Anosmia Clinical Trials

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

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
California
Stanford Sinus Center / Stanford University School of Medicine
RECRUITING
Palo Alto
Contact Information
Primary
Homer Abaya, BS
habaya@stanford.edu
(650) 725-6500
Backup
Maxime Fieux, MD, PhD
fieuxma@stanford.edu
+33621611643
Time Frame
Start Date: 2024-11-23
Estimated Completion Date: 2027-03-22
Participants
Target number of participants: 40
Treatments
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.
Active_comparator: Saline
Participants receive saline injections into the olfactory cleft three times, separated by two weeks each. (Sham/placebo injections).
Related Therapeutic Areas
Sponsors
Leads: Stanford University

This content was sourced from clinicaltrials.gov