Cardiac MRI   [1] 
Mean (Standard Deviation)
Unit of measure:  Milliliter (ml)
Number Analyzed 30 participants 28 participants 32 participants 90 participants
85.544  (34.8935) 91.728  (30.4476) 92.163  (33.1251) 89.821  (32.7025)
[1]
Measure Analysis Population Description: Full analysis population included all participants who were randomized, underwent PCI and had infusion of study product initiated as randomized. Number analyzed are the number of participants with data available for LVESV at Baseline. Baseline is defined as value measured at Day 2 to 4.
1.Primary Outcome
Title Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Hide Description Safety measure: An AE is any unfavorable and unintended sign, symptom, or disease, whether or not related to the investigational product. A TEAE was defined as any AE with onset post study drug treatment. An SAE was defined as any untoward medical occurrence that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is medically important.
Time Frame Up to approximately 8 years
Hide Outcome Measure Data
Hide Analysis Population Description
The safety set included all participants who were randomly assigned to a treatment at screening and received treatment. Overall number analyzed is the participants available for analyses.
Arm/Group Title Placebo Mesenchymal Precursor Cells (MPC) 12.5 M Mesenchymal Precursor Cells (MPC) 25 M
Hide Arm/Group Description:
Participants received matching-placebo solution 2 mL/min infused Intracoronary for 60 min including line flush [0 Mesenchymal Precursor Cells (MPCs)/min] on Day 0.
Participants received MPC 12.5 solution 2 mL/min infused Intracoronary for 60 min including line flush (2.5x10^5 MPCs/min) on Day 0.
Participants received MPC 12.5 solution 2 mL/min infused Intracoronary for 60 min including line flush (5.0x10^5 MPCs/min) on Day 0.
Overall Number of Participants Analyzed 34 34 35
Measure Type: Count of Participants
Unit of Measure: Participants
TEAEs
28
  82.4%
30
  88.2%
31
  88.6%
SAEs
14
  41.2%
16
  47.1%
14
  40.0%
Time Frame Up to approximately 8 years
Adverse Event Reporting Description The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
 
Arm/Group Title Placebo Mesenchymal Precursor Cells (MPC) 12.5 M Mesenchymal Precursor Cells (MPC) 25 M
Hide Arm/Group Description Participants received matching-placebo solution 2 mL/min infused Intracoronary for 60 mins including line flush [0 Mesenchymal Precursor Cells (MPCs)/min] on Day 0. Participants received MPC 12.5 solution 2 mL/min infused Intracoronary for 60 mins including line flush (2.5x10^5 MPCs/min) on Day 0. Participants received MPC 12.5 solution 2 mL/min infused Intracoronary for 60 mins including line flush (5.0x10^5 MPCs/min) on Day 0.
All-Cause Mortality
Placebo Mesenchymal Precursor Cells (MPC) 12.5 M Mesenchymal Precursor Cells (MPC) 25 M
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/34 (0.00%)   2/34 (5.88%)   2/35 (5.71%) 
Hide Serious Adverse Events
Placebo Mesenchymal Precursor Cells (MPC) 12.5 M Mesenchymal Precursor Cells (MPC) 25 M
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   14/34 (41.18%)   16/34 (47.06%)   14/35 (40.00%) 
Blood and lymphatic system disorders       
Iron deficiency anaemia   0/34 (0.00%)  1/34 (2.94%)  0/35 (0.00%) 
Cardiac disorders       
Cardiac failure   2/34 (5.88%)  3/34 (8.82%)  1/35 (2.86%) 
Angina pectoris   2/34 (5.88%)  0/34 (0.00%)  1/35 (2.86%) 
Acute coronary syndrome   0/34 (0.00%)  1/34 (2.94%)  1/35 (2.86%) 
Angina unstable   1/34 (2.94%)  1/34 (2.94%)  0/35 (0.00%) 
Atrioventricular block complete   2/34 (5.88%)  0/34 (0.00%)  0/35 (0.00%) 
Cardiac ventricular thrombosis   0/34 (0.00%)  2/34 (5.88%)  0/35 (0.00%) 
Coronary artery disease   1/34 (2.94%)  1/34 (2.94%)  0/35 (0.00%) 
Coronary artery stenosis   1/34 (2.94%)  0/34 (0.00%)  1/35 (2.86%) 
Acute myocardial infarction   0/34 (0.00%)  0/34 (0.00%)  1/35 (2.86%) 
Arteriospasm coronary   1/34 (2.94%)  0/34 (0.00%)  0/35 (0.00%) 
Atrial fibrillation   0/34 (0.00%)  0/34 (0.00%)  1/35 (2.86%) 
Cardiac failure acute   0/34 (0.00%)  0/34 (0.00%)  1/35 (2.86%) 
Cardiac failure chronic   1/34 (2.94%)  0/34 (0.00%)  0/35 (0.00%) 
Cardiogenic shock   1/34 (2.94%)  0/34 (0.00%)  0/35 (0.00%) 
Myocardial infarction   0/34 (0.00%)  1/34 (2.94%)  0/35 (0.00%) 
Ventricular tachycardia   0/34 (0.00%)  0/34 (0.00%)  1/35 (2.86%) 
General disorders       
Non-cardiac chest pain   1/34 (2.94%)  1/34 (2.94%)  3/35 (8.57%) 
Chest pain   1/34 (2.94%)  0/34 (0.00%)  1/35 (2.86%) 
Multiple organ dysfunction syndrome   0/34 (0.00%)  1/34 (2.94%)  0/35 (0.00%) 
Vascular stent thrombosis   0/34 (0.00%)  0/34 (0.00%)  1/35 (2.86%) 
Infections and infestations       
Pneumonia   1/34 (2.94%)  2/34 (5.88%)  0/35 (0.00%) 
Urosepsis   0/34 (0.00%)  1/34 (2.94%)  1/35 (2.86%) 
Diaphragmatic hernia gangrenous   1/34 (2.94%)  0/34 (0.00%)  0/35 (0.00%) 
Intervertebral discitis   0/34 (0.00%)  1/34 (2.94%)  0/35 (0.00%) 
Respiratory tract infection   0/34 (0.00%)  0/34 (0.00%)  1/35 (2.86%) 
Sepsis   0/34 (0.00%)  1/34 (2.94%)  0/35 (0.00%) 
Injury, poisoning and procedural complications       
Accidental overdose   1/34 (2.94%)  0/34 (0.00%)  0/35 (0.00%) 
Head injury   0/34 (0.00%)  0/34 (0.00%)  1/35 (2.86%) 
Overdose   0/34 (0.00%)  1/34 (2.94%)  0/35 (0.00%) 
Tibia fracture   0/34 (0.00%)  1/34 (2.94%)  0/35 (0.00%) 
Wound complication   0/34 (0.00%)  1/34 (2.94%)  0/35 (0.00%) 
Metabolism and nutrition disorders       
Hypovolaemia   0/34 (0.00%)  0/34 (0.00%)  1/35 (2.86%) 
Musculoskeletal and connective tissue disorders       
Osteoarthritis   1/34 (2.94%)  0/34 (0.00%)  0/35 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Adenocarcinoma of colon   0/34 (0.00%)  1/34 (2.94%)  0/35 (0.00%) 
B-cell lymphoma   0/34 (0.00%)  0/34 (0.00%)  1/35 (2.86%) 
Gastrointestinal stromal tumour   0/34 (0.00%)  1/34 (2.94%)  0/35 (0.00%) 
Lymphoma   0/34 (0.00%)  0/34 (0.00%)  1/35 (2.86%) 
Thyroid adenoma   0/34 (0.00%)  0/34 (0.00%)  1/35 (2.86%) 
Nervous system disorders       
Syncope   1/34 (2.94%)  1/34 (2.94%)  0/35 (0.00%) 
Cerebrovascular accident   0/34 (0.00%)  0/34 (0.00%)  1/35 (2.86%) 
Ischaemic stroke   1/34 (2.94%)  0/34 (0.00%)  0/35 (0.00%) 
Migraine with aura   1/34 (2.94%)  0/34 (0.00%)  0/35 (0.00%) 
Transient ischaemic attack   0/34 (0.00%)  0/34 (0.00%)  1/35 (2.86%) 
Psychiatric disorders       
Depression   1/34 (2.94%)  1/34 (2.94%)  0/35 (0.00%) 
Acute psychosis   1/34 (2.94%)  0/34 (0.00%)  0/35 (0.00%) 
Anxiety   0/34 (0.00%)  1/34 (2.94%)  0/35 (0.00%) 
Renal and urinary disorders       
Acute kidney injury   0/34 (0.00%)  0/34 (0.00%)  1/35 (2.86%) 
Ureterolithiasis   0/34 (0.00%)  1/34 (2.94%)  0/35 (0.00%) 
Respiratory, thoracic and mediastinal disorders       
Pulmonary embolism   0/34 (0.00%)  1/34 (2.94%)  0/35 (0.00%) 
Vascular disorders       
Hypertension   0/34 (0.00%)  1/34 (2.94%)  0/35 (0.00%) 
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo Mesenchymal Precursor Cells (MPC) 12.5 M Mesenchymal Precursor Cells (MPC) 25 M
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   26/34 (76.47%)   33/34 (97.06%)   31/35 (88.57%) 
Blood and lymphatic system disorders       
Anaemia   2/34 (5.88%)  2/34 (5.88%)  0/35 (0.00%) 
Iron deficiency anaemia   0/34 (0.00%)  2/34 (5.88%)  0/35 (0.00%) 
Cardiac disorders       
Ventricular tachycardia   1/34 (2.94%)  3/34 (8.82%)  6/35 (17.14%) 
Bradycardia   1/34 (2.94%)  2/34 (5.88%)  2/35 (5.71%) 
Atrial fibrillation   1/34 (2.94%)  2/34 (5.88%)  2/35 (5.71%) 
Palpitations   0/34 (0.00%)  3/34 (8.82%)  1/35 (2.86%) 
Pericarditis   0/34 (0.00%)  1/34 (2.94%)  3/35 (8.57%) 
Arteriospasm coronary   2/34 (5.88%)  0/34 (0.00%)  0/35 (0.00%) 
Ventricular extrasystoles   0/34 (0.00%)  0/34 (0.00%)  2/35 (5.71%) 
Cardiac failure   1/34 (2.94%)  1/34 (2.94%)  3/35 (8.57%) 
Angina pectoris   2/34 (5.88%)  3/34 (8.82%)  1/35 (2.86%) 
Cardiac ventricular thrombosis   1/34 (2.94%)  4/34 (11.76%)  0/35 (0.00%) 
Eye disorders       
Vision blurred   0/34 (0.00%)  2/34 (5.88%)  0/35 (0.00%) 
Gastrointestinal disorders       
Diarrhoea   4/34 (11.76%)  3/34 (8.82%)  5/35 (14.29%) 
Nausea   1/34 (2.94%)  5/34 (14.71%)  3/35 (8.57%) 
Constipation   1/34 (2.94%)  5/34 (14.71%)  1/35 (2.86%) 
Vomiting   2/34 (5.88%)  2/34 (5.88%)  3/35 (8.57%) 
Abdominal pain   1/34 (2.94%)  2/34 (5.88%)  2/35 (5.71%) 
Gastrooesophageal reflux disease   0/34 (0.00%)  2/34 (5.88%)  0/35 (0.00%) 
General disorders       
Pyrexia   5/34 (14.71%)  2/34 (5.88%)  3/35 (8.57%) 
Chest pain   2/34 (5.88%)  1/34 (2.94%)  4/35 (11.43%) 
Fatigue   2/34 (5.88%)  3/34 (8.82%)  1/35 (2.86%) 
Catheter site haematoma   1/34 (2.94%)  2/34 (5.88%)  1/35 (2.86%) 
Oedema peripheral   0/34 (0.00%)  2/34 (5.88%)  2/35 (5.71%) 
Multiple organ dysfunction syndrome   0/34 (0.00%)  2/34 (5.88%)  0/35 (0.00%) 
Non-cardiac chest pain   2/34 (5.88%)  5/34 (14.71%)  2/35 (5.71%) 
Infections and infestations       
Lower respiratory tract infection   0/34 (0.00%)  2/34 (5.88%)  3/35 (8.57%) 
Influenza   2/34 (5.88%)  1/34 (2.94%)  1/35 (2.86%) 
Nasopharyngitis   3/34 (8.82%)  0/34 (0.00%)  1/35 (2.86%) 
Respiratory tract infection   0/34 (0.00%)  1/34 (2.94%)  3/35 (8.57%) 
Urinary tract infection   1/34 (2.94%)  3/34 (8.82%)  0/35 (0.00%) 
Upper respiratory tract infection   0/34 (0.00%)  0/34 (0.00%)  2/35 (5.71%) 
Pneumonia   0/34 (0.00%)  2/34 (5.88%)  1/35 (2.86%) 
Injury, poisoning and procedural complications       
Post procedural haematoma   4/34 (11.76%)  1/34 (2.94%)  0/35 (0.00%) 
Contusion   0/34 (0.00%)  2/34 (5.88%)  0/35 (0.00%) 
Investigations       
Blood triglycerides increased   0/34 (0.00%)  0/34 (0.00%)  2/35 (5.71%) 
Metabolism and nutrition disorders       
Hypokalaemia   2/34 (5.88%)  1/34 (2.94%)  1/35 (2.86%) 
Dyslipidaemia   0/34 (0.00%)  0/34 (0.00%)  2/35 (5.71%) 
Musculoskeletal and connective tissue disorders       
Musculoskeletal pain   1/34 (2.94%)  4/34 (11.76%)  1/35 (2.86%) 
Back pain   0/34 (0.00%)  1/34 (2.94%)  4/35 (11.43%) 
Muscle spasms   2/34 (5.88%)  1/34 (2.94%)  1/35 (2.86%) 
Musculoskeletal chest pain   0/34 (0.00%)  2/34 (5.88%)  2/35 (5.71%) 
Myalgia   2/34 (5.88%)  1/34 (2.94%)  0/35 (0.00%) 
Pain in extremity   1/34 (2.94%)  0/34 (0.00%)  2/35 (5.71%) 
Nervous system disorders       
Dizziness   4/34 (11.76%)  8/34 (23.53%)  5/35 (14.29%) 
Headache   2/34 (5.88%)  1/34 (2.94%)  2/35 (5.71%) 
Lethargy   1/34 (2.94%)  3/34 (8.82%)  1/35 (2.86%) 
Dizziness postural   1/34 (2.94%)  2/34 (5.88%)  0/35 (0.00%) 
Presyncope   1/34 (2.94%)  2/34 (5.88%)  0/35 (0.00%) 
Psychiatric disorders       
Anxiety   1/34 (2.94%)  3/34 (8.82%)  1/35 (2.86%) 
Insomnia   1/34 (2.94%)  1/34 (2.94%)  2/35 (5.71%) 
Renal and urinary disorders       
Dysuria   0/34 (0.00%)  0/34 (0.00%)  3/35 (8.57%) 
Lower urinary tract symptoms   0/34 (0.00%)  2/34 (5.88%)  0/35 (0.00%) 
Rales   2/34 (5.88%)  1/34 (2.94%)  0/35 (0.00%) 
Dysphonia   2/34 (5.88%)  0/34 (0.00%)  0/35 (0.00%) 
Reproductive system and breast disorders       
Erectile dysfunction   2/34 (5.88%)  0/34 (0.00%)  2/35 (5.71%) 
Respiratory, thoracic and mediastinal disorders       
Dyspnoea   2/34 (5.88%)  8/34 (23.53%)  2/35 (5.71%) 
Cough   2/34 (5.88%)  2/34 (5.88%)  5/35 (14.29%) 
Epistaxis   2/34 (5.88%)  0/34 (0.00%)  1/35 (2.86%) 
Vascular disorders       
Hypotension   2/34 (5.88%)  4/34 (11.76%)  1/35 (2.86%) 
Hypertension   1/34 (2.94%)  2/34 (5.88%)  3/35 (8.57%) 
Peripheral coldness   1/34 (2.94%)  4/34 (11.76%)  1/35 (2.86%) 
Indicates events were collected by systematic assessment
Originally, 225 de novo anterior STEMI participants were to undergo primary PCI. However, due to difficulty in consenting participants and operationalizing protocol under emergency conditions associated with acute STEMI, a major protocol amendment was required. The protocol was adjusted to randomize 105 participants. This 53% reduction in participants from the original protocol allowed preliminary evaluations of safety and feasibility.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Publications (abstracts, posters or presentations) must be presented to Publication Steering Committee for review prior to submission or public display and are not allowed prior to the publication of the primary manuscript, or eighteen (18) months from the conclusion of the Study. PI shall provide Sponsor a copy of any proposed public disclosure at least 30 days prior to submission. Sponsor may ask PI to delay the disclosure for a maximum of 60 days to file proprietary protection.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Kenneth Borow, MD (Lead, Global Cardiovascular Development)
Organization: Mesoblast, Inc.
Phone: (212) 880-2060 ext 7951
EMail: Ken.Borow@Mesoblast.com
Layout table for additonal information
Responsible Party: Mesoblast, Ltd. ( Mesoblast, Inc. )
ClinicalTrials.gov Identifier: NCT01781390    
Other Study ID Numbers: ANG.AMI-IC001
2010-020497-41 ( EudraCT Number )
First Submitted: January 14, 2013
First Posted: February 1, 2013
Results First Submitted: December 17, 2021
Results First Posted: January 18, 2022
Last Update Posted: June 23, 2022