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

Conditions

• Paraosmia

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Platelet-rich Plasma (PRP) — OTHER
  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 — OTHER
  Saline intranasal injection (sham injection)

Study Details

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 Dates

Start date

Nov 23, 2024

Status verified

Nov 2024

Primary completion

Mar 22, 2027

Completion

Mar 22, 2027

Study Design

Enrollment

40 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

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).

Primary Outcome Measure

Change in Sniffin Sticks Parosmia Test (SSParoT) [ Time Frame: Assessed at baseline, 1 month, and 3 months ]

Central Contacts

• Homer Abaya, BS
  (650) 725-6500
  [email protected]
• Maxime Fieux, MD, PhD
  +33621611643
  [email protected]

Locations (1)

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