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Allogeneic Adipose-Derived Adult Mesenchymal Stem Cells Expanded

A groundbreaking clinical trial is underway to investigate the potential of allogeneic adipose-derived adult mesenchymal stem cells in treating hidradenitis suppurativa, a chronic skin condition characterized by painful, inflamed lesions. This phase I-II study aims to evaluate both the safety and efficacy of these stem cells when administered intralesionally to patients with draining fistulas, a common complication of the disease. The trial represents a promising step forward in exploring innovative treatments for this challenging condition.

Table of Contents

What is the Treatment?

The treatment being studied is called “Allogeneic Adipose-Derived Adult Mesenchymal Stem Cells Expanded.” This is a type of advanced therapy medicinal product that uses stem cells derived from fat tissue (adipose tissue) from a donor (allogeneic means from another person)[1]. These stem cells are grown (expanded) in a laboratory before being used as a treatment.

What is Hidradenitis Suppurativa?

Hidradenitis suppurativa (HS) is a chronic skin condition that causes painful, swollen bumps to form in areas where skin rubs together, such as the armpits, groin, and buttocks. In some cases, these bumps can develop into deep, inflamed lesions or tunnels under the skin called fistulas[1]. These fistulas can be particularly challenging to treat and significantly impact a person’s quality of life.

How Does the Treatment Work?

The treatment involves injecting the expanded stem cells directly into the draining fistulas caused by hidradenitis suppurativa. These mesenchymal stem cells are believed to have anti-inflammatory and tissue-regenerating properties, which could potentially help in healing the fistulas and reducing symptoms[1].

Clinical Trial Details

A clinical trial is being conducted to evaluate this treatment. Here are some key details:

  • It’s a Phase I-II trial, which means it’s testing both the safety and potential effectiveness of the treatment[1].
  • The trial is randomized and double-blind, meaning participants will be randomly assigned to either receive the stem cell treatment or a placebo, and neither the participants nor the researchers will know who receives which[1].
  • The main goals are to assess the safety of the treatment and its effectiveness in achieving combined remission of draining fistulas after 24 weeks[1].

Eligibility Criteria

To participate in this trial, patients must meet certain criteria, including:

  • Be between 18 and 70 years old[1].
  • Have been diagnosed with hidradenitis suppurativa for at least 6 months[1].
  • Have a draining fistula that has been active for at least 4 weeks[1].
  • Be currently receiving treatment with Adalimumab (a medication commonly used for HS) for at least 12 weeks[1].

There are also several exclusion criteria, such as pregnancy, certain medical conditions, or recent participation in other clinical trials[1].

Potential Benefits

If successful, this treatment could offer several benefits for patients with hidradenitis suppurativa:

  • Closure of draining fistulas[1].
  • Reduction in symptoms such as pain, suppuration (discharge of pus), itching, and bad odor[1].
  • Improvement in quality of life[1].
  • Potential reduction in inflammation at both the local and systemic level[1].

Safety Considerations

As with any new treatment, safety is a primary concern. The trial will closely monitor for any adverse events or serious adverse events related to the treatment[1]. Participants will be followed for 24 months after receiving the treatment to assess long-term safety.

It’s important to note that this is still an experimental treatment, and its safety and effectiveness have not yet been fully established. Patients considering participating in this or any clinical trial should discuss the potential risks and benefits with their healthcare provider.

Aspect Details
Study Type Phase I-II, Single-Center, Randomized, Double-blind, Placebo-controlled Clinical Trial
Condition Hidradenitis suppurativa with draining fistulas
Intervention Allogeneic adipose-derived adult mesenchymal stem cells (intralesional administration)
Primary Objectives 1. Evaluate safety of stem cell administration
2. Assess efficacy in terms of combined remission of draining fistula after 24 weeks
Key Inclusion Criteria 1. Age 18-70 years
2. Diagnosed with HS for at least 6 months
3. Draining fistula with active drainage
4. On Adalimumab treatment for at least 12 weeks
Key Exclusion Criteria 1. Large abscess or inflammatory collection
2. Contraindication to anesthetic procedure
3. Pregnancy or breastfeeding
4. Active malignancy or history of malignant tumor
Follow-up Duration 24 months
Secondary Outcomes 1. Clinical remission of treated fistula
2. Changes in symptoms (pain, functional limitation, itching, etc.)
3. Quality of life assessment
4. Pro-inflammatory biomarker profile

FAQ

  • What is the main purpose of this clinical trial? The main purpose of this clinical trial is to evaluate the safety and efficacy of using allogeneic adipose-derived adult mesenchymal stem cells to treat draining fistulas in patients with hidradenitis suppurativa. The study will assess both the occurrence of adverse events and the potential for combined remission of the treated fistulas.
  • Who can participate in this clinical trial? Participants must be between 18 and 70 years old, diagnosed with hidradenitis suppurativa for at least 6 months, and have a draining fistula with active drainage. They must also be on Adalimumab treatment for at least 12 weeks and meet specific health criteria, including normal kidney and liver function.
  • How will the stem cells be administered in this trial? The stem cells will be administered intralesionally, which means they will be injected directly into the affected area (the draining fistula) of patients with hidradenitis suppurativa.
  • What are the primary outcomes being measured in this study? The primary outcomes include safety, measured by the occurrence of adverse events related to the treatment, and efficacy, determined by the combined remission of the treated draining fistula after 24 weeks. Remission is defined by the closure of all fistulous openings, absence of suppuration, no collections larger than 2 cm, and absence of inflammation.
  • How long will participants be followed in this clinical trial? Participants will be followed for 24 months after the administration of the stem cell treatment to assess long-term safety and efficacy outcomes.

Ongoing Clinical Trials on Allogeneic Adipose-Derived Adult Mesenchymal Stem Cells Expanded

  • Study on the Use of Adipose-Derived Stem Cells for Treating Hidradenitis Suppurativa in Patients with Draining Fistulas

    Recruiting

    1 1
    Investigated drugs:
    Spain

  • Evaluation of Mesenchymal Stem Cell Eye Injections for Dry Eye Disease in Patients with Graft-versus-Host Disease Who Haven’t Responded to Standard Treatments

    Not yet recruiting

    2 1 1
    Investigated diseases:
    Investigated drugs:
    Spain

  • Study on the Safety and Effectiveness of Allogeneic Adipose-Derived Adult Mesenchymal Stem Cells for Treating Fecal Incontinence in Patients

    Not yet recruiting

    2 1 1
    Investigated drugs:
    Spain

Glossary

  • Hidradenitis suppurativa: A chronic skin condition characterized by painful, inflamed lesions typically in areas where skin rubs together, such as the armpits, groin, and under the breasts.
  • Allogeneic: Referring to cells or tissues that are taken from a different individual of the same species, rather than from the patient themselves.
  • Mesenchymal stem cells: A type of adult stem cell that can develop into various cell types, including bone, cartilage, muscle, and fat cells.
  • Intralesional administration: The process of injecting a treatment directly into a lesion or affected area of the skin.
  • Draining fistula: An abnormal connection between two body parts or between a body part and the skin surface that is actively releasing fluid or pus.
  • Combined remission: In this study, it refers to the closure of all fistulous openings, absence of suppuration, no collections larger than 2 cm, and absence of inflammation in the treated area.
  • Adalimumab: A biologic medication used to treat various inflammatory conditions, including hidradenitis suppurativa.
  • Visual analog scale (VAS): A measurement tool used to assess subjective characteristics or attitudes that cannot be directly measured, such as pain intensity.
  • Pro-inflammatory biomarkers: Substances in the body that indicate the presence of inflammation, such as certain proteins or cytokines.
  • Advanced Therapy Medicinal Product: A class of innovative therapeutic products based on genes, cells, or tissues, which offers groundbreaking new opportunities for the treatment of disease and injury.

References

  1. http://clinicaltrials.eu/trial/study-on-the-use-of-adipose-derived-stem-cells-for-treating-hidradenitis-suppurativa-in-patients-with-draining-fistulas/