In short
Bone marrow-derived mesenchymal stem cells are a cell therapy product made from adult human bone marrow cells. They are not yet an authorised medicine in the EU but are being investigated in clinical trials. One completed trial with 200 participants looked at the long-term safety of an intravenous infusion called StromaForte MSC.
Key points
- Bone marrow-derived mesenchymal stem cells are a type of advanced therapy medicinal product made from adult human bone marrow.
- One completed clinical trial enrolled 200 participants to study long-term safety.
- The trial used an intravenous infusion of a product called StromaForte MSC.
- The main goal was to measure adverse events and serious adverse events, including laboratory abnormalities.
- The product is classified as a somatic cell therapy medicinal product by the European Medicines Agency.
What is bone marrow-derived mesenchymal stem cells?
Bone marrow-derived mesenchymal stem cells (BM-MSCs) are a type of cell therapy. They are made from mesenchymal stem cells taken from adult human bone marrow and expanded outside the body in a laboratory. The product used in the registered trial is called StromaForte MSC solution for infusion. The substance is classified as a cell therapy of structurally diverse origin. It has no marketing authorisation in the product records and is therefore an investigational substance. The European Medicines Agency (EMA) has classified a similar product of ex-vivo expanded adult human bone-marrow derived pooled allogeneic mesenchymal stromal cells as a somatic cell therapy medicinal product.
How does bone marrow-derived mesenchymal stem cells work?
Mesenchymal stem cells are thought to act through immunological and trophic mechanisms, meaning they may influence the immune system and support tissue repair. Research in laboratory models suggests that bone marrow mesenchymal stem cells can affect the polarization of macrophages, a type of immune cell, which may be one way they modulate inflammation and healing. The exact way these cells work in human disease is still being studied.
Which conditions is it used or studied for?
The registered clinical trial does not specify a particular condition; it is a safety study in a general population. A related product has been proposed for use in thromboangiitis obliterans (Buerger’s disease), a rare condition that affects blood vessels in the arms and legs.
How is bone marrow-derived mesenchymal stem cells given?
The product is given as a cell suspension for injection by intravenous infusion, meaning it is dripped directly into a vein. In the registered trial, the dose was 5 million cells per infusion.
What do the clinical trials show?
There is one registered clinical trial in the EU Clinical Trials Information System. The trial, 2024-517011-74-01, is completed and enrolled 200 participants. It is described as a low intervention study, meaning the treatment is given in addition to usual care with minimal additional burden. The primary outcome is the rate of adverse events and serious adverse events, including clinically significant laboratory abnormalities. The trial was designed to evaluate the long-term safety of treatment with Cellcolabs-produced mesenchymal stem cells.
What side effects are known?
The completed trial measured adverse events and serious adverse events as its main outcome, but the results are not described in the available registry data. The supplementary sources do not list specific side effects for this product.