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
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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RECRUITING
PHASE1
20 participants
INTERVENTIONAL
2024-08-17
2027-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
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.
AlloEx
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
Eligibility Criteria
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Inclusion Criteria
* Understanding and willingness to sign a written informed consent document
Exclusion Criteria
* 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
ALL
No
Sponsors
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The Foundation for Orthopaedics and Regenerative Medicine
OTHER
Responsible Party
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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
Countries
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Facility Contacts
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Other Identifiers
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ATG-1-MSC-016
Identifier Type: -
Identifier Source: org_study_id
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