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Study on Long-Term Safety of Bone Marrow-Derived Mesenchymal Stem Cells for Patients with Unspecified Conditions

InvestigationalNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the long-term effects of a treatment using bone marrow-derived mesenchymal stem cells (MSCs), which are special cells that can develop into different types of cells in the body. The treatment being tested is called StromaForte MSC solution for infusion, which is given as a cell suspension for injection. The study aims to evaluate the long-term safety of this treatment and its effects on certain markers related to inflammation, the immune system, and aging.

The study involves two groups of participants. One group will have received the MSC treatment, while the other group will not have received it. Participants will be monitored over a long period to observe any potential side effects and changes in health markers. The study will look at the rates of adverse events, which are any unwanted effects that occur during the study, and changes in health-related quality of life and laboratory parameters.

The purpose of this study is to gather information on the safety and potential benefits of using MSCs for treatment. This research could help in understanding how these stem cells affect the body over time and whether they can be safely used in medical treatments. Participants will be followed up to see how their health changes after receiving the treatment, providing valuable insights into the long-term impact of MSCs.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, participants are divided into two groups. Group A consists of individuals who have received treatment with Cellcolabs produced MSCs within the last 12 months. Group B includes individuals who have not received this treatment but match certain demographic and physical criteria.

    Participants must be willing and able to comply with the study procedures, which include reading and understanding the participant information sheet and signing the informed consent form.

  2. Step 2

    Treatment administration

    Participants in Group A have already received treatment with StromaForte MSC solution for infusion. This treatment involves an intravenous infusion of bone marrow-derived mesenchymal stem cells, which are suspended in a solution for injection.

    The study does not specify additional doses or frequency of administration for Group A, as the focus is on long-term follow-up.

  3. Step 3

    Follow-up and monitoring

    Participants will be monitored for any adverse events or serious adverse events, including any significant changes in laboratory test results.

    The study will also assess changes in health-related quality of life and laboratory parameters from the baseline, which is the initial set of measurements taken at the start of the study.

  4. Step 4

    Study duration

    The study is expected to continue until December 31, 2032. Participants will be involved in long-term follow-up to evaluate the safety and effects of the treatment over time.

    Regular assessments will be conducted to monitor the participants' health and any changes in specific biomarkers related to inflammation, immune response, and aging.

Who can join the trial?

8 criteria

  • For the MSC Treatment Group A:
    • Must have received treatment with Cellcolabs produced MSCs (which stands for Mesenchymal Stem Cells, a type of cell used in therapy) in any setting within the last 12 months.
    • Must be willing and able to follow the study procedures.
    • Must be able to read and understand the participant information sheet and the informed consent form.
    • For the Non-treated Control Group B:
      • Must match the demographic (age, gender, etc.) and anthropometric (body measurements) criteria based on the existing group of MSC treated study participants.
      • Must be willing and able to follow the study procedures, including giving blood samples.
      • Must be able to read and understand the participant information sheet and the informed consent form.
      • Participants can be of any gender.
      • Participants should not belong to a vulnerable population (such as children or those unable to consent).

Who cannot join the trial?

3 criteria

  • Patients who are not within the specified age range cannot participate.
  • Both male and female patients are eligible, but certain conditions may exclude participation.
  • Patients who are part of a vulnerable population are not eligible. This means groups who may need special protection or care.
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Investigated drugs

MSCs are a type of therapy that uses special cells called mesenchymal stem cells. These cells are taken from the body and have the ability to develop into different types of cells. In this trial, the MSCs are produced by a company called Cellcolabs. The main goal of using MSCs in this study is to see if they are safe for long-term use. Researchers are also interested in understanding how these cells might affect inflammation, the immune system, and signs of aging in the body. By studying these effects, scientists hope to learn more about how MSCs can be used to treat various conditions in the future.

What is already known about the treatment

Cellcolabs MSCs – This medication is administered through a method involving the use of mesenchymal stem cells (MSCs), which are typically given via injection. Currently, the substance is under investigation in clinical trials, focusing on its long-term safety and effects on inflammation, immune response, and aging-related biomarkers. The main therapeutic indications are not specifically defined, as the study aims to explore various potential benefits. At the molecular level, MSCs are believed to work by modulating the immune system and reducing inflammation, although the exact mechanisms are still being studied. This medication falls under the pharmacological classification of cell-based therapies.

Investigated diseases

Not possible to specify – The disease being studied is not specified in the provided data. Therefore, a detailed description of its nature and progression cannot be given. The study focuses on evaluating the safety of a treatment rather than a specific disease. The lack of specification means that the disease could potentially involve various symptoms and progressions. The study's objective is to assess the treatment's long-term safety, which implies monitoring for adverse events. Without further details, the disease remains undefined in this context.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase ITrial ID2024-517011-74-01Protocol code2024-001-SWEEstimated enrolment200 patientsSponsorCellcolabs AB

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