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Intranasal Injection of PRP Versus Saline for Treatment of Olfactory Dysfunction

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04406584
Recruitment Status : Not yet recruiting
First Posted : May 28, 2020
Last Update Posted : May 28, 2020
Sponsor:
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. We have completed a pilot study here evaluating it's use in olfactory loss which demonstrated safety and also suggested efficacy. Therefore, we 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 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 our institution demonstrated improved olfactory thresholds in patients with partial olfactory loss who received PrP injections. In this randomized clinical trial, we 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 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 (this has been discussed with staff at the laboratory who are aware of our study). 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. Patients will then receive 1ml of autologous PrP or saline, 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. 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.) 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 Sniffin' Sticks score will be recorded at baseline (initial research visit). Then for the following three weeks after this initial research visit, patients will return to our clinic for repeat Sniffin' sticks test, blood draw and injection of PrP or saline. In total, participants will receive 4 injections of PrP or saline. Following the last injection, patients will return at 1, 3, and 6 months for repeat Sniffin' Sticks smell test. THE 1- AND 3-MONTH VISITS ARE FOR RESEARCH PURPOSES, WHILE THE 6-MONTH VISIT IS PART OF STANDARD OF CARE.

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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
Primary Purpose: Treatment
Official Title: Intranasal Injection of Platelet-rich Plasma Versus Saline for Treatment of Olfactory Dysfunction
Estimated Study Start Date : May 2020
Estimated Primary Completion Date : May 2021
Estimated Study Completion Date : July 2021

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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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

Sponsors and Collaborators
Stanford University
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Responsible Party: Zara M. Patel, Associate Professor, Stanford University
ClinicalTrials.gov Identifier: NCT04406584    
Other Study ID Numbers: IRB-55353
First Posted: May 28, 2020    Key Record Dates
Last Update Posted: May 28, 2020
Last Verified: May 2020
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
Additional relevant MeSH terms:
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Nervous System Diseases
Olfaction Disorders
Olfactory Nerve Injuries
Olfactory Nerve Diseases
Disease
Pathologic Processes
Sensation Disorders
Neurologic Manifestations
Cranial Nerve Injuries
Cranial Nerve Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries