Randomized Clinical Trial of Intranasal Injection of Platelet-Rich Plasma for Treatment of Parosmia

November 20, 2024 updated by: Zara M. Patel, Stanford University
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • California
      • Palo Alto, California, United States, 94304
        • Recruiting
        • Stanford Sinus Center / Stanford University School of Medicine
        • Contact:
        • Contact:
        • Contact:
          • Zara Patel, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Platelet Rich Plasma (PRP)
Participants receive PRP intranasal injection into the olfactory cleft three times, separated by two weeks each. Blood is drawn from the patient. This is placed in a centrifuge and using a specialized PRP kit (Emcyte), the sequential spinning process isolates the platelet-rich plasma portion of the blood and we inject that back into the patient within the nasal cavity.
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.
Active Comparator: Saline
Participants receive saline injections into the olfactory cleft three times, separated by two weeks each. (Sham/placebo injections).
Other: Saline
Saline intranasal injection (sham injection)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Sniffin Sticks Parosmia Test (SSParoT)
Time Frame: Assessed at baseline, 1 month, and 3 months

The test consists of a total of 22 sticks, 11 of which are pleasant odors and 11 of which are unpleasant odors. In this test, the test subject is offered a pair of sticks, 1 with an unpleasant odor and 1 with a pleasant odor.

The SSParoT is the first test to measure qualitative olfactory function. This test uses hedonic estimates of two oppositely odors (pleasant and unpleasant) to assess the Hedonic Range (HR) and Hedonic Direction (HD). These values represent the qualitative olfactory perception.
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
The QOD is a 25-item validated instrument in the measurement of olfactory-specific QOL (total score on 75) described by Hummel et al. Patients will undergo nasal endoscopy as part of their initial standard of care appointment to exclude structural causes of smell loss including mass or tumor, as well as ensuring there is no structural obstruction to the olfactory cleft such as severe septal deviation.
Assessed at baseline, 1 month, and 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stanford University

Investigators

  • Principal Investigator: Zara Patel, MD, Stanford Otolaryngology - Head and Neck Surgery

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

November 23, 2024

Primary Completion (Estimated)

March 22, 2027

Study Completion (Estimated)

March 22, 2027

Study Registration Dates

First Submitted

February 21, 2024

First Submitted That Met QC Criteria

February 27, 2024

First Posted (Actual)

February 28, 2024

Study Record Updates

Last Update Posted (Estimated)

November 22, 2024

Last Update Submitted That Met QC Criteria

November 20, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 73225

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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