NCT07106021

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for phase_1

Timeline
62mo left

Started Jul 2025

Longer than P75 for phase_1

Geographic Reach
1 country

3 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress14%
Jul 2025Jun 2031

Study Start

First participant enrolled

July 17, 2025

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

July 21, 2025

Completed
16 days until next milestone

First Posted

Study publicly available on registry

August 6, 2025

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2027

Expected
3.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2031

Last Updated

January 23, 2026

Status Verified

January 1, 2026

Enrollment Period

2.1 years

First QC Date

July 21, 2025

Last Update Submit

January 22, 2026

Conditions

Parkinson's DiseaseIdiopathic Parkinson´s Disease

Keywords

RNDP-001

Outcome Measures

Primary Outcomes (1)

  • Safety and Tolerability

    The incidence of adverse events (AEs), serious AEs, AEs of special interest, and patient withdrawals

    Baseline to 15 months post-transplant

Secondary Outcomes (2)

  • Changes from Baseline in Quality ON time measured by PD diary

    Baseline to 15 months post-transplant

  • Changes in Dopaminergic Function and Activity in the Brain

    Baseline to 15 months post-transplant

Study Arms (3)

First patient group

EXPERIMENTAL

Low dose

Biological: RNDP-001Device: Syringe Front-Loading Device

Second patient group

EXPERIMENTAL

High dose

Biological: RNDP-001Device: Syringe Front-Loading Device

Third patient group

EXPERIMENTAL

Best dose

Biological: RNDP-001Device: Syringe Front-Loading Device

Interventions

RNDP-001BIOLOGICAL

Stem cells

First patient groupSecond patient groupThird patient group
Syringe Front-Loading DeviceDEVICE

Delivers the stem cells

First patient groupSecond patient groupThird patient group

Eligibility Criteria

Age45 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

University of Arizona

Tucson, Arizona, 85721, United States

RECRUITING

Keck Medical Center of University of Southern California

Los Angeles, California, 90033, United States

RECRUITING

The Ohio State University Wexner Medical Center

Columbus, Ohio, 43210, United States

RECRUITING

Related Links

Central Study Contacts

General Inquiries

CONTACT

<need to obtain>patients@kenaitx.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 21, 2025

First Posted

August 6, 2025

Study Start

July 17, 2025

Primary Completion (Estimated)

September 1, 2027

Study Completion (Estimated)

June 1, 2031

Last Updated

January 23, 2026

Record last verified: 2026-01

Locations

US(3)