Recruiting

Platelet-Rich Plasma

Sponsor:

Stanford University

Code:

NCT06283745

Conditions

Paraosmia

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Platelet-rich Plasma (PRP)

Saline

Study Details

Brief 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.

Conditions

Paraosmia

Study ID

NCT06283745

Start date

Nov 23, 2024

Status verified date

Nov, 2024

Completion date

Mar 22, 2027

Anticipated

Primary completion date

Mar 22, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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).

Interventions

Platelet-rich Plasma (PRP)

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

Saline intranasal injection (sham injection)

Primary outcome measure

  • Change in Sniffin Sticks Parosmia Test (SSParoT) [ Time Frame: Assessed at baseline, 1 month, and 3 months ]
  • Change in questionnaire of olfactory disorders (QOD) scale score [ Time Frame: Assessed at baseline, 1 month, and 3 months ]

Central Contacts and Locations

Central contacts

Homer Abaya, BS

(650) 725-6500habaya@stanford.edu

Maxime Fieux, MD, PhD

+33621611643fieuxma@stanford.edu

Locations

Stanford Sinus Center / Stanford University School of Medicine

Recruiting

Palo Alto, California, United States, 94304

Contacts

Homer Abaya, BS

(650) 725-6500habaya@stanford.edu

Maxime Fieux, MD, PhD

+33621611643fieuxma@stanford.edu

More Information

Sponsor

Stanford University

Last update posted

Nov 22, 2024

Last verified

Nov, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Stanford University on 2024-11-22.