SYMBOL CLINICAL : Treatment of severe ocular chemical burns by subconjunctival injection of allogeneic mesenchymal stem cells: a multicentre, single-arm, open-label phase II trial

Conditions

Patient with severe eye chemical burns

Brief summary

Absence of corneal perforation as assessed by the clinician

Detailed description

All criteria refer to the eye receiving treatment in the study: Assessed by the clinician using a fluorescein test at the slit lamp examination., All criteria refer to the eye receiving treatment in the study: Classification by the LSCD international working group, All criteria refer to the eye receiving treatment in the study: Tauber and Foster classification, All criteria refer to the eye receiving treatment in the study: Percentage of HLA-DR positive cells on conjunctival impression cytology, All criteria refer to the eye receiving treatment in the study: Snellen scale, All criteria refer to the eye receiving treatment in the study: OCT of the anterior segment (Optical Coherence Tomography), All criteria refer to the eye receiving treatment in the study: Collected from the patient's medical file, All criteria refer to the eye receiving treatment in the study: Collected from the patient's medical file, All criteria refer to the eye receiving treatment in the study: Incidence rate, type and severity of adverse events

Related papers

No related papers found yet.

Papers published before 2008-02-04 may not appear yet. Historical indexing is in progress.

Interventions

DRUGFLUORESCEINE FAURE 0

DRUG5 POUR CENT

DRUGcollyre en solution en récipient unidose

DRUGPARACETAMOL AGUETTANT 10 mg/ml

DRUGsolution pour perfusion

DRUGSTERDEX

DRUGpommade ophtalmique en récipient unidose

DRUGCHLORHYDRATE D’OXYBUPROCAINE THEA 1

DRUG6 mg/0

DRUG4 ml

DRUGcollyre en récipient unidose

DRUGMIDAZOLAM VIATRIS 5 mg/ml

DRUGsolution injectable ou rectale

DRUGPROPOFOL FRESENIUS 10 mg/ml

DRUGémulsion injectable ou pour perfusion

DRUGALBUTEIN 50 g/L

DRUGBone marrow-derived Mesenchymal Stromal Cells cryopreserved at passage P2

DRUGthawed

DRUGwashed and syringe-conditioned in 0.9% NaCl - 0.5% human serum albumin injection solution at a dose of 5.10^6 Mesenchymal Stromal Cells

DRUGIBUPROFENE ARROW 400 mg

DRUGcomprimé pelliculé

DRUGDOLIPRANE 500 mg

DRUGgélule

DRUGBETADINE 5 POUR CENT

DRUGsolution pour irrigation oculaire en récipient unidose

DRUGREMIFENTANIL VIATRIS 2 mg

DRUGpoudre pour solution injectable ou pour perfusion

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Absence of corneal perforation as assessed by the clinician	—

Secondary

Measure	Time frame
All criteria refer to the eye receiving treatment in the study: Assessed by the clinician using a fluorescein test at the slit lamp examination., All criteria refer to the eye receiving treatment in the study: Classification by the LSCD international working group, All criteria refer to the eye receiving treatment in the study: Tauber and Foster classification, All criteria refer to the eye receiving treatment in the study: Percentage of HLA-DR positive cells on conjunctival impression cytology, All criteria refer to the eye receiving treatment in the study: Snellen scale, All criteria refer to the eye receiving treatment in the study: OCT of the anterior segment (Optical Coherence Tomography), All criteria refer to the eye receiving treatment in the study: Collected from the patient's medical file, All criteria refer to the eye receiving treatment in the study: Collected from the patient's medical file, All criteria refer to the eye receiving treatment in the study: Incidence rate, ty	—

Measure

Time frame

All criteria refer to the eye receiving treatment in the study: Assessed by the clinician using a fluorescein test at the slit lamp examination., All criteria refer to the eye receiving treatment in the study: Classification by the LSCD international working group, All criteria refer to the eye receiving treatment in the study: Tauber and Foster classification, All criteria refer to the eye receiving treatment in the study: Percentage of HLA-DR positive cells on conjunctival impression cytology, All criteria refer to the eye receiving treatment in the study: Snellen scale, All criteria refer to the eye receiving treatment in the study: OCT of the anterior segment (Optical Coherence Tomography), All criteria refer to the eye receiving treatment in the study: Collected from the patient's medical file, All criteria refer to the eye receiving treatment in the study: Collected from the patient's medical file, All criteria refer to the eye receiving treatment in the study: Incidence rate, ty

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Countries

France

Outcome results

None listed