Table of contents
- Overview of the clinical trial
- Who the study is for
- Study design and phase
- What the study measures
- Main trial details
Overview of the clinical trial
The available study is a multi-centre, single-arm trial of ALLOGENEIC BONE MARROW-DERIVED MESENCHYMAL STROMAL CELLS, FROM SELECTED DONORS combined with biomaterial for bone healing after delayed union or non-union of long bone fractures.[1]
The trial is designed to test whether this combined treatment can help the bone heal in patients whose fracture is not closing as expected.[1]
Who the study is for
The target population is patients with delayed consolidation or non-union of a long bone fracture.[1]
Delayed consolidation means the bone is healing more slowly than expected, while non-union means the bone has not healed together properly.[1]
The study data do not list more detailed age or sex rules, so the main eligibility point we can confirm is the type of fracture healing problem.[1]
Study design and phase
This is an interventional study, which means the researchers give a treatment and then measure the result.[1]
It is a Phase 3 trial, which usually means the treatment is being tested in a larger group to see how well it works in real patients.[1]
The trial is described as single-arm, so all enrolled patients receive the study treatment rather than being split into different treatment groups.[1]
The status in the source data is Authorised, and the planned enrollment is 80 patients.[1]
What the study measures
The main endpoint is the percentage of patients with radiological consolidation at 12 months after the intervention.[1]
Radiological consolidation means the bone looks healed on imaging tests, such as an X-ray.[1]
The brief summary says the study aims to find out whether the combined treatment can achieve radiological consolidation in more than 90% of patients 12 months after surgery.[1]
Main trial details
The trial uses the intervention listed as ORTHOALLO-BM-MSC, described in the source as a drug for intraosseous use, together with biomaterial.[1]
The study title also describes the treatment as a combined advanced therapy medicinal product, which means the cell therapy and biomaterial are used together as one treatment approach.[1]
Because the source data include only one trial, the current evidence summary is limited to this single Phase 3 study in patients with difficult-to-heal long bone fractures.[1]
