In short
Allogeneic bone marrow-derived mesenchymal stromal cells are an investigational cell therapy being studied for the treatment of severe chemical burns of the eye. The cells are taken from healthy donors, grown in a laboratory, and injected under the outer membrane of the eye (subconjunctival injection). One Phase 2 trial is currently authorised to test whether a single injection of these cells can help preserve the eye after a severe chemical burn, with 21 participants planned.
Key points
- Allogeneic bone marrow-derived mesenchymal stromal cells are donor-derived cells being tested as a cell therapy.
- The cells are given by subconjunctival injection directly under the outer membrane of the eye.
- One Phase 2 trial is authorised in patients with severe chemical burns of the eye.
- The trial plans to enrol 21 participants and is a single-arm, open-label study.
- The main goal is to measure absence of corneal perforation six months after treatment.
What is allogeneic bone marrow-derived mesenchymal stromal cells?
Allogeneic bone marrow-derived mesenchymal stromal cells (BM-MSCs) are a type of cell therapy. The cells are collected from the bone marrow of healthy donors, then grown and multiplied in a laboratory before being prepared for injection. The term "allogeneic" means the cells come from a donor rather than from the patient being treated. This substance is classified as an investigational cell therapy with no marketing authorisation in the product records, meaning it is not yet approved as a medicine. It is listed under the ATC code S01XA, a group for "other ophthalmologicals" — medicines used in eye care that do not fit standard categories.
How does allogeneic bone marrow-derived mesenchymal stromal cells work?
Mesenchymal stromal cells are known for their ability to support tissue repair and to influence the immune system. In the eye, the aim of injecting these cells under the conjunctiva is to help preserve the eyeball after a severe chemical burn. The trial's goal is to evaluate whether the cells can prevent corneal perforation — a hole forming in the clear front surface of the eye — in the months following injury. Preclinical research in other settings has shown that bone marrow-derived mesenchymal stromal cells can promote tissue repair and modulate inflammation, but the exact mechanism in the eye after chemical burns is still being studied.
Which conditions is it used or studied for?
- Severe chemical burns of the eye — the current Phase 2 trial studies patients with stage VI ocular surface burns according to the Dua classification, the most severe grade of chemical injury to the eye.
How is allogeneic bone marrow-derived mesenchymal stromal cells given?
The cells are prepared as a suspension for injection and given by subconjunctival use — an injection under the conjunctiva, the clear membrane covering the white part of the eye. In the trial, the product consists of bone marrow-derived mesenchymal stromal cells that are cryopreserved (frozen), thawed, washed, and prepared in a saline solution with human serum albumin at a dose of 5 million cells per millilitre.
What do the clinical trials show?
One Phase 2 trial is authorised for this substance. It is a multicentre, single-arm, open-label study, meaning all participants receive the cell therapy and both researchers and participants know what treatment is being given. The trial plans to enrol 21 participants with severe chemical burns of the eye.
The primary outcome — the main measure of whether the treatment works — is the absence of corneal perforation as assessed by the clinician. This is evaluated six months after the first injection to see whether the eye has been preserved.
The trial is currently in the Authorised status, meaning it has received approval to proceed but results are not yet available. The study is conducted under the sponsorship of the Rothschild Foundation Hospital.
What side effects are known?
No side effect data specific to this use in severe eye burns has been published in the provided sources. Research on bone marrow-derived mesenchymal stromal cells in other settings, such as after kidney transplantation, has reported that the cells are generally being evaluated for safety, but detailed side effect profiles for subconjunctival use in the eye are not available from the current data.