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Treatment of Severe Ocular Chemical Burns by Subconjunctival Injection of Allogeneic Mesenchymal Stem Cells: An Open-Label, Single-Arm, Multicenter Phase II Trial

NCT07329569 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2026-01-09

No results posted yet for this study

Summary

Severe chemical burns of the eye are serious injuries that can cause intense inflammation of the ocular surface and destroy limbal epithelial stem cells, which are essential for corneal healing. These injuries may lead to severe vision loss, blindness, or even loss of the eye despite standard medical and surgical treatments. Current therapies aim to control inflammation and promote healing, but outcomes remain poor in the most severe cases.

This Phase II clinical trial, called SYMBOL-Clinical, is designed to evaluate the safety and potential effectiveness of allogeneic bone marrow-derived mesenchymal stem cells (BM-MSCs) administered by subconjunctival injection in patients with severe ocular chemical burns (stage VI according to the Dua classification). Mesenchymal stem cells have shown anti-inflammatory and tissue-protective effects in preclinical studies, mainly through the release of paracrine factors that support healing.

This is an open-label, single-arm, multicenter study conducted in 13 centers in France and coordinated by the Adolphe de Rothschild Foundation Hospital. Adult patients (18 years or older) with a recent severe chemical burn of the ocular surface (within 15 days of injury) may be eligible to participate.

Participants will receive a subconjunctival injection of 5 million allogeneic BM-MSCs in the affected eye. A second injection may be administered within 21 days if corneal healing remains insufficient, as assessed by an expert ophthalmologist. All injections are performed under strict sterile conditions, with local anesthesia and conscious sedation when needed.

The primary objective of the study is to assess:

Safety, by monitoring the occurrence, type, and severity of adverse events.

Effectiveness, defined as preservation of the eye without corneal perforation at 6 months after the first injection.

Secondary objectives include evaluating corneal epithelial healing, limbal stem cell deficiency, conjunctival fibrosis, ocular surface inflammation, visual acuity, corneal thickness, the need for additional eye surgeries, and the use of local immunosuppressive treatments over a 12-month follow-up period.

Patients will be followed closely with regular ophthalmologic examinations, imaging (including anterior segment OCT), visual acuity testing, and safety assessments for up to 12 months after treatment. The total duration of participation for each patient is approximately 13 months, and the overall study duration is expected to be up to 49 months.

The study plans to enroll between 12 and 21 evaluable patients, using a two-stage Simon design to allow early stopping if the treatment does not show sufficient benefit.

The results of this study may help determine whether subconjunctival injection of allogeneic mesenchymal stem cells is a safe and promising treatment option for patients with the most severe forms of ocular chemical burns.

Conditions

  • Chemical Burns
  • Ocular Burns

Interventions

BIOLOGICAL

Subconjunctival injection of 1 mL with 5 million allogeneic BM-MSCs; one repeat within 21 days.

Subconjunctival injection of a 1 mL suspension containing 5 million allogeneic BM-MSCs. A single injection or one repeat injection may be administered within 21 days if corneal epithelialization remains below 25%, as assessed by an expert clinician at the Adolphe de Rothschild Foundation Hospital, based on evaluation performed 7 to 10 days after the first injection.

Sponsors & Collaborators

  • Fondation Ophtalmologique Adolphe de Rothschild

    lead NETWORK

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-31
Primary Completion
2029-09-30
Completion
2030-04-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07329569 on ClinicalTrials.gov