PANDORA: Evaluation of Platelet-rich Plasma in Non-tumoural Odour Disorders: a Descriptive Pilot Study.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Proportion of participants with clinically meaningful improvement in olfactory function (Sniffin' Sticks Test TDI score)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Autologous Platelet-Rich Plasma (PRP) Injection (Biological)
结局指标
主要结局
Proportion of participants with clinically meaningful improvement in olfactory function (Sniffin' Sticks Test TDI score)
时间窗: 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).
次要结局
- 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))