In short
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.
Key points
- Clinical trials of Human Mesenchymal Stem Cells in the source data are focused on systemic sclerosis, especially patients with peripheral vascular complications. The listed study is a Phase 2 interventional trial with 20 participants. Researchers are testing whether treatment is feasible, safe, and potentially effective. The main endpoint is toxicity at 12 weeks after treatment. Safety checks include local inflammation, ulcer changes, hematomes, and other adverse events.
Trial overview
The MANUS trial is an interventional study of Human Mesenchymal Stem Cells in people with systemic sclerosis and peripheral vascular complications. The brief goal is to see whether intramuscular allogeneic BM-MSC therapy is feasible, safe, and potentially effective.
Who the trial is for
The source data focus on patients with systemic sclerosis, also called SSc, who have peripheral vascular complications. 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.
What treatment is being studied
The intervention listed is mesenchymal stem cells given by intramuscular use, along with a suspension and solvent for injection. 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.
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. It is an interventional study, so the research team gives the treatment and then measures what happens afterward.
The planned enrollment is 20 participants, which shows that this is a small clinical study. The trial status is listed as Authorised.
What outcomes are measured
The primary outcome is toxicity 12 weeks after Human Mesenchymal Stem Cells are given. Toxicity means harmful effects from the treatment, and the study checks for both local and general problems.
- Local toxicity is checked by looking for signs of local inflammation, such as swelling, warmth, or impairment of function.
- The study also watches for worsening ulcers, new ulcers, or hematomes after treatment.
- 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.
Trial status and size
The MANUS trial is listed as Authorised and includes 20 participants. 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.