---
title: Assess intranasal AlloEx exosome safety
nct_id: NCT05152394
phase: PHASE1
status: RECRUITING
sponsor: The Foundation for Orthopaedics and Regenerative Medicine
study_type: INTERVENTIONAL
canonical_url: "https://parkinsonspathways.com/trial/NCT05152394"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT05152394"
last_fetched: "2026-05-10T14:01:36.316Z"
source: "Parkinson's Pathways (curated)"
---
# Assess intranasal AlloEx exosome safety

**Goal (in five words):** Assess intranasal AlloEx exosome safety

**Official Title:** Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cell Exosome Intranasal Instillation for the Treatment of Parkinson's Disease

**Trial ID:** [NCT05152394](https://clinicaltrials.gov/study/NCT05152394)

## Key Facts

- **Phase:** PHASE1
- **Status:** RECRUITING
- **Study Type:** INTERVENTIONAL
- **Sponsor:** The Foundation for Orthopaedics and Regenerative Medicine
- **Target Enrollment:** 20 participants
- **Start Date:** 2024-08-17
- **Completion Date:** 2027-01
- **Conditions:** Parkinson Disease
- **Interventions:** AlloEx
- **Intervention Types:** BIOLOGICAL

## Summary For Families

Goal: To check whether donor umbilical cord mesenchymal stem cell exosomes delivered through the nose are safe and well tolerated in people with Parkinson's, with the longer-term aim of seeing if brain delivery of these signals might help.  
Approach: The treatment uses purified exosomes, tiny packets of proteins and regulatory RNAs from stem cells, given intranasally to reach the brain where they may reduce neuroinflammation and support neuron health; it is an experimental add-on approach and not a replacement for levodopa, and no specific drug interactions are reported.  
Eligibility: About 20 adults with a diagnosed Parkinson's disease who can give informed consent are being sought, excluding people with active infection or cancer, chronic organ failure, pregnancy, anticoagulant use, prior organ transplant, ongoing drug abuse, sulfur hypersensitivity, or other medical issues that could raise safety concerns.

## Eligibility

- **Sex:** ALL

### Full Criteria

```
Inclusion Criteria:

* Diagnosis of Parkinson's Disease
* Understanding and willingness to sign a written informed consent document

Exclusion Criteria:

* Active infection
* Active cancer
* Chronic multisystem organ failure
* Pregnancy
* Clinically significant Abnormalities on pre-treatment laboratory evaluation
* Medical condition that would (based on the opinion of the investigator) compromise patient's safety.
* Continued drug abuse
* Pre-menopausal women not using contraception
* Previous organ transplant
* Hypersensitivity to sulfur
* Anticoagulation medicine use
```

## Locations (1)

- Medical Surgical Associates Center, St John's, Antigua and Barbuda _(17.1210, -61.8433)_
  - Chadwick Prodromos, M.D. — (CONTACT) — 8476996810 — care@thepsci.com

---

*Canonical: https://parkinsonspathways.com/trial/NCT05152394*  
*HTML version: https://parkinsonspathways.com/trial/NCT05152394*  
*Source data: https://clinicaltrials.gov/study/NCT05152394*