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Intranasal Injection of PRP Versus Saline for Treatment of Olfactory Dysfunction

Not Recruiting

Trial ID: NCT04406584

Age - 18 Years-N/A Gender - All Accepting Healthy Volunteers - No

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

Stanford Investigator(s)

Zara Patel, MD
Zara Patel, MD

Professor of Otolaryngology - Head & Neck Surgery (OHNS)

Eligibility


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

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Intervention(s):

procedure: Injection into olfactory cleft

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Zara M Patel, MD
650-723-5651

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