2022.03.28

人胃腸上皮組織類器官的構(gòu)建與保藏操作指南(T/CMBA 017-2022)

中國(guó)醫(yī)藥生物技術(shù)協(xié)會(huì)

2022.09.20

人源肺癌類器官培養(yǎng)技術(shù)規(guī)范(T/SHSYCXH 12-2022)

上海市遺傳學(xué)會(huì)

2022.09.23

人腸癌類器官(T/CSCB 0006-2022)

中國(guó)細(xì)胞生物學(xué)學(xué)協(xié)會(huì)

2022.09.23

人腸道類器官(T/CSCB 0005-2022)

中國(guó)細(xì)胞生物學(xué)學(xué)協(xié)會(huì)

2023.02.22

人正常乳腺及乳腺癌類器官制備、凍存、復(fù)蘇和鑒定操作指南(T/CMBA 020-2023)

中國(guó)醫(yī)藥生物技術(shù)協(xié)會(huì)

2023.06.29

腦腫瘤類器官模型構(gòu)建技術(shù)規(guī)范(T/SHDSGY 167-2023)

上海都市型工業(yè)協(xié)會(huì)

2023.07.20

人肝祖細(xì)胞類器官構(gòu)建、質(zhì)量控制與保藏操作指南(T/CRHA 017-2023)

中國(guó)研究型醫(yī)院學(xué)會(huì)

2023.07.20

人肝膽腫瘤細(xì)胞類器官構(gòu)建、質(zhì)量控制與保藏操作指南(T/CRHA 018-2023)

中國(guó)研究型醫(yī)院學(xué)會(huì)

2023.07.20

人膽系上皮組織類器官構(gòu)建、質(zhì)量控制與保藏操作指南(T/CRHA 019-2023)

中國(guó)研究型醫(yī)院學(xué)會(huì)

2024.03.25

人肝內(nèi)膽管癌類器官培養(yǎng)與鑒定(T/QMHIPA 001-2024

青島市醫(yī)養(yǎng)健康產(chǎn)業(yè)促進(jìn)會(huì)

2024.05.23

人胃癌類器官構(gòu)建、質(zhì)量控制與保藏(T/1984CACA 1-2024)

中國(guó)抗癌協(xié)會(huì)

2024.05.20

基于人源肝臟類器官的藥物肝臟毒性評(píng)價(jià)技術(shù)(T/CRHA 052-2024)

中國(guó)研究型醫(yī)院學(xué)會(huì)

Project Title

研究項(xiàng)目名稱

Acronym Of The Project (if any)

研究項(xiàng)目首字母縮略詞（如有）

Type of Organoid

Organoid for Basic Research

YES/NO

用于基礎(chǔ)研究的類器官

Factoroid (Organoid for Bioproduction)

YES/NO

用于生物生產(chǎn)的類器官

Organoid for Preclinical Research

YES/NO

用于臨床前研究的類器官

Organoid for Clinical Use

YES/NO

臨床用類器官

Others (If Yes, Specify)

YES/NO

其他（如有則需明確）

Name of The Organoid

如類器官已有共識(shí)命名則應(yīng)使用該命名,避免用"迷你腸/迷你大腦/合成大腦"等錯(cuò)誤名稱

Purpose of The Project

描述項(xiàng)目的目的是什么，包括適當(dāng)?shù)谋O(jiān)管文件

Does   your research involve human material?

YES/NO

類器官研究涉及人體材料嗎？

If   YES：

Is the material obtained from volunteers?

YES/NO

材料是否來自志愿者？

Has   informed consent been obtained?

YES/NO

是否獲得知情同意？

Provide   details of the informed consent:

提供知情同意書的詳細(xì)信息

Is the volunteer a patient?

YES/NO

材料是否來自患者志愿者？

Is the genetic identity at arrival known?

YES/NO

材料接收時(shí)遺傳身份是否已知？

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

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

YES/NO

人體組織活檢是否了解取材患者：

性別、年齡、解剖區(qū)域、診斷及病毒狀態(tài)等？

Please   list items.

請(qǐng)列出相關(guān)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臨床數(shù)據(jù)？

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

YES/NO

實(shí)驗(yàn)室是否有權(quán)制備備和保存人體材料？

Give details and references of the collection declaration.

提供收集聲明的詳細(xì)信息和參考。

Is   the starting material a cell line?

YES/NO

起始材料是否為細(xì)胞系？

If   YES：

Is   the genetic identity at arrival known?

YES/NO

材料接收時(shí)其遺傳身份是否已知？

Please   specify

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

具體說明(DNA序列、SNP、PCR、STR、CGH陣列等）

Is   there genetic quality control

(karyotype,   STR, PCR, etc.)?

YES/NO

是否有基因質(zhì)量控制（核型、STR、PCR等）？

Please   describe.

請(qǐng)說明。

Is the cell line functionally validated

(differentiation test for pluripotency of iPSC, permeability tests for epithelial cell, etc.)?

YES/NO

細(xì)胞系是否經(jīng)過功能驗(yàn)證

（iPSC多能性分化實(shí)驗(yàn)、上皮細(xì)胞滲透性實(shí)驗(yàn)等）？

Please describe.

請(qǐng)說明。

Is the cell identity validated after X passages?

YES/NO

細(xì)胞身份在經(jīng)過X次傳代后是否經(jīng)過驗(yàn)證？

Specify X.

請(qǐng)說明。

Are   cell type markers identified

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

YES/NO

是否確定了細(xì)胞類型標(biāo)記物

（如：標(biāo)記物名稱、檢測(cè)方法、目標(biāo)值）？

Please   list.

請(qǐng)列出。

Is the number of passages at arrival known.

YES/NO

材料接收時(shí)傳代數(shù)是否已知。

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

YES/NO

在器官原體形成之前，傳代數(shù)是否已確定？

Are   the storage conditions known?

YES/NO

是否已知儲(chǔ)存條件？

Please   describe preservation protocol

(culture,   freezing, thawing protocol, storage modalities)

請(qǐng)描述保存方案

（培養(yǎng)、冷凍、解凍方案、儲(chǔ)存方式）

Does   the material contain mutations

(genetic   disease)?

YES/NO

材料是否含有突變（遺傳疾?。?/span>

Is   the sanitary status known?

YES/NO

材料的衛(wèi)生潔凈狀況是否已知？

Please   give details of tests

(mycoplasma, bacteriological, fungal, etc.)

請(qǐng)?zhí)峁z測(cè)詳情（支原體、細(xì)菌學(xué)、真菌等）。

Is the starting material primary cells from patients?

YES/NO

起始材料是否為患者原代細(xì)胞？

If   YES：

Is the genetic identity at arrival known?

YES/NO

材料接收時(shí)遺傳身份是否已知？

Please   specify

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

具體說明(DNA序列、SNPs、PCR、STR、CGH陣列等）

Is there genetic quality control

(karyotype, STR, PCR, etc.)?

YES/NO

是否有基因質(zhì)量控制（核型、STR、PCR等）？

Please   describe.

請(qǐng)說明。

Is the cell line functionally validated

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

YES/NO

細(xì)胞系是否經(jīng)過功能驗(yàn)證

（iPSCs的多能性分化實(shí)驗(yàn)、上皮細(xì)胞的滲透性實(shí)驗(yàn)等）。

Please   describe.

請(qǐng)說明。

Is the cell identity validated after X passages?

YES/NO

經(jīng)過X次傳代后是否確認(rèn)了細(xì)胞特性？

Specify   X.

定義傳代數(shù)

Are cell type markers identified

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

YES/NO

是否確定了細(xì)胞類型標(biāo)記物

（如：標(biāo)記物名稱、檢測(cè)方法、目標(biāo)值）？

Please   list.

請(qǐng)列出。

Is the number of passages at arrival known?

YES/NO

材料接收時(shí)傳代數(shù)量是否已知？

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

YES/NO

在類器官生成前是否已知所用細(xì)胞傳代數(shù)？

Are the storage conditions known?

YES/NO

是否已知儲(chǔ)存條件？

Please describe preservation protocol

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

描述保存方案（培養(yǎng)、冷凍、解凍方案、儲(chǔ)存方式）。

Does the material contain mutations

(genetic   disease)?

YES/NO

材料是否含有遺傳突變疾??？

Is   the sanitary status known?

YES/NO

衛(wèi)生狀況是否已知？

Please   give details of tests

(mycoplasma, bacteriological, fungal, etc.)

提供檢測(cè)詳情（支原體、細(xì)菌學(xué)、真菌等）

Are   the cell culture conditions precisely described?

YES/NO

是否準(zhǔn)確描述了細(xì)胞培養(yǎng)條件？

If   YES：

Are   the culture conditions well defined?

YES/NO

培養(yǎng)條件是否明確？

Provide details of culture conditions

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

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

提供培養(yǎng)基、性質(zhì)、來源、所用補(bǔ)充物的詳細(xì)信息

（生長(zhǎng)因子、葡萄糖、血清、抗生素、CO2/O2濃度等）

Are the nature and treatment of the substrates well described?

YES/NO

基質(zhì)的性質(zhì)和處理是否描述得當(dāng)？

Are the seeding conditions well described?

YES/NO

接種條件是否描述清楚？

Is the frequency of media changes defined?

YES/NO

是否描述了培養(yǎng)基更新頻率？

Are O2/CO2 concentrations given?

YES/NO

是否給出了細(xì)胞培養(yǎng)的O2/CO2濃度？

Provide details of the culture conditions

提供培養(yǎng)條件的詳細(xì)信息

What are the storage conditions for the lines or cells?

細(xì)胞株或細(xì)胞系儲(chǔ)存條件是什么?

Are there cell master banks?

YES/NO

是否有細(xì)胞主庫？

Describe protocols and drift control.

描述協(xié)議和漂移控制。

Are there cell working banks?

YES/NO

是否有細(xì)胞工作庫？

Describe protocols and drift control.

描述協(xié)議和漂移控制。

Are storage conditions indicated?

YES/NO

是否指明了儲(chǔ)存條件？

Describe   the freezing and thawing protocol.

描述冷凍和解凍方案。

Are   the storage modalities given?

YES/NO

是否提供了儲(chǔ)存方式？

Please   specify.

請(qǐng)說明。

Does   the project include 2D differentiation?

YES/NO

項(xiàng)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.)

提供培養(yǎng)基、性質(zhì)、來源、所用補(bǔ)充物詳細(xì)信息

（生長(zhǎng)因子、葡萄糖、血清、抗生素、CO2/O2濃度等）

Describe   the sequence and duration of differentiation treatments.

描述分化處理的順序和持續(xù)時(shí)間。

Are the culture substrates treated?

YES/NO

培養(yǎng)基是否經(jīng)過處理？

Describe   the seeding conditions and frequency of media changes

描述接種條件和培養(yǎng)基更換頻率

Is   there quality control for the differentiation process?

YES/NO

分化過程是否有質(zhì)量控制？

Provide details (e.g. morphology, material homogeneity, max and min confluence,

proliferation, functional test, monitoring of markers, possible sorting, mortality rate)

提供細(xì)胞分化的詳細(xì)信息

（如形態(tài)、材料均勻性、融合度、增殖、功能測(cè)試、標(biāo)記物、分類、死亡率）

Does the project include the generation of (3D) organoids? General considerations

YES/NO

該項(xiàng)目是否包括生成3D 類器官？一般注意事項(xiàng)

If   YES：

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

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

提供培養(yǎng)基、性質(zhì)、來源、所用補(bǔ)充物詳細(xì)信息

（生長(zhǎng)因子、葡萄糖、血清、抗生素、CO2/O2濃度等）

Describe the sequence and duration of differentiation treatments

描述分化處理的順序和持續(xù)時(shí)間

Are the culture substrates treated?

YES/NO

培養(yǎng)基是否經(jīng)過處理？

Describe the seeding conditions and frequency of media changes.

描述接種條件和培養(yǎng)基更換頻率

Is   there quality control for the differentiation process?

YES/NO

分化過程是否有質(zhì)量控制？

Provide details (e.g. morphology, material homogeneity, max and min confluence,

proliferation, functional test, monitoring of markers, possible sorting, mortality rate).

提供細(xì)胞分化的詳細(xì)信息

（如形態(tài)、材料均勻性、融合度、增殖、功能測(cè)試、標(biāo)記物、分類、死亡率）

Does   organoid generation make use of matrices?

YES/NO

類器官的生成是否利用了基質(zhì)？

If   YES：

Describe the nature of the matrix

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

描述接種基質(zhì)的性質(zhì)

(matrigel、水凝膠、透明質(zhì)酸、人脫細(xì)胞基質(zhì)材料等）

Give the matrix concentration.

給出基質(zhì)濃度。

Give details of the preparation method

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

給出制備方法的詳細(xì)信息

（溫度、聚合時(shí)間、滴加或?qū)訝罱Y(jié)構(gòu)等）

Give the seeding density per matrix volume unit.

給出基質(zhì)單位體積的接種密度。

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

培養(yǎng)基中每單位面積的基質(zhì)液滴體積和滴數(shù)

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

根據(jù)孔的大小給出培養(yǎng)基的量

Describe the matrix dissociation method for organoid recovery.

描述回收類器官時(shí)基質(zhì)解離方法

Describe the organoid dissociation method used for their expansion.

描述類器官擴(kuò)增時(shí)的解離方法

Does the culture take place on a solid 3D substrate

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

YES/NO

培養(yǎng)是否在固體3D基質(zhì)上進(jìn)行

（如骨骼用礦物基質(zhì)、液-氣界面基質(zhì)）？

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固體基質(zhì)的制備方法

（待凍干的培養(yǎng)基組成、凍干條件）

Give details on the seeding method.

提供接種方法的詳細(xì)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).

說明芯片設(shè)計(jì)（提供一張圖）

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

類器官是否在懸浮液中生長(zhǎng)？

If   YES：

Specify   the type of container.

指定容器類型。

Describe the nature and protocol for agitation.

描述基質(zhì)的性質(zhì)和攪拌方案

Indicate the nature and concentrations of matrices.

指出基質(zhì)的性質(zhì)和濃度

Does   the culture include multiple cell types?

YES/NO

培養(yǎng)物是否包含多種細(xì)胞類型？

If   YES：

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

描述共培養(yǎng)、共培養(yǎng)培養(yǎng)基的順序。

Indicate  the proportions of cell types.

標(biāo)明細(xì)胞類型的比例。

Has a morphological/structural characterization been performed?

YES/NO

是否進(jìn)行了形態(tài)學(xué)/結(jié)構(gòu)表征？

If   YES：

Describe the appearance, size, shape

 [circularity, tubularity, regularity of contours (budding),   etc.].

描述外觀、大小、形狀[圓形度、管狀度、輪廓（出芽）規(guī)則性等

Evaluate opacity/ refringency.

評(píng)估不透明度/折射率

Quantify intra and inter-organoid homogeneity.

量化器官內(nèi)和器官間的同質(zhì)性

Give details of expected morphological, architectural and ultrastructural features,

and organisation of cell types (identity,  proportions, distribution).

提供預(yù)期的形態(tài)學(xué)、結(jié)構(gòu)和超微結(jié)構(gòu)特征以及組織細(xì)胞類型

Has a molecular characterisation been performed?

YES/NO

是否進(jìn)行了分子表征？

If   YES：

Provide elements of genomics, transcriptomics, metabolomics, proteomics.

提供基因組、轉(zhuǎn)錄組、代謝組和蛋白質(zhì)組學(xué)信息

Indicate expected specific molecular markers, epigenetic characteristics.

指出預(yù)期的特異性分子標(biāo)記物、表觀遺傳特征

Has a functional characterisation been performed?

YES/NO

是否進(jìn)行了功能表征？

If YES：

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

定性和（如可能的話）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).

如用于治療目的

說明治療方案、治療反應(yīng)（藥物、化學(xué)、物理、激素等）和評(píng)價(jià)（定量或定性）

Are traceability and organoid drift evaluated?

YES/NO

是否評(píng)價(jià)了可追溯性和類器官漂移？

If   YES：

Describe how the traceability of components is evaluated

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

描述如何評(píng)估組分的可追溯性

（批次、供應(yīng)商等、環(huán)境、補(bǔ)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).

給出條件培養(yǎng)基可追溯標(biāo)準(zhǔn)，至少一種生長(zhǎng)因子質(zhì)控

Describe  the qualitative drift criteria

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

Specify  indices if applicable.

如適用，描述每種類器官的定性漂移標(biāo)準(zhǔn)

（形態(tài)學(xué)、結(jié)構(gòu)、功能、分子等）

How is robustness evaluated

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

如適用，如何評(píng)估穩(wěn)健性

（相同的起始細(xì)胞，相同的類器官）？

Are  the organoids designed for basic research?

YES/NO

類器官是否設(shè)計(jì)用于基礎(chǔ)研究？

If   YES：

Is compliance with GLP required for organoid production?

YES/NO

類器官生產(chǎn)是否需符合GLP？

Give   details, if applicable.

提供詳細(xì)信息（如果適用）

Are the organoids designed for bioproduction?

YES/NO

類器官是否設(shè)計(jì)用于生物生產(chǎn)？

If   YES：

Is compliance with GLP

(good laboratory practice) required for organoid production?

類器官生產(chǎn)是否需遵守GLP法規(guī)？

Give   details, if applicable.

提供詳細(xì)信息（如果適用）

Are the organoids designed for preclinical research

(pharmacology,   toxicology, etc.)?

YES/NO

類器官是否設(shè)計(jì)用于臨床前研究

（藥理學(xué)、毒理學(xué)等）？

If   YES：

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

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

指示類器官和模擬器官之間的功能相似性標(biāo)準(zhǔn)

（要執(zhí)行的一組控件，帶有目標(biāo)值）

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

(IND file)?

YES/NO

是用于候選藥物臨床前開發(fā)的類器官

（IND 文件）？

Indicate   the number of usable passages.

標(biāo)明可用傳代數(shù)。

Is the organoid used to define predictive signatures of responses

(companion   test)?

YES/NO

是否用類器官來定義反應(yīng)的預(yù)測(cè)性特征？

（配套檢測(cè)）

Indicate   the number of usable passages.

標(biāo)明可用傳代數(shù)。

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

YES/NO

類器官是用來驗(yàn)證篩選特定患者的治療方案？

Indicate   the number of usable passages.

標(biāo)明可用傳代數(shù)。

Are  the organoids designed for clinical research

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

YES/NO/N.A.  

類器官是否設(shè)計(jì)用于臨床研究？

（個(gè)性化/預(yù)測(cè)性/再生醫(yī)學(xué)/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

類器官是否用于護(hù)理方案？

如：

用于測(cè)試化療療效的腫瘤類器官；

用于優(yōu)化個(gè)性化治療方案的類器官。

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

說明GMP認(rèn)證流程、組件總可追溯性、組件鑒定

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).

給出類器官和活檢之間相似性的標(biāo)準(zhǔn)

（支持用類器官選擇療法合理性的客觀要素）

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

YES/NO

類器官是否像已用于細(xì)胞和組織療法一樣要用于再生醫(yī)學(xué)？

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

說明GMP認(rèn)證流程、組件總可追溯性、組件鑒定

Specify functionality and safety criteria

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

說明功能和安全標(biāo)準(zhǔn)

（生物材料生成和癌癥風(fēng)險(xiǎn)評(píng)估）

Are  the organoids to be used for other purposes?

YES/NO

類器官是否用于其他目的？

If   YES：

Specify   other uses of organoids

規(guī)定類器官的其他用途