Parkinson's Disease Clinical Trial
Official title:
Feasibility and Safety of autoloGous UncondItioneD pEripheral Nerve Tissue Delivery to the Substantia Nigra
This 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.
We recently designed open-label safety studies to investigate the use of an autologous source of cellular tissue from the peripheral nervous system (van Horne et al., 2017, 2018; Quintero et al. 2022), reparative peripheral (sural) nerve tissue containing a variety of cells and neuroprotective factors (Chau et al. 2022). While our previous studies have used injury-activated peripheral nerve tissue (PNT), where the sural nerve is transected and allowed to regenerate in situ for up to about 2 weeks before implantation, here we propose to use naïve, previously uninjured, nerve tissue delivered bilaterally to the substantia nigra at the time participants are undergoing deep brain stimulation (DBS) surgery. Participants will be assessed preoperatively, then undergo DBS surgery and delivery of autologous PNT, and then assessed postoperatively at two weeks after surgery, 6 months, 12 months and annually thereafter for adverse events and clinical outcomes. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT02915848 -
Long-term Stability of LFP Recorded From the STN and the Effects of DBS
|
||
| Recruiting |
NCT03648905 -
Clinical Laboratory Evaluation of Chronic Autonomic Failure
|
||
| Terminated |
NCT02688465 -
Effect of an Apomorphine Pump on the Quality of Sleep in Parkinson's Disease Patients (POMPRENELLE).
|
Phase 4 | |
| Completed |
NCT05040048 -
Taxonomy of Neurodegenerative Diseases : Observational Study in Alzheimer's Disease and Parkinson's Disease
|
||
| Active, not recruiting |
NCT04006210 -
Efficacy, Safety and Tolerability Study of ND0612 vs. Oral Immediate Release Levodopa/Carbidopa (IR-LD/CD) in Subjects With Parkinson's Disease Experiencing Motor Fluctuations
|
Phase 3 | |
| Completed |
NCT02562768 -
A Study of LY3154207 in Healthy Participants and Participants With Parkinson's Disease
|
Phase 1 | |
| Completed |
NCT00105521 -
Sarizotan in Participants With Parkinson's Disease Suffering From Treatment Associated Dyskinesia
|
Phase 3 | |
| Completed |
NCT00105508 -
Sarizotan HC1 in Patients With Parkinson's Disease Suffering From Treatment-associated Dyskinesia
|
Phase 3 | |
| Recruiting |
NCT06002581 -
Repetitive Transcranial Magnetic Stimulation(rTMS) Regulating Slow-wave to Delay the Progression of Parkinson's Disease
|
N/A | |
| Completed |
NCT02236260 -
Evaluation of the Benefit Provided by Acupuncture During a Surgery of Deep Brain Stimulation
|
N/A | |
| Completed |
NCT00529724 -
Body Weight Gain, Parkinson, Subthalamic Stimulation
|
Phase 2 | |
| Recruiting |
NCT05699460 -
Pre-Gene Therapy Study in Parkinson's Disease and Multiple System Atrophy
|
||
| Completed |
NCT03703570 -
A Study of KW-6356 in Patients With Parkinson's Disease on Treatment With Levodopa-containing Preparations
|
Phase 2 | |
| Completed |
NCT03462680 -
GPR109A and Parkinson's Disease: Role of Niacin in Outcome Measures
|
N/A | |
| Completed |
NCT02837172 -
Diagnosis of PD and PD Progression Using DWI
|
||
| Not yet recruiting |
NCT04046276 -
Intensity of Aerobic Training and Neuroprotection in Parkinson's Disease
|
N/A | |
| Recruiting |
NCT02952391 -
Assessing Cholinergic Innervation in Parkinson's Disease Using the PET Imaging Marker [18F]Fluoroethoxybenzovesamicol
|
N/A | |
| Active, not recruiting |
NCT02937324 -
The CloudUPDRS Smartphone Software in Parkinson's Study.
|
N/A | |
| Completed |
NCT02927691 -
Novel Management of Airway Protection in Parkinson's Disease: A Clinical Trial
|
Phase 2 | |
| Terminated |
NCT02924194 -
Deep Brain Stimulation of the nbM to Treat Mild Cognitive Impairment in Parkinson's Disease
|
N/A |