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
Summary For Families
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.
- Will I get the real drug or a placebo?
- It depends on the trial design. Some Parkinson's trials are placebo controlled, meaning a portion of participants get an inactive comparison while others get the experimental treatment. Some use crossover designs so everyone eventually receives the active treatment at some point. Observational trials do not use a placebo at all because they are not testing a new treatment. The consent form for any specific trial spells out the design and your odds of being assigned to placebo before you enroll.
- How often will I need to visit the study site?
- Visit frequency varies by trial. Many Parkinson's studies require an in person visit every 4 to 12 weeks during the active treatment phase, with shorter or longer gaps depending on the design. The site coordinator can give you the full visit schedule before you sign anything, so you know what the time commitment looks like.
- Can I leave the trial if I change my mind?
- Yes. You can withdraw from any clinical trial at any time, for any reason, without affecting your standard medical care. Trials are voluntary by law. The team may ask if you are willing to do a brief exit visit so they can collect safety information, but you are not obligated.
- Will travel or parking be reimbursed?
- Many trials reimburse for parking, mileage, and sometimes lodging if the site is far from your home. Reimbursement policies vary by sponsor and site. When you contact the trial team, ask specifically what is covered and how reimbursement is processed.
- Can my spouse or care partner come with me to visits?
- In most cases yes, and it is often encouraged. Care partners can help with notes, questions, and getting home safely after a long visit. Some study assessments do need to happen one on one, but care partners are usually welcome for the rest of the appointment.