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

Обзор

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.

Подробное описание

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.

Вмешательства

• Биопрепарат 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.

Первичные конечные точки

• Proportion of participants with clinically meaningful improvement in olfactory function (Sniffin' Sticks Test TDI score) [Срок оценки: Baseline (Visit 1, prior to first injection) to Month 6 follow-up (Visit 5)]

Вторичные конечные точки (5)

• Occurrence of treatment-related adverse events [Срок оценки: From first injection (Day 0) to Month 6 follow-up visit]
• Change in olfactory function at Month 3 (TDI score) [Срок оценки: Baseline (Visit 1) to Month 3 follow-up (Visit 4)]
• Change in olfactory function at Month 6 (TDI score) [Срок оценки: Baseline (Visit 1) to Month 6 follow-up (Visit 5)]
• Change in quality of life (SNOT-22 score) [Срок оценки: Baseline (Visit 1) to Month 6 follow-up (Visit 5)]
• Change in patient-reported olfactory impairment (Visual Analog Scale) [Срок оценки: Baseline (Visit 1) to Month 6 follow-up (Visit 5)]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Франция · 1 центр

• Hôpital Lyon Sud — Pierre-Bénite

Идентификаторы

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

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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