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

Verified siteInvestigationalNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

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.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 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.
Step 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.
Step 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.
Step 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.
Step 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 trial?

6 criteria

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 trial?

3 criteria

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.

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Verified sites

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Verified
Tartu University Hospital
Tartu, Estonia

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Investigated drugs

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.

Autologous Adipose Tissue-Derived Stromal Vascular Fraction

What is already known about the treatment

Nanofat – This medication is administered through injection directly into the temporomandibular joint. It is currently being studied in clinical trials for its potential benefits in treating temporomandibular joint osteoarthritis, particularly in advanced stages classified as Wilkes 4-5. The main therapeutic indication is to slow the progression of degenerative changes and promote regeneration of the joint surface, thereby improving patients' quality of life. At the molecular level, nanofat is believed to work by providing regenerative cells that aid in tissue repair and reduce inflammation. It is classified under regenerative medicine therapies.

Investigated diseases

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.