Study on the Use of Autologous Adipose Tissue-Derived Stromal Vascular Fraction for Patients with Advanced Temporomandibular Joint Osteoarthritis

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What is this study about?

This clinical trial is focused on studying the effects of a treatment for temporomandibular joint osteoarthritis, a condition that affects the joint connecting the jaw to the skull, often leading to pain and difficulty in moving the jaw. The treatment being tested involves the use of autologous adipose tissue-derived stromal vascular fraction, which is a type of cell therapy derived from the patient’s own fat tissue. This treatment is administered as a cell suspension for injection directly into the affected joint.

The purpose of the study is to determine if injecting this cell therapy into the temporomandibular joint can slow down the progression of the disease, help regenerate the joint surface, and improve the quality of life for patients. The study will involve collecting data on patients’ symptoms, clinical examinations, and imaging results to analyze the effectiveness of the treatment.

Participants in the study will receive either the cell therapy or a placebo through an intra-articular injection, which means the injection is given directly into the joint. The study will monitor the patients over a period to observe any changes in their condition and gather information that could be used in future clinical practice.

1 initial assessment

An initial assessment is conducted to confirm eligibility for the study. This includes verifying the diagnosis of temporomandibular joint osteoarthritis (TMJ OA) classified as stage 4 or 5 according to the Wilkes classification.

Eligibility requires that the patient is between 18 and 65 years old and has not responded to at least 6 months of conservative treatment.

2 consent and enrollment

Upon meeting the eligibility criteria, the patient is informed about the study details and provides consent to participate.

Participation is voluntary, and the patient may withdraw at any stage.

3 treatment administration

The treatment involves an intra-articular injection of autologous adipose tissue-derived stromal vascular fraction containing 5 million cells.

This is administered as a cell suspension for injection directly into the temporomandibular joint.

4 follow-up evaluations

Regular follow-up evaluations are conducted to monitor the patient’s progress.

These evaluations include radiological assessments and questionnaires to gather data on the patient’s symptoms and joint condition.

5 data analysis and conclusion

The collected data is analyzed to determine the effectiveness of the treatment in slowing the progression of degenerative changes and promoting joint regeneration.

The study aims to apply the results in clinical practice to improve the quality of life for patients with TMJ OA.

Who Can Join the Study?

Patients must be between the ages of 18 and 65 years old.
Patients must have a condition called temporomandibular joint osteoarthritis (TMJ OA), which is a type of arthritis affecting the jaw joint.
The TMJ OA must be classified as stage 4 or 5 according to the Wilkes classification, which is a system used to describe the severity of the condition.
Patients must have tried at least 6 months of conservative treatment, which means non-surgical methods like medication or physical therapy, without success.
Participation in the study is voluntary, meaning patients choose to join and can leave the study at any time if they wish.
Both men and women are eligible to participate in the study.

Who Cannot Join the Study?

Patients with a different condition than temporomandibular joint osteoarthritis classified as Wilkes 4-5 cannot participate. This condition affects the joint connecting the jaw to the skull.
Patients who are not within the specified age range for the study cannot participate.
Patients who are part of a vulnerable population, which means they might need special protection or care, cannot participate.

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
Tartu University Hospital	Tartu	Estonia

Trial status

Country	Status	Recruitment Start
Estonia	Not yet recruiting	01.09.2022

Trial locations

Investigated drugs:

Autologous Adipose Tissue-Derived Stromal Vascular Fraction

Nanofat is a type of fat that is processed into very small particles. In this clinical trial, nanofat is used as a treatment for temporomandibular joint osteoarthritis (TMJ OA). The goal is to inject this nanofat into the joint to see if it can slow down the worsening of joint damage, help repair the joint surface, and improve the patient’s quality of life.

Investigated diseases:

Osteoarthritis

Temporomandibular Joint Osteoarthritis – This condition affects the temporomandibular joint, which connects the jaw to the skull. It is characterized by the degeneration of the joint’s cartilage and changes in the bone structure. As the disease progresses, individuals may experience pain, stiffness, and a reduced range of motion in the jaw. Over time, the joint may become deformed, leading to difficulties in chewing and speaking. The Wilkes classification 4-5 indicates advanced stages of the disease, where significant structural changes and symptoms are present.

Trial ID:

2024-520244-41-00

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on the Use of Autologous Adipose Tissue-Derived Stromal Vascular Fraction for Patients with Advanced Temporomandibular Joint Osteoarthritis

What is this study about?

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