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

NCT ID: NCT05152394

Last Updated: 2025-04-17

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

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-08-17

Study Completion Date

2027-01-31

Brief Summary

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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

Detailed Description

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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.

Conditions

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Parkinson Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treatment Group (AlloEx)

Intranasal instillations of 4 CCs of AlloEx, approximately 800 billion exosomes. Treatments on back-to-back days, totaling 2 doses.

Group Type EXPERIMENTAL

AlloEx

Intervention Type BIOLOGICAL

cultured allogeneic adult umbilical cord derived mesenchymal stem cell exosomes

Interventions

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AlloEx

cultured allogeneic adult umbilical cord derived mesenchymal stem cell exosomes

Intervention Type BIOLOGICAL

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Foundation for Orthopaedics and Regenerative Medicine

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Chadwick Prodromos, MD

Role: PRINCIPAL_INVESTIGATOR

The Foundation for Orthopaedics and Regenerative Medicine

Locations

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Medical Surgical Associates Center

St John's, , Antigua and Barbuda

Site Status RECRUITING

Countries

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Antigua and Barbuda

Facility Contacts

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Chadwick Prodromos, M.D.

Role: primary

8476996810

Other Identifiers

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ATG-1-MSC-016

Identifier Type: -

Identifier Source: org_study_id

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