---
title: Restore dopamine production in putamen
nct_id: NCT07106021
phase: PHASE1, PHASE2
status: RECRUITING
sponsor: Kenai Therapeutics
study_type: INTERVENTIONAL
canonical_url: "https://parkinsonspathways.com/trial/NCT07106021"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT07106021"
last_fetched: "2026-05-10T14:07:22.645Z"
source: "Parkinson's Pathways (curated)"
---
# Restore dopamine production in putamen

**Goal (in five words):** Restore dopamine production in putamen

**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

**Trial ID:** [NCT07106021](https://clinicaltrials.gov/study/NCT07106021)

## Key Facts

- **Phase:** PHASE1, PHASE2
- **Status:** RECRUITING
- **Study Type:** INTERVENTIONAL
- **Sponsor:** Kenai Therapeutics
- **Target Enrollment:** 12 participants
- **Start Date:** 2025-07-17
- **Completion Date:** 2027-09
- **Conditions:** Idiopathic Parkinson´s Disease, Parkinson's Disease
- **Interventions:** RNDP-001, Syringe Front-Loading Device
- **Intervention Types:** BIOLOGICAL, DEVICE

## Summary For Families

The goal is to replace the dopamine-making cells lost in Parkinson's by putting new dopaminergic stem cells into the putamen, hoping to improve motor symptoms and eventually reduce reliance on levodopa. The treatment, called RNDP-001, is a stem cell product delivered surgically with a syringe front-loading device so the new cells can produce dopamine locally rather than changing how levodopa works; the trial is focused on early safety and signals of benefit while people may remain on their usual medications. Eligible participants are adults 45 to 75 with idiopathic Parkinson's who are medically stable for brain surgery; people with known Parkinson's gene mutations, prior Parkinson's surgeries or infusion therapies, MRI contraindications, or significant medical problems are excluded. The trial is a small, early-phase study planning to enroll about 12 participants.

## Eligibility

- **Minimum age:** 45 Years
- **Maximum age:** 75 Years
- **Sex:** ALL

### Full Criteria

```
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
```

## Locations (3)

- University of Arizona, Tucson, Arizona, United States _(32.2217, -110.9265)_
  - Marisa Valletta — (CONTACT) — 1 (520) 626-7322 — COM-Neurosurgtrials@arizona.edu
- Keck Medical Center of University of Southern California, Los Angeles, California, United States _(34.0522, -118.2437)_
- The Ohio State University Wexner Medical Center, Columbus, Ohio, United States _(39.9612, -82.9988)_
  - (CONTACT) — 1 (614) 366-1648 — Caitlyn.Evanovich@osumc.edu

## Central Contacts

- General Inquiries — (CONTACT) — <need to obtain> — patients@kenaitx.com

---

*Canonical: https://parkinsonspathways.com/trial/NCT07106021*  
*HTML version: https://parkinsonspathways.com/trial/NCT07106021*  
*Source data: https://clinicaltrials.gov/study/NCT07106021*