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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 : 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

Tracking Information
First Submitted Date  ICMJE May 11, 2020
First Posted Date  ICMJE May 28, 2020
Last Update Posted Date May 28, 2020
Estimated Study Start Date  ICMJE May 2020
Estimated Primary Completion Date May 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 23, 2020)
Smelling ability [ Time Frame: 6 months ]
Using Sniffin' Sticks olfactory testing pens to test smell
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Intranasal Injection of PRP Versus Saline for Treatment of Olfactory Dysfunction
Official Title  ICMJE Intranasal Injection of Platelet-rich Plasma Versus Saline for Treatment of Olfactory Dysfunction
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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE
  • Olfactory Disorder
  • Olfaction Disorders
  • Olfactory Nerve Injuries
  • Olfactory Nerve Disorder
  • Olfactory Nerve Diseases
Intervention  ICMJE Procedure: Injection into olfactory cleft
Already stated above.
Study Arms  ICMJE
  • Placebo Comparator: Saline
    Injection of 1cc saline into olfactory cleft x4
    Intervention: Procedure: Injection into olfactory cleft
  • Experimental: Platelet Rich Plasma
    Injection of 1cc patient's own platelet rich plasma (PRP) into olfactory cleft x4
    Intervention: Procedure: Injection into olfactory cleft
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: May 23, 2020)
20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 2021
Estimated Primary Completion Date May 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Zara M Patel, MD 6507235651 zmpatel@stanford.edu
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04406584
Other Study ID Numbers  ICMJE IRB-55353
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Zara M. Patel, Stanford University
Study Sponsor  ICMJE Stanford University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Stanford University
Verification Date May 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP