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Intranasal Injection of PRP Versus Saline for Treatment of Olfactory Dysfunction

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ClinicalTrials.gov Identifier: NCT04406584
Recruitment Status : Recruiting
First Posted : May 28, 2020
Last Update Posted : September 17, 2021
Sponsor:
Collaborator:
University of California, San Diego
Information provided by (Responsible Party):
Zara M. Patel, Stanford University

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.

Condition or disease Intervention/treatment Phase
Olfactory Disorder Olfaction Disorders Olfactory Nerve Injuries Olfactory Nerve Disorder Olfactory Nerve Diseases Covid19 Post-Viral Disorder Procedure: Injection into olfactory cleft Not Applicable

Detailed Description:

Olfactory dysfunction constitutes a common impairment in the general population, affecting nearly 20 million in the USA and severely impairing quality of life. Unfortunately, this problem is often permanent, and no effective treatment is available at this time. Although many etiologies exist for olfactory loss, the underlying pathology is thought to be permanent damage to the olfactory bulb, nerves or basal cells of the olfactory system. Platelet-rich plasma (PRP) is an autologous treatment derived from a patient's own blood and has been found to have pro-nerve regenerative properties in animal and human studies. A small pilot study at the principal investigator's institution demonstrated improved olfactory thresholds in patients with partial olfactory loss who received PrP injections. In this randomized clinical trial, the investigators aim to further evaluate the ability of PRP injections to restore olfactory function in human subjects. Given the lack of effective current treatments, a therapeutic benefit of PrP would represent a crucial advancement in research and treatment of olfactory loss, which affects a large swath of the population.

Patients will be seen at the Stanford Sinus center, or at the newly added collaborating institution UCSD, and those with smell loss will be identified by the clinically validated patient directed survey: The UPSIT (University of Pennsylvania Smell Identification Test). They will undergo nasal endoscopy to exclude structural causes of smell loss including mass or tumor. Nasal endoscopy will be performed to exclude structural causes of olfactory, using topical anesthesia (1% phenylephrine & 4% lidocaine topical spray). THESE ABOVE STEPS CONSTITUTE STANDARD OF CARE FOR EVALUATION OF OLFACTORY LOSS.

The timing of the initial research visit will depend on the evolution of the current covid-19 pandemic and adhere to Stanford guidelines regarding research visits. At the initial research visit, patients meeting inclusion criteria will be evaluated in a procedure room at the Stanford Sinus center. A baseline Sniffin' sticks smell test will be performed (see below). A small vial of blood will be drawn from the patient at the Blake Wilbur first floor laboratory. The research coordinator will walk the patient back to clinic along with the patient's blood smple. PRP will be isolated from the blood by the study investigator, following manufacturer instructions from the PurePRP preparation kit (Emcyte corporation), which will involve use of a centrifuge located in the clinic for this purpose. 0.5 mL of the PRP solution will be set aside for platelet quantification. From the remaining PRP solution, patients will then receive 1ml of autologous PrP or sterile saline (0.9% Sodium Chloride), which will be injected into the superior septum mucosa near the olfactory groove bilaterally. Patients will be blindfolded during injection to prevent identification of the injected specimen, and will previously be randomized in a 1:1 ratio via a random number generator. Patients will be monitored for side effects for 15 minutes. (We routinely perform nasal endoscopy with injection and associated procedures in our clinic, which patients tolerate very well.) Injections will then be performed twice more at 2-weeks and 4-weeks after the initial injection, for a total of 3 biweekly injections. ALL OF THE ABOVE STEPS ARE FOR RESEARCH PURPOSES.

The Sniffin' Sticks test is a validated, non-invasive assessment of olfactory function via presentation of scented felt pens to blindfolded patients. The output is the TDI score (threshold, discrimination, identification). The TDI score will be recorded at baseline (initial research visit), and then at 1-month and 3-months after the initial test, for a total of 3 tests. The first test will occur before the first injection, and the second test will be performed before the third injection. There will be no injection at the last (third) test. THE ABOVE VISITS ARE FOR RESEARCH PURPOSES.

The study time-line is summarized as follows Visit 1: 1st Sniffin' Sticks test, 1st injection Visit 2: 2 weeks after Visit 1, second injection Visit 3: 4 weeks after Visit 1, second test, third injection Visit 4: 3 months after Visit 1, third test

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Comparison of two randomized groups
Masking: Single (Participant)
Masking Description: Blindfold during injection and during portions of the smell test
Primary Purpose: Treatment
Official Title: Intranasal Injection of Platelet-rich Plasma Versus Saline for Treatment of Olfactory Dysfunction
Actual Study Start Date : June 22, 2021
Estimated Primary Completion Date : May 2022
Estimated Study Completion Date : July 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Saline
Injection of 1cc saline into olfactory cleft x4
Procedure: Injection into olfactory cleft
Already stated above.

Experimental: Platelet Rich Plasma
Injection of 1cc patient's own platelet rich plasma (PRP) into olfactory cleft x4
Procedure: Injection into olfactory cleft
Already stated above.




Primary Outcome Measures :
  1. Smelling ability [ Time Frame: 6 months ]
    Using Sniffin' Sticks olfactory testing pens to test smell



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04406584


Contacts
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Contact: Zara M Patel, MD 6507235651 zmpatel@stanford.edu

Locations
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United States, California
University of California - San Diego Recruiting
San Diego, California, United States, 92093
Contact: Carol Yan, MD       c1yan@health.ucsd.edu   
Stanford University Recruiting
Stanford, California, United States, 94305
Contact: Zara M Patel, MD    650-723-5651    zmpatel@stanford.edu   
Sponsors and Collaborators
Stanford University
University of California, San Diego
Investigators
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Principal Investigator: Zara M. Patel, MD Stanford University
Additional Information:
Publications:
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Responsible Party: Zara M. Patel, Associate Professor and Director of Endoscopic Skull Base Surgery, Stanford University
ClinicalTrials.gov Identifier: NCT04406584    
Other Study ID Numbers: IRB-55353
First Posted: May 28, 2020    Key Record Dates
Last Update Posted: September 17, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Zara M. Patel, Stanford University:
olfactory
olfactory loss
anosmia
hyposmia
olfactory dysfunction
prp
platelet enriched plasma
platelet rich plasma
endoscopic
covid19
post-viral disorder
Additional relevant MeSH terms:
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COVID-19
Virus Diseases
Nervous System Diseases
Olfaction Disorders
Olfactory Nerve Injuries
Olfactory Nerve Diseases
Disease
Pathologic Processes
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Sensation Disorders
Neurologic Manifestations
Cranial Nerve Injuries
Cranial Nerve Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries