Overview
Sponsor-declared trial summary
Temporomandibular joint osteoarthritis, Wilkes classification 4-5
The aim of this study is to determine the effectiveness of using nanofat in the treatment of temporomandibular joint osteoarthritis (TMJ OA). The study seeks to identify correlations between the patient's subjective symptoms, clinical presentation, and radiological findings, perform data analysis, and apply the results…
Key facts
- Sponsor
- Tartu University Hospital
- Participant type
- Patients
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Musculoskeletal Diseases [C05], Diseases [C] - Stomatognathic Diseases [C07]
- Decision date (initial)
- 2025-03-12
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-520244-41-00
- EudraCT number
- 2022-000501-26
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Therapy
The aim of this study is to determine the effectiveness of using nanofat in the treatment of temporomandibular joint osteoarthritis (TMJ OA). The study seeks to identify correlations between the patient's subjective symptoms, clinical presentation, and radiological findings, perform data analysis, and apply the results in clinical practice.
The hypothesis of this study is that the injection of autologous nanofat into the temporomandibular joint slows the progression of degenerative changes, promotes the regeneration of the deformed joint surface, and thereby improves the quality of life for patients.
Conditions and MedDRA coding
Temporomandibular joint osteoarthritis, Wilkes classification 4-5
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 1
- The study plans to include patients aged 18-65 years, with TMJ OA classified as stage 4 or 5 according to the Wilkes classification (9), and who have not responded to at least 6 months of conservative treatment. Participation in the study is voluntary, and the participant may withdraw at any stage.
Exclusion criteria 1
- Exclusion criteria include pregnancy, severe chronic diseases (malignant tumors, lymphoproliferative disorders, coagulation disorders, diabetes, acute viral infections, and severe general health conditions), or prior surgical treatment of the temporomandibular joint.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Collected radiological evaluations and questionnaires
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
Autologous Adipose Tissue-Derived Stromal Vascular Fraction 5 Millions Cells
PRD11489019 · Product
- Active substance
- Autologous Adipose Tissue-Derived Stromal Vascular Fraction
- Substance synonyms
- Autologous stromal vascular cell fraction from adipose tissue
- Pharmaceutical form
- CELL SUSPENSION FOR INJECTION
- Route of administration
- INTRA-ARTICULAR INJECTION
- Max daily dose
- 1 ml millilitre(s)
- Max total dose
- 1 ml millilitre(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Not Authorised
- MA holder
- CENTRE HOSPITALIER UNIVERSITAIRE ROUEN
- Paediatric formulation
- No
- Orphan designation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Tartu University Hospital
- Sponsor organisation
- Tartu University Hospital
- Address
- L. Puusepa Tn 1a
- City
- Tartu Linn
- Postcode
- 50406
- Country
- Estonia
Scientific contact point
- Organisation
- Tartu University Hospital
- Contact name
- Oksana Ivask
Public contact point
- Organisation
- Tartu University Hospital
- Contact name
- Oksana Ivask
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Estonia | Authorised, recruitment pending | 14 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 4 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | Olar Tammik uurimustoo kavand | 1 |
| Recruitment arrangements (for publication) | Recruitment Arrangements | 1 |
| Subject information and informed consent form (for publication) | Patsiendi informatsioon ja nousolek | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | KASUTUSJUHEND LIPOCUBE | 1 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-03-07 | Estonia | Acceptable 2025-03-12
|
2025-03-12 |