allogeneic bone marrow-derived mesenchymal stem cell / University of Texas Health Science Center at Houston, Michael J. Fox Foundation - LARVOL DELTA

Phase IIa Randomized Placebo Controlled Trial: Mesenchymal Stem Cells as a Disease-modifying Therapy for iPD (clinicaltrials.gov) - P2 | N=45 | Completed | Sponsor: The University of Texas Health Science Center, Houston | Phase classification: P2a ➔ P2

Phase classification • CNS Disorders • Movement Disorders • Parkinson's Disease

Phase IIa Randomized Placebo Controlled Trial: Mesenchymal Stem Cells as a Disease-modifying Therapy for iPD (clinicaltrials.gov) - P2a | N=45 | Completed | Sponsor: The University of Texas Health Science Center, Houston | Active, not recruiting ➔ Completed | Trial completion date: Dec 2023 ➔ Jul 2023

Trial completion • Trial completion date • CNS Disorders • Movement Disorders • Parkinson's Disease • BDNF • CCL2 • CXCL10 • IL1B • IL6 • TNFA

Design and Baseline characteristic of Phase II clinical trial of allogeneic bone marrow-derived Mesenchymal Stem Cells as a disease-modifying therapy for idiopathic Parkinson’s disease (AAN 2023) - "Preliminary findings showed that repeated doses of intravenous infusion of allogeneic bone marrow-derived MSCs are safe and well-tolerated in PD. Efficacy and preliminary mechanism of action data will be reported in December 2023."

Clinical • P2 data • CNS Disorders • Immune Modulation • Inflammation • Movement Disorders • Parkinson's Disease

Phase IIa Randomized Placebo Controlled Trial: Mesenchymal Stem Cells as a Disease-modifying Therapy for iPD (clinicaltrials.gov) - P2a | N=45 | Active, not recruiting | Sponsor: The University of Texas Health Science Center, Houston | Trial completion date: May 2023 ➔ Dec 2023

Trial completion date • CNS Disorders • Movement Disorders • Parkinson's Disease • BDNF • CCL2 • CXCL10 • IL1B • IL6 • TNFA

Phase IIa Randomized Placebo Controlled Trial: Mesenchymal Stem Cells as a Disease-modifying Therapy for iPD (clinicaltrials.gov) - P2a; N=45; Active, not recruiting; Sponsor: The University of Texas Health Science Center, Houston; Recruiting ➔ Active, not recruiting

Clinical • Enrollment closed • CNS Disorders • Movement Disorders • Parkinson's Disease • BDNF • CCL2 • CXCL10 • IL1B • IL6 • TNFA

Phase 2 Trial of Stem Cell Therapy in Parkinson’s Patients Enrolling (Parkinson's News Today) - "A newly opened Phase 2 clinical trial is evaluating adult stem cells as a potentially disease-modifying treatment for Parkinson's...The trial is actively recruiting up to 45 Parkinson's patients, ages 50 to 79, at a single site in Houston...The enrolling Phase 2 trial (NCT04506073) aims to identify the safest and most effective number of stem cell infusions needed to slow disease progression, as measured by Part III of the Movement Disorder Society Unified Parkinson's Disease Rating Scale, compared to placebo infusions....'By investigating a treatment that can slow or stop the progression, we hope to improve the quality of life of those suffering from the disease,' Schiess said. 'The ultimate goal is to use this treatment in individuals with a prodromal condition, meaning they are showing early signs of Parkinson's disease but are not yet clinically symptomatic,' she added."

Trial status • CNS Disorders • Parkinson's Disease

Allogeneic Bone Marrow-Derived Mesenchymal Stem Cell Safety in Idiopathic Parkinson's Disease. (PubMed, Mov Disord) - "A single intravenous infusion of allogeneic bone marrow-derived mesenchymal stem cells at doses of 1, 3, 6, or 10 × 10 allogeneic bone marrow-derived mesenchymal stem cells/kg is safe, well tolerated, and not immunogenic in mild/moderate PD patients."

Clinical • Journal • Chronic Lymphocytic Leukemia • CNS Disorders • Hematological Malignancies • Hypertension • Immune Modulation • Immunology • Inflammation • Leukemia • Movement Disorders • Parkinson's Disease • BDNF • CCL22 • TNFA

Phase IIa Randomized Placebo Controlled Trial: Mesenchymal Stem Cells as a Disease-modifying Therapy for iPD (clinicaltrials.gov) - P2a; N=45; Recruiting; Sponsor: The University of Texas Health Science Center, Houston; Not yet recruiting ➔ Recruiting

Enrollment open • CNS Disorders • Movement Disorders • Parkinson's Disease • IL1B • TNFA

[VIRTUAL] Safety and Tolerability of Bone Marrow-Derived Allogeneic Mesenchymal Stem Cells in Parkinson’s Disease Patients (ANA 2020) - "Objective: Prove the safety and feasibility of delivering allogeneic bone marrow-derived mesenchymal stem cells (MSC) intravenously in escalated doses to patients with idiopathic Parkinson’s disease (PD)... This study demonstrates that a single infusion of allogeneic MSCs is safe and well-tolerated in mild/ moderate PD patients. Further placebo-controlled studies are warranted to explore the mechanism of action and to corroborate the efficacy of MSCs in PD."

Clinical • CNS Disorders • Pain • Parkinson's Disease • BDNF • CCL2 • CCL22 • TNFA

Allogeneic Bone Marrow-Derived Mesenchymal Stem Cell Therapy for Idiopathic Parkinson's Disease (clinicaltrials.gov) - P1; N=20; Completed; Sponsor: The University of Texas Health Science Center, Houston; Phase classification: P1/2 ➔ P1

Phase classification • CNS Disorders • Movement Disorders • Parkinson's Disease