Last reviewed · How we verify
PANDORA: Evaluation of Platelet-rich Plasma in Non-tumoural Odour Disorders: a Descriptive Pilot Study.
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.
Details
| Lead sponsor | Hospices Civils de Lyon |
|---|---|
| Phase | NA |
| Status | NOT_YET_RECRUITING |
| Enrolment | 30 |
| Start date | 2026-05 |
| Completion | 2028-05 |
Conditions
- Olfactory Dysfunction
- Post-traumatic Olfactory Dysfunction
- Age-related Degenerative Olfactory Dysfunction
Interventions
- Autologous Platelet-Rich Plasma (PRP) Injection
Primary outcomes
- Proportion of participants with clinically meaningful improvement in olfactory function (Sniffin' Sticks Test TDI score) — Baseline (Visit 1, prior to first injection) to Month 6 follow-up (Visit 5)
Proportion of participants whose change in olfactory function, measured using the Sniffin' Sticks Test (Threshold, Discrimination, Identification score - TDI), between baseline (Visit 1, prior to the first PRP injection) and the 6-month follow-up visit reaches or exceeds the minimal clinically significant difference (MCID) of 5.5 points on the 48-point TDI scale. The TDI score combines three components: olfactory threshold (T), odor discrimination (D), and odor identification (I).
Countries
France