Randomized Clinical Trial of Intranasal Injection of Platelet-Rich Plasma for Treatment of Parosmia
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Platelet-rich Plasma (PRP), Saline.
- Who it may be relevant to
- Registry conditions: Paraosmia. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Interventions
- Other 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. - Other Saline
Saline intranasal injection (sham injection)
Primary outcome measures
- Change in Sniffin Sticks Parosmia Test (SSParoT) [Time frame: Assessed at baseline, 1 month, and 3 months]
- Change in questionnaire of olfactory disorders (QOD) scale score [Time frame: Assessed at baseline, 1 month, and 3 months]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Stanford Sinus Center / Stanford University School of Medicine — Palo Alto
Publications
- 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
Identifiers
NCT: NCT06283745 · 73225