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Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cell Exosomes for Parkinson's Disease

Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cell Exosomes for Parkinson's Disease

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Phase 1

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Overview

This trial will study the safety and efficacy of intranasal instillation of cultured allogeneic adult umbilical cord derived mesenchymal stem cell exosomes for the treatment of Parkinson's Disease

Description

This patient funded trial aims to study the safety and efficacy of intranasal installation of cultured allogeneic adult umbilical cord derived mesenchymal stem cell (UC-MSC) exosomes for the treatment of Parkinson's Disease. Patients will receive a dose of 4 CCs of AlloEx, approximately 800 billion exosomes, between both nasal cavities. A second equivalent dose will be administered on the subsequent day. Patients will be evaluated within one month pre treatment and at 1, 6, 12, 24, 36, and 48 months post treatment for safety and efficacy.

Eligibility

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

Study details
    Parkinson Disease

NCT05152394

The Foundation for Orthopaedics and Regenerative Medicine

29 April 2025

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FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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