2023-509713-37-00招募中2 期
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
Hopital Fondation Adolphe De Rothschild11 个研究点 分布在 1 个国家目标入组 21 人开始时间: 2025年12月9日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 21
- 试验地点
- 11
- 主要终点
- Absence of corneal perforation as assessed by the clinician
研究概览
简要总结
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.
研究设计
- 分配方式
- Not Applicable
- 主要目的
- Symbol Treatment Of Severe Ocular Chemical Burns By Subconjunctival Injection Of Allogeneic Mesench
- 盲法
- None
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.)
结局指标
主要结局
Absence of corneal perforation as assessed by the clinician
Absence of corneal perforation as assessed by the clinician
次要结局
- 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: Incidence rate, type and severity of adverse events
研究者
Clinical research department
Scientific
Hopital Fondation Adolphe De Rothschild
研究点 (11)
Loading locations...
相似试验
撤回
3 期
A prospective, observer-blind, randomized clinical trial to investigate and compare the clinical efficacy of Chloroprocaine 3% gel and Oxybuprocaine 0.4% eye drops anesthesia for clinical practice in pediatric population.2023-504477-21-00Sintetica S.A.74
Unknown
2 期
Results of Suprachoroidal Steroids Injections in Two Chorioretinal DiseasesIrvine-Gass SyndromePars PlanitisCentral Serous ChorioretinopathyCystoid Macular EdemaNCT05337332Benha University50
进行中（未招募）
3 期
SMR001 滴眼液在中至重度干眼患者中的有效性和安全性的 III 期临床研究CTR20254690800
已完成
不适用
Early treatment of central serous retinopathy by photodynamic therapy. A randomized controlled trial.Central serous retinopathy.NL-OMON20530Het Oogziekenhuis RotterdamSchiedamse Vest 180 3011 BH Rotterdam Nederland60
招募中
2 期
Phase I/II Follow-up Study of SAR422459 in Patients with Stargardt’s Macular Degeneration2024-513501-31-00Sanofi-Aventis Recherche & Developpement14