Clinical trial NCT06283745: Randomized Clinical Trial of Intranasal Injection of Platelet-Rich Plasma for Treatment of Parosmia
Official title: Randomized Clinical Trial of Intranasal Injection of Platelet-Rich Plasma for Treatment of Parosmia
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Paraosmia
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2024-02-28
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: PRP injections will be given to one arm while sham saline injections will be given to the other arm.
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Change in Sniffin Sticks Parosmia Test (SSParoT)
timeFrame: Assessed at baseline, 1 month, and 3 months
measure: Change in questionnaire of olfactory disorders (QOD) scale score
timeFrame: Assessed at baseline, 1 month, and 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Stanford Sinus Center / Stanford University School of Medicine
state: California
Study officials:
affiliation: Stanford Otolaryngology - Head and Neck Surgery
name: Zara Patel, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: Anjayani S, Wirohadidjojo YW, Adam AM, Suwandi D, Seweng A, Amiruddin MD. Sensory improvement of leprosy peripheral neuropathy in patients treated with perineural injection of platelet-rich plasma. Int J Dermatol. 2014 Jan;53(1):109-13. doi: 10.1111/ijd.12162. Epub 2013 Oct 29.
citation: Hibner M, Castellanos ME, Drachman D, Balducci J. Repeat operation for treatment of persistent pudendal nerve entrapment after pudendal neurolysis. J Minim Invasive Gynecol. 2012 May-Jun;19(3):325-30. doi: 10.1016/j.jmig.2011.12.022. Epub 2012 Feb 4.
citation: Yan CH, Jang SS, Lin HC, Ma Y, Khanwalkar AR, Thai A, Patel ZM. Use of platelet-rich plasma for COVID-19-related olfactory loss: a randomized controlled trial. Int Forum Allergy Rhinol. 2023 Jun;13(6):989-997. doi: 10.1002/alr.23116. Epub 2022 Dec 21.
citation: Liu DT, Welge-Lussen A, Besser G, Mueller CA, Renner B. Assessment of odor hedonic perception: the Sniffin' sticks parosmia test (SSParoT). Sci Rep. 2020 Oct 22;10(1):18019. doi: 10.1038/s41598-020-74967-0.
citation: Frasnelli J, Hummel T. Olfactory dysfunction and daily life. Eur Arch Otorhinolaryngol. 2005 Mar;262(3):231-5. doi: 10.1007/s00405-004-0796-y. Epub 2004 May 5.