Multiple System AtrophyPhase 1LEAPNCT06683365
Autologous suraL nervE Grafting to the Substantia nigrA in Patients With Synuclienopathies
A Phase 1 study testing Sural Nerve Graft to the Substantia Nigra in people with Multiple System Atrophy and Parkinsons Disease, run by Craig van Horne, MD, PhD at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Multiple System Atrophy, Parkinsons Disease
- What is being tested?
- Sural Nerve Graft to the Substantia Nigra
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Feb 2025to 2 Dec 2030
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of clinically established or clinically probable PD or MSA as defined by MDS criteria
- Disease duration greater than 2 years
- Age 40-75, inclusive
- MDS-Unified Parkinson's Disease Rating Scale (UPDRS) Part III greater than or equal to 20 points but less than or equal to 35 points, off anti-parkinsonian medication for PD or MDS-Unified Multiple System Atrophy Rating Scale (UMSARS) less than or equal to 30 points off anti-parkinsonian medication
- No MDS-UPDRS Part III score >3 on items 3.3, 3.4, 3.5, 3.6, 3.7, 3.8, 3.14 while off medication
- Able and willing to undergo ioflupane/SPECT
Show all 9Show fewer
- Able to tolerate the surgical procedure
- Able to undergo all planned assessments
- Available access to the sural nerve
Who cannot join
- Previous PD surgery or intracranial surgery
- Ongoing major medical or psychiatric disorder incl. depression and psychosis
- Other concomitant treatment with neuroleptics
- Typical, nonparkinsonian syndrome ioflupane/SPECT signal
- Unable to undergo an MRI
- An obstructed trajectory path to the substantia nigra
Show all 10Show fewer
- Significant microvascular disease
- Use of anticoagulants other than aspirin
- Female who is pregnant, lactating, or of child-bearing potential unwilling to use an adequate birth control method during the period of the study
- Consent capacity will be assessed and determined during and throughout a participant's neuropsychological exam. A participant who experiences a decline in consent capacity prior to surgery, will be removed from the study by the PI. A decline in consent capacity after surgery will not result in the removal of the participant in the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Group Monitored Email contact
United States1 site, 1 recruiting
- Recruiting
University of Kentucky
Lexington, Kentucky, 40536
Jaimie Hixson, 859-323-1908, jaimie.henderson@uky.edu
Craig van Horne, MD, PhD
About this study
Official title: A Phase I Study of the Feasibility and Safety of SuraL nervE Tissue Grafting to the Substantia nigrA in Patients With Synucleinopathies (LEAP)
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.
Read the detailed description
This phase I double blind clinical trial will be used to plan future, larger clinical trials that would test how autologous cells from the peripheral nerve may help in the repair of damaged brain cells in Parkinson's Disease (PD) or Multiple System Atrophy (MSA) and slow the progression of the diseases. We will be judging the feasibility of implanting a participant's own cells from a nerve in the leg into the substantia nigra area of the brain. Patients eligible for participation will be at an earlier in stage of the disease with symptoms being less severe and therefore would not yet qualify for DBS. The LEAP trial is a study where the first participant will receive an implantation of the cells from their own sural nerve (a nerve near the ankle), into the substantia nigra on both sides of their brain. The 6 participants who follow, will be randomized to one of two arms. The 3 participants assigned to the experimental arm will receive the graft. The 3 participants assigned to the control arm will receive a sham surgical procedure, where the sural nerve will be biopsied, and bilateral scalp incisions will be made. Those who do not receive the cells initially may be eligible to undergo another surgery at the end of the study, after un-blinding has occurred, to receive the cell implants.
- Conditions
- Multiple System Atrophy, Parkinsons Disease
- Being tested
- Sural Nerve Graft to the Substantia Nigra, Sham surgery
- Keywords
- Synucleinopathies, Cell and Tissue Based Therapy, Multiple System Atrophy, Parkinsons Disease
- Medical subject headings
- Multiple System Atrophy, Parkinson Disease, Synucleinopathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sural Nerve Graft to the Substantia NigraProcedure or surgery
Participants assigned to this arm will have the sural nerve biopsied from one of their ankles. This cellular tissue will be deposited bilaterally into the substantia nigra area of their brain by a specialized cannula via bilateral scalp incisions and skull burr holes.
Sham surgeryProcedure or surgery
Participants assigned to this arm will have the sural nerve from one of their ankles biopsied in the same fashion as the experimental arm. Bilateral incisions will be made on the participants scalp but no burr holes into the skull and no cannula passes into the brain will occur.
| Study group | Role | What they receive |
|---|---|---|
| Nerve Graft Recipients | Experimental | Not described Receives: Procedure: Sural Nerve Graft to the Substantia Nigra |
| Placebo Group | Placebo comparator | Not described Receives: Procedure: Sham surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Meet recruitment goal
Ability to recruit, enroll, and assign participants to the trial within 12 months of the trial opening.
Measured: Trial opening through 12 months
Secondary outcomes (21)
Study-related serious adverse events as assessed by MedDRA v.27
Total number of serious adverse events associated with bilateral PNT collection and deployment to the substantia nigra. Serious adverse events will be defined as an abscess, tumor, infection of the bed of the graft, altered mental state, seizure, ankle or foot infection, wound dehiscence at the ankle incision, spread of neuropathy of the ankle or foot on the ipsilateral side of the nerve biopsy, or other event determined by the PI/investigators to be important.
Measured: Enrollment through 12 months
Study-related adverse events as assessed by MedDRA v27
Total number of adverse events experienced by participants categorized by System Organ Class and/or High Level Group Term using MedDRA v27 for designation.
Measured: Enrollment through 6 month study visit
Number of deployment attempts required to deliver bilateral PNT
Per protocol, the surgeon has two chances to successfully deploy 60% of the PNT tissue loaded in the guide-tube into the brain per hemisphere. The number of attempted deployments will be documented and if <60% of the tissue is deployed after two attempts, a failed delivery will be documented and no other attempts will be made.
Measured: During the procedure
Duration of procedure
Number of minutes it takes for the procedure to be completed. This will be defined by the anesthesia start time and anesthesia end time.
Measured: During the procedure
Length of hospital admission
The number of days each participant is admitted to the inpatient hospital for the procedure and acute post-operative care.
Measured: Admission for the procedure through hospital discharge
Percent of study visit completed by participants
The number of designated study visits completed compared to the total number of study visits that are scheduled to occur.
Measured: Enrollement through 12 month study visit
Change in Neuropsychological diagnosis
Changes in participant neuropsychological diagnoses during scheduled evaluations will be reported. e.g. No cognitive diagnosis progressing to mild neurocognitive disorder.
Measured: Baseline and 12 months
Mean change in Neuropsychological assessment scores
Participants complete a neuropsychological assessment battery that meets the MDS guidelines for determining mild cognitive impairment/mild neurocognitive disorder. Domains include attention and working memory, executive functioning, memory (verbal and visual), language, and visuospatial skills. Participants' raw scores will be converted to standardized scores based on appropriate norms (e.g., age-based norms). Participants' 12 month re-evaluation will be compared to their baseline pre-surgical assessment to determine change from baseline on each measure. A change that exceeds 1.5 standard deviation from their baseline performance will be considered notable.
Measured: Baseline to 12 months
Mean change in Montreal Cognitive Assessment (MoCA) scores
Mean change in MoCA scores for participants at study visits compared to baseline by group allocation. Assessment is scored from 0-30 with a score of 26 or better indicating normal cognition. A score less than 26 indicates a cognitive deficit.
Measured: Baseline, 4 weeks, 6 months, and 12 months
Mean change of the Movement Disorder Society - Unified Parkinsons Disease Rating Scale (MDS-UPDRS) Part I scores
MDS-UPDRS Part I scores non-motor symptoms effecting activities of daily living in those with Parkinson's Disease. Scores range from 0-52 with higher scores indicating greater symptom severity.
Measured: 4 weeks, 6 and 12 months as compared to baseline
Mean change of the MDS-UPDRS Part II scores
MDS-UPDRS Part II scores motor symptoms effecting activities of daily living in those with Parkinson's Disease. Scores range from 0-52 with higher scores indicating greater symptom severity.
Measured: 4 weeks, 6 months, and 12 months compared to baseline
Mean change in MDS-UPDRS Part III scores
MDS-UPDRS Part III scores motor symptoms associated with Parkinson's Disease. Part III scores range from 0-132 with higher scores indicating higher symptom severity.
Measured: 4 weeks, 6 and 12 months compared to baseline
Mean change in MDS-UPDRS Part IV scores
MDS-UPDRS Part IV scores motor complications such as fluctuations and dyskinesia's associated with anti-Parkinson's medications. Scores range from 0-24 with higher scores indicating greater severity in motor complications.
Measured: 4 weeks, 6 and 12 months compared to baseline
Mean change of the Movement Disorder Society - Unified Multiple System Atrophy Rating Scale (MDS-UMSARS) Part I scores
MDS-UMSARS Part I rates patient reported functional disabilities. Scores for this section range from 0-48 with higher scores indicating greater disability
Measured: 4 weeks, 6 and 12 months as compared to baseline
Mean change of the MDS-UMSARS Part II scores
MDS-UMSARS Part II scores motor symptoms associated with multiple system atrophy. Scores range from 0-56 with higher scores indicating greater symptom severity.
Measured: 4 weeks, 6 months, and 12 months compared to baseline
Mean change in MDS-UMSARS Part III scores
MDS-UMSARS Part III assesses orthostatic hypertension symptoms. This part examines blood pressure changes when a participant stands up after laying down for two minutes. It is scored as either a "Yes" the participant experiences orthostatic hypertension, or a "No" the participant does not don't experience orthostatic hypertension.
Measured: 4 weeks, 6 and 12 months compared to baseline
Mean change in MDS-UMSARS Part IV scores
MDS-UMSARS Part IV assess the participants global disability. Scores range from 1-5 with 1 being completely independent and 5 being totally dependent/bedridden.
Measured: 4 weeks, 6 and 12 months compared to baseline
Mean change in Parkinson's Disease Questionnaire-8 (PDQ-8) quality of life scores
Assess changes in participant's quality of life. Questionnaire is scored from 0-32 with higher scores indicating poorer quality of life.
Measured: Monthly through 12 month study visit compared to baseline
Mean change in Modified Schwab and England Scale of Activities of Daily Living scores
Mean change participant independence levels as measured in Schwab and England Scale of Activities of Daily Living scores. 100% = completed independent and 0% being completely dependent.
Measured: At 6 and 12 months compared to baseline
Mean change in Non-motor symptom scale scores
Assessment used to identify Parkinson's disease related non-motor symptoms experienced by participants. The scale measures the frequency and severity of symptoms and is scored from 0-360 with higher scores indicating more frequent and severe symptoms.
Measured: Baseline and 12 months
Participants electing to receive Deep Brain Stimulator (DBS)
Number of study participants who elect to have DBS implanted prior to completing the 12 month study visit.
Measured: Enrollment through 12 month study visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2024
- Study start25 Feb 2025
- Primary completion2 Dec 2028 (estimated)
- Study completion2 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Multiple System AtrophyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 7 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Craig van Horne, MD, PhD
- Sponsor type
- University, hospital or other
- Collaborators
- University of Kentucky CCTS, National Center for Advancing Translational Sciences (NCATS)
- Responsible party
- Sponsor-investigator, Craig van Horne, MD, PhD, University of Kentucky
- Investigators
- Craig van Horne, MD, PhD, Principal investigator, University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06683365
- Sponsor's protocol ID
- 95534
- Other IDs
- UL1TR001998
- Acronym
- LEAP
- Status last verified
- Aug 2026
- First submitted
- 7 Nov 2024
- Last updated
- 31 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Images and results may be made available to other researchers by asking participants, at the time of consent, their willingness to permit sharing of data and bio-specimens.
Publications
Quintero JE, Slevin JT, Gurwell JA, McLouth CJ, El Khouli R, Chau MJ, Guduru Z, Gerhardt GA, van Horne CG. Direct delivery of an investigational cell therapy in patients with Parkinson's disease: an interim analysis of feasibility and safety of an open-label study using DBS-Plus clinical trial design. BMJ Neurol Open. 2022 Jul 14;4(2):e000301. doi: 10.1136/bmjno-2022-000301. eCollection 2022.
PubMed 35949912van Horne CG, Quintero JE, Gurwell JA, Wagner RP, Slevin JT, Gerhardt GA. Implantation of autologous peripheral nerve grafts into the substantia nigra of subjects with idiopathic Parkinson's disease treated with bilateral STN DBS: a report of safety and feasibility. J Neurosurg. 2017 Apr;126(4):1140-1147. doi: 10.3171/2016.2.JNS151988. Epub 2016 May 6.
PubMed 27153166van Horne CG, Quintero JE, Slevin JT, Anderson-Mooney A, Gurwell JA, Welleford AS, Lamm JR, Wagner RP, Gerhardt GA. Peripheral nerve grafts implanted into the substantia nigra in patients with Parkinson's disease during deep brain stimulation surgery: 1-year follow-up study of safety, feasibility, and clinical outcome. J Neurosurg. 2018 Dec 1;129(6):1550-1561. doi: 10.3171/2017.8.JNS163222. Epub 2018 Feb 18.
PubMed 29451447
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study of the Feasibility and Safety of SuraL nervE Tissue Grafting to the Substantia nigrA in Patients With Synucleinopathies (LEAP)
- ClinicalTrials.gov ID
- NCT06683365
- Acronym / sponsor ID
- LEAP / 95534
- Conditions
- Multiple System Atrophy, Parkinsons Disease
- Keywords
- Synucleinopathies, Cell and Tissue Based Therapy, Multiple System Atrophy, Parkinsons Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 7 participants (estimated)
- Lead sponsor
- Craig van Horne, MD, PhDUniversity, hospital or other
- Collaborators
- University of Kentucky CCTS, National Center for Advancing Translational Sciences (NCATS)
- Study start
- 25 Feb 2025 (actual)
- Primary completion
- 2 Dec 2028 (estimated)
- Study completion
- 2 Dec 2030 (estimated)
- First posted
- 12 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This phase I double blind clinical trial will be used to plan future, larger clinical trials that would test how autologous cells from the peripheral nerve may help in the repair of damaged brain cells in Parkinson's Disease (PD) or Multiple System Atrophy (MSA) and slow the progression of the diseases. We will be judging the feasibility of implanting a participant's own cells from a nerve in the leg into the substantia nigra area of the brain. Patients eligible for participation will be at an earlier in stage of the disease with symptoms being less severe and therefore would not yet qualify for DBS. The LEAP trial is a study where the first participant will receive an implantation of the cells from their own sural nerve (a nerve near the ankle), into the substantia nigra on both sides of their brain. The 6 participants who follow, will be randomized to one of two arms. The 3 participants assigned to the experimental arm will receive the graft. The 3 participants assigned to the control arm will receive a sham surgical procedure, where the sural nerve will be biopsied, and bilateral scalp incisions will be made. Those who do not receive the cells initially may be eligible to undergo another surgery at the end of the study, after un-blinding has occurred, to receive the cell implants.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nerve Graft Recipients | Experimental | Procedure: Sural Nerve Graft to the Substantia Nigra |
| Placebo Group | Placebo comparator | Procedure: Sham surgery |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Diagnosis of clinically established or clinically probable PD or MSA as defined by MDS criteria
- Disease duration greater than 2 years
- Age 40-75, inclusive
- MDS-Unified Parkinson's Disease Rating Scale (UPDRS) Part III greater than or equal to 20 points but less than or equal to 35 points, off anti-parkinsonian medication for PD or MDS-Unified Multiple System Atrophy Rating Scale (UMSARS) less than or equal to 30 points off anti-parkinsonian medication
- No MDS-UPDRS Part III score >3 on items 3.3, 3.4, 3.5, 3.6, 3.7, 3.8, 3.14 while off medication
Key exclusion criteria (10 listed)
- Previous PD surgery or intracranial surgery
- Ongoing major medical or psychiatric disorder incl. depression and psychosis
- Other concomitant treatment with neuroleptics
- Typical, nonparkinsonian syndrome ioflupane/SPECT signal
- Unable to undergo an MRI
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sural Nerve Graft to the Substantia NigraParticipants assigned to this arm will have the sural nerve biopsied from one of their ankles. This cellular tissue will be deposited bilaterally into the substantia nigra area of their brain by a specialized cannula via bilateral scalp incisions and skull burr holes. | Procedure or surgery | Nerve Graft Recipients |
| Sham surgeryParticipants assigned to this arm will have the sural nerve from one of their ankles biopsied in the same fashion as the experimental arm. Bilateral incisions will be made on the participants scalp but no burr holes into the skull and no cannula passes into the brain will occur. | Procedure or surgery | Placebo Group |
Primary outcome
Meet recruitment goal
Time frame: Trial opening through 12 months
Ability to recruit, enroll, and assign participants to the trial within 12 months of the trial opening.
21 secondary outcomes
Study-related serious adverse events as assessed by MedDRA v.27
Time frame: Enrollment through 12 months
Study-related adverse events as assessed by MedDRA v27
Time frame: Enrollment through 6 month study visit
Number of deployment attempts required to deliver bilateral PNT
Time frame: During the procedure
Duration of procedure
Time frame: During the procedure
Length of hospital admission
Time frame: Admission for the procedure through hospital discharge
Percent of study visit completed by participants
Time frame: Enrollement through 12 month study visit
Change in Neuropsychological diagnosis
Time frame: Baseline and 12 months
Mean change in Neuropsychological assessment scores
Time frame: Baseline to 12 months
Mean change in Montreal Cognitive Assessment (MoCA) scores
Time frame: Baseline, 4 weeks, 6 months, and 12 months
Mean change of the Movement Disorder Society - Unified Parkinsons Disease Rating Scale (MDS-UPDRS) Part I scores
Time frame: 4 weeks, 6 and 12 months as compared to baseline
Mean change of the MDS-UPDRS Part II scores
Time frame: 4 weeks, 6 months, and 12 months compared to baseline
Mean change in MDS-UPDRS Part III scores
Time frame: 4 weeks, 6 and 12 months compared to baseline
Mean change in MDS-UPDRS Part IV scores
Time frame: 4 weeks, 6 and 12 months compared to baseline
Mean change of the Movement Disorder Society - Unified Multiple System Atrophy Rating Scale (MDS-UMSARS) Part I scores
Time frame: 4 weeks, 6 and 12 months as compared to baseline
Mean change of the MDS-UMSARS Part II scores
Time frame: 4 weeks, 6 months, and 12 months compared to baseline
Mean change in MDS-UMSARS Part III scores
Time frame: 4 weeks, 6 and 12 months compared to baseline
Mean change in MDS-UMSARS Part IV scores
Time frame: 4 weeks, 6 and 12 months compared to baseline
Mean change in Parkinson's Disease Questionnaire-8 (PDQ-8) quality of life scores
Time frame: Monthly through 12 month study visit compared to baseline
Mean change in Modified Schwab and England Scale of Activities of Daily Living scores
Time frame: At 6 and 12 months compared to baseline
Mean change in Non-motor symptom scale scores
Time frame: Baseline and 12 months
Participants electing to receive Deep Brain Stimulator (DBS)
Time frame: Enrollment through 12 month study visit
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2026.
- Results publication: PubMed 35949912Quintero JE, Slevin JT, Gurwell JA, McLouth CJ, El Khouli R, Chau MJ, Guduru Z, Gerhardt GA, van Horne CG. Direct delivery of an investigational cell therapy in patients with Parkinson's disease: an interim analysis of feasibility and safety of an open-label study using DBS-Plus clinical trial design. BMJ Neurol Open. 2022 Jul 14;4(2):e000301. doi: 10.1136/bmjno-2022-000301. eCollection 2022.
- Results publication: PubMed 27153166van Horne CG, Quintero JE, Gurwell JA, Wagner RP, Slevin JT, Gerhardt GA. Implantation of autologous peripheral nerve grafts into the substantia nigra of subjects with idiopathic Parkinson's disease treated with bilateral STN DBS: a report of safety and feasibility. J Neurosurg. 2017 Apr;126(4):1140-1147. doi: 10.3171/2016.2.JNS151988. Epub 2016 May 6.
- Results publication: PubMed 29451447van Horne CG, Quintero JE, Slevin JT, Anderson-Mooney A, Gurwell JA, Welleford AS, Lamm JR, Wagner RP, Gerhardt GA. Peripheral nerve grafts implanted into the substantia nigra in patients with Parkinson's disease during deep brain stimulation surgery: 1-year follow-up study of safety, feasibility, and clinical outcome. J Neurosurg. 2018 Dec 1;129(6):1550-1561. doi: 10.3171/2017.8.JNS163222. Epub 2018 Feb 18.
- Individual participant dataSharing planned: Yes. Images and results may be made available to other researchers by asking participants, at the time of consent, their willingness to permit sharing of data and bio-specimens.
Related trials for Multiple System Atrophy
Enrolling by invitationObservational study
Early Molecular Biomarkers for Differentiating Parkinsonian Syndromes
PARKINSON DISEASE (Disorder), Atypical Parkinsonism
Active, not recruitingPhase 2
A Trial to Test if TEV-56286 is Effective for Treatment of Participants With Multiple System Atrophy
Multiple System Atrophy
RecruitingPhase 1/2
Tributyrin for Progressive Supranuclear Palsy (PSP): Virtual Trial
Parkinson Disease, Multiple System Atrophy
RecruitingObservational study
A Study of Risdiplam in Participants With Type I and Type II Spinal Muscle Atrophy (SMA)
Spinal Muscle Atrophy
RecruitingObservational study
Comparison of Individuals With Primary Ciliary Dyskinesia and Healthy Controls
Primary Ciliary Dyskinesia (PCD)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Group Monitored Email contact
Craig van Horne, MD, PhD principal investigator
University of Kentucky
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Sural Nerve Graft to the Substantia Nigra in people with Multiple System Atrophy and Parkinsons Disease, run by Craig van Horne, MD, PhD at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 31 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jaimie Hixson (859-323-1908, jaimie.henderson@uky.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Meet recruitment goal (time frame: Trial opening through 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06683365, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2026.