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Nerve Graft Recipients for Multiple System Atrophy (LEAP Trial)

Phase 1
Waitlist Available
Research Sponsored by Craig van Horne, MD, PhD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
* Diagnosis of clinically established or clinically probable PD or MSA as defined by MDS criteria
* Disease duration greater than 2 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 4 weeks, 6 months, and 12 months
Awards & highlights
No Placebo-Only Group

Summary

This 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.

Who is the study for?
This trial is for early-stage Parkinson's Disease or Multiple System Atrophy patients with mild symptoms. It involves a surgical procedure where nerve tissue from the patient's own body is implanted into their brain, specifically in an area called substantia nigra.
What is being tested?
The study tests the safety of transplanting one's own sural nerve to the brain region affected by Parkinson's and MSA versus a sham surgery (a pretend operation). Out of 7 participants, 4 will get the actual surgery and 3 will have sham surgery, followed up for one year.
What are the potential side effects?
Potential side effects may include typical surgical risks like infection, bleeding, or reaction to anesthesia. Since it’s a new procedure specific to neurological conditions, there might be unknown risks affecting movement or other brain functions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 4 weeks, 6 months, and 12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 4 weeks, 6 months, and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Meet recruitment goal
Secondary study objectives
Change in Neuropsychological diagnosis
Duration of procedure
Length of hospital admission
+18 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Nerve Graft RecipientsExperimental Treatment1 Intervention
Group II: Placebo GroupPlacebo Group1 Intervention

Find a Location

Who is running the clinical trial?

University of Kentucky CCTSUNKNOWN
1 Previous Clinical Trials
60 Total Patients Enrolled
Craig van Horne, MD, PhDLead Sponsor
4 Previous Clinical Trials
112 Total Patients Enrolled
~5 spots leftby Dec 2028
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