bone marrow-derived allogeneic stem cells (hMSCs) / University of Miami - LARVOL DELTA

Allogeneic Mesenchymal Human Stem Cell Infusion Therapy for Endothelial DySfunctiOn in Diabetic Subjects With Symptomatic Ischemic Heart Disease. (ACESO-IHD) (clinicaltrials.gov) - P1/2 | N=26 | Completed | Sponsor: Joshua M Hare | Active, not recruiting ➔ Completed

Trial completion • Cardiovascular • Coronary Artery Disease • Diabetes • Heart Failure • Metabolic Disorders

Allogeneic mesenchymal stem cell therapy with laromestrocel in mild Alzheimer's disease: a randomized controlled phase 2a trial. (PubMed, Nat Med) - P2 | "Larger-scale clinical trials of laromestrocel in AD are warranted. ClinicalTrials.gov registration: NCT05233774 ."

Clinical • Journal • P2a data • Alzheimer's Disease • CNS Disorders • Immunology • Inflammation

First-in-Man Report of Acute Intra-Arterial Allogeneic Mesenchymal Stem Cell Therapy in Two Patients with Locked-In Syndrome Post-Thrombectomy: (AAN 2025) - "This first-in-man report of IA alMSCs in two cLIS stroke patients demonstrated favorable safety and a signal of benefit in one case, supporting future clinical trials of IA MSCs for ischemic stroke."

Clinical • Cardiovascular • CNS Disorders • Hematological Disorders • Ischemic stroke • Pain • IL6

Allogeneic Mesenchymal Human Stem Cell Infusion Therapy for Endothelial DySfunctiOn in Diabetic Subjects with Symptomatic Ischemic Heart Disease. (ACESO-IHD) (clinicaltrials.gov) - P1/2 | N=30 | Active, not recruiting | Sponsor: University of Miami | Recruiting ➔ Active, not recruiting | Trial completion date: Dec 2024 ➔ Sep 2025 | Trial primary completion date: Dec 2024 ➔ Mar 2025

Enrollment closed • Trial completion date • Trial primary completion date • Cardiovascular • Coronary Artery Disease • Diabetes • Heart Failure • Metabolic Disorders

Allogeneic Mesenchymal Human Stem Cell Infusion Therapy for Endothelial DySfunctiOn in Diabetic Subjects With Symptomatic Ischemic Heart Disease. (ACESO-IHD) (clinicaltrials.gov) - P1/2 | N=30 | Recruiting | Sponsor: University of Miami | Trial completion date: Jul 2024 ➔ Dec 2024 | Trial primary completion date: Jul 2024 ➔ Dec 2024

Trial completion date • Trial primary completion date • Cardiovascular • Coronary Artery Disease • Diabetes • Heart Failure • Metabolic Disorders

Expanded Access Multi-Patient Experimental Treatment Involving Allogeneic Human Mesenchymal Stem Cells (hMSCs) in Subjects With Acute Ischemic Stroke (EXPAND) (clinicaltrials.gov) - P=N/A | N=N/A | Temporarily Not Available | Sponsor: University of Miami

New trial • Cardiovascular • Ischemic stroke

ACESO: Allogeneic Mesenchymal Human Stem Cells Infusion Therapy for Endothelial DySfunctiOn in Diabetic Subjects (clinicaltrials.gov) - P1/2 | N=16 | Completed | Sponsor: Joshua M Hare | Active, not recruiting ➔ Completed | N=10 ➔ 16

Enrollment change • Trial completion • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus • CRP • CXCL12 • IL6 • TNFA

Allogeneic HUman Mesenchymal Stem Cell InfusioN Versus Placebo in Subjects With Alcohol Use Disorder and Major DepreSsion. (clinicaltrials.gov) - P1/2; N=80; Recruiting; Sponsor: Joshua M Hare; Active, not recruiting ➔ Recruiting; Trial primary completion date: Oct 2019 ➔ Oct 2022

Clinical • Enrollment open • Trial primary completion date • Addiction (Opioid and Alcohol) • CNS Disorders • Depression • Major Depressive Disorder • Mood Disorders • Psychiatry • CRP • IL6 • TNFA

Allogeneic Mesenchymal Human Stem Cell Infusion Therapy for Endothelial DySfunctiOn in Diabetic Subjects With Symptomatic Ischemic Heart Disease. (ACESO-IHD) (clinicaltrials.gov) - P1/2; N=30; Recruiting; Sponsor: Joshua M Hare; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Cardiovascular • Coronary Artery Disease • Diabetes • Heart Failure • Metabolic Disorders • CD69 • CXCL12

[VIRTUAL] A Phase I Study Of Allogeneic Mesenchymal Stem Cell Therapy In Patients With Heart Failure Secondary To Anthracycline-induced Cardiomyopathy: The Cctrn Stem Cell Injection In Cancer Survivors (Seneca) Trial (HFSA 2020) - "In this first-in-human study of cell therapy in patients with AIC, transendocardial administration of allo-MSCs appears safe and feasible and MRI was successfully performed in the majority of patients with devices. This study provides crucial information for designing Phase II trials aimed at assessing efficacy of cell therapy in patients with AIC."

Clinical • P1 data • Cardiomyopathy • Cardiovascular • Congestive Heart Failure • Fibrosis • Heart Failure • Immunology • Inflammation • Oncology

[VIRTUAL] Clinical Evaluation of Allogeneic Mesenchymal Stem Cells for Alzheimer's Disease (AAIC 2020) - P1 | "Background: Therapeutic interventions that can broadly target the complex multiple pathological features of Alzheimers disease (AD) would be highly desirable approaches for treating these disorders. The results support the conclusion that LMSCs are safe in AD patients, and that advancing to higher phase clinical studies is warranted. We thank the Alzheimers Association for supporting this research through the Part the Cloud Challenge on Neuroinflammation grant awards #PTC C-16-422443 and PTC-CS-19-623225."

Clinical • Alzheimer's Disease • CNS Disorders • Immunology • MRI