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Study on the Tolerance of Intra-Articular Injection of Autologous Stromal Vascular Fraction for Adults with Thumb Arthritis (Rhizarthrosis)

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What is this study about?

This clinical trial is focused on studying the treatment of rhizarthrosis, a type of arthritis that affects the base of the thumb. The treatment being tested is an injection of a special type of cell therapy called autologous adipose tissue-derived stromal vascular fraction. This means that cells are taken from a person’s own fat tissue, processed, and then injected back into the joint to potentially help with the condition.

The purpose of the study is to assess how well people tolerate this treatment over a period of six months. Participants will receive an injection directly into the affected joint. Throughout the study, the participants’ hand function and pain levels will be monitored at different intervals, specifically at one, three, and six months. This will help researchers understand how the treatment affects the joint and if it helps in reducing pain and improving hand function.

Additionally, the study will look at any side effects that might occur from the treatment. The researchers will also use imaging techniques like MRI and X-rays to see if there are any changes in the cartilage of the joint. This study aims to provide valuable information on the potential benefits and safety of using this cell therapy for treating rhizarthrosis.

1 initial visit

During the initial visit, eligibility for the study is confirmed. This includes being an adult with rhizarthrosis stage 1 to 3, having experienced ineffective symptomatic treatment for at least 6 months, and meeting specific pain and functional scores.

A negative pregnancy test is required for women of childbearing age, and effective contraception must be in place for both men and women as applicable.

2 treatment administration

The treatment involves an intra-articular injection of autologous adipose tissue-derived stromal vascular fraction, which is a cell suspension containing 5 million cells.

This injection is administered directly into the joint affected by rhizarthrosis.

3 follow-up assessments

Follow-up assessments occur at 1, 3, and 6 months after the injection.

These assessments include evaluating hand function using various tests, measuring pain levels, and monitoring any changes in cartilage through MRI and X-ray imaging.

The progress of long-term pain management is also monitored, and any adverse events are recorded.

4 final evaluation

The primary goal is to assess the tolerance of the treatment over a 6-month period, focusing on any significant adverse reactions.

Secondary evaluations include functional improvements, pain reduction, and cartilage regeneration.

Who Can Join the Study?

  • Must be an adult (18 years or older).
  • Have a condition called rhizarthrosis at stages 1 to 3. This is a type of arthritis affecting the base of the thumb.
  • Have tried medical treatments for at least 6 months, such as painkillers, braces, anti-inflammatory drugs, or injections into the thumb joint, but these treatments are no longer working.
  • Experience pain with a score of 4 or higher on a pain scale called EVA.
  • Have a score of 20 or higher on a hand function test called Quick Dash or PRWHE.
  • Be part of a social security scheme.
  • Have read and understood the information about the study and signed a consent form agreeing to participate.
  • If a woman of childbearing age, must use effective birth control methods for 3 months and have a negative pregnancy test at the start of the study. If postmenopausal, must not have had a period for at least 12 months before starting the study.
  • If a man, must have surgical sterility, use a condom, or have a partner using effective birth control for at least 3 months and during the study. If the partner is postmenopausal, she must not have had a period for at least 12 months before starting the study.

Who Cannot Join the Study?

  • Patients who have a different stage of rhizarthrosis than DELL 1 to 3.
  • Individuals who are not adults.
  • People who are not able to give their consent to participate in the study.
  • Patients who have other medical conditions that might interfere with the study.
  • Individuals who are pregnant or breastfeeding.
  • People who have had a recent injury or surgery in the area being studied.
  • Patients who are currently participating in another clinical trial.
  • Individuals who have allergies to the substances used in the study.
  • People who have a history of severe allergic reactions.
  • Patients who have an infection in the area being studied.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

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Other Sites

Site Name City Country Status
Centre Hospitalier Universitaire Rouen Rouen France
Centre Hospitalier Universitaire Amiens Picardie Amiens France
Centre Hospitalier Universitaire De Caen Normandie Caen France

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
France France
Recruiting
15.02.2024

Trial locations

Investigated drugs:

Autologous Stromal Vascular Fraction (FVS) is a therapy used in this clinical trial. It involves taking a small amount of fat tissue from the patient’s own body, processing it to extract a mixture of cells, and then injecting these cells into the joint affected by rhizarthrosis. The goal is to help reduce pain and improve joint function by using the body’s own cells to promote healing and repair.

Investigated diseases:

Rhizarthrosis – Rhizarthrosis, also known as thumb osteoarthritis, is a degenerative joint disease affecting the base of the thumb. It occurs when the cartilage that cushions the joint wears down over time, leading to pain, stiffness, and reduced range of motion. As the condition progresses, individuals may experience difficulty in gripping or pinching objects, and the joint may become swollen or tender. The disease typically affects adults and can vary in severity, with some experiencing mild discomfort and others facing significant functional impairment. Over time, the joint may develop bony enlargements or deformities, further impacting hand function.

Trial ID:
2024-515317-18-00
Protocol code:
2018/0419/HP
NCT ID:
NCT05708430
Trial Phase:
Therapeutic exploratory (Phase II)

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