Intranasal Injection of PRP Versus Saline for Treatment of Olfactory Dysfunction

NCT04406584 | Completed

• 1 other identifier: IRB-55353
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

Brief Summary

This randomized clinical trial will evaluate the benefit of platelet-rich plasma (PrP) in the treatment of olfactory dysfunction. 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 pilot study here evaluating it's use in olfactory loss which demonstrated safety and also suggested efficacy. Therefore, the investigators aim to assess the ability of PrP to improve olfactory function in patients with decreased sense of smell.

Conditions

Olfactory Disorder; Olfaction Disorders; Olfactory Nerve Injuries; Olfactory Nerve Disorder; Olfactory Nerve Diseases; Covid19; Post-Viral Disorder

Keywords

olfactory; olfactory loss; anosmia; hyposmia; olfactory dysfunction; prp; platelet enriched plasma; platelet rich plasma; endoscopic; covid19; post-viral disorder

Outcome Measures

Primary Outcomes (1)

• Smelling ability

  Using Sniffin' Sticks olfactory testing pens to test smell

  6 months

Study Arms (2)

Saline

PLACEBO COMPARATOR

Injection of 1cc saline into olfactory cleft x4

Procedure: Injection into olfactory cleft

Platelet Rich Plasma

EXPERIMENTAL

Injection of 1cc patient's own platelet rich plasma (PRP) into olfactory cleft x4

Procedure: Injection into olfactory cleft

Interventions

Injection into olfactory cleft PROCEDURE

Already stated above.

Platelet Rich Plasma; Saline

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients \>= 18 years of age
• Patients who have olfactory loss (based off of UPSIT score \<= 33 out of 40)
• Patients who also have an age-adjusted TDI Sniffin' Sticks score that demonstrates hyposmia (TDI\>16 and \<30)
• Etiology of olfactory loss is due to URI or idiopathic
• At least 6 months of olfactory loss but less than 12 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
• Agree to participate in the study
• Be able and willing to provide Informed Consent

You may not qualify if:

• Patients \< 18 years of age
• Pregnant females
• Patient who have any structural abnormalities on nasal endoscopy or radiographic imaging
• Olfactory loss due to trauma, chronic sinusitis / inflammation / polyps, neoplasms, or neurodegenerative diseases
• Patients who have had olfactory loss \> 12 months
• Patients with bleeding disorders or on blood thinners such as coumadin and plavix

Sponsors & Collaborators

• Stanford University: lead
• University of California, San Diego: collaborator

Study Sites (2)

University of California - San Diego

San Diego, California, 92093, United States

Location

Stanford University

Stanford, California, 94305, United States

Location

Related Publications (2)

• 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 BACKGROUND

• 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.

  PMID: 36507615 RESULT

Related Links

• Dr. Patel's Stanford University School of Medicine Profile and Link to Donate to Research

MeSH Terms

Conditions

Olfaction Disorders; Olfactory Nerve Injuries; Olfactory Nerve Diseases; COVID-19; Anosmia; Insomnia, Fatal Familial

Condition Hierarchy (Ancestors)

Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Cranial Nerve Injuries; Cranial Nerve Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Prion Diseases; Central Nervous System Infections; Central Nervous System Diseases; Neurodegenerative Diseases; Sleep Initiation and Maintenance Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders

Study Officials

• Zara M. Patel, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Blindfold during injection and during portions of the smell test
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Director of Endoscopic Skull Base Surgery

Model Details: Comparison of two randomized groups

Study Record Dates

• First Submitted: May 11, 2020
• First Posted: May 28, 2020
• Study Start: June 22, 2021
• Primary Completion: May 12, 2022
• Study Completion: August 11, 2022
• Last Updated: March 13, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)