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Study on Degenerative Disc Disease: Effects of Autologous Adipose-Derived Mesenchymal Stem Cells in Patients with Degenerative Disc Disease

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What is this study about?

This clinical trial is focused on studying degenerative disc disease, a condition that affects the spine and can cause back pain. The treatment being tested involves the use of autologous adipose-derived mesenchymal stem cells, which are special cells taken from a person’s own body fat and then grown in a lab. These cells are prepared as a suspension for injection and are given to patients through a procedure called intradiscal use, which means they are injected directly into the affected disc in the spine.

The purpose of the study is to observe how patients respond to this stem cell therapy and to monitor any potential side effects. Participants in the study will be divided into two groups: one receiving the stem cell treatment and the other serving as a control group, which may receive a placebo. The study will track the success of the treatment by looking at pain reduction and other health measures over a period of two years. This includes keeping a pain diary and using various health questionnaires like the VAS-score and EQ-5D to assess the patient’s quality of life and pain levels.

Throughout the study, researchers will also use MRI scans to examine changes in the discs, such as their height and water content. The trial aims to provide valuable insights into whether this stem cell therapy can effectively regenerate intervertebral discs and improve symptoms for those suffering from degenerative disc disease.

1 joining the study

Upon joining the study, eligibility is confirmed based on criteria such as age between 20 to 60 years, lumbar back pain affecting a maximum of two levels, and moderate disc degeneration.

Participation involves understanding the study’s purpose, which is to monitor the response and potential side effects of a treatment using autologous adipose-derived mesenchymal stem cells for degenerative disc disease.

2 treatment administration

The treatment involves the use of autologous adipose-derived mesenchymal stem cells, which are cells taken from your own body fat, expanded in a lab, and prepared as a suspension for injection.

The injection is administered directly into the intervertebral disc, a procedure known as intradiscal use.

3 monitoring and follow-up

After the treatment, regular monitoring is conducted to assess the success of the treatment and any side effects. This includes tracking pain reduction compared to a control group over a period of two years.

Various tools are used to measure outcomes, including the VAS-score (a scale for pain intensity), a pain diary, and questionnaires like EQ-5D, ODI, SF-36, and LBPRS to evaluate quality of life and physical function.

4 imaging assessments

Secondary assessments involve imaging tests such as MRI to evaluate changes in the disc’s structure, including height, water content, and the presence of substances like fat, lipid, lactose, glucose, proteoglycans, and collagen.

5 completion of the study

The study is expected to conclude by the end of 2026, with all data collected and analyzed to determine the effectiveness and safety of the treatment.

Who Can Join the Study?

  • Patients must have lumbar back pain, which means pain in the lower back, affecting a maximum of 2 levels of the spine.
  • Patients should be between the ages of 20 to 60 years.
  • Patients must have moderate disc degeneration, which is a condition where the spinal discs have worn down to a moderate level, specifically classified as Pfirman grade 2-3.

Who Cannot Join the Study?

  • Patients who do not have degenerative disc disease cannot participate.
  • Patients who are not within the specified age range cannot participate.
  • Patients who are part of a vulnerable population cannot participate.

Where you can join this trial?

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Other Sites

Site Name City Country Status
Abxptn Uzdziysqvv Hjithotd Aarhus Denmark

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

Trial status

Country Status Recruitment Start
Denmark Denmark
Not recruiting
16.05.2024

Trial locations

Investigated drugs:

AD-MSC therapy is a treatment that uses a patient’s own stem cells to help repair damaged tissues in the spine. These stem cells are taken from the patient’s body, usually from fat tissue, and then processed in a lab. Once ready, they are injected into the damaged area of the spine. The goal of this therapy is to help regenerate the intervertebral discs, which are the cushions between the bones in your spine. This treatment aims to reduce pain and improve function in patients with degenerative disc disease (DDD).

Degenerative Disc Disease – Degenerative Disc Disease is a condition where the intervertebral discs, which act as cushions between the bones of the spine, begin to break down. This degeneration can lead to a loss of disc height and changes in the disc’s structure and function. As the discs deteriorate, they may cause pain, which can vary in intensity and may be chronic or episodic. The condition can also lead to reduced flexibility and mobility in the spine. Over time, the degeneration may result in the development of bone spurs or herniated discs. These changes can further contribute to discomfort and may affect the surrounding nerves.

Trial ID:
2024-514475-17-00
Trial Phase:
Human Pharmacology (Phase I) – Other

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