Reparative Autologous peripheral n… for Parkinson's (NCT06683378)
Protect substantia nigra dopamine neurons
- Trial ID
- NCT06683378
- Official Title
- Phase I Randomized, Double-blind Study to Evaluate Feasibility, Safety, and Clinical Responses of Implanting Autologous Peripheral Nerve Tissue Into the Nucleus Basalis of Meynert or Substantia Nigra for Non-motor or Motor Symptoms in Patients With Parkinson's Disease Undergoing DBS Surgery
- Goal
- Protect substantia nigra dopamine neurons
- Phase
- PHASE1
- Status
- RECRUITING
- Sponsor
- Craig van Horne, MD, PhD
- Study Type
- INTERVENTIONAL
- Enrollment
- 24 participants
- Conditions
- Parkinson's Disease
- Interventions
- Reparative Autologous peripheral nerve tissue
Summary For Families
It aims to help the specific motor problems tied to the substantia nigra or the non-motor issues linked to the nucleus basalis of Meynert by giving local, reparative support to those brain regions. The team takes a small piece of your own peripheral nerve, usually the sural nerve, and implants that autologous tissue into the target area during your planned DBS surgery; the graft releases growth factors and supportive cells that may protect or help repair dying neurons, so it is intended to complement, not replace, levodopa or DBS. The trial is a phase 1 safety and feasibility study enrolling about 24 people. Eligible participants are age 45 to 75 with clinically established or probable Parkinsons who are already scheduled for DBS, can tolerate MRI and surgery, have an available sural nerve, and do not have dementia, prior brain surgery, or an obstructed surgical path.
Locations
- University of Kentucky, Lexington, Kentucky, United States
Frequently Asked Questions
- What is this trial testing?
- This trial is studying Reparative Autologous peripheral nerve tissue. It aims to help the specific motor problems tied to the substantia nigra or the non-motor issues linked to the nucleus basalis of Meynert by giving local, reparative support to those brain regions. The team takes a small piece of your own peripheral nerve, usually the sural nerve, and implants that autologous tissue into the target area during your planned DBS surgery; the graft releases growth factors and supportive cells that may protect or help repair dying neurons, so it is intended to complement, not replace, levodopa or DBS. The trial is a phase 1 safety and feasibility study enrolling about 24 people. Eligible participants are age 45 to 75 with clinically established or probable Parkinsons who are already scheduled for DBS, can tolerate MRI and surgery, have an available sural nerve, and do not have dementia, prior brain surgery, or an obstructed surgical path.
- Who can participate?
- Participants must be between 45 Years and 75 Years.
- Where is this trial located?
- This trial is recruiting at 1 location.
- Does it cost anything to join?
- You are never charged a fee to join a legitimate clinical trial, and the study treatment and study-specific tests are provided by the trial sponsor at no charge. In the US, routine care you would receive anyway can still be billed to you or your insurance; coverage rules differ by country, and trials in the UK and Canada usually run through public health systems. Travel, parking, and time are real costs, and some trials reimburse them while others do not. Before enrolling, ask the study coordinator to explain in writing what is and is not covered.
- How long does the trial last?
- This Phase 1 trial is estimated to last approximately 1 year and 5 months.
- Can I leave the trial if I change my mind?
- Yes. You can withdraw from any clinical trial at any time, for any reason, without affecting your standard medical care. Trials are voluntary by law. The team may ask if you are willing to do a brief exit visit so they can collect safety information, but you are not obligated.
- Can my spouse or care partner come with me to visits?
- In most cases yes, and it is often encouraged. Care partners can help with notes, questions, and getting home safely after a long visit. Some study assessments do need to happen one on one, but care partners are usually welcome for the rest of the appointment.
- Will I get a placebo in this trial?
- There is no placebo group. Everyone receives an active treatment; the study compares one treatment against another.
- How many visits does this trial involve?
- You will be evaluated at enrollment before surgery, two-weeks after surgery, and at 6, 12, and 24 months after surgery (spanning 24 months).
- What procedures are involved in this trial?
- Based on the protocol, this trial involves: Brain surgery / implanted device (invasive); Surgical procedure (invasive). Confirm the full schedule with the study coordinator.