Craig van Horne, MD, PhD — Biomedical Watch V2

Traitements9programmes

Essais4liés

Publications3liées

SourceDBlocale

Traitements

9

Molécule	Indication / population	Phase	Objectif	Pays	Résultat
Autologous Peripheral Nerve GraftThis pilot study is designed to follow up on a previous, preliminary study and test the long-term safety and feasibility of the implantation of autologous peripheral nerve grafts into the substantia nigra, basal forebrain, putamen, and/or STN of participants with PD undergoing deep brain stimulation (DBS) surgery. Peripheral nerve tissue contains Schwann cells which produce growth factors that have been demonstrated to support the survival and function of neurons. Participants will serve as their own donor for the tissue, which will be implanted at the time they undergo DBS surgery.	Parkinson	Phase 1		United States	À vérifier
Peripheral Nerve Tissue ImplantationThis is an open-label, non-randomized, single-arm trial design to actively follow participants for 12 months. Ten participants will be enrolled to receive bilateral delivery of Peripheral Nerve Tissue (PNT) to the Substantia Nigra at the time of Deep Brain Stimulation (DBS) surgery. After 12 months, participants will be followed long term through annual visits for the rest of their lives. Participants will serve as their own donor for the tissue.	Parkinson	Phase 1	À vérifier	United States	À vérifier
Reparative Autologous peripheral nerve tissueThe investigators propose a Phase I single surgical-center, double-blinded randomized parallel clinical trial involving bilateral autologous peripheral nerve tissue (PNT) delivery into the NBM or the alternate target also affecting cognition in this population, the substantia nigra (SN), to address "repair cell" support of these areas. Twenty-four participants with idiopathic Parkinson's Disease (PD) who have selected, qualified and agreed to receive as standard of care deep brain stimulation (DBS) will be enrolled and randomly allocated to receive bilateral PNT deployment to either the NBM or SN at the time of DBS surgery. Participants will be allocated equally among both assignments over the course of three years (8 Year 1, 10 Year 2, 6 Year 3). Participants will be evaluated for neurocognitive, motoric function, activities of daily living, and quality of life at enrollment before surgery, two-weeks after surgery, and 6, 12, and 24 months after surgery.	Parkinson	Phase 1		United States	À vérifier
Sham surgeryStudy BRT-DA01-301 is a Phase 3 multicenter, randomized, sham surgery-controlled, double-blind study to assess efficacy and safety of bemdaneprocel in approximately 102 adults with Parkinson's Disease (PD).	Parkinson	Phase 1	À vérifier	United States	À vérifier
Sural Nerve Graft to the Substantia NigraThis phase I double-blind study focuses on the safety and feasibility of implanting autologous peripheral nerve tissue (PNT) into the substantia nigra area of the brain in persons who have been diagnosed with either Parkinson's disease (PD) or Multiple System Atrophy (MSA). 7 participants will be enrolled, with 4 participants receiving the graft and 3 receiving a sham surgery. Eligible participants will be early in their diagnosis with a lower burden of symptoms. Participants will be followed initially for one year after surgery.	Parkinson	Phase 1	Traitement symptomatique	United States	À vérifier
Autologous Peripheral Nerve GraftThis pilot study is designed to follow up on a previous, preliminary study and test the long-term safety and feasibility of the implantation of autologous peripheral nerve grafts into the substantia nigra, basal forebrain, putamen, and/or STN of participants with PD undergoing deep brain stimulation (DBS) surgery. Peripheral nerve tissue contains Schwann cells which produce growth factors that have been demonstrated to support the survival and function of neurons. Participants will serve as their own donor for the tissue, which will be implanted at the time they undergo DBS surgery.	Parkinson	Phase 1		United States	À vérifier
Reparative Autologous peripheral nerve tissueThe investigators propose a Phase I single surgical-center, double-blinded randomized parallel clinical trial involving bilateral autologous peripheral nerve tissue (PNT) delivery into the NBM or the alternate target also affecting cognition in this population, the substantia nigra (SN), to address "repair cell" support of these areas. Twenty-four participants with idiopathic Parkinson's Disease (PD) who have selected, qualified and agreed to receive as standard of care deep brain stimulation (DBS) will be enrolled and randomly allocated to receive bilateral PNT deployment to either the NBM or SN at the time of DBS surgery. Participants will be allocated equally among both assignments over the course of three years (8 Year 1, 10 Year 2, 6 Year 3). Participants will be evaluated for neurocognitive, motoric function, activities of daily living, and quality of life at enrollment before surgery, two-weeks after surgery, and 6, 12, and 24 months after surgery.	Parkinson	Phase 1	Traitement symptomatique	United States	À vérifier
Sural Nerve Graft to the Substantia NigraThis phase I double-blind study focuses on the safety and feasibility of implanting autologous peripheral nerve tissue (PNT) into the substantia nigra area of the brain in persons who have been diagnosed with either Parkinson's disease (PD) or Multiple System Atrophy (MSA). 7 participants will be enrolled, with 4 participants receiving the graft and 3 receiving a sham surgery. Eligible participants will be early in their diagnosis with a lower burden of symptoms. Participants will be followed initially for one year after surgery.	Parkinson	Phase 1	Traitement symptomatique	United States	À vérifier
Peripheral Nerve Tissue ImplantationThis is an open-label, non-randomized, single-arm trial design to actively follow participants for 12 months. Ten participants will be enrolled to receive bilateral delivery of Peripheral Nerve Tissue (PNT) to the Substantia Nigra at the time of Deep Brain Stimulation (DBS) surgery. After 12 months, participants will be followed long term through annual visits for the rest of their lives. Participants will serve as their own donor for the tissue.	Parkinson	Phase 1		United States	À vérifier

Essais cliniques

4

Molécule	Indication / population	Phase	NCT	Titre	Statut
Peripheral Nerve Tissue Implantation	Parkinson	Phase 1	NCT05377281	Feasibility and Safety of autoloGous UncondItioneD pEripheral Nerve Tissue Delivery to the Substantia Nigra (GUIDE)	ACTIVE_NOT_RECRUITING
Sural Nerve Graft to the Substantia Nigra	Parkinson	Phase 1	NCT06683365	LEAP — Autologous suraL nervE Grafting to the Substantia nigrA in Patients With Synuclienopathies	RECRUITING
Reparative Autologous peripheral nerve tissue	Parkinson	Phase 1	NCT06683378	STAR — A Study to Evaluate Feasibility, Safety, and Clinical Responses of Implanting Autologous Peripheral Nerve Tissue Into the Brain for Non-motor or Motor Symptoms in Patients With Parkinson's Disease Undergoing DBS Surgery	RECRUITING
Autologous Peripheral Nerve Graft	Parkinson	Phase 1	NCT02369003	CAPNG — Cont. of a Study to Evaluate Implanting Peripheral Nerve Grafts Into Subjects With Parkinson's Disease (PD) During DBS	ACTIVE_NOT_RECRUITING

Publications

3

Molécule	Indication / population	Titre	Journal	Date
Sham surgery		Endolymphatic duct blockage for Ménière's disease: a double-blind, randomised controlled trial.	The Lancet regional health. Europe
Sham surgery		Reduced myocardial NRG-1/ErbB4 signaling is associated with STING-linked macrophage pyroptotic signaling in sepsis-induced cardiac injury.	International immunopharmacology
Sham surgery		Combined environmental enrichment and aerobic exercise improve cognitive recovery in male rats after bilateral common carotid artery occlusion.	Physiology & behavior