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Mesenchymal Stromal Cells, Ex Vivo Cultured

Mesenchymal stromal cells (MSCs), a type of adult stem cell, are at the forefront of regenerative medicine research. These cells, which can be cultured outside the body, are being investigated in various clinical trials for their potential to treat a wide range of conditions. From graft-versus-host disease to multiple sclerosis and bone regeneration, MSCs offer promising therapeutic possibilities due to their ability to differentiate into various cell types and modulate the immune system.

Table of Contents

What are Mesenchymal Stromal Cells (MSCs)?

Mesenchymal Stromal Cells (MSCs), also known as mesenchymal stem cells, are a type of adult stem cell that can be derived from various tissues in the body. These cells have the unique ability to differentiate into different cell types and possess immunomodulatory properties, making them a promising candidate for treating various medical conditions[1].

MSCs are being studied under different names, including:

  • ImmuStem
  • Ex vivo cultured human mesenchymal stromal cells
  • MC0518 (a specific product under investigation)

Medical Conditions Treated with MSCs

Clinical trials are exploring the use of MSCs in treating several medical conditions, including:

  1. Steroid-refractory Acute Graft-versus-Host Disease (SR-aGvHD): This is a serious complication that can occur after allogeneic stem cell transplantation, where the donor’s immune cells attack the recipient’s tissues[2].
  2. Progressive Multiple Sclerosis (MS): A chronic neurological condition affecting the central nervous system[3].
  3. Alveolar Bone Augmentation: A procedure to increase bone volume in the jaw for dental implant placement[4].

How are MSCs Administered?

The administration of MSCs varies depending on the condition being treated:

  • For SR-aGvHD, MSCs are typically administered intravenously (through a vein)[1].
  • In the case of progressive MS, MSCs are injected intrathecally (into the spinal fluid)[3].
  • For alveolar bone augmentation, MSCs are applied directly to the site of bone defect during a surgical procedure[4].

Efficacy of MSC Treatment

The efficacy of MSC treatment is being evaluated in various clinical trials:

  • In SR-aGvHD, researchers are assessing the overall response rate at 28 days after treatment, comparing MSCs to the best available therapy[2].
  • For progressive MS, the primary objective is to investigate neuroregenerative efficacy as measured by neurophysiological parameters[3].
  • In alveolar bone augmentation, efficacy is measured by the change in bone width and the ability to place dental implants in the reconstructed area[4].

Safety Considerations

Safety is a crucial aspect of MSC treatment. Clinical trials are closely monitoring:

  • Adverse events and serious adverse events
  • Changes in vital signs
  • Physical examination findings
  • Clinical laboratory results

It’s important to note that MSC treatment may not be suitable for everyone. Exclusion criteria often include:

  • History of malignancy
  • Uncontrolled infections
  • Severe respiratory diseases
  • Pregnancy or breastfeeding

Ongoing Research and Future Directions

Several clinical trials are currently underway to further investigate the potential of MSCs:

  • The BALDER Trial is studying MC0518 in pediatric patients with SR-aGvHD[1].
  • The IDUNN Trial is evaluating MC0518 in adult and adolescent patients with SR-aGvHD[2].
  • The SMART-MS study is exploring the use of autologous MSCs in progressive multiple sclerosis[3].
  • A multicentre clinical trial is investigating alveolar bone augmentation using MSCs and biphasic calcium phosphate granules[4].

These ongoing studies aim to provide more comprehensive data on the efficacy, safety, and long-term outcomes of MSC treatment across various medical conditions.

Aspect Details
Cell Type Mesenchymal Stromal Cells (MSCs), ex vivo cultured
Main Conditions Studied Steroid-refractory acute Graft-versus-host Disease, Progressive Multiple Sclerosis, Alveolar bone defects
Administration Routes Intravenous, Intrathecal, Transplantation
Trial Phases Phase II, Phase III
Key Objectives Assess safety and efficacy, evaluate overall response rates, investigate neuroregenerative potential, bone regeneration capabilities
Patient Age Range Varies by study: from 12 years to adults
Follow-up Duration 6 months to 24 months
Primary Endpoints Overall response rate, changes in neurophysiological parameters, bone width changes
Safety Monitoring Adverse events, infections, changes in vital signs and laboratory results

FAQ

  • What are mesenchymal stromal cells (MSCs)? Mesenchymal stromal cells are a type of adult stem cell that can be cultured outside the body. They have the ability to develop into different types of cells and can help modulate the immune system, making them potentially useful for various medical treatments.
  • What conditions are being studied using MSCs in clinical trials? Clinical trials are exploring the use of MSCs for various conditions, including steroid-refractory acute graft-versus-host disease, progressive multiple sclerosis, and alveolar bone augmentation for jaw bone defects.
  • How are MSCs administered in these trials? The administration of MSCs varies depending on the condition being treated. They may be given intravenously, intrathecally (into the spinal fluid), or transplanted directly into the affected area, such as in bone augmentation procedures.
  • Are there any risks associated with MSC treatments? As with any medical treatment, there are potential risks. Clinical trials carefully monitor for adverse events and side effects. Some trials exclude patients with certain conditions or medical histories to minimize risks. It's important to discuss potential risks with healthcare providers.
  • How long do the clinical trials for MSC treatments typically last? The duration of clinical trials varies. Some studies follow patients for 6 months, while others continue observations for up to 24 months or longer to assess long-term safety and efficacy of the treatment.

Ongoing Clinical Trials on Mesenchymal Stromal Cells, Ex Vivo Cultured

  • Study of Mesenchymal Stromal Cells Treatment for Patients with Traumatic Brain Injury: A Safety and Effectiveness Trial

    Recruiting

    2 1 1
    Investigated drugs:
    Italy

  • Study on Mesenchymal Stromal Cells (MC0518) for Treating Steroid-Resistant Acute Graft Versus Host Disease in Adults and Adolescents

    Recruiting

    3 1 1 1
    Investigated drugs:
    France Germany Poland Spain

  • Study on the Use of Mesenchymal Stem Cells and Sodium Chloride for Patients with Progressive Multiple Sclerosis

    Recruiting

    2 1 1 1
    Investigated diseases:
    Investigated drugs:
    Norway

  • A study to evaluate the effectiveness of MC0518 (mesenchymal stromal cells) in adults with acute graft-versus-host disease that has not responded to steroids and ruxolitinib

    Not yet recruiting

    2 1 1
    Investigated diseases:
    Investigated drugs:
    Italy

  • Study on Alveolar Bone Augmentation Using Mesenchymal Stem Cells and Biphasic Calcium Phosphate for Patients with Jaw Bone Defects

    Not recruiting

    4 1 1
    Investigated diseases:
    Investigated drugs:
    Norway Spain

  • Study on the Effectiveness of Mesenchymal Stromal Cells in Children with Steroid-Refractory Acute Graft-Versus-Host Disease

    Not recruiting

    2 1 1 1
    Investigated drugs:
    France Germany Italy Poland Spain

Glossary

  • Mesenchymal Stromal Cells (MSCs): A type of adult stem cell that can be cultured outside the body and has the potential to develop into various cell types. MSCs are being studied for their ability to regenerate tissues and modulate the immune system.
  • Graft-versus-host Disease (GvHD): A condition that can occur after a stem cell or bone marrow transplant, where the donor's immune cells attack the recipient's tissues.
  • Steroid-refractory: A condition that does not respond adequately to treatment with steroid medications.
  • Allogeneic: Referring to cells, tissues, or organs that are transferred from one individual to another of the same species.
  • Intrathecal: Referring to the space under the arachnoid membrane of the brain or spinal cord, where cerebrospinal fluid circulates.
  • Multiple Sclerosis (MS): A chronic disease affecting the central nervous system, where the immune system attacks the protective covering of nerves.
  • Alveolar Bone Augmentation: A surgical procedure to increase the amount of bone in the jaw, often performed before dental implant placement.
  • Biphasic Calcium Phosphate: A biocompatible material used in bone grafting procedures, composed of hydroxyapatite and beta-tricalcium phosphate.
  • CBCT: Cone Beam Computed Tomography, a type of X-ray imaging used in dental and maxillofacial procedures.
  • Immunomodulatory: Capable of modifying or regulating immune responses in the body.

References

  1. http://clinicaltrials.eu/trial/study-on-the-effectiveness-of-mesenchymal-stromal-cells-in-children-with-steroid-refractory-acute-graft-versus-host-disease/
  2. http://clinicaltrials.eu/trial/study-on-mesenchymal-stromal-cells-mc0518-for-treating-steroid-resistant-acute-graft-versus-host-disease-in-adults-and-adolescents/
  3. http://clinicaltrials.eu/trial/study-on-the-use-of-mesenchymal-stem-cells-and-sodium-chloride-for-patients-with-progressive-multiple-sclerosis/
  4. http://clinicaltrials.eu/trial/study-on-alveolar-bone-augmentation-using-mesenchymal-stem-cells-and-biphasic-calcium-phosphate-for-patients-with-jaw-bone-defects/