Olfactory DysfunctionPANDORANCT07473830
PANDORA: Evaluation of Platelet-rich Plasma in Non-tumoural Odour Disorders: a Descriptive Pilot Study.
A study testing Autologous Platelet-Rich Plasma (PRP) Injection in people with Olfactory Dysfunction and Post-traumatic Olfactory Dysfunction, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
This is a prospective, single-center, single-arm, non-comparative descriptive pilot study evaluating autologous platelet-rich plasma (PRP) injections in adults with persistent (>6 months) non-tumoural olfactory dysfunction, either age-related degenerative olfactory dysfunction (DOD) or post-traumatic olfactory… Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Olfactory Dysfunction, Post-traumatic Olfactory Dysfunction, Age-related Degenerative Olfactory Dysfunction
- What is being tested?
- Autologous Platelet-Rich Plasma (PRP) Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- May 2026to May 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults with persistent (>6 months) non-tumoural olfactory dysfunction: age-related degenerative olfactory dysfunction (DOD) or post-traumatic olfactory dysfunction (DOPT).
- Objective olfactory impairment confirmed by Sniffin' Sticks Test (TDI ≤ 30.5/48).
- MRI within the last 6 months after onset excluding tumoural etiology or central cause.
- Normal nasal endoscopy.
- Affiliated to a social security system (or equivalent).
- Written informed consent.
Who cannot join
- Inflammatory rhinosinus disease (e.g., nasal polyposis) or granulomatosis with polyangiitis.
- Coagulation disorder.
- Brain radiotherapy history or ongoing chemotherapy.
- Olfactory disorder temporally linked to SARS-CoV-2 infection (delay <1 month).
- History of sinus or skull base surgery (except septoplasty/turbinoplasty/rhinoseptoplasty).
- Therapeutic-dose anticoagulants.
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- Refusal to discontinue chronic NSAID use if applicable.
- Pregnancy/labor/breastfeeding.
- Vulnerable persons (deprived of liberty; legal protection; etc.).
- Participation in another interventional study with ongoing exclusion period.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
Hôpital Lyon Sud
Pierre-Bénite, 69310
Maxime FIEUX, Dr, 0033 4 72 66 64 15 ext. +33, maxime.fieux@chu-lyon.fr
About this study
This is a prospective, single-center, single-arm, non-comparative descriptive pilot study evaluating autologous platelet-rich plasma (PRP) injections in adults with persistent (>6 months) non-tumoural olfactory dysfunction, either age-related degenerative olfactory dysfunction (DOD) or post-traumatic olfactory dysfunction (DOPT). Participants receive three PRP injections over 4 weeks (Day 0, Day 14, Day 28), with follow-up visits at Month 3 and Month 6 after the first injection. Olfactory function is assessed using the Sniffin' Sticks Test (TDI score). Patient-reported outcomes include SNOT-22 and a visual analog scale (VAS) for perceived olfactory impairment. Safety is assessed through adverse event collection.
Read the detailed description
Prospective consecutive recruitment in an ENT department at Hôpital Lyon Sud (Hospices Civils de Lyon). Eligible participants are enrolled into one of two diagnostic cohorts (DOD or DOPT), and analyses are performed separately by cohort. PRP is prepared from autologous venous blood using a standardized preparation system and injected under endoscopic guidance in the olfactory cleft area (superior nasal septum mucosa). Follow-up assessments are performed at baseline and at Months 3 and 6 after the first injection.
- Conditions
- Olfactory Dysfunction, Post-traumatic Olfactory Dysfunction, Age-related Degenerative Olfactory Dysfunction
- Being tested
- Autologous Platelet-Rich Plasma (PRP) Injection
- Keywords
- Platelet-rich plasma, PRP, Sniffin' Sticks, Olfactory cleft, Hyposmia, Anosmia
- Medical subject headings
- Anosmia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autologous Platelet-Rich Plasma (PRP) InjectionBiological
At each injection visit (Day 0, Day 14 ±1, Day 28 ±1), venous blood is collected and processed to obtain autologous PRP using a standardized preparation system. PRP is injected under endoscopic guidance into the superior nasal septum mucosa near the olfactory cleft, up to a total volume of 4 mL per visit. Participants are monitored after each injection and adverse events are recorded.
| Study group | Role | What they receive |
|---|---|---|
| PRP injections | Experimental | Single arm receiving autologous platelet-rich plasma injections at Day 0, Day 14 (±1), and Day 28 (±1), with follow-up at Months 3 and 6. Receives: Biological: Autologous Platelet-Rich Plasma (PRP) Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of participants with clinically meaningful improvement in olfactory function (Sniffin' Sticks Test TDI score)
Proportion of participants whose change in olfactory function, measured using the Sniffin' Sticks Test (Threshold, Discrimination, Identification score - TDI), between baseline (Visit 1, prior to the first PRP injection) and the 6-month follow-up visit reaches or exceeds the minimal clinically significant difference (MCID) of 5.5 points on the 48-point TDI scale. The TDI score combines three components: olfactory threshold (T), odor discrimination (D), and odor identification (I).
Measured: Baseline (Visit 1, prior to first injection) to Month 6 follow-up (Visit 5)
Secondary outcomes (5)
Occurrence of treatment-related adverse events
ccurrence and type of adverse events during the study period. Adverse events will be classified according to the Common Terminology Criteria for Adverse Events (CTCAE v5.0). For each adverse event, the investigator will assess severity and relationship to the experimental treatment.
Measured: From first injection (Day 0) to Month 6 follow-up visit
Change in olfactory function at Month 3 (TDI score)
Change in olfactory function measured by the Sniffin' Sticks Test (TDI score) between baseline (Visit 1, before the first injection) and the Month 3 follow-up visit.
Measured: Baseline (Visit 1) to Month 3 follow-up (Visit 4)
Change in olfactory function at Month 6 (TDI score)
Change in olfactory function measured by the Sniffin' Sticks Test (TDI score) between baseline (Visit 1, before the first injection) and the Month 6 follow-up visit.
Measured: Baseline (Visit 1) to Month 6 follow-up (Visit 5)
Change in quality of life (SNOT-22 score)
Change in quality of life assessed using the Sino-Nasal Outcome Test (SNOT-22) questionnaire between baseline and Month 6. The SNOT-22 score ranges from 0 to 110, with higher scores indicating greater symptom burden. A minimal clinically significant difference is considered to be 8.9 points.
Measured: Baseline (Visit 1) to Month 6 follow-up (Visit 5)
Change in patient-reported olfactory impairment (Visual Analog Scale)
Change in patient-reported olfactory impairment assessed using a Visual Analog Scale (VAS) ranging from 0 (no discomfort) to 10 (unbearable discomfort) between baseline and Month 6.
Measured: Baseline (Visit 1) to Month 6 follow-up (Visit 5)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2026
- Study startMay 2026 (estimated)
- Primary completionMay 2028 (estimated)
- Study completionMay 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Olfactory DysfunctionStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single-arm descriptive pilot study with two diagnostic cohorts analyzed separately (DOD and DOPT).
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07473830
- Sponsor's protocol ID
- 69HCL24_1192
- Other IDs
- 2025-A02847-42
- Acronym
- PANDORA
- Status last verified
- Mar 2026
- First submitted
- 11 Mar 2026
- Last updated
- 20 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PANDORA: Evaluation of Platelet-rich Plasma in Non-tumoural Odour Disorders: a Descriptive Pilot Study.
- ClinicalTrials.gov ID
- NCT07473830
- Acronym / sponsor ID
- PANDORA / 69HCL24_1192
- Conditions
- Olfactory Dysfunction, Post-traumatic Olfactory Dysfunction, Age-related Degenerative Olfactory Dysfunction
- Keywords
- Platelet-rich plasma, PRP, Sniffin' Sticks, Olfactory cleft, Hyposmia, Anosmia
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- May 2026 (estimated)
- Primary completion
- May 2028 (estimated)
- Study completion
- May 2028 (estimated)
- First posted
- 16 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a prospective, single-center, single-arm, non-comparative descriptive pilot study evaluating autologous platelet-rich plasma (PRP) injections in adults with persistent (>6 months) non-tumoural olfactory dysfunction, either age-related degenerative olfactory dysfunction (DOD) or post-traumatic olfactory dysfunction (DOPT). Participants receive three PRP injections over 4 weeks (Day 0, Day 14, Day 28), with follow-up visits at Month 3 and Month 6 after the first injection. Olfactory function is assessed using the Sniffin' Sticks Test (TDI score). Patient-reported outcomes include SNOT-22 and a visual analog scale (VAS) for perceived olfactory impairment. Safety is assessed through adverse event collection.
Detailed description
Prospective consecutive recruitment in an ENT department at Hôpital Lyon Sud (Hospices Civils de Lyon). Eligible participants are enrolled into one of two diagnostic cohorts (DOD or DOPT), and analyses are performed separately by cohort. PRP is prepared from autologous venous blood using a standardized preparation system and injected under endoscopic guidance in the olfactory cleft area (superior nasal septum mucosa). Follow-up assessments are performed at baseline and at Months 3 and 6 after the first injection.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single-arm descriptive pilot study with two diagnostic cohorts analyzed separately (DOD and DOPT).
| Arm | Type | Receives |
|---|---|---|
| PRP injections | Experimental | Biological: Autologous Platelet-Rich Plasma (PRP) InjectionSingle arm receiving autologous platelet-rich plasma injections at Day 0, Day 14 (±1), and Day 28 (±1), with follow-up at Months 3 and 6. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adults with persistent (>6 months) non-tumoural olfactory dysfunction: age-related degenerative olfactory dysfunction (DOD) or post-traumatic olfactory dysfunction (DOPT).
- Objective olfactory impairment confirmed by Sniffin' Sticks Test (TDI ≤ 30.5/48).
- MRI within the last 6 months after onset excluding tumoural etiology or central cause.
- Normal nasal endoscopy.
- Affiliated to a social security system (or equivalent).
Key exclusion criteria (10 listed)
- Inflammatory rhinosinus disease (e.g., nasal polyposis) or granulomatosis with polyangiitis.
- Coagulation disorder.
- Brain radiotherapy history or ongoing chemotherapy.
- Olfactory disorder temporally linked to SARS-CoV-2 infection (delay <1 month).
- History of sinus or skull base surgery (except septoplasty/turbinoplasty/rhinoseptoplasty).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Autologous Platelet-Rich Plasma (PRP) InjectionAt each injection visit (Day 0, Day 14 ±1, Day 28 ±1), venous blood is collected and processed to obtain autologous PRP using a standardized preparation system. PRP is injected under endoscopic guidance into the superior nasal septum mucosa near the olfactory cleft, up to a total volume of 4 mL per visit. Participants are monitored after each injection and adverse events are recorded. | Biological | PRP injections |
Primary outcome
Proportion of participants with clinically meaningful improvement in olfactory function (Sniffin' Sticks Test TDI score)
Time frame: Baseline (Visit 1, prior to first injection) to Month 6 follow-up (Visit 5)
Proportion of participants whose change in olfactory function, measured using the Sniffin' Sticks Test (Threshold, Discrimination, Identification score - TDI), between baseline (Visit 1, prior to the first PRP injection) and the 6-month follow-up visit reaches or exceeds the minimal clinically significant difference (MCID) of 5.5 points on the 48-point TDI scale. The TDI score combines three components: olfactory threshold (T), odor discrimination (D), and odor identification (I).
5 secondary outcomes
Occurrence of treatment-related adverse events
Time frame: From first injection (Day 0) to Month 6 follow-up visit
Change in olfactory function at Month 3 (TDI score)
Time frame: Baseline (Visit 1) to Month 3 follow-up (Visit 4)
Change in olfactory function at Month 6 (TDI score)
Time frame: Baseline (Visit 1) to Month 6 follow-up (Visit 5)
Change in quality of life (SNOT-22 score)
Time frame: Baseline (Visit 1) to Month 6 follow-up (Visit 5)
Change in patient-reported olfactory impairment (Visual Analog Scale)
Time frame: Baseline (Visit 1) to Month 6 follow-up (Visit 5)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Autologous Platelet-Rich Plasma (PRP) Injection in people with Olfactory Dysfunction and Post-traumatic Olfactory Dysfunction, run by Hospices Civils de Lyon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 20 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact MAxime FIEUX, Dr (0033 4 72 66 64 15 ext. +33, maxime.fieux@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of participants with clinically meaningful improvement in olfactory function (Sniffin' Sticks Test TDI score) (time frame: Baseline (Visit 1, prior to first injection) to Month 6 follow-up (Visit 5)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2026.