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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
Phase 1 trial testing Reparative Autologous peripheral nerve tissue in Parkinson's Disease in 24 participants. Currently enrolling.
31 December 2026
Quick facts
| Lead sponsor | Craig van Horne, MD, PhD |
|---|---|
| Phase | Phase 1 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 24 |
| Start date | 21 July 2025 |
| Primary completion | 31 December 2026 |
| Estimated completion | 28 February 2028 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Reparative Autologous peripheral nerve tissue
Conditions studied
- Parkinson's Disease — all drugs for Parkinson's Disease →
Sponsor
Craig van Horne, MD, PhD
Who can join
Adults 45 to 75, any sex, with Parkinson's Disease. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The 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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06683378
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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Currently open trials in the same condition.
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- NCT07384429 — Effects of Lemborexant on Motor-sleep Comorbidity in Parkinson's Disease · Phase 4 · recruiting
- NCT07384442 — Effects of Targeted Temporal Interference Stimulation of Cerebellar Nuclei on Tremor and Gait Disturbance in Parkinson's · NA · recruiting
- NCT06562569 — Non-invasive VNS for PD Gait · NA · recruiting
Other Craig van Horne, MD, PhD trials
Trials by the same sponsor.
- NCT06683365 — Autologous suraL nervE Grafting to the Substantia nigrA in Patients With Synuclienopathies · Phase 1 · recruiting
- NCT05377281 — Feasibility and Safety of autoloGous UncondItioneD pEripheral Nerve Tissue Delivery to the Substantia Nigra (GUIDE) · Phase 1 · active not recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06683378 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Craig van Horne, MD, PhD
- Last refreshed: 14 August 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06683378.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing