COVID-19 Inpatient Trials
MSCs in COVID-19 ARDS
The purpose of this trial is to determine whether MSCs (mesenchymal stromal cells) are effective and safe in helping patients with moderate to severe ARDS due to COVID-19 infection. The MSCs used in this study are called remestemcel-L, and these human stem cells are derived from the bone marrow of healthy volunteers and cultured (grown) in a laboratory. This treatment is experimental, meaning that it has not been approved by the Food and Drug Administration (FDA) as a treatment for ARDS. The treatment is being developed by Mesoblast for the treatment of multiple diseases including ARDS due to COVID-19 Infection. Patients are still eligible for this trial if they are receiving remdesivir outside of a clinical trial.
- 18 years or older
- Patient requiring mechanical ventilator support with moderate to severe ARDS
- Patients who have intubated for more than 72 hours
- Patients currently receiving ECMO or HFOVaccep
Dipyridamole to Arrest Progression of Mild/moderate CoV-19 infection DICER
The most severe manifestations of COVID-19 include respiratory failure, coagulation problems, and death. Inflammation and blood clotting are believed to play an important role in these manifestations. Research in humans has shown that dipyridamole (an FDA-approved drug) can reduce blood clotting. This research study is being conducted to learn whether 14 days of treatment with dipyridamole will reduce excessive blood clotting in COVID-19. This study will enroll participants with confirmed coronavirus (SARS-CoV)-2 infection that are admitted to University of Michigan. Eligible participants will be randomized to receive dipyridamole or placebo for 14 days in the hospital. In addition, data will be collected from the medical record, and there will also be blood draws during the hospitalization.
- 18 years or older
- Confirmed coronavirus infection, ≤ 72 hours of hospital admission or of COVID-19 confirmation
- Currently hospitalized or anticipated hospitalization requiring supplemental oxygen ≤ 6 LPM by nasal cannula.
- Unlikely to survive for greater than 48 from screening
- Currently on invasive mechanical ventilation
For non-urgent questions about the COVID-19 inpatient trials above, contact CVCVolunteer@med.umich.edu.
Mitral And Tricuspid Program (MATRIx) Clinical Trials
The Michigan Medicine Frankel Cardiovascular Center’s Percutaneous Mitral And Tricuspid (MATRIx) program is at the forefront of minimally invasive and endovascular treatment technologies for mitral valve and tricuspid valve repair and replacement.
With the goal of advancing the fight against cardiovascular disease, our team is leading the way in exciting clinical trials focused on the treatment of mitral and tricuspid valves. These include:
APOLLO Trial: The purpose of this trial is to evaluate the safety and efficacy of Medtronic Intrepid™ Transcatheter Mitral Valve Replacement System in patients with at least moderate-to-severe mitral regurgitation who may not be good candidates for transcatheter mitral valve repair or surgical mitral valve intervention:
RESTORE Trial: The purpose of this study is to evaluate the safety and effectiveness (usefulness) of the HARPOON™ Beating Heart Mitral Valve Repair System. The HARPOON™ Beating Heart Mitral Valve Repair System, is designed to reduce the degree of mitral regurgitation caused by degenerative mitral valve disease: https://UMHealthResearch.org/#studies/HUM00182827
REPAIR MR Trial: The purpose of this trial is to evaluate the medical device called the MitraClip™ Mitral Valve Repair System (or the MitraClip system) for an investigational use in patients with severe primary mitral regurgitation who are at moderate surgical risk: https://UMHealthResearch.org/#studies/HUM00186017
ENRAPTUS Trial: The purpose of this study is to evaluate the safety and effectiveness (usefulness) of the ENRAPT US Epicardial Mitral Touch System for mitral insufficiency. This new repair system is being studied to treat patients who have moderate to severe mitral regurgitation and also are scheduled to have coronary artery bypass surgery: https://UMHealthResearch.org/#studies/HUM00186582
CLASP IID/IIF Pivotal Trial: The goal of this study is to assess the safety and performance of the PASCAL System compared to the MitraClip System in patients with at least moderate-to-severe degenerative or functional mitral regurgitation who may not be ideal candidates for mitral valve surgery and may be eligible for transcatheter mitral valve repair: https://UMHealthResearch.org/#studies/HUM00162937
- TRILUMINATE Pivotal Trial: A study to assess the safety and performance of the TriClip™ plus optimal drug therapy compared to optimal drug therapy along in patients with symptomatic moderate or greater tricuspid regurgitation who may not be ideal candidates for surgery and may be eligible for Transcatheter tricuspid valve repair.
TRILUMINATE Pivotal Trial: https://clinicaltrials.gov/ct2/show/NCT03904147
- Edwards PASCAL Transcatheter Valve Repair System Pivotal Clinical Trial (CLASP II TR): A study to evaluate the safety and performance of the PASCAL System with optimal medical therapy (OMT) compared to OMT alone in patients with symptomatic severe tricuspid regurgitation who may n/div>ot be ideal candidates for surgery and may be eligible for transcatheter repair.
CLASP II TR Trial: https://clinicaltrials.gov/ct2/show/NCT04097145
To learn more about other clinical trials at Michigan Medicine, visit UMHealthResearch.org.