Idiopathic Parkinson´s DiseasePhase 1/2NCT07106021
A Study to Assess Safety and Efficacy of Surgical Implant of RNDP-001 in Patients With Idiopathic Parkinson's Disease
A Phase 1/2 study testing RNDP-001 and Syringe Front-Loading Device in people with Idiopathic Parkinson´s Disease and Parkinson's Disease, run by Kenai Therapeutics at 3 sites in United States.
Trial summary
This clinical trial is designed to test the safety and tolerability of the study intervention, RNDP-001, which will be implanted into the brain of study participants during a surgical procedure. Read more about this study
- Who is it for?
- Ages 45 to 75 years
- Conditions the study is for
- Idiopathic Parkinson´s Disease, Parkinson's Disease
- What is being tested?
- RNDP-001 and Syringe Front-Loading Device
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 3 sitesUnited States
- Study dates
- 17 Jul 2025to Jun 2031
- Phase
- Phase 1/2
- 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 45 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of idiopathic Parkinson's disease consistent with the Movement Disorders Society Clinical Criteria
- Age 45 to 75
- Medically stable to undergo a surgical procedure
Who cannot join
- Known Parkinson's disease gene mutation or variant
- Previous infusion therapy or surgery for Parkinson's disease
- History of allergic reaction or intolerance to an immunotherapeutic agent
- Contraindication to MRI
- Clinically significant medical conditions likely to interfere with the surgical procedure or study assessments
Trial locations and contacts
3 sites in 1 country.
United States3 sites
The Ohio State University Wexner Medical Center
Columbus, Ohio, 43210
Keck Medical Center of University of Southern California
Los Angeles, California, 90033
University of Arizona
Tucson, Arizona, 85721
About this study
Official title: A Phase 1b/2a Study Assessing the Safety and Efficacy of Intraputamenal Dopaminergic Stem Cell Transplants in Patients With Idiopathic Parkinson's Disease
This clinical trial is designed to test the safety and tolerability of the study intervention, RNDP-001, which will be implanted into the brain of study participants during a surgical procedure.
- Being tested
- RNDP-001, Syringe Front-Loading Device
- Keywords
- RNDP-001
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RNDP-001Biological
Stem cells
Syringe Front-Loading DeviceDevice
Delivers the stem cells
| Study group | Role | What they receive |
|---|---|---|
| First patient group | Experimental | Low dose Receives: Biological: RNDP-001; Device: Syringe Front-Loading Device |
| Second patient group | Experimental | High dose Receives: Biological: RNDP-001; Device: Syringe Front-Loading Device |
| Third patient group | Experimental | Best dose Receives: Biological: RNDP-001; Device: Syringe Front-Loading Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and Tolerability
The incidence of adverse events (AEs), serious AEs, AEs of special interest, and patient withdrawals
Measured: Baseline to 15 months post-transplant
Secondary outcomes (2)
Changes from Baseline in Quality ON time measured by PD diary
Measured: Baseline to 15 months post-transplant
Changes in Dopaminergic Function and Activity in the Brain
Changes in L-DOPA-positron emission tomography (PET)
Measured: Baseline to 15 months post-transplant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2025
- Study start17 Jul 2025
- Primary completionSep 2027 (estimated)
- Study completionJun 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Idiopathic Parkinson´s DiseaseStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kenai Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- California Institute for Regenerative Medicine (CIRM)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07106021
- Sponsor's protocol ID
- RNDP-001-02
- Status last verified
- Jul 2026
- First submitted
- 21 Jul 2025
- Last updated
- 27 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided: IPD sharing plan will be determined later in the development.
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1b/2a Study Assessing the Safety and Efficacy of Intraputamenal Dopaminergic Stem Cell Transplants in Patients With Idiopathic Parkinson's Disease
- ClinicalTrials.gov ID
- NCT07106021
- Acronym / sponsor ID
- RNDP-001-02
- Keywords
- RNDP-001
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Kenai TherapeuticsIndustry (pharma, biotech, devices)
- Collaborators
- California Institute for Regenerative Medicine (CIRM)
- Study start
- 17 Jul 2025 (actual)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Jun 2031 (estimated)
- First posted
- 6 Aug 2025 (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 clinical trial is designed to test the safety and tolerability of the study intervention, RNDP-001, which will be implanted into the brain of study participants during a surgical procedure.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| First patient group | Experimental | Biological: RNDP-001, Device: Syringe Front-Loading DeviceLow dose |
| Second patient group | Experimental | Biological: RNDP-001, Device: Syringe Front-Loading DeviceHigh dose |
| Third patient group | Experimental | Biological: RNDP-001, Device: Syringe Front-Loading DeviceBest dose |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosis of idiopathic Parkinson's disease consistent with the Movement Disorders Society Clinical Criteria
- Age 45 to 75
- Medically stable to undergo a surgical procedure
Key exclusion criteria (5 listed)
- Known Parkinson's disease gene mutation or variant
- Previous infusion therapy or surgery for Parkinson's disease
- History of allergic reaction or intolerance to an immunotherapeutic agent
- Contraindication to MRI
- Clinically significant medical conditions likely to interfere with the surgical procedure or study assessments
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 |
|---|---|---|
| RNDP-001Stem cells | Biological | First patient group, Second patient group, Third patient group |
| Syringe Front-Loading DeviceDelivers the stem cells | Device | First patient group, Second patient group, Third patient group |
Primary outcome
Safety and Tolerability
Time frame: Baseline to 15 months post-transplant
The incidence of adverse events (AEs), serious AEs, AEs of special interest, and patient withdrawals
2 secondary outcomes
Changes from Baseline in Quality ON time measured by PD diary
Time frame: Baseline to 15 months post-transplant
Changes in Dopaminergic Function and Activity in the Brain
Time frame: Baseline to 15 months post-transplant
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 27 Jul 2026.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided. IPD sharing plan will be determined later in the development.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing RNDP-001 and Syringe Front-Loading Device in people with Idiopathic Parkinson´s Disease and Parkinson's Disease, run by Kenai Therapeutics at 3 sites 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 3 inclusion and 5 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: under way, not looking for participants, as of the sponsor's last update on 27 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and Tolerability (time frame: Baseline to 15 months post-transplant). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Jul 2026.