Randomized Clinical Trial of Intranasal Injection of Platelet-Rich Plasma for Treatment of Parosmia

Обзор

This randomized clinical trial will evaluate the benefit of platelet-rich plasma (PRP) in the treatment of qualitative olfactory dysfunction (parosmia). PRP can be isolated from a patient's own blood and has been found in previous studies to have anti-inflammatory and pro-regenerative properties. It has been used across multiple specialties, such as Orthopedics, Facial Plastics, Dermatology, Neurology in injected form to treat a wide variety of tissues to encourage the body's inherent regenerative capacity. The investigators have completed a randomized controlled trial here, ending in 2022, evaluating it's use in post-SARS-CoV-2 olfactory loss which demonstrated safety and efficacy. Therefore, the investigators aim to assess the ability of PRP to improve olfactory function in patients with parosmia.

Вмешательства

• Другое Platelet-rich Plasma (PRP)
  Platelet-rich plasma (PRP) intranasal injection in the treatment of qualitative olfactory dysfunction (parosmia). This is taken from a blog draw from the patient themselves, and thus no external drug/biologic product will be given - only the concentrated plasma portion from the patient's own blood.
• Другое Saline
  Saline intranasal injection (sham injection)

Первичные конечные точки

• Change in Sniffin Sticks Parosmia Test (SSParoT) [Срок оценки: Assessed at baseline, 1 month, and 3 months]
• Change in questionnaire of olfactory disorders (QOD) scale score [Срок оценки: Assessed at baseline, 1 month, and 3 months]

Критерии участия

Критерии включения

• Patients >= 18 years of age
• Patients who have qualitative olfactory distortion
• Etiology of qualitative olfactory distortion is due to upper respiratory infection
• Quantitative score under the 10th percentile on the SSParoT (HedRang and HedDir)
• Quantitative score ≥ 8 on the QOD.
• At least 6 months of parosmia but less than 24 months
• Patients can have been previously treated with oral and topical steroids but this is not a requirement
• Patients will receive concurrent olfactory training - the practice of smelling strong odors (standard of care)
• Be able to read and understand English
• Be able and willing to provide Informed Consent

Критерии исключения

• Patients < 18 years of age, pregnant females, patients who have structural abnormalities on nasal endoscopy or radiographic imaging that would prevent injection into the olfactory cleft
• Olfactory loss due to trauma, chronic sinusitis / inflammation / polyps, neoplasms, or neurodegenerative diseases or patients who have had olfactory loss > 24 months
• Patients with bleeding disorders or on blood thinners such as coumadin and plavix

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Stanford Sinus Center / Stanford University School of Medicine — Palo Alto

Публикации

• Prognosis and persistence of smell and taste dysfunction in patients with covid-19: meta-analysis with parametric cure modelling of recovery curves. BMJ. 2022 Aug 9;378:o1939. doi: 10.1136/bmj.o1939. No abstract available. PMID 35944915
• Pence TS, Reiter ER, DiNardo LJ, Costanzo RM. Risk factors for hazardous events in olfactory-impaired patients. JAMA Otolaryngol Head Neck Surg. 2014 Oct;140(10):951-5. doi: 10.1001/jamaoto.2014.1675. PMID 25170573
• Pellegrino R, Mainland JD, Kelly CE, Parker JK, Hummel T. Prevalence and correlates of parosmia and phantosmia among smell disorders. Chem Senses. 2021 Jan 1;46:bjab046. doi: 10.1093/chemse/bjab046. PMID 34698820
• Chang MT, Patel ZM. Novel Therapies in Olfactory Disorders. Curr Otorhinolaryngol Rep. 2022;10(4):427-432. doi: 10.1007/s40136-022-00436-z. Epub 2022 Oct 22. PMID 36312744
• Yan CH, Mundy DC, Patel ZM. The use of platelet-rich plasma in treatment of olfactory dysfunction: A pilot study. Laryngoscope Investig Otolaryngol. 2020 Feb 21;5(2):187-193. doi: 10.1002/lio2.357. eCollection 2020 Apr. PMID 32337347
• Zahn J, Loibl M, Sprecher C, Nerlich M, Alini M, Verrier S, Herrmann M. Platelet-Rich Plasma as an Autologous and Proangiogenic Cell Delivery System. Mediators Inflamm. 2017;2017:1075975. doi: 10.1155/2017/1075975. Epub 2017 Aug 6. PMID 28845088
• Kaux JF, Croisier JL, Forthomme B, Le Goff C, Buhler F, Savanier B, Delcour S, Gothot A, Crielaard JM. Using platelet-rich plasma to treat jumper's knees: Exploring the effect of a second closely-timed infiltration. J Sci Med Sport. 2016 Mar;19(3):200-204. doi: 10.1016/j.jsams.2015.03.006. Epub 2015 Mar 21. PMID 25840691
• Chen SR, Shen YP, Ho TY, Li TY, Su YC, Chou YC, Chen LC, Wu YT. One-Year Efficacy of Platelet-Rich Plasma for Moderate-to-Severe Carpal Tunnel Syndrome: A Prospective, Randomized, Double-Blind, Controlled Trial. Arch Phys Med Rehabil. 2021 May;102(5):951-958. doi: 10.1016/j.apmr.2020.12.025. Epub 2021 Feb 3. PMID 33548206

Идентификаторы

NCT: NCT06283745 · 73225

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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