ALLOGENEIC BONE MARROW-DERIVED MESENCHYMAL STROMAL CELLS for Severe ocular chemical burn

Inclusion criteria

• {"criterion_text":"- Age ≥ 18 years\n- Uni or bilateral chemical burn of the ocular surface\n- Severe ocular burn of at least one eye: stage VI of Dua severity classification (involving the entire limbus and conjunctiva)\n- Time between burn and inclusion ≤ 15 days\n- Patient having received informed information about the study and having signed a consent to participate in the study\n- Affiliated or beneficiary of a social security scheme"}

Exclusion criteria

• {"criterion_text":"- Impending corneal perforation (loss of corneal tissue > 2/3 of corneal thickness)\n- Adults subject to a legal protection measure (L1121-8) Persons deprived of their liberty by judicial or administrative decision, persons subject to psychiatric care under articles L3212-1 and L3123-1 and persons admitted to a health or social establishment for purposes other than research (L1121-6).\n- Pregnant or breast-feeding women\n- Participation in other interventional research (RIPH 1, clinical drug trials, clinical investigations) for the duration of their follow-up.\n- Secondary exclusion criteria : Grade VI of the Dua classification not confirmed by the expert ophthalmologist at the Hôpital Fondation A. de Rothschild\n- Secondary exclusion criteria : Patient did not receive subconjunctival injection of allogeneic BM-MSCs\n- Secondary exclusion criteria : Positive pregnancy test before the first subconjunctival injection of allogeneic BM-MSCs.\n- Ocular infection\n- Loss of palpebral substance with permanent corneal exposure\n- Known allergy (hypersensitivity) to human albumin preparations\n- Known history of total or partial limbic insufficiency\n- Uncontrolled glaucoma prior to ocular burns\n- Recipient of an organ or cell transplant\n- Previous cancer ≤ 5 years\n- Current treatment with immunosuppressive drugs (systemic corticosteroids, TNFα antagonists, azathioprine, methotrexate, mycophenolate mofetil, etc.)"}

Primary endpoints

• {"endpoint_text":"- Absence of corneal perforation as assessed by the clinician","definition_or_measurement_approach":"As written: assessed by the clinician (clinician evaluation of corneal perforation)."}

Secondary endpoints

• {"endpoint_text":"- All criteria refer to the eye receiving treatment in the study: Assessed by the clinician using a fluorescein test at the slit lamp examination.","definition_or_measurement_approach":"Assessed by the clinician using a fluorescein test at slit lamp examination (per the endpoint text)."}
• {"endpoint_text":"- All criteria refer to the eye receiving treatment in the study: Classification by the LSCD international working group","definition_or_measurement_approach":"Classification by the LSCD International Working Group (per the endpoint text)."}
• {"endpoint_text":"- All criteria refer to the eye receiving treatment in the study: Tauber and Foster classification","definition_or_measurement_approach":"Tauber and Foster classification (per the endpoint text)."}
• {"endpoint_text":"- All criteria refer to the eye receiving treatment in the study: Percentage of HLA-DR positive cells on conjunctival impression cytology","definition_or_measurement_approach":"Measurement: percentage of HLA-DR positive cells on conjunctival impression cytology (per the endpoint text)."}
• {"endpoint_text":"- All criteria refer to the eye receiving treatment in the study: Snellen scale","definition_or_measurement_approach":"Measurement: visual acuity using the Snellen scale (per the endpoint text)."}
• {"endpoint_text":"- All criteria refer to the eye receiving treatment in the study: OCT of the anterior segment (Optical Coherence Tomography)","definition_or_measurement_approach":"Measurement: anterior segment OCT imaging (per the endpoint text)."}
• {"endpoint_text":"- All criteria refer to the eye receiving treatment in the study: Collected from the patient's medical file","definition_or_measurement_approach":"Data collection from the patient's medical record (per the endpoint text)."}
• {"endpoint_text":"- All criteria refer to the eye receiving treatment in the study: Collected from the patient's medical file","definition_or_measurement_approach":"Data collection from the patient's medical record (per the endpoint text)."}
• {"endpoint_text":"- All criteria refer to the eye receiving treatment in the study: Incidence rate, type and severity of adverse events","definition_or_measurement_approach":"Safety measurement: incidence, type and severity of adverse events (per the endpoint text)."}

France

Earliest CTIS Part Ii Submission Date

07-11-2025

Latest Decision Or Authorization Date

09-12-2025

Processing Time Days

32

Number Of Sites

13

Number Of Participants

21

Primary sponsor

Full Name

Hopital Fondation Adolphe De Rothschild

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

France