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NCT Number: NCT06283745

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

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.

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Key information

Conditions

Paraosmia Nervous System Diseases Neurologic Manifestations Olfaction Disorders Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Platelet-rich plasma (PRP)

Other

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.

Saline

Other

Saline intranasal injection (sham injection)

Primary outcomes

  1. 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.

  2. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Homer Abaya, BS

CONTACT

[email protected]

(650) 725-6500

Maxime Fieux, MD, PhD

CONTACT

[email protected]

+33621611643

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Feb 28, 2024
Registry last updated
Nov 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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