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Human Mesenchymal Stem Cells

Clinical trials of Human Mesenchymal Stem Cells are studying whether this treatment is safe and may help people with systemic sclerosis. The main focus is on feasibility, safety, and possible benefit in patients with peripheral vascular complications. These trials look at short-term toxicity and other clinical outcomes after treatment.

Table of contents

Trial overview

The MANUS trial is an interventional study of Human Mesenchymal Stem Cells in people with systemic sclerosis and peripheral vascular complications[1]. The brief goal is to see whether intramuscular allogeneic BM-MSC therapy is feasible, safe, and potentially effective[1].

Who the trial is for

The source data focus on patients with systemic sclerosis, also called SSc, who have peripheral vascular complications[1]. The trial record does not list the full inclusion and exclusion rules, so the exact participation criteria are not fully available in the source data[1].

What treatment is being studied

The intervention listed is mesenchymal stem cells given by intramuscular use, along with a suspension and solvent for injection[1]. The trial summary also describes the therapy as allogeneic BM-MSC therapy, which means the cells come from a donor and are bone marrow-derived[1].

Phase and study design

This is a Phase 2 trial, which usually means the study is looking more closely at safety and early signs of benefit after earlier testing[1]. It is an interventional study, so the research team gives the treatment and then measures what happens afterward[1].

The planned enrollment is 20 participants, which shows that this is a small clinical study[1]. The trial status is listed as Authorised[1].

What outcomes are measured

The primary outcome is toxicity 12 weeks after Human Mesenchymal Stem Cells are given[1]. Toxicity means harmful effects from the treatment, and the study checks for both local and general problems[1].

  • Local toxicity is checked by looking for signs of local inflammation, such as swelling, warmth, or impairment of function[1].
  • The study also watches for worsening ulcers, new ulcers, or hematomes after treatment[1].
  • Other adverse events are recorded and graded using the Common Terminology Criteria for Adverse Events, which is a standard system for classifying unwanted medical problems in trials[1].

Trial status and size

The MANUS trial is listed as Authorised and includes 20 participants[1]. Based on the source data, it is a focused study designed to learn whether this treatment approach can be used safely in a small group of patients with systemic sclerosis-related vascular problems[1].

Trial ID Phase Condition studied Status Enrollment
2024-515387-31-00 Phase 2 Systemic Sclerosis Authorised 20

FAQ

  • What are clinical trials of Human Mesenchymal Stem Cells trying to find out? They are mainly checking whether the treatment is safe, feasible, and possibly effective. In the trial data, the focus is on people with systemic sclerosis and peripheral vascular complications.
  • Who can take part in these trials? The trial data describe patients with systemic sclerosis, especially those with peripheral vascular complications. The exact entry rules are not fully listed in the source data.
  • What phase is the Human Mesenchymal Stem Cells trial? The trial listed in the source data is Phase 2. This means it is a mid-stage study that looks more closely at safety and early signs of benefit.
  • What condition is being studied? The trial is studying systemic sclerosis, also called SSc. This is a condition that can affect blood vessels and cause peripheral vascular complications.
  • What outcomes are being measured? The main outcome is toxicity 12 weeks after treatment. The study checks for local inflammation, worsening or new ulcers, hematomes, and other adverse events.

Ongoing Clinical Trials on Human Mesenchymal Stem Cells

  • Study on Mesenchymal Stem Cells for Patients with Systemic Sclerosis and Digital Ulcers

    Recruiting

    2 1
    Investigated drugs:
    The Netherlands

Glossary

  • Systemic sclerosis: A long-term disease that can affect the skin, blood vessels, and internal organs. In this trial, it is the main condition being studied.
  • Peripheral vascular complications: Problems with blood flow in the arms, legs, or other outer parts of the body. The trial is focused on patients who have these complications related to systemic sclerosis.
  • Phase 2: A study stage that looks more closely at safety and early signs that a treatment may work. It usually involves a small number of participants.
  • Interventional study: A trial where researchers give a treatment and then measure what happens. This is different from a study that only observes patients.
  • Feasible: Possible to carry out in real patients. In this trial, researchers want to know if the treatment can be given in a practical way.
  • Safety: How well a treatment can be used without causing harmful problems. The trial checks for toxicity and other side effects.
  • Toxicity: Harmful effects caused by a treatment. The trial measures toxicity 12 weeks after Human Mesenchymal Stem Cells are given.
  • Local inflammation: Swelling, warmth, or reduced function at the place where the treatment is given. This is one of the main safety checks in the trial.
  • Ulcer: An open sore on the skin. The trial checks whether ulcers get worse or if new ulcers appear after treatment.
  • Hematome: A collection of blood under the skin, similar to a bruise or swelling with blood. The trial monitors for this after treatment.
  • Adverse event: Any unwanted medical problem that happens during a study. The trial records these events and grades them using a standard system.

References

  1. https://clinicaltrials.gov/study/2024-515387-31-00