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

Recruiting now · Not applicable · Has a placebo group

Conditions studied: Paraosmia

In brief

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.

Key facts

Study ID

NCT06283745

Run by

Stanford University

People needed

40

Starts

2024-11-23

Expected to finish

2027-03-22

Last updated by the study team

2024-11-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Stanford Sinus Center / Stanford University School of Medicine — Palo Alto, California, United States (enrolling)

Full record on ClinicalTrials.gov

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