Clinical Trials Logo
  1. Home
  2. Other
  3. NCT01495364

NBS10 (Also Known as AMR-001) Versus Placebo Post ST Segment Elevation Myocardial Infarction — PreSERVE-AMI  

ST Segment Elevation Myocardial Infarction Clinical Trial

Official title:
A Prospective Randomized Double Blind Placebo Controlled Phase II Trial of Intra-coronary Infusion of AMR-001, a Bone Marrow Derived Autologous CD34+ Selected Cell Product, in Patients With Acute Myocardial Infarction.

Clinical Trial Summary

This study will assess the safety and efficacy of intracoronary artery administered autologous bone marrow derived stem cells in subjects post ST segment elevation myocardial infarction (STEMI). This will be assessed by evaluating and comparing the autologous stem cell treatment group to the control group in terms of the occurrence of AE's, SAE's and Major Adverse Cardiac Events (MACE), by the change in myocardial perfusion (RTSS) measured quantitatively by gated single photon emission computed tomography myocardial perfusion imaging (gated SPECT MPI), and other secondary endpoints such as LVEF measured by cardiac MRI in addition to other endpoints.

Clinical Trial Description

Efficacy endpoint is at 6 months. Clinical endpoints and safety will be measured through 36 months. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01495364
Study type Interventional
Source Caladrius Biosciences, Inc.
Contact
Status Completed
Phase Phase 2
Start date December 2011
Completion date April 2016
View Details
See also
  Status Clinical Trial Phase
Recruiting NCT02869906 - Instantaneous Wave-Free Ratio and Fractional Flow Reserve for the Assessment of Non Culprit Lesions in Patients With ST-segment Elevation Myocardial Infarction N/A
Not yet recruiting NCT03895983 - ST Segment Resolution After Primary Percutaneous Coronary Intervention.
Not yet recruiting NCT03252665 - Efficacy of Intracoronary Infusion of Different Medicine in STEMI Patients Undergoing Primary PCI Phase 4
Completed NCT02026219 - Comparison of Clopidogrel and Ticagrelor on Microvascular Dysfunction in ST-Segment Elevation Myocardial Infarction Phase 4
Completed NCT03247738 - Platelet Inhibition With Cangrelor and Crushed Ticagrelor in STEMI Phase 4
Recruiting NCT05461781 - Distal Transradial Access for Primary PCI in STEMI Patients to Prevent RAO N/A
Recruiting NCT03561389 - iFR-guided Revascularization in STEMI
Completed NCT01538303 - Microvascular Dysfunction in Acute Myocardial Infarction (AMI) and Its Relation to Outcome
Recruiting NCT02979236 - Italian Multi-center Registry of Self-apposing Coronary Stent in Patients With STEMI N/A
Completed NCT05705089 - Rivaroxaban vErsus Warfarin for Antithrombotic TheRapy in Patients With LeFt Ventricular Thrombus After Acute STEMI Phase 3
Completed NCT01897350 - Myocardial Oedema in ST Segment Elevation Myocardial Infarction Myocardial N/A
Not yet recruiting NCT03753269 - Early Intracoronary Administration of Fasudil in the Primary PCI of ST-segment-Elevation Myocardial Infarction Phase 4
Completed NCT03234348 - MAGnesium-based Bioresorbable Scaffold in ST Segment Elevation Myocardial Infarction Phase 3
Recruiting NCT03406832 - Prevention of Coronary Slow Flow or No-Reflow During EPCI in Patients With Acute STEMI N/A
Recruiting NCT03406819 - Prevention of Coronary Slow Flow or No-Reflow During PPCI in Patients With Acute STEMI N/A
Recruiting NCT03508232 - Doxycycline to Protect Heart Muscle After Heart Attacks Phase 2
Recruiting NCT04220736 - Early Prediction of QFR in STEMI-Pharmaco-invasice
Completed NCT03780335 - Early Prediction of QFR in STEMI-I
Recruiting NCT03787745 - Ischemic Postconditioning in STEMI Patients Treated With Primary PCI N/A
Recruiting NCT03621111 - A Trial on the Role of Community Pharmacist in Improving Adherence and Clinical Outcomes in Post-Infarction N/A