Table of contents
- Trial overview
- Who is being studied
- Treatment and study design
- Main endpoint
- Trial status and size
- What this means for patients
Trial overview
The trial titled OrthoAlloUnion is a multi-centre, single-arm study of bone marrow allogeneic mesenchymal cells combined with biomaterial for bone healing after long bone fractures.[1] It is studying ALLOGENEIC BONE MARROW-DERIVED MESENCHYMAL STROMAL CELLS, FROM SELECTED DONORS in people with delayed union or non-union, which means the bone is healing slowly or has not healed.[1]
Who is being studied
The target population is patients with delayed consolidation or non-union after a long bone fracture.[1] A long bone fracture is a break in a major bone such as the thigh, shin, or upper arm bone.
The trial record does not list more detailed inclusion or exclusion rules, so the available data only show the broad patient group being studied.[1]
Treatment and study design
This is an interventional study, which means the research team gives a treatment and then measures the results.[1] It is also a single-arm study, so there is no separate comparison group in the trial record provided.[1]
The intervention is listed as ORTHOALLO-BM-MSC, described as bone marrow allogeneic mesenchymal cells combined with biomaterial and given for intraosseous use, meaning it is used inside the bone.[1] The trial is in Phase 3, which is a later-stage study that usually looks at how well a treatment works in a larger group of patients.[1]
Main endpoint
The main outcome is the percentage of patients with radiological consolidation at 12 months after the intervention.[1] Radiological consolidation means the bone appears healed on imaging tests, such as X-rays.[1]
The brief summary says the study aims to see whether the combined treatment leads to radiological consolidation in more than 90% of patients at 12 months after surgery for delayed union or non-union long bone fracture.[1]
Trial status and size
The trial status is Authorised.[1] The planned enrollment is 80 patients, which means the study aims to include 80 participants.[1]
The study is multi-centre, so it is planned to run at more than one hospital or research site.[1]
What this means for patients
Based on the trial record, the research is focused on people whose long bone fractures are not healing as expected.[1] The study is not about general bone health; it is specifically testing whether the combined treatment can help difficult fractures show healing on imaging after 12 months.[1]
Because the trial is single-arm, every participant receives the same study treatment, and the main question is how many patients achieve bone healing by the end of follow-up.[1]
