Assess intranasal AlloEx exosome safety
- Trial ID
- NCT05152394
- Official Title
- Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cell Exosome Intranasal Instillation for the Treatment of Parkinson's Disease
- Goal
- Assess intranasal AlloEx exosome safety
- Phase
- PHASE1
- Status
- RECRUITING
- Sponsor
- The Foundation for Orthopaedics and Regenerative Medicine
- Study Type
- INTERVENTIONAL
- Enrollment
- 20 participants
- Conditions
- Parkinson Disease
- Interventions
- AlloEx
Plain-Language Summary
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.
Locations
- Medical Surgical Associates Center, St John's, Antigua and Barbuda
Frequently Asked Questions
- What is this trial testing?
- This trial is studying AlloEx. 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.
- Who can participate?
- Eligibility criteria vary. Check the full listing on ClinicalTrials.gov for detailed inclusion and exclusion criteria.
- Where is this trial located?
- This trial is recruiting at 1 location.
- Does it cost anything to join?
- No. There is no cost to participate. Study-related care and treatment are provided at no charge.
- How long does the trial last?
- This Phase 1 trial is estimated to last approximately 2 years and 4 months.