关于欧盟类器官及用途的最低限度信息标准及研究报告实例的解析-中篇

Project Title

研究项目名称

Acronym Of The Project (if any)

研究项目首字母缩略词（如有）

Type of Organoid

Organoid for Basic Research

YES/NO

用于基础研究的类器官

Factoroid (Organoid for Bioproduction)

YES/NO

用于生物生产的类器官

Organoid for Preclinical Research

YES/NO

用于临床前研究的类器官

Organoid for Clinical Use

YES/NO

临床用类器官

Others (If Yes, Specify)

YES/NO

其他（如有则需明确）

Name of The Organoid

如此类器官已有共识命名，则应使用该命名。

避免用“迷你肠，迷你大脑，合成大脑”等错误名称

Purpose of The Project

描述项目的目的是什么，包括适当的监管文件

Does   your research involve human material?

YES/NO

类器官研究涉及人体材料吗？

If   YES：

Is the material obtained from volunteers?

YES/NO

材料是否来自志愿者？

Has   informed consent been obtained?

YES/NO

是否获得知情同意？

Provide   details of the informed consent:

提供知情同意书的详细信息

Is the volunteer a patient?

YES/NO

材料是否来自患者志愿者？

Is the genetic identity at arrival known?

YES/NO

材料接收时遗传身份是否已知？

If  starting material is obtained from a biopsy, are descriptors known

(gender, age, anatomical regions, diagnosis, viral status, etc.)?

YES/NO

人体组织活检是否了解取材患者：

性别、年龄、解剖区域、诊断及病毒状态等？

Please   list items.

请列出相关信息。

Does the sponsor of the research hold clinical data on the patient?

YES/NO

研究者是否持有患者临床数据？

Is the laboratory authorised to prepare and conserve human body elements for scientific purposes?

YES/NO

实验室是否有权制备备和保存人体材料？

Give   details and references of the collection declaration.

提供收集声明的详细信息和参考。

Is   the starting material a cell line?

YES/NO

起始材料是否为细胞系？

If   YES：

Is   the genetic identity at arrival known?

YES/NO

材料接收时其遗传身份是否已知？

Please   specify

(DNA   sequence, SNPs, PCR, STR, CGH array, etc.)

请具体说明(DNA序列、SNP、PCR、STR、CGH阵列等）

Is   there genetic quality control

(karyotype,   STR, PCR, etc.)?

YES/NO

是否有基因质量控制（核型、STR、PCR等）？

Please   describe.

请说明。

Is   the cell line functionally validated

(differentiation test for pluripotency of iPSCs, permeability tests for epithelial cells,   etc.)?

YES/NO

细胞系是否经过功能验证

（iPSCs的多能性分化实验、上皮细胞渗透性实验等）？

Please   describe.

请说明。

Is   the cell identity validated after X passages?

YES/NO

细胞身份在经过X次传代后是否经过验证？

Specify   X.

请说明。

Are   cell type markers identified

(example:   marker name, detection method, target value)?

YES/NO

是否确定了细胞类型标记物

（如：标记物名称、检测方法、目标值）？

Please   list.

请列出。

Is the number of passages at arrival known.

YES/NO

材料接收时传代数是否已知。

Is the number of possible, or required, passages before the genesis of organoids defined?

YES/NO

在器官原体形成之前，传代数是否已确定？

Are   the storage conditions known?

YES/NO

是否已知储存条件？

Please   describe preservation protocol

(culture,   freezing, thawing protocol, storage modalities)

请描述保存方案（培养、冷冻、解冻方案、储存方式）

Does   the material contain mutations

(genetic   disease)?

YES/NO

材料是否含有突变（遗传疾病）？

Is   the sanitary status known?

YES/NO

材料的卫生洁净状况是否已知？

Please   give details of tests

(mycoplasma,   bacteriological, fungal, etc.)

请提供检测详情（支原体、细菌学、真菌等）。

Is   the starting material primary cells from patients?

YES/NO

起始材料是否为患者原代细胞？

If   YES：

Is   the genetic identity at arrival known?

YES/NO

材料接收时遗传身份是否已知？

Please   specify

(DNA   sequence, SNPs, PCR, STR, CGH array, etc.)

请具体说明(DNA序列、SNPs、PCR、STR、CGH阵列等）

Is   there genetic quality control

(karyotype,   STR, PCR, etc.)?

YES/NO

是否有基因质量控制（核型、STR、PCR等）？

Please   describe.

请说明。

Is the cell line functionally validated

(differentiation test for pluripotency of iPSCs, permeability tests for epithelial cells,   etc.).

YES/NO

细胞系是否经过功能验证

（iPSCs的多能性分化实验、上皮细胞的渗透性实验等）。

Please   describe.

请说明。

Is the cell identity validated after X passages?

YES/NO

经过X次传代后是否确认了细胞特性？

Specify   X.

定义传代数

Are cell type markers identified

(example: marker name, detection method, target value)?

YES/NO

是否确定了细胞类型标记物

（如：标记物名称、检测方法、目标值）？

Please   list.

请列出。

Is the number of passages at arrival known?

YES/NO

材料接收时传代数量是否已知？

Is the number of possible, or required, passages before the genesis of organoids known?

YES/NO

在类器官生成前是否已知所用细胞传代数？

Are the storage conditions known?

YES/NO

是否已知储存条件？

Please describe preservation protocol

(culture, freezing, thawing protocol, storage modalities).

请描述保存方案（培养、冷冻、解冻方案、储存方式）。

Does the material contain mutations

(genetic   disease)?

YES/NO

材料是否含有遗传突变疾病？

Is   the sanitary status known?

YES/NO

卫生状况是否已知？

Please   give details of tests

(mycoplasma, bacteriological, fungal, etc.)

请提供检测详情（支原体、细菌学、真菌等）

Are   the cell culture conditions precisely described?

YES/NO

是否准确描述了细胞培养条件？

If   YES：

Are   the culture conditions well defined?

YES/NO

培养条件是否明确？

Provide details of culture conditions

(composition of culture media, nature, origin and quantities of supplements used

 - e.g. glucose, serum, antibiotics, growth factors etc.)

提供培养基、性质、来源、所用补充物的详细信息

（生长因子、葡萄糖、血清、抗生素、CO2/O2浓度等）

Are the nature and treatment of the substrates well described?

YES/NO

基质的性质和处理是否描述得当？

Are the seeding conditions well described?

YES/NO

接种条件是否描述清楚？

Is the frequency of media changes defined?

YES/NO

是否描述了培养基更新频率？

Are O2/CO2 concentrations given?

YES/NO

是否给出了细胞培养的O2/CO2浓度？

Provide details of the culture conditions

提供培养条件的详细信息

What are the storage conditions for the lines or cells?

细胞株或细胞系储存条件是什么?

Are there cell master banks?

YES/NO

是否有细胞主库？

Describe protocols and drift control.

描述协议和漂移控制。

Are there cell working banks?

YES/NO

是否有细胞工作库？

Describe protocols and drift control.

描述协议和漂移控制。

Are storage conditions indicated?

YES/NO

是否指明了储存条件？

Describe   the freezing and thawing protocol.

描述冷冻和解冻方案。

Are   the storage modalities given?

YES/NO

是否提供了储存方式？

Please   specify.

请说明。

Does   the project include 2D differentiation?

YES/NO

项目是否包括2D分化？

If   YES：

Provide details on culture media, nature, origin, supplements used

(e.g.   growth factors glucose, serum, antibiotics, CO2/O2 concentrations, etc.)

提供培养基、性质、来源、所用补充物详细信息

（生长因子、葡萄糖、血清、抗生素、CO2/O2浓度等）

Describe   the sequence and duration of differentiation treatments.

描述分化处理的顺序和持续时间。

Are the culture substrates treated?

YES/NO

培养基是否经过处理？

Describe   the seeding conditions and frequency of media changes

描述接种条件和培养基更换频率

Is   there quality control for the differentiation process?

YES/NO

分化过程是否有质量控制？

Provide   details

(e.g. morphology, material homogeneity, max and min confluence, proliferation,   functional test, monitoring of markers, possible sorting, mortality rate).

提供细胞分化的详细信息

（如形态、材料均匀性、融合度、增殖、功能测试、标记物、分类、死亡率）。

Does   the project include the generation of

(3D)   organoids? General considerations

YES/NO

该项目是否包括生成3D 类器官？一般注意事项

If   YES：

Provide details on culture media, nature, origin, supplements used

(e.g. growth factors glucose, serum, antibiotics, CO2/O2 concentrations, etc.).

提供培养基、性质、来源、所用补充物详细信息

（生长因子、葡萄糖、血清、抗生素、CO2/O2浓度等）

Describe the sequence and duration of differentiation treatments

描述分化处理的顺序和持续时间

Are the culture substrates treated?

YES/NO

培养基是否经过处理？

Describe   the seeding conditions and frequency of media changes.

描述接种条件和培养基更换频率

Is   there quality control for the differentiation process?

YES/NO

分化过程是否有质量控制？

Provide   details

(e.g.   morphology, material homogeneity, max and min confluence, proliferation,   functional test, monitoring of markers, possible sorting, mortality rate).

提供细胞分化的详细信息

（如形态、材料均匀性、融合度、增殖、功能测试、标记物、分类、死亡率）。

Does   organoid generation make use of matrices?

YES/NO

类器官的生成是否利用了基质？

If   YES：

Describe   the nature of the matrix

(matrigel,   hydrogels, hyaluronic acid, human decellularized matrix, etc.)

描述接种基质的性质

(matrigel、水凝胶、透明质酸、人脱细胞基质材料等）

Give   the matrix concentration.

给出基质浓度。

Give   details of the preparation method

(temperature,   polymerization time, drop or layer structure, etc.).

给出制备方法的详细信息

（温度、聚合时间、滴加或层状结构等）。

Give   the seeding density per matrix volume unit.

给出基质单位体积的接种密度。

Specify the volume and number of drops of matrix per unit area in the culture medium.

培养基中每单位面积的基质液滴体积和滴数。

Specify the amount of medium depending on the size of the well.

根据孔的大小给出培养基的量。

Describe   the matrix dissociation method for organoid recovery.

描述回收类器官时基质解离方法。

Describe   the organoid dissociation method used for their expansion.

描述类器官扩增时的解离方法。

Does   the culture take place on a solid 3D substrate

(e.g.: mineral substrate for bones, substrate for liquid-gas interfaces)?

YES/NO

培养是否在固体3D基质上进行

（如骨骼用矿物基质、液-气界面基质）？

If   YES：

Describe   the preparation method for the 3D solid substrate

(composition of the medium to be freeze-dried, freeze-drying conditions).

描述3D固体基质的制备方法

（待冻干的培养基组成、冻干条件）。

Give   details on the seeding method.

提供接种方法的详细信息。

List   biocompatible materials used

(PDMS,   COC, Silicon, etc.):

列出所用生物相容性材料(PDMS、COC、硅等）

Indicate   chip design

(provide   a map).

说明芯片设计（提供一张图）。

Provide   the physical characteristics of the chip.

提供芯片的物理特性。

Does   the organoid grow in suspension

(self-organisation)?

YES/NO

类器官是否在悬浮液中生长？

If   YES：

Specify   the type of container.

指定容器类型。

Describe the nature and protocol for agitation.

描述基质的性质和搅拌方案。

Indicate the nature and concentrations of matrices.

指出基质的性质和浓度。

Does   the culture include multiple cell types?

YES/NO

培养物是否包含多种细胞类型？

If   YES：

Describe the sequence for co-culturing and adaptation of the co-culture media.

描述共培养、共培养培养基的顺序。

Indicate  the proportions of cell types.

标明细胞类型的比例。

Has a morphological/structural characterization been performed?

YES/NO

是否进行了形态学/结构表征？

If   YES：

Describe the appearance, size, shape [circularity, tubularity, regularity of contours (budding),   etc.].

描述外观、大小、形状[圆形度、管状度、轮廓（出芽）规则性等。

Evaluate opacity/ refringency.

评估不透明度/折射率。

Quantify intra and inter-organoid homogeneity.

量化器官内和器官间的同质性。

Give details of expected morphological, architectural and ultrastructural   features, and organisation of cell types

(identity,  proportions, distribution).

提供预期的形态学、结构和超微结构特征以及组织的细胞类型。

Has   a molecular characterisation been performed?

YES/NO

是否进行了分子表征？

If   YES：

Provide elements of genomics, transcriptomics, metabolomics, proteomics.

提供基因组、转录组、代谢组和蛋白质组学信息。

Indicate expected specific molecular markers, epigenetic characteristics.

指出预期的特异性分子标记物、表观遗传特征。

Has   a functional characterisation been performed?

YES/NO

是否进行了功能表征？

If   YES：

What are the qualitative and (if possible) quantitative functional   characteristics?

定性和（如可能的话）定量的功能特征是什么？

If   treatments are applied,

detail the treatment protocol, response to treatments(pharmacological, chemical, physical, hormonal, etc.),

and evaluation(quantitative or qualitative).

如应用治疗

详细说明治疗方案、治疗反应（药物、化学、物理、激素等）和评价（定量或定性）。

Are traceability and organoid drift evaluated?

YES/NO

是否评价了可追溯性和类器官漂移？

If   YES：

Describe how the traceability of components is evaluated

(batches, suppliers etc., environments, complements).

描述如何评估组分的可追溯性

（批次、供应商等、环境、补充物）。

Indicate criteria for the traceability of conditioned media

(drift of cells used for conditioning, control of lines, such as those at the origin of the organoid), control of at least one of the growth factors).

给出条件培养基可追溯标准，至少一种生长因子质控）。

（用于条件培养的细胞漂移、对照细胞系，如类器官起源细胞系）

Describe  the qualitative drift criteria

(morphological, structural, functional, molecular, etc.) specific to each organoid.

Specify  indices if applicable.

如适用，描述每种类器官的定性漂移标准（形态学、结构、功能、分子等）。

How is robustness evaluated

(same starting cells, same organoid)? Specify indices if applicable.

如适用，如何评估稳健性

（相同的起始细胞，相同的类器官）？

Are  the organoids designed for basic research?

YES/NO

类器官是否设计用于基础研究？

If   YES：

Is compliance with GLP required for organoid production?

YES/NO

类器官生产是否需符合GLP？

Give   details, if applicable.

提供详细信息（如果适用）。

Are the organoids designed for bioproduction?

YES/NO

类器官是否设计用于生物生产？

If   YES：

Is compliance with GLP

(good laboratory practice) required for organoid production?

类器官生产是否需遵守GLP法规？

Give   details, if applicable.

提供详细信息（如果适用）。

Are the organoids designed for preclinical research

(pharmacology,   toxicology, etc.)?

YES/NO

类器官是否设计用于临床前研究

（药理学、毒理学等）？

If   YES：

Indicate the functional similarity criteria between the organoid and the mimicked organ

(battery of controls to be performed, with target values).

指示类器官和模拟器官之间的功能相似性标准

（要执行的一组控件，带有目标值）。。

Is the organoid to be used for the preclinical development of a drug candidate

(IND file)?

YES/NO

是用于候选药物临床前开发的类器官

（IND 文件）？

Indicate   the number of usable passages.

标明可用传代数。

Is the organoid used to define predictive signatures of responses

(companion   test)?

YES/NO

是否用类器官来定义反应的预测性特征？

（伴配套检测）

Indicate   the number of usable passages.

标明可用传代数。

Is the organoid to be used to validate a care protocol (specific patient) on a cohort: choice of a therapy.

YES/NO

类器官是用来验证筛选特定患者的治疗方案？

Indicate   the number of usable passages.

标明可用传代数。

Are  the organoids designed for clinical research

(personalized, predictive and regenerative medicine, transplantation, etc.)?

YES/NO/N.A.  

类器官是否设计用于临床研究？

（个性化/预测性/再生医学/移植等）

If   YES：

Is the organoid to be used for: a care protocol?

e.g., tumoroid that will   be used to test the efficacy of a chemotherapy, organoids used to optimize personalised medicine to orient a therapeutic choice.

YES/NO

类器官是否用于护理方案？

如：

用于测试化疗疗效的肿瘤类器官；

用于优化个性化治疗方案的类器官。

Specify the process for GMP certification, the total traceability of components, the   qualification of components.

说明GMP认证流程、组件总可追溯性、组件鉴定。

Give   criteria for the similarity between the organoid and the biopsy

(objective elements to support the plausibility of using an organoid for the choice of a therapy).

给出类器官和活检之间相似性的标准

（支持用类器官选择疗法合理性的客观要素）

Is the organoid to be used in regenerative medicine, as already done for cell and tissue therapies?

YES/NO

类器官是否像已用于细胞和组织疗法一样要用于再生医学？

Specify the process for GMP certification, the total traceability of components, the qualification of components.

说明GMP认证流程、组件总可追溯性、组件鉴定。

Specify functionality and safety criteria

(derivation of biological material and evaluation of the risk of cancer).

说明功能和安全标准

（生物材料生成和癌症风险评估）。

Are  the organoids to be used for other purposes?

YES/NO

类器官是否用于其他目的？

If   YES：

Specify   other uses of organoids

规定类器官的其他用途