AlloEx for Parkinson's (NCT05152394)
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
Making Contact: How to Call This Study Site
Who to ask for
Ask for the study coordinator. Some sites call this person the research coordinator. They are the right person for questions about joining a study. If you reach a front desk or a doctor's office scheduler, ask them to connect you with the research team for this study.
What to say
It is fine to read this out loud, word for word:
Hello, my name is ____. I am calling about a Parkinson's study at your site. The study number is NCT05152394. It is the one about "Assess intranasal AlloEx exosome safety". Could I speak with the study coordinator about taking part?
If you are calling for a family member, use their name and mention that you help with their care.
What they will ask you
- The year of diagnosis
- Current medications and their doses
- Other health conditions
- Any procedures already done, such as deep brain stimulation (DBS)
- How far you are able to travel for study visits
- Whether a care partner can come to visits with you
What to have ready
- A written list of current medications and doses
- Your neurologist's name and phone number
- The diagnosis date. The year is enough.
- A recent visit summary from the neurologist, if you have one
What to ask them
- How many visits are there, and how long does each visit take? The listing already answers this: Patients receive 2 doses given on back-to-back days and are evaluated within one month before treatment and at 1, 6, 12, 24, 36, and 48 months after treatment. Ask the coordinator to confirm it still applies.
- Is travel, parking, or my time reimbursed?
- Is there a placebo group, and what is my chance of being in it? The listing already answers this: Everyone in this trial receives the experimental treatment. There is no placebo group. Ask the coordinator to confirm it still applies.
- Would I need to stop or pause any of my current medications?
- What happens when the study ends? Could I stay on the treatment if it helps?
What to expect
- Expect to wait a few days for a callback. A week is common. Calling or emailing again after that is fine and normal.
- Many callers do not end up joining. Screening out is common and is not a judgment about you or your health.
- Asking questions commits you to nothing. You can stop the process at any point.
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?
- Most legitimate trials are free to participants, and reputable studies do not charge you to take part. We've flagged this listing for extra caution, so confirm any costs in writing and discuss them with your own doctor before enrolling. See parkinsonspathways.com/learn/how-to-spot-a-questionable-clinical-trial.
- How long does the trial last?
- This Phase 1 trial is estimated to last approximately 2 years and 4 months.
- 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.
- 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.
- Will I get a placebo in this trial?
- Everyone in this trial receives the experimental treatment. There is no placebo group.
- How many visits does this trial involve?
- Patients receive 2 doses given on back-to-back days and are evaluated within one month before treatment and at 1, 6, 12, 24, 36, and 48 months after treatment.