5 completed, 5 withdrawn, 4 terminated, 1 active not recruiting. 13 Phase 1, 9 Phase 2.
| Phase | Trials | Status |
|---|---|---|
| Phase 1 | 13 | Withdrawn 5, Completed 4, Terminated 4 |
| Phase 2 | 9 | Completed 4, Terminated 2, Withdrawn 2, Active not recruiting 1 |
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Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| The Transendocardial Autologous Cells (hMSC) or (hMSC) and (hCSC) in Ischemic Heart Failure Trial. Autologous hMSCs, Autologous Human C-Kit CSCs II, Placebo - Chronic Ischemic Left Ventricular Dysfunction, Myocardial Infarction | Phase 1 / Phase 2 | Withdrawn | Joshua M Hare | 2025-03-01 | 2020-10-22 | |
| Umbilical Cord Tissue (UC) Derived Mesenchymal Stem Cells (MSCs) Versus Placebo to Treat Acute Pulmonary Inflammation Due to COVID-19 UCMSCs, Placebo - COVID-19, Acute Respiratory Distress Syndrome | Phase 1 | Withdrawn | Joshua M Hare | 2022-10-01 | 2022-05-12 | |
| Allogeneic Mesenchymal Human Stem Cell Infusion Therapy for Endothelial DySfunctiOn in Diabetic Subjects With Symptomatic Ischemic Heart Disease. (ACESO-IHD) 100 million Allogeneic Mesenchymal Human Stem Cells, Placebo - Diabetes Mellitus, Ischemic Heart Disease | Phase 1 / Phase 2 | Completed | Joshua M Hare | 26 | 2021-08-16 | 2026-06-16 |
| Administration of Allogeneic-MSC in Patients With Non-Ischemic Dilated Cardiomyopathy allogeneic human mesenchymal stem cells (hMSCs), Placebo - Non-ischemic Dilated Cardiomyopathy | Phase 2 | Active not recruiting | Joshua M Hare | 107 | 2021-05-07 | 2026-09-29 |
| Human MesenchymAl Stem Cells Infusion in Patients With Cystic Fibrosis Allo-hMSCs, Placebo - Cystic Fibrosis | Phase 1 | Withdrawn | Joshua M Hare | 2020-12-01 | 2020-05-13 | |
| Allogeneic Human Mesenchymal Stem Cell Injection in PAtieNts With FaceTogenic Back Pain Allogeneic Human Mesenchymal Stem Cells (hMSCs), Placebo - Facetogenic Back Pain, Back Pain | Phase 1 / Phase 2 | Withdrawn | Joshua M Hare | 2020-12-01 | 2020-10-20 | |
| AlloGeneic Human Mesenchymal Stem Cells (hMSC) in PAtients With FistuLizing Crohn's Disease Via PErifistula iNjEctions (GALENE) Allogeneic Bone Marrow derived Human Mesenchymal Stem Cells (hMSCs) - Crohn's Disease, Fistulizing Crohn's Disease | Phase 1 | Withdrawn | Joshua M Hare | 2019-12-01 | 2026-01-27 | |
| The CHILD Trial: Hypoplastic Left Heart Syndrome Study. c-kit+ cells - Hypoplastic Left Heart Syndrome | Phase 1 | Completed | Joshua M Hare | 25 | 2019-10-16 | 2026-01-23 |
| Infusion of Umbilical Cord Versus Bone Marrow Derived Mesenchymal Stem Cells to Evaluate Cytokine Suppression. UCMSCs, BMMSCs, Placebo - Endothelial Dysfunction, Metabolic Syndrome | Phase 1 / Phase 2 | Terminated | Joshua M Hare | 14 | 2018-04-12 | 2022-11-08 |
| Allogeneic Human Mesenchymal Stem Cells (hMSCs) Infusion in Patients With Treatment Resistant Depression Allo-hMSCs, Placebo - Treatment Resistant Depression | Phase 1 | Terminated | Joshua M Hare | 1 | 2017-10-31 | 2019-04-01 |
| Allogeneic Mesenchymal Human Stem Cells Infusion Therapy for Endothelial DySfunctiOn in Diabetic Subjects 20 million Allogeneic Mesenchymal Human Stem Cells, 100 million Allogeneic Mesenchymal Human Stem Cells - Diabetes Mellitus, Type 2 | Phase 1 / Phase 2 | Completed | Joshua M Hare | 16 | 2017-10-20 | 2022-05-11 |
| The TRansendocardial Stem Cell Injection Delivery Effects on Neomyogenesis STudy (The TRIDENT Study) Allogeneic hMSCs - Chronic Ischemic Left Ventricular Dysfunction, Myocardial Infarction | Phase 2 | Completed | Joshua M Hare | 30 | 2014-02-13 | 2020-02-11 |
| Allogeneic Human Cells (hMSC)in Patients With Idiopathic Pulmonary Fibrosis Via Intravenous Delivery (AETHER) Allogeneic Adult Human Mesenchymal Stem Cells (hMSCs), matched placebo - Idiopathic Pulmonary Fibrosis (IPF) | Phase 1 | Terminated | Joshua M Hare | 9 | 2013-11-13 | 2021-03-09 |
| PercutaneOus StEm Cell Injection Delivery Effects On Neomyogenesis in Dilated CardioMyopathy (The POSEIDON-DCM Study) Autologous hMSCs, Allogeneic hMSCs - Non-ischemic Dilated Cardiomyopathy | Phase 1 / Phase 2 | Completed | Joshua M Hare | 37 | 2011-05-19 | 2018-02-15 |
| Prospective Randomized Study of Mesenchymal Stem Cell Therapy in Patients Undergoing Cardiac Surgery (PROMETHEUS) Lower dose mesenchymal stem cell (MSC) injection, Placebo, Higher dose MSC injection - Stem Cell Transplantation, Ventricular Dysfunction, Left | Phase 1 / Phase 2 | Terminated | Joshua M Hare | 9 | 2007-11-01 | 2019-09-10 |
Diabetes Mellitus (2) · Myocardial Infarction (2) · Back Pain (1) · COVID-19 (1) · Cardiomyopathy, Dilated (1) · Coronavirus Infections (1) · Crohn Disease (1) · Cystic Fibrosis (1) · Depression (1) · Depressive Disorder, Treatment-Resistant (1) · Diabetes Mellitus, Type 2 (1) · Heart Failure (1) · Hypoplastic Left Heart Syndrome (1) · Idiopathic Pulmonary Fibrosis (1) · Metabolic Syndrome (1)
Injections (1)
United States (12)
Andrew Sherman, MD (1) · David Kerman, MD (1) · Gary Gerstenblith, MD (1) · John V. Conte, MD (1) · Joshua Hare, MD (1) · Kristopher Deatrick, MD (1) · Marilyn K. Glassberg, MD (1) · Matthias A Salathe, MD (1) · Nikolaos Spilias, MD (1) · Richard Ohye, MD (1) · Steven P. Schulman, MD (1) · William Mahle, MD (1)
PMID 24565698, PMID 25354998, PMID 30005555, PMID 31616309, PMID 34217109, PMID 35394149, PMID 41258851
R01HL134558 (2), R01HL110737 (1), U54HL081028 (1)