DK2967836T3 - Kryokonservering af levedygtige menneskehudsubstitutter - Google Patents
Kryokonservering af levedygtige menneskehudsubstitutter Download PDFInfo
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- DK2967836T3 DK2967836T3 DK14775892.4T DK14775892T DK2967836T3 DK 2967836 T3 DK2967836 T3 DK 2967836T3 DK 14775892 T DK14775892 T DK 14775892T DK 2967836 T3 DK2967836 T3 DK 2967836T3
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- skin equivalent
- tissues
- skin
- cryopreserved
- cryoprotectant
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Classifications
-
- A—HUMAN NECESSITIES
- A01—AGRICULTURE; FORESTRY; ANIMAL HUSBANDRY; HUNTING; TRAPPING; FISHING
- A01N—PRESERVATION OF BODIES OF HUMANS OR ANIMALS OR PLANTS OR PARTS THEREOF; BIOCIDES, e.g. AS DISINFECTANTS, AS PESTICIDES OR AS HERBICIDES; PEST REPELLANTS OR ATTRACTANTS; PLANT GROWTH REGULATORS
- A01N1/00—Preservation of bodies of humans or animals, or parts thereof
- A01N1/10—Preservation of living parts
- A01N1/12—Chemical aspects of preservation
- A01N1/122—Preservation or perfusion media
- A01N1/125—Freeze protecting agents, e.g. cryoprotectants or osmolarity regulators
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P17/00—Drugs for dermatological disorders
- A61P17/02—Drugs for dermatological disorders for treating wounds, ulcers, burns, scars, keloids, or the like
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- Life Sciences & Earth Sciences (AREA)
- Health & Medical Sciences (AREA)
- Engineering & Computer Science (AREA)
- General Health & Medical Sciences (AREA)
- Dentistry (AREA)
- Wood Science & Technology (AREA)
- Zoology (AREA)
- Environmental Sciences (AREA)
- General Chemical & Material Sciences (AREA)
- Organic Chemistry (AREA)
- Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Medicinal Chemistry (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Dermatology (AREA)
- Pharmacology & Pharmacy (AREA)
- Animal Behavior & Ethology (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Micro-Organisms Or Cultivation Processes Thereof (AREA)
- Medicines Containing Material From Animals Or Micro-Organisms (AREA)
- Materials For Medical Uses (AREA)
- Medicinal Preparation (AREA)
Claims (15)
1. Fremgangsmåde til kryokonservering afen organotypisk dyrket hudækvivalent til opretholdelse af levedygtigt væv, omfattende: a) at behandle en organotypisk dyrket hudækvivalent i en kryobeskyttende opløsning i et enkelt trin, hvor den organotypisk dyrkede hudækvivalent omfatter lagdelt pladeepitel på et dermalt lag omfattende fibroblast, og hvor det kryobeskyttende middel er tilvejebragt i en opløsning omfattende 21 til 70 volumen%, fortrinsvis 21 til 45 volumen% eller 37,5 til 62,5 volumen%, mere foretrukket 25 til 40 volumen% eller 42,5 til 57,5 volumen% af opløsningen, og det kryobeskyttende middel er glycerol; b) at separere den behandlede organotypisk dyrkede hudækvivalent fra overskydende kryobeskyttende opløsning og emballere den behandlede organotypisk dyrkede hudækvivalent i fravær af yderligere kryobeskyttende middel til tilvejebringelse af en emballeret hudækvivalent, hvor emballeringen fortrinsvis endvidere omfatter at indeslutte den kryokonserverede hudækvivalent i en steril pose og indeslutte den sterile pose i en anden pose; og c) at fryse den emballerede organotypisk dyrkede hudækvivalent til tilvejebringelse af en kryokonserveret hudækvivalent.
2. Fremgangsmåde ifølge krav 1, hvor behandlingen afen organotypisk dyrket hudækvivalent i en kryobeskyttende opløsning i et enkelt trin er ved en temperatur på 2° C til 8° C eller 15° C til 30° C.
3. Fremgangsmåde ifølge krav 1, hvor frysningen endvidere omfatter frysning ved -80° C eller direkte udsættelse for temperaturer i området fra -50° C til -100° C.
4. Fremgangsmåde ifølge krav 1, hvor de organotypisk dyrkede hudækvivalenter omfatter NIKS-celler (nær-diploide immortaliserede keratinocytter), hvor NIKS-cellerne fortrinsvis omfatter en eksogen nukleinsyresekvens, der koder for et eksogent polypeptid.
5. Fremgangsmåde ifølge krav 1, hvor hudækvivalenten bibeholder levedygtighed efter optøning, hvor den kryokonserverede hudækvivalent fortrinsvis har en A550 på mindst 50% af en referencehudækvivalent som bestemt ved hjælp af et MTT-assay.
6. Fremgangsmåde til optøning af en kryokonserveret hudækvivalent, der er fremstillet ved hjælp af fremgangsmåden ifølge krav 1, til påføring på en patient, omfattende: a) at opvarme den kryokonserverede hudækvivalent, hvor opvarmningen fortrinsvis omfatter udsættelse for rumtemperatur på anvendelsesstedet; og b) at bringe den kryokonserverede hudækvivalent i kontakt med en diffusionsmediator omfattende en vævskompatibel opløsning, fortrinsvis en bufret vævskompatibel opløsning, til fjernelse af den kryobeskyttende opløsning ved diffusion, og hvor diffusionsmediatoren er valgt fra gruppen bestående af et absorberende medium, hvor det absorberende medium fortrinsvis er valgt fra gruppen bestående af - Telfa-pads, skumpads, gazepads og cellulosepads indeholdende det vævskompatible medium, - en membran og - en dialysepose.
7. Kryokonserveret hudækvivalent fremstillet ved hjælp af fremgangsmåden ifølge krav 1.
8. System omfattende hudækvivalenten ifølge krav 7, der er anbragt på et absorberende medium.
9. Emballeret kryokonserveret hudækvivalent ifølge krav 7 til anvendelse ved behandling af sår, hvor hudækvivalenten er til påføring på et sår under betingelser, hvor hudækvivalenten kommer i kontakt med såret.
10. Kit omfattende en kryokonserveret hudækvivalent ifølge krav 7, en diffusionsmediator og en vævskompatibel opløsning.
11. Kit ifølge krav 10, hvor den kryokonserverede hudækvivalent er emballeret i en indeslutning, der kan forsegles, eller den kryokonserverede hudækvivalent er tilvejebragt i en dyrkningsbeholder, der er emballeret i en pose.
12. Fremgangsmåde ifølge krav 1, endvidere omfattende at udforme den or-ganotypisk dyrkede hudækvivalent før trin (a) ved: at tilvejebringe en dyrkningsskål omfattende et cellekultursubstrat, der kan bevæges mellem definerede øvre og nedre positioner i dyrkningsskålen, at udforme en hudækvivalent på cellekultursubstratet, hvor cellekultursubstratet er i den øvre position, og derefter sænke cellekultursubstratet til den nedre position til udførelse af trin (a) ifølge krav 1.
13. Fremgangsmåde ifølge krav 1, endvidere omfattende at udforme den or-ganotypisk dyrkede hudækvivalent før trin (a) ved: at tilvejebringe en dyrkningsskål omfattende en indsats, der kan bevæges mellem øvre og nedre positioner i dyrkningsskålen, hvor indsatsen har en plan bundflade, der er dannet af en porøs membran, at udforme en dermal ækvivalent omfattende fibroblastceller på den porøse membran i indsatsen, hvor indsatsen er anbragt i den øvre position i dyrkningsskålen, at dyrke fibroblastcellerne til dannelse af en dermal ækvivalent, at påføre keratinocytter på den dermale ækvivalent, dyrke keratinocytterne i et dyrkningsmedium under betingelser, hvor keratinocytterne danner en hudækvivalent omfattende lagdelt epitel, at fjerne dyrkningsmediet, at sænke indsatsen til den nedre position til udførelse af trin (a) ifølge krav 1.
14. Emballeret kryokonserveret hudækvivalent, der er fremstillet ifølge krav 1, til anvendelse ved behandling af en patient, hvor den kryokonserverede hudækvivalent før påføring på patienten a) optøs og ikke renses; eller b) opvarmes, overføres aseptisk fra emballagen og bringes i kontakt med et absorberende medium omfattende en vævskompatibel opløsning for at muliggøre fjernelse af den kryobeskyttende opløsning ved diffusion.
15. Fremgangsmåde ifølge krav 1, hvor hudækvivalenten i trin (a) inkuberes i den kryobeskyttende opløsning i 10 til 60 minutter, fortrinsvis fra 20 til 30 minutter.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
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| US201361779661P | 2013-03-13 | 2013-03-13 | |
| PCT/US2014/025599 WO2014160000A1 (en) | 2013-03-13 | 2014-03-13 | Cryopreservation of viable human skin substitutes |
Publications (1)
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| DK2967836T3 true DK2967836T3 (da) | 2019-01-28 |
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| DK14775892.4T DK2967836T3 (da) | 2013-03-13 | 2014-03-13 | Kryokonservering af levedygtige menneskehudsubstitutter |
| DK18197432.0T DK3470018T3 (da) | 2013-03-13 | 2014-03-13 | Kryokonservering af levedygtige menneskehudssubstitutter |
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| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| DK18197432.0T DK3470018T3 (da) | 2013-03-13 | 2014-03-13 | Kryokonservering af levedygtige menneskehudssubstitutter |
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| EP (3) | EP2967836B1 (da) |
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| CA (2) | CA3071928A1 (da) |
| DK (2) | DK2967836T3 (da) |
| ES (2) | ES2893844T3 (da) |
| IL (1) | IL241448B (da) |
| PT (2) | PT2967836T (da) |
| WO (1) | WO2014160000A1 (da) |
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| CA3071928A1 (en) * | 2013-03-13 | 2014-10-02 | Stratatech Corporation | Cryopreservation of viable human skin substitutes |
| AU2015287760B2 (en) * | 2014-07-09 | 2019-06-20 | Genentech, Inc. | pH adjustment to improve thaw recovery of cell banks |
| US9777064B2 (en) | 2015-03-17 | 2017-10-03 | Chimera Bioengineering, Inc. | Smart CAR devices, DE CAR polypeptides, side CARs and uses thereof |
| US11052111B2 (en) * | 2015-12-08 | 2021-07-06 | Chimera Bioengineering, Inc. | Smart CAR devices and DE CAR polypeptides for treating disease and methods for enhancing immune responses |
| EP3458077A4 (en) | 2016-05-17 | 2020-04-01 | Chimera Bioengineering Inc. | METHODS OF MANUFACTURING NEW AREAS OF ANTIGEN BINDING |
| CN112481217A (zh) | 2016-09-01 | 2021-03-12 | 嵌合体生物工程公司 | Gold优化的car t-细胞 |
| CN111989108B (zh) | 2018-02-13 | 2024-07-16 | 嵌合体生物工程公司 | 利用rna去稳定元件协调基因表达 |
| JP7669266B2 (ja) | 2018-08-31 | 2025-04-28 | ウィスコンシン アラムニ リサーチ ファンデーション | 動脈内皮細胞を播種した血管移植片の生成 |
| WO2020102854A1 (en) * | 2018-11-22 | 2020-05-28 | Cryogenics Holdings Pty Ltd. | Method and apparatus for freezing of biological products |
| JP2022546282A (ja) | 2019-08-18 | 2022-11-04 | キメラ・バイオエンジニアリング，インコーポレーテッド | Ｇｏｌｄ制御導入遺伝子による併用療法 |
| EP4034038A4 (en) * | 2019-09-27 | 2023-11-01 | Stratatech Corporation | METHODS OF TREATING ACUTE WOUNDS AND IMPROVING RESULTS |
| CN114836291B (zh) * | 2021-02-01 | 2025-11-21 | 深圳拜尔洛克生物技术有限公司 | 生物材料解冻复苏的系统及其方法 |
| US20240358766A1 (en) * | 2021-05-28 | 2024-10-31 | Stratatech Corporation | Allogeneic cultured keratinocyte products |
| AU2022282461A1 (en) * | 2021-05-28 | 2023-11-16 | Stratatech Corporation | Tissue container systems |
| WO2023056194A2 (en) | 2021-09-29 | 2023-04-06 | Chimera Bioengineering, Inc. | Compositions and methods for anti-tnmuc1 gold car t-cells |
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2014
- 2014-03-13 CA CA3071928A patent/CA3071928A1/en active Pending
- 2014-03-13 AU AU2014244264A patent/AU2014244264B2/en not_active Ceased
- 2014-03-13 JP JP2016501891A patent/JP6580028B2/ja active Active
- 2014-03-13 CA CA2905656A patent/CA2905656C/en active Active
- 2014-03-13 ES ES18197432T patent/ES2893844T3/es active Active
- 2014-03-13 DK DK14775892.4T patent/DK2967836T3/da active
- 2014-03-13 DK DK18197432.0T patent/DK3470018T3/da active
- 2014-03-13 EP EP14775892.4A patent/EP2967836B1/en active Active
- 2014-03-13 PT PT14775892T patent/PT2967836T/pt unknown
- 2014-03-13 PT PT18197432T patent/PT3470018T/pt unknown
- 2014-03-13 EP EP21177142.3A patent/EP3900534A1/en not_active Withdrawn
- 2014-03-13 EP EP18197432.0A patent/EP3470018B1/en active Active
- 2014-03-13 WO PCT/US2014/025599 patent/WO2014160000A1/en not_active Ceased
- 2014-03-13 ES ES14775892T patent/ES2705043T3/es active Active
- 2014-03-13 US US14/208,439 patent/US10091983B2/en active Active
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2015
- 2015-09-10 IL IL241448A patent/IL241448B/en active IP Right Grant
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2017
- 2017-07-17 AU AU2017206148A patent/AU2017206148B2/en not_active Ceased
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2018
- 2018-09-05 US US16/122,598 patent/US11297829B2/en active Active
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2019
- 2019-08-27 JP JP2019154515A patent/JP7220640B2/ja active Active
- 2019-09-17 AU AU2019232795A patent/AU2019232795B2/en not_active Ceased
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2021
- 2021-11-05 AU AU2021261937A patent/AU2021261937B2/en not_active Ceased
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2022
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