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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
EU CTIS ID: 2023-509713-37-00
What this study is testing
To evaluate the efficacy of a protocol of subconjunctival injection of allogeneic BM-MSC in the acute phase of a severe chemical burn of the ocular surface (stage VI according to the Dua classification) on the preservation of the eyeball 6 months after the first injection.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Age ≥ 18 years
- Uni or bilateral chemical burn of the ocular surface
- Severe ocular burn of at least one eye: stage VI of Dua severity classification (involving the entire limbus and conjunctiva)
- Time between burn and inclusion ≤ 15 days
- Patient having received informed information about the study and having signed a consent to participate in the study
- Affiliated or beneficiary of a social security scheme
You likely can't join if
- Impending corneal perforation (loss of corneal tissue > 2/3 of corneal thickness)
- 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).
- Pregnant or breast-feeding women
- Participation in other interventional research (RIPH 1, clinical drug trials, clinical investigations) for the duration of their follow-up.
- Secondary exclusion criteria : Grade VI of the Dua classification not confirmed by the expert ophthalmologist at the Hôpital Fondation A. de Rothschild
- Secondary exclusion criteria : Patient did not receive subconjunctival injection of allogeneic BM-MSCs
See the full eligibility criteria
- Age ≥ 18 years
- Uni or bilateral chemical burn of the ocular surface
- Severe ocular burn of at least one eye: stage VI of Dua severity classification (involving the entire limbus and conjunctiva)
- Time between burn and inclusion ≤ 15 days
- Patient having received informed information about the study and having signed a consent to participate in the study
- Affiliated or beneficiary of a social security scheme
- Impending corneal perforation (loss of corneal tissue > 2/3 of corneal thickness)
- 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).
- Pregnant or breast-feeding women
- Participation in other interventional research (RIPH 1, clinical drug trials, clinical investigations) for the duration of their follow-up.
- Secondary exclusion criteria : Grade VI of the Dua classification not confirmed by the expert ophthalmologist at the Hôpital Fondation A. de Rothschild
- Secondary exclusion criteria : Patient did not receive subconjunctival injection of allogeneic BM-MSCs
- Secondary exclusion criteria : Positive pregnancy test before the first subconjunctival injection of allogeneic BM-MSCs.
- Ocular infection
- Loss of palpebral substance with permanent corneal exposure
- Known allergy (hypersensitivity) to human albumin preparations
- Known history of total or partial limbic insufficiency
- Uncontrolled glaucoma prior to ocular burns
- Recipient of an organ or cell transplant
- Previous cancer ≤ 5 years
- Current treatment with immunosuppressive drugs (systemic corticosteroids, TNFα antagonists, azathioprine, methotrexate, mycophenolate mofetil, etc.)
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.