Parkinson Disease
Conditions
Keywords
Parkinson's Disease, stem cell treatment
Brief summary
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
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.
Interventions
BIOLOGICALAlloEx
cultured allogeneic adult umbilical cord derived mesenchymal stem cell exosomes
Sponsors
The Foundation for Orthopaedics and Regenerative Medicine
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety (adverse events) | Four year follow-up | Clinical monitoring of possible adverse events or complications |
Countries
Antigua and Barbuda
Outcome results
None listed