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NCT01781390: AMICI

Safety Study of Allogeneic Mesenchymal Precursor Cell Infusion in Myocardial Infarction

Completed Phase 2 Results posted Last updated 23 June 2022
What this trial tests

Phase 2 trial testing Placebo in Acute Myocardial Infarction in 106 participants. Completed in 6 April 2021.

Timeline
11 March 2013
Primary endpoint
6 April 2021
6 April 2021

Quick facts

Lead sponsorMesoblast, Inc.
PhasePhase 2
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingquadruple
Primary purposetreatment
Enrollment106
Start date11 March 2013
Primary completion6 April 2021
Estimated completion6 April 2021

Drugs / interventions tested

Conditions studied

Sponsor

Mesoblast, Inc. — full company profile →

Who can join

18 and older, any sex, with Acute Myocardial Infarction. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) Primary · Up to approximately 8 years

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.

TEAEs
GroupValue95% CI
Placebo28
Mesenchymal Precursor Cells (MPC) 12.5 M30
Mesenchymal Precursor Cells (MPC) 25 M31
SAEs
GroupValue95% CI
Placebo14
Mesenchymal Precursor Cells (MPC) 12.5 M16
Mesenchymal Precursor Cells (MPC) 25 M14

Adverse events — posted to ClinicalTrials.gov

Time frame: Up to approximately 8 years. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Placebo
Serious: 14/34 (41%)
Deaths: 0/34
Mesenchymal Precursor Cells (MPC) 12.5 M
Serious: 16/34 (47%)
Deaths: 2/34
Mesenchymal Precursor Cells (MPC) 25 M
Serious: 14/35 (40%)
Deaths: 2/35

Serious adverse events (51 terms)

ReactionSystemPlaceboMesenchymal Precursor Cell…Mesenchymal Precursor Cell…
Cardiac failureCardiac disorders
Non-cardiac chest painGeneral disorders
Angina pectorisCardiac disorders
Atrioventricular block completeCardiac disorders
Cardiac ventricular thrombosisCardiac disorders
PneumoniaInfections and infestations
Acute coronary syndromeCardiac disorders
Angina unstableCardiac disorders
Coronary artery diseaseCardiac disorders
Coronary artery stenosisCardiac disorders
Acute myocardial infarctionCardiac disorders
Arteriospasm coronaryCardiac disorders
Atrial fibrillationCardiac disorders
Cardiac failure acuteCardiac disorders
Cardiac failure chronicCardiac disorders
Cardiogenic shockCardiac disorders
Myocardial infarctionCardiac disorders
Ventricular tachycardiaCardiac disorders
Chest painGeneral disorders
Multiple organ dysfunction syndromeGeneral disorders
Vascular stent thrombosisGeneral disorders
UrosepsisInfections and infestations
Diaphragmatic hernia gangrenousInfections and infestations
Intervertebral discitisInfections and infestations
Respiratory tract infectionInfections and infestations
Other adverse events (62 terms — click to expand)

ReactionSystemPlaceboMesenchymal Precursor Cell…Mesenchymal Precursor Cell…
DyspnoeaRespiratory, thoracic and mediastinal disorders
DizzinessNervous system disorders
Ventricular tachycardiaCardiac disorders
PyrexiaGeneral disorders
DiarrhoeaGastrointestinal disorders
NauseaGastrointestinal disorders
ConstipationGastrointestinal disorders
CoughRespiratory, thoracic and mediastinal disorders
Non-cardiac chest painGeneral disorders
Chest painGeneral disorders
Musculoskeletal painMusculoskeletal and connective tissue disorders
Back painMusculoskeletal and connective tissue disorders
HypotensionVascular disorders
Peripheral coldnessVascular disorders
Post procedural haematomaInjury, poisoning and procedural complications
Cardiac ventricular thrombosisCardiac disorders
PalpitationsCardiac disorders
PericarditisCardiac disorders
FatigueGeneral disorders
VomitingGastrointestinal disorders
Lower respiratory tract infectionInfections and infestations
NasopharyngitisInfections and infestations
Respiratory tract infectionInfections and infestations
Urinary tract infectionInfections and infestations
LethargyNervous system disorders
HypertensionVascular disorders
DysuriaRenal and urinary disorders
AnxietyPsychiatric disorders
Cardiac failureCardiac disorders
Angina pectorisCardiac disorders
BradycardiaCardiac disorders
Atrial fibrillationCardiac disorders
Arteriospasm coronaryCardiac disorders
Ventricular extrasystolesCardiac disorders
Catheter site haematomaGeneral disorders
Oedema peripheralGeneral disorders
Multiple organ dysfunction syndromeGeneral disorders
Abdominal painGastrointestinal disorders
Gastrooesophageal reflux diseaseGastrointestinal disorders
InfluenzaInfections and infestations

Most-reported serious reactions: Cardiac failure, Non-cardiac chest pain, Angina pectoris, Atrioventricular block complete, Cardiac ventricular thrombosis, Pneumonia, Acute coronary syndrome, Angina unstable.

Data from ClinicalTrials.gov NCT01781390 adverse events section.

Sponsor's own description

This was a double-blind, randomized, placebo-controlled study that was designed to enroll a total of 225 participants with de novo anterior wall acute ST-segment elevation myocardial infarction (STEMI) due to a lesion of the left anterior descending coronary artery undergoing percutaneous coronary intervention (PCI). Eligible participants were to be enrolled and undergo revascularization of the culprit left anterior descending (LAD) coronary artery. The interventional procedure included as dose ranging assessment of intracoronary (IC) delivery of MPC or placebo infused into the stented coronary artery. This study compared two doses of MPCs and a placebo control group. Study participants were randomly assigned in 1:1:1 fashion to receive either 12.5 Million or 25 Million MPCs or placebo (saline). Initially, each group was designed to have approximately 75 patients per treatment group. The Primary Objective of the study was to determine the safety and feasibility of IC infusion of investigational MPCs in this acute STEMI population. The Primary Objective of the study was to determine the safety and feasibility of IC infusion of investigational MPCs in this acute STEMI population. Feasibility of the infusion of the investigational agent was assessed by measurement of thrombolysis in myocardial infarction (TIMI) flow and perfusion (1) immediately prior to, (2) during (after approximately 50% of total investigational agent volume infused) and (3) following the investigational agent infusion after successful PCI and stenting. There was no evidence of clinically important coronary microvascular obstruction related to infusion of the investigational agent.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Use of mesenchymal stem cells for therapy of cardiac disease.
    Karantalis V, Hare JM. · · 2015 · cited 324× · PMID 25858066 · DOI 10.1161/circresaha.116.303614
  2. Rebuilding the Damaged Heart: Mesenchymal Stem Cells, Cell-Based Therapy, and Engineered Heart Tissue.
    Golpanian S, Wolf A, Hatzistergos KE, Hare JM. · · 2016 · cited 239× · PMID 27335447 · DOI 10.1152/physrev.00019.2015
  3. Clinical Studies of Cell Therapy in Cardiovascular Medicine: Recent Developments and Future Directions.
    Banerjee MN, Bolli R, Hare JM. · · 2018 · cited 129× · PMID 29976692 · DOI 10.1161/circresaha.118.311217
  4. Concise Review: Mesenchymal Stem Cells in Cardiovascular Regeneration: Emerging Research Directions and Clinical Applications.
    Majka M, Sułkowski M, Badyra B, Musiałek P. · · 2017 · cited 86× · PMID 28836732 · DOI 10.1002/sctm.16-0484
  5. Concise Review: Rational Use of Mesenchymal Stem Cells in the Treatment of Ischemic Heart Disease.
    Ward MR, Abadeh A, Connelly KA. · · 2018 · cited 65× · PMID 29665255 · DOI 10.1002/sctm.17-0210
  6. The advancing field of cell-based therapy: insights and lessons from clinical trials.
    Telukuntla KS, Suncion VY, Schulman IH, Hare JM. · · 2013 · cited 65× · PMID 24113326 · DOI 10.1161/jaha.113.000338
  7. Is Cardioprotection Dead?
    Lefer DJ, Marbán E. · · 2017 · cited 59× · PMID 28674094 · DOI 10.1161/circulationaha.116.027039
  8. Promising Therapeutic Strategies for Mesenchymal Stem Cell-Based Cardiovascular Regeneration: From Cell Priming to Tissue Engineering.
    Ji ST, Kim H, Yun J, Chung JS, et al · · 2017 · cited 53× · PMID 28303152 · DOI 10.1155/2017/3945403

Verify or expand the search:

Other recruiting trials for Acute Myocardial Infarction

Currently open trials in the same condition.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01781390.

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