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NOT YET RECRUITING
NCT07473830
NA

PANDORA: Evaluation of Platelet-rich Plasma in Non-tumoural Odour Disorders: a Descriptive Pilot Study.

Sponsor: Hospices Civils de Lyon

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - 99 Years

Study Type

INTERVENTIONAL

Enrollment

30

Start Date

2026-05

Completion Date

2028-05

Last Updated

2026-03-20

Healthy Volunteers

No

Interventions

BIOLOGICAL

Autologous Platelet-Rich Plasma (PRP) Injection

At each injection visit (Day 0, Day 14 ±1, Day 28 ±1), venous blood is collected and processed to obtain autologous PRP using a standardized preparation system. PRP is injected under endoscopic guidance into the superior nasal septum mucosa near the olfactory cleft, up to a total volume of 4 mL per visit. Participants are monitored after each injection and adverse events are recorded.

Locations (1)

Hôpital Lyon Sud

Pierre-Bénite, France