A Study to Assess Safety and Efficacy of Surgical Implant of RNDP-001 in Patients With Idiopathic Parkinson's Disease

NCT ID: NCT07106021

Last Updated: 2026-01-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1/PHASE2

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-07-17

Study Completion Date

2031-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Idiopathic Parkinson´s Disease Parkinson's Disease

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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First patient group

Low dose

Group Type EXPERIMENTAL

RNDP-001

Intervention Type BIOLOGICAL

Stem cells

Syringe Front-Loading Device

Intervention Type DEVICE

Delivers the stem cells

Second patient group

High dose

Group Type EXPERIMENTAL

RNDP-001

Intervention Type BIOLOGICAL

Stem cells

Syringe Front-Loading Device

Intervention Type DEVICE

Delivers the stem cells

Third patient group

Best dose

Group Type EXPERIMENTAL

RNDP-001

Intervention Type BIOLOGICAL

Stem cells

Syringe Front-Loading Device

Intervention Type DEVICE

Delivers the stem cells

Interventions

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RNDP-001

Stem cells

Intervention Type BIOLOGICAL

Syringe Front-Loading Device

Delivers the stem cells

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

45 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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California Institute for Regenerative Medicine (CIRM)

OTHER

Sponsor Role collaborator

Kenai Therapeutics

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University of Arizona

Tucson, Arizona, United States

Site Status RECRUITING

Keck Medical Center of University of Southern California

Los Angeles, California, United States

Site Status RECRUITING

The Ohio State University Wexner Medical Center

Columbus, Ohio, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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General Inquiries

Role: CONTACT

<need to obtain>

Facility Contacts

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Marisa Valletta

Role: primary

1 (520) 626-7322

Role: primary

1 (614) 366-1648

Related Links

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Other Identifiers

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RNDP-001-02

Identifier Type: -

Identifier Source: org_study_id

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