Intranasal Injection of PRP Versus Saline for Treatment of Olfactory Dysfunction

Trial ID or NCT#

NCT04406584

Status

not recruiting iconNOT RECRUITING

Purpose

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.

Official Title

Intranasal Injection of Platelet-rich Plasma Versus Saline for Treatment of Olfactory Dysfunction

Eligibility Criteria

Ages Eligible for Study: Older than 18 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. - 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:
  1. - 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
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Investigator(s)

Zara Patel, MD
Zara Patel, MD
Head and neck surgeon, Otolaryngologist, Rhinologist, Smelling Disorders Specialist
Professor of Otolaryngology - Head & Neck Surgery (OHNS)

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Contact

Zara M Patel, MD
650-723-5651

View on ClinicalTrials.gov