#1 Clinical Trials Search in Europe

Autologous Adipose Tissue-Derived Stromal Vascular Fraction

Autologous Adipose Tissue-Derived Stromal Vascular Fraction (ADSVF) is an innovative treatment being studied in clinical trials for various medical conditions. This article explores the use of ADSVF in treating urethral strictures, rhizarthrosis (thumb arthritis), diabetic foot ulcers, scarred vocal folds, and perianal Crohn’s disease fistulas. These trials aim to evaluate the safety, efficacy, and potential benefits of ADSVF in addressing challenging medical issues.

Table of Contents

What is Autologous Adipose Tissue-Derived Stromal Vascular Fraction (ADSVF)?

Autologous Adipose Tissue-Derived Stromal Vascular Fraction (ADSVF) is an innovative cellular therapy that uses a patient’s own fat tissue to obtain a mixture of cells with potential regenerative properties[1]. The term “autologous” means the cells come from the patient’s own body, reducing the risk of rejection. ADSVF contains a variety of cell types, including stem cells, which may have the ability to repair and regenerate damaged tissues.

How ADSVF is Obtained

The process of obtaining ADSVF involves several steps:

  1. Liposuction: A small amount of fat tissue is removed from the patient’s body, typically from the abdomen or thighs, through a minimally invasive procedure called liposuction[2].
  2. Processing: The extracted fat tissue is then processed in a laboratory to isolate the stromal vascular fraction, which contains the desired cells.
  3. Preparation: The isolated cells are prepared into a suspension for injection.

This process allows for the creation of a personalized treatment using the patient’s own cells.

Potential Medical Applications of ADSVF

Research is ongoing to explore the potential of ADSVF in treating various medical conditions. Some of the areas being investigated include:

  • Urethral Stricture: ADSVF is being studied as a potential treatment for recurrent urethral stricture, a condition where the urethra narrows, making it difficult to urinate[1].
  • Rhizarthrosis (Thumb Arthritis): Researchers are investigating whether ADSVF injections can help alleviate symptoms and potentially regenerate cartilage in patients with thumb arthritis[2].
  • Diabetic Foot Ulcers: ADSVF is being explored as a novel treatment for diabetic foot ulcers that are unresponsive to standard care[3].
  • Scarred Vocal Folds: Studies are underway to determine if ADSVF injections can improve voice quality in patients with scarred vocal folds[4].
  • Perianal Crohn’s Disease Fistulas: ADSVF is being investigated as a potential treatment for complex, refractory perianal fistulas in patients with Crohn’s disease[5].

Ongoing Clinical Research

Several clinical trials are currently underway to evaluate the safety and efficacy of ADSVF for various conditions:

  • A study is assessing the safety of ADSVF injection for recurrent urethral stricture[1].
  • Another trial is investigating the tolerance and potential effects of ADSVF injections for thumb arthritis (rhizarthrosis)[2].
  • Researchers are evaluating ADSVF as a treatment for diabetic foot ulcers that haven’t responded to conventional treatments[3].
  • A study is comparing ADSVF injections to placebo for treating scarred vocal folds[4].
  • ADSVF is being studied in combination with microfat injections for treating complex perianal fistulas in Crohn’s disease patients[5].

How ADSVF is Administered

The method of administering ADSVF varies depending on the condition being treated:

  • Injection: For many conditions, ADSVF is administered through direct injection into the affected area. This may include intra-articular injections (into a joint), subcutaneous injections (under the skin), or local injections into specific tissues[1][2][4].
  • Transdermal Application: In some cases, such as for diabetic foot ulcers, ADSVF may be applied directly to the wound[3].

The exact dosage and frequency of administration are still being determined through clinical research and may vary based on the specific condition and individual patient factors.

Safety Considerations

While ADSVF shows promise, it’s important to note that it is still an experimental treatment. Potential risks and safety considerations include:

  • Procedure-related risks: As with any medical procedure, there may be risks associated with the liposuction and injection processes[2].
  • Infection risk: Although the cells come from the patient’s own body, there is still a small risk of infection[1].
  • Unknown long-term effects: As this is a relatively new treatment, the long-term effects are not yet fully understood.

Clinical trials are carefully monitoring patients for any adverse events to ensure the safety of this treatment approach.

Future Outlook

ADSVF represents an exciting area of regenerative medicine with potential applications across various medical fields. As research progresses, we may gain a better understanding of how ADSVF works and in which conditions it is most effective. However, it’s important to remember that while early results are promising, more research is needed to fully establish the safety and efficacy of this treatment.

Patients interested in ADSVF should discuss this option with their healthcare providers and consider participating in clinical trials if appropriate. As with any experimental treatment, it’s crucial to weigh the potential benefits against the risks and to make informed decisions based on the most up-to-date scientific evidence.

Condition Treatment Administration Primary Endpoint Trial Duration
Urethral stricture ADSVF Injection Safety and tolerability at 6 months 24 months
Rhizarthrosis (thumb arthritis) ADSVF Intra-articular injection Tolerance at 6 months 6 months
Diabetic foot ulcer ADSVF Local injection Percentage of wounds healed at 20 weeks 20 weeks
Scarred vocal folds ADSVF Local injection Improvement in Voice Handicap Index at 6 months 6 months
Perianal Crohn’s fistulas ADSVF with microfat Local injection Fistula closure at 24 weeks 52 weeks

FAQ

  • What is Autologous Adipose Tissue-Derived Stromal Vascular Fraction (ADSVF)? ADSVF is a mixture of cells obtained from a patient's own fat tissue. It contains various types of cells, including stem cells, that have potential healing and regenerative properties.
  • How is ADSVF administered in these clinical trials? ADSVF is typically administered through local injection into the affected area, such as the urethra, thumb joint, foot ulcer, vocal folds, or perianal fistulas.
  • What medical conditions are being studied using ADSVF in these trials? The clinical trials are investigating ADSVF for treating urethral strictures, rhizarthrosis (thumb arthritis), diabetic foot ulcers, scarred vocal folds, and perianal Crohn's disease fistulas.
  • Are there any common side effects or risks associated with ADSVF treatment? While specific side effects vary depending on the treatment area, common risks may include injection site reactions, pain, or infection. Each trial carefully monitors for adverse events to ensure patient safety.
  • How long do these clinical trials typically last? The duration of these trials varies, but most follow patients for several months to a year or more to assess both short-term and long-term effects of the ADSVF treatment.

Ongoing Clinical Trials on Autologous Adipose Tissue-Derived Stromal Vascular Fraction

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

    Recruiting

    2 1 1
    Investigated diseases:
    Investigated drugs:
    France

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

    Not yet recruiting

    2 1 1
    Investigated diseases:
    Investigated drugs:
    Estonia

Glossary

  • Autologous: Derived from the patient's own body, in this case, the patient's own fat tissue.
  • Stromal Vascular Fraction (SVF): A mixture of cells obtained from fat tissue, including stem cells and other supportive cells, that may have regenerative properties.
  • Urethral stricture: A narrowing of the urethra, the tube that carries urine out of the body, which can cause difficulty urinating.
  • Rhizarthrosis: Also known as thumb arthritis, it's a condition causing pain and stiffness in the joint at the base of the thumb.
  • Diabetic foot ulcer: An open sore or wound that occurs in people with diabetes, typically on the bottom of the foot.
  • Perianal fistula: An abnormal connection between the anal canal and the skin around the anus, often occurring in people with Crohn's disease.
  • Crohn's disease: A type of inflammatory bowel disease that causes inflammation of the digestive tract.
  • Scarred vocal folds: A condition where scar tissue forms on the vocal cords, affecting voice quality and production.
  • Intra-articular injection: An injection directly into a joint space.
  • Placebo: A substance with no active therapeutic effect, used as a control in testing new drugs.
  • Dysphonia: Difficulty in speaking or producing voice sounds.
  • Voice Handicap Index (VHI): A self-assessment tool used to measure the psychosocial consequences of voice disorders.
  • Microfat: A refined fat graft used in some medical procedures.
  • MRI: Magnetic Resonance Imaging, a medical imaging technique used to form pictures of the anatomy and physiological processes of the body.

References

  1. http://clinicaltrials.eu/trial/study-on-the-safety-of-autologous-adipose-tissue-derived-stromal-vascular-fraction-cells-for-patients-with-recurrent-urethral-stricture/
  2. http://clinicaltrials.eu/trial/study-on-the-tolerance-of-intra-articular-injection-of-autologous-stromal-vascular-fraction-for-adults-with-thumb-arthritis-rhizarthrosis/
  3. http://clinicaltrials.eu/trial/study-on-treating-diabetic-foot-ulcers-with-autologous-adipose-tissue-derived-stromal-vascular-fraction-cells-for-patients-unresponsive-to-standard-care/
  4. http://clinicaltrials.eu/trial/study-on-the-effectiveness-of-autologous-adipose-derived-stromal-vascular-fraction-cells-for-patients-with-scarred-vocal-folds/
  5. http://clinicaltrials.eu/trial/study-of-autologous-adipose-tissue-derived-stromal-vascular-fraction-cells-and-microfat-for-patients-with-refractory-perianal-crohns-disease-fistulas/