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Not yet recruiting NCT07473830

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

No phase Interventional Olfactory Dysfunction Post-traumatic Olfactory Dysfunction Age-related Degenerative Olfactory Dysfunction

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Autologous Platelet-Rich Plasma (PRP) Injection.
Who it may be relevant to
Registry conditions: Olfactory Dysfunction, Post-traumatic Olfactory Dysfunction, Age-related Degenerative Olfactory Dysfunction. Basic parameters: 18 years — 99 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Detailed description

Prospective consecutive recruitment in an ENT department at Hôpital Lyon Sud (Hospices Civils de Lyon). Eligible participants are enrolled into one of two diagnostic cohorts (DOD or DOPT), and analyses are performed separately by cohort. PRP is prepared from autologous venous blood using a standardized preparation system and injected under endoscopic guidance in the olfactory cleft area (superior nasal septum mucosa). Follow-up assessments are performed at baseline and at Months 3 and 6 after the first injection.

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.

Primary outcome measures

  • Proportion of participants with clinically meaningful improvement in olfactory function (Sniffin' Sticks Test TDI score) [Time frame: Baseline (Visit 1, prior to first injection) to Month 6 follow-up (Visit 5)]
Secondary outcome measures (5)
  • Occurrence of treatment-related adverse events [Time frame: From first injection (Day 0) to Month 6 follow-up visit]
  • Change in olfactory function at Month 3 (TDI score) [Time frame: Baseline (Visit 1) to Month 3 follow-up (Visit 4)]
  • Change in olfactory function at Month 6 (TDI score) [Time frame: Baseline (Visit 1) to Month 6 follow-up (Visit 5)]
  • Change in quality of life (SNOT-22 score) [Time frame: Baseline (Visit 1) to Month 6 follow-up (Visit 5)]
  • Change in patient-reported olfactory impairment (Visual Analog Scale) [Time frame: Baseline (Visit 1) to Month 6 follow-up (Visit 5)]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

France · 1 center
  • Hôpital Lyon Sud — Pierre-Bénite

Identifiers

NCT: NCT07473830 · 69HCL24_1192 · 2025-A02847-42

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗