PANDORA: Evaluation of Platelet-rich Plasma in Non-tumoural Odour Disorders: a Descriptive Pilot Study.
Overview
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Hospices Civils de Lyon
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Proportion of participants with clinically meaningful improvement in olfactory function (Sniffin' Sticks Test TDI score)
Overview
Brief 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.
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 99 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
PRP injections
Single arm receiving autologous platelet-rich plasma injections at Day 0, Day 14 (±1), and Day 28 (±1), with follow-up at Months 3 and 6.
Intervention: Autologous Platelet-Rich Plasma (PRP) Injection (Biological)
Outcomes
Primary Outcomes
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)
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).
Secondary Outcomes
- Occurrence of treatment-related adverse events(From first injection (Day 0) to Month 6 follow-up visit)
- Change in olfactory function at Month 3 (TDI score)(Baseline (Visit 1) to Month 3 follow-up (Visit 4))
- Change in olfactory function at Month 6 (TDI score)(Baseline (Visit 1) to Month 6 follow-up (Visit 5))
- Change in quality of life (SNOT-22 score)(Baseline (Visit 1) to Month 6 follow-up (Visit 5))
- Change in patient-reported olfactory impairment (Visual Analog Scale)(Baseline (Visit 1) to Month 6 follow-up (Visit 5))