Table 1.
Future and Ongoing MSC Clinical Trials
| Study Name | NCT # Clinicaltrials.gov | Description | Potential Advantages | Status |
|---|---|---|---|---|
| Adipose‐Derived MSCs | ||||
| APOLLO Trial: A Randomized Clinical Trial of AdiPOse‐derived Stem ceLLs in the Treatment of Patients With ST‐elevation myOcardial Infarction | NCT00442806 | Phase I trial to establish the safety profile of adipose‐derived stem and regenerative cells (ADRCs) in patients who have suffered ST‐elevation AMI | Ease of access to cells | Active Phase I, not recruiting |
| ADVANCE Study: ADRCs Delivered Via the Intracoronary Route in the Treatment of Patients With ST‐elevation Acute Myocardial Infarction | NCT01216995 | A double‐blind, prospective, randomized, placebo controlled safety and efficacy trial to evaluate the intracoronary delivery of ADRCs in patients with ST‐elevation AMI. Will enroll 216 patients | Ease of access to cells Large patient population Multi‐center |
Phase II, recruiting |
| MyStromalCell Trial: MesenchYmal STROMAL CELL Therapy in Patients With Chronic Myocardial Ischemia | NCT01449032 | After promising pilot study that demonstrated safety of adipose‐derived MSCs, this will be a double‐blind, placebo‐controlled phase II to evaluate if adipose derived MSCs are able to improve cardiac tissue perfusion, exercise capacity and reduce symptoms in patients with CAD | Ease of access to cells | Phase II, recruiting |
| MSC Precursor Types | ||||
| AMICI Trial: Safety Study of Allogeneic Mesenchymal Precursor Cell Infusion in MyoCardial Infarction | NCT01781390 | Double‐blind, randomized, placebo‐controlled trial that will enroll 225 patients with AMI due to lesion in LAD. They will undergo revascularization with PCI followed by intracoronary delivery of placebo or Stro3 MPC cells. Conducted by Angioblast systems | Cell type that improves paracrine activity and engraftment rates Demonstrates multilineage potential | Phase II, not yet open for recruiting |
| Safety Study of Allogeneic Mesenchymal Precursor Cells (MPCs) in Subjects With Recent Acute Myocardial Infarction | NCT00555828 | This trial will evaluate the safety and efficacy of dose‐dependent (25, 75, 150 mol/L) transendocardial injections of allogeneic stro3 MPCs using the Biosense NogaStarTM Mapping Catheter in patients with AMI. | Assess optimal dose for stro3 MPCs Explore late‐term dose related tolerance at days 90, 180, 360 |
Phase Ib/IIa, recruiting |
| Umbilical Cord‐Derived MSCs | ||||
| Randomized Clinical Trial of Intravenous Infusion Umbilical Cord Mesenchymal Stem Cells on Cardiopathy (RIMECARD) | NCT01739777 | This trial will evaluate safety and efficacy of umbilical cord derived mesenchymal stem cells (ucMSC) in patients with compensated dilated cardiomyopathy. Aims to have 30 patients with 2 arms; the first group will receive intravenous injection of ucMSC and other group will serve as control. | Ease of Access to MSCs Does not require invasive procedures to isolate MSCs |
Phase I/II, recruiting |
| Intracoronary Human Wharton's Jelly‐ Derived Mesenchymal Stem Cells (WJ‐MSCs) Transfer in Patients With Acute Myocardial Infarction (AMI) (WJ‐MSC‐AMI) | NCT01291329 | This is a double‐blind, placebo‐controlled, multicenter trial that involved 160 patients with acute STEMI. Patients received intracoronary infusion of WJ‐MSCs or placebo medium into infarct artery 4 to 7 days after a successful PCI therapy. | WJ‐MSCs have short doubling time which allows them to be quickly produced in large numbers. | Study has been completed |
| Allogeneic Bone Marrow‐Derived MSCs | ||||
| The POSEIDON‐DCM Study PercutaneOus StEm Cell Injection Delivery Effects On Neomyogenesis in Dilated CardioMyopathy | NCT01392625 | This is a pilot study with 36 patients that will evaluate the safety and efficacy of transendocardial injections of allogeneic and autologous MSCs in patients with non‐ischemic dilated cardiomyopathy. | Allogeneic MSCs offer the potential “off the shelf” therapy | Phase I/II, active recruiting |
| STEMI: A Study of Allogeneic Mesenchymal Bone Marrow Cells in Subjects With ST Segment Elevation Myocardial Infarction | NCT01770613 | This trial will evaluate the safety and efficacy of allogeneic mesenchymal bone marrow cells that will be administered intravenously to patients who have experienced STEMI. Estimated enrollment will be 40 subjects. | Allogeneic MSCs offer the potential “off the shelf” therapy | Phase II, not yet open for recruiting |
| MSCs and other Stem Cell Combinations | ||||
| AIRMID Trial: Autologous Cardioblasts for Reverse Remodeling in Ischemic Dilated Cardiomyopathy | Not Registered | Planning Phase | ||
AMI indicates acute myocardial infarction; CAD, coronary artery disease LAD, left anterior descending; MSCs, mesenchymal stem cells; PCI, percutaneous coronary intervention.