PANDORA: Evaluation of Platelet-rich Plasma in Non-tumoural Odour Disorders: a Descriptive Pilot … (NCT07473830) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
PANDORA: Evaluation of Platelet-rich Plasma in Non-tumoural Odour Disorders: a Descriptive Pilot Study.
France30 participantsStarted 2026-05
Plain-language summary
This is a prospective, single-center, single-arm, non-comparative descriptive pilot study evaluating autologous platelet-rich plasma (PRP) injections in adults with persistent (\>6 months) non-tumoural olfactory dysfunction, either age-related degenerative olfactory dysfunction (DOD) or post-traumatic olfactory dysfunction (DOPT). Participants receive three PRP injections over 4 weeks (Day 0, Day 14, Day 28), with follow-up visits at Month 3 and Month 6 after the first injection. Olfactory function is assessed using the Sniffin' Sticks Test (TDI score). Patient-reported outcomes include SNOT-22 and a visual analog scale (VAS) for perceived olfactory impairment. Safety is assessed through adverse event collection.
Who can participate
Age range
18 Years – 99 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria
* Adults with persistent (\>6 months) non-tumoural olfactory dysfunction: age-related degenerative olfactory dysfunction (DOD) or post-traumatic olfactory dysfunction (DOPT).
* Objective olfactory impairment confirmed by Sniffin' Sticks Test (TDI ≤ 30.5/48).
* MRI within the last 6 months after onset excluding tumoural etiology or central cause.
* Normal nasal endoscopy.
* Affiliated to a social security system (or equivalent).
* Written informed consent.
Exclusion Criteria
* Inflammatory rhinosinus disease (e.g., nasal polyposis) or granulomatosis with polyangiitis.
* Coagulation disorder.
* Brain radiotherapy history or ongoing chemotherapy.
* Olfactory disorder temporally linked to SARS-CoV-2 infection (delay \<1 month).
* History of sinus or skull base surgery (except septoplasty/turbinoplasty/rhinoseptoplasty).
* Therapeutic-dose anticoagulants.
* Refusal to discontinue chronic NSAID use if applicable.
* Pregnancy/labor/breastfeeding.
* Vulnerable persons (deprived of liberty; legal protection; etc.).
* Participation in another interventional study with ongoing exclusion period.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Proportion of participants with clinically meaningful improvement in olfactory function (Sniffin' Sticks Test TDI score)
Timeframe: Baseline (Visit 1, prior to first injection) to Month 6 follow-up (Visit 5)