HRP20220539T1 - Stromalne matične stanice iz masnog tkiva za uporabu u liječenju refraktornih kompleksnih perianalnih fistula kod crohnove bolesti - Google Patents
Stromalne matične stanice iz masnog tkiva za uporabu u liječenju refraktornih kompleksnih perianalnih fistula kod crohnove bolesti Download PDFInfo
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- HRP20220539T1 HRP20220539T1 HRP20220539TT HRP20220539T HRP20220539T1 HR P20220539 T1 HRP20220539 T1 HR P20220539T1 HR P20220539T T HRP20220539T T HR P20220539TT HR P20220539 T HRP20220539 T HR P20220539T HR P20220539 T1 HRP20220539 T1 HR P20220539T1
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- adipose tissue
- stromal stem
- allogeneic adipose
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- 210000000577 adipose tissue Anatomy 0.000 title claims 18
- 210000000130 stem cell Anatomy 0.000 title claims 18
- 208000011231 Crohn disease Diseases 0.000 title claims 4
- 206010002156 anal fistula Diseases 0.000 title claims 2
- 230000000735 allogeneic effect Effects 0.000 claims 17
- 206010016717 Fistula Diseases 0.000 claims 8
- 230000003890 fistula Effects 0.000 claims 8
- 238000002560 therapeutic procedure Methods 0.000 claims 8
- -1 CD11c Proteins 0.000 claims 2
- 102100022464 5'-nucleotidase Human genes 0.000 claims 1
- 102100032912 CD44 antigen Human genes 0.000 claims 1
- 102100022002 CD59 glycoprotein Human genes 0.000 claims 1
- 102100037241 Endoglin Human genes 0.000 claims 1
- 102100031573 Hematopoietic progenitor cell antigen CD34 Human genes 0.000 claims 1
- 101000678236 Homo sapiens 5'-nucleotidase Proteins 0.000 claims 1
- 101000868273 Homo sapiens CD44 antigen Proteins 0.000 claims 1
- 101000897400 Homo sapiens CD59 glycoprotein Proteins 0.000 claims 1
- 101000881679 Homo sapiens Endoglin Proteins 0.000 claims 1
- 101000777663 Homo sapiens Hematopoietic progenitor cell antigen CD34 Proteins 0.000 claims 1
- 101001046686 Homo sapiens Integrin alpha-M Proteins 0.000 claims 1
- 101000935043 Homo sapiens Integrin beta-1 Proteins 0.000 claims 1
- 101000946889 Homo sapiens Monocyte differentiation antigen CD14 Proteins 0.000 claims 1
- 101000738771 Homo sapiens Receptor-type tyrosine-protein phosphatase C Proteins 0.000 claims 1
- 101000914484 Homo sapiens T-lymphocyte activation antigen CD80 Proteins 0.000 claims 1
- 101000800116 Homo sapiens Thy-1 membrane glycoprotein Proteins 0.000 claims 1
- 102100022338 Integrin alpha-M Human genes 0.000 claims 1
- 102100022297 Integrin alpha-X Human genes 0.000 claims 1
- 102100025304 Integrin beta-1 Human genes 0.000 claims 1
- 102100035877 Monocyte differentiation antigen CD14 Human genes 0.000 claims 1
- 102100024616 Platelet endothelial cell adhesion molecule Human genes 0.000 claims 1
- 102100037422 Receptor-type tyrosine-protein phosphatase C Human genes 0.000 claims 1
- 102100027222 T-lymphocyte activation antigen CD80 Human genes 0.000 claims 1
- 102100033523 Thy-1 membrane glycoprotein Human genes 0.000 claims 1
- 239000003242 anti bacterial agent Substances 0.000 claims 1
- 229940088710 antibiotic agent Drugs 0.000 claims 1
- 210000004027 cell Anatomy 0.000 claims 1
- 230000009266 disease activity Effects 0.000 claims 1
- 229960003444 immunosuppressant agent Drugs 0.000 claims 1
- 239000003018 immunosuppressive agent Substances 0.000 claims 1
- 238000002650 immunosuppressive therapy Methods 0.000 claims 1
- 238000002595 magnetic resonance imaging Methods 0.000 claims 1
- 238000000034 method Methods 0.000 claims 1
- 210000001519 tissue Anatomy 0.000 claims 1
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- C—CHEMISTRY; METALLURGY
- C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
- C12N—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
- C12N5/00—Undifferentiated human, animal or plant cells, e.g. cell lines; Tissues; Cultivation or maintenance thereof; Culture media therefor
- C12N5/06—Animal cells or tissues; Human cells or tissues
- C12N5/0602—Vertebrate cells
- C12N5/0652—Cells of skeletal and connective tissues; Mesenchyme
- C12N5/0662—Stem cells
- C12N5/0667—Adipose-derived stem cells [ADSC]; Adipose stromal stem cells
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K35/00—Medicinal preparations containing materials or reaction products thereof with undetermined constitution
- A61K35/12—Materials from mammals; Compositions comprising non-specified tissues or cells; Compositions comprising non-embryonic stem cells; Genetically modified cells
- A61K35/28—Bone marrow; Haematopoietic stem cells; Mesenchymal stem cells of any origin, e.g. adipose-derived stem cells
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K35/00—Medicinal preparations containing materials or reaction products thereof with undetermined constitution
- A61K35/12—Materials from mammals; Compositions comprising non-specified tissues or cells; Compositions comprising non-embryonic stem cells; Genetically modified cells
- A61K35/35—Fat tissue; Adipocytes; Stromal cells; Connective tissues
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
- A61P1/04—Drugs for disorders of the alimentary tract or the digestive system for ulcers, gastritis or reflux esophagitis, e.g. antacids, inhibitors of acid secretion, mucosal protectants
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P9/00—Drugs for disorders of the cardiovascular system
- A61P9/14—Vasoprotectives; Antihaemorrhoidals; Drugs for varicose therapy; Capillary stabilisers
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- C—CHEMISTRY; METALLURGY
- C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
- C12N—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
- C12N5/00—Undifferentiated human, animal or plant cells, e.g. cell lines; Tissues; Cultivation or maintenance thereof; Culture media therefor
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- C—CHEMISTRY; METALLURGY
- C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
- C12N—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
- C12N5/00—Undifferentiated human, animal or plant cells, e.g. cell lines; Tissues; Cultivation or maintenance thereof; Culture media therefor
- C12N5/06—Animal cells or tissues; Human cells or tissues
- C12N5/0602—Vertebrate cells
- C12N5/0652—Cells of skeletal and connective tissues; Mesenchyme
- C12N5/0653—Adipocytes; Adipose tissue
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K2121/00—Preparations for use in therapy
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- Engineering & Computer Science (AREA)
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- Biomedical Technology (AREA)
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- General Health & Medical Sciences (AREA)
- Developmental Biology & Embryology (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Biotechnology (AREA)
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- Pharmacology & Pharmacy (AREA)
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- Virology (AREA)
- Epidemiology (AREA)
- Genetics & Genomics (AREA)
- Wood Science & Technology (AREA)
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- General Chemical & Material Sciences (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Hematology (AREA)
- Microbiology (AREA)
- Biochemistry (AREA)
- General Engineering & Computer Science (AREA)
- Rheumatology (AREA)
- Heart & Thoracic Surgery (AREA)
- Cardiology (AREA)
- Vascular Medicine (AREA)
- Micro-Organisms Or Cultivation Processes Thereof (AREA)
- Medicines Containing Material From Animals Or Micro-Organisms (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
Claims (15)
1. Proširene stromalne matične stanice dobivene iz alogenog masnog tkiva za uporabu u postupku liječenja refraktorne kompleksne perianalne fistule kod bolesnika s Crohnovom bolešću, pri čemu:
(i) fistula se sastoji od više traktova;
(ii) pacijentu se daje doza od 120 milijuna stanica u jednom postupku pri čemu svaki trakt fistule prima barem dio ove doze i pri čemu se približno polovica doze ubrizgava u tkivo koje okružuje unutarnji otvor ili otvore i druga polovica se ubrizgava u zidove fistule duž cijelog trakta fistule; i
(iii) terapija izaziva kliničku remisiju unutar 24 tjedna.
2. Proširene stromalne matične stanice dobivene iz alogenog masnog tkiva za uporabu prema zahtjevu 1, naznačene time što fistula sadrži 2 unutarnja otvora.
3. Proširene stromalne matične stanice dobivene iz alogenog masnog tkiva za uporabu prema zahtjevu 1 ili zahtjevu 2, naznačene time što fistula sadrži 2 ili 3 vanjska otvora.
4. Proširene stromalne matične stanice dobivene iz alogenog masnog tkiva za uporabu prema bilo kojem od zahtjeva 1-3, naznačene time što terapija izaziva kliničku remisiju unutar 18 tjedana, unutar 12 tjedana, ili unutar 10 tjedana.
5. Proširene stromalne matične stanice dobivene iz alogenog masnog tkiva za uporabu prema zahtjevu 4, naznačene time što terapija izaziva kliničku remisiju unutar 8 tjedana.
6. Proširene stromalne matične stanice dobivene iz alogenog masnog tkiva za uporabu prema zahtjevu 5, naznačene time što terapija izaziva kliničku remisiju unutar 6 tjedana.
7. Proširene stromalne matične stanice dobivene iz alogenog masnog tkiva za uporabu prema bilo kojem prethodnom zahtjevu, naznačene time što se klinička remisija održava do 24 tjedna od terapije.
8. Proširene stromalne matične stanice dobivene iz alogenog masnog tkiva za uporabu prema bilo kojem prethodnom zahtjevu, naznačene time što terapija izaziva kombiniranu remisiju unutar 24 tjedna, unutar 18 tjedana, unutar 12 tjedana, unutar 10 tjedana, unutar 8 tjedana, ili unutar 6 tjedana.
9. Proširene stromalne matične stanice dobivene iz alogenog masnog tkiva za uporabu prema bilo kojem prethodnom zahtjevu, naznačene time što se poboljšanje indeksa aktivnosti perianalne bolesti (PDAI) postiže unutar 24 tjedna, unutar 18 tjedana, unutar 12 tjedana, unutar 10 tjedana, unutar 8 tjedana, ili unutar 6 tjedana.
10. Proširene stromalne matične stanice dobivene iz alogenog masnog tkiva za prema zahtjevu 9, naznačene time što je poboljšanje PDAI poboljšanje za više od 1.5 PDAI bodova, izborno poboljšanje od najmanje dva PDAI boda.
11. Proširene stromalne matične stanice dobivene iz alogenog masnog tkiva za uporabu prema bilo kojem od prethodnih zahtjeva, naznačene time što je fistula otporna na jedan ili više od (i) antibiotika, (ii) imunosupresiva i (iii) anti-TNF terapije.
12. Proširene stromalne matične stanice dobivene iz alogenog masnog tkiva za uporabu prema bilo kojem prethodnom zahtjevu, naznačene time što pacijent prima niti jednu ili obje anti-TNF terapije i imunosupresivnu terapiju.
13. Proširene stromalne matične stanice dobivene iz alogenog masnog tkiva za uporabu prema bilo kojem od prethodnih zahtjeva, naznačene time što pacijent:
(a) ima neaktivnu ili blago aktivnu Crohnovu bolest; i/ili
(b) luminalnu Crohnovu bolest.
14. Proširene stromalne matične stanice dobivene iz alogenog masnog tkiva za uporabu prema bilo kojem od prethodnih zahtjeva, naznačene time što se fistula prati magnetskom rezonancom (MRI).
15. Proširene stromalne matične stanice dobivene iz alogenog masnog tkiva za prema bilo kojem od prethodnih zahtjeva, naznačene time što najmanje 90% ili najmanje 95% proširenih stromalnih matičnih stanica dobivenih iz alogenog masnog tkiva izražavaju površinske markere HLA I, CD29, CD44, CD59 , CD73, CD90, i CD105 i/ili pri čemu manje od 5% proširenih stromalnih matičnih stanica dobivenih iz alogenog masnog tkiva izražavaju površinske markere HLAII, CD11b, CD11c, CD14, CD45, CD31, CD34, CD80 i CD86.
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
GBGB1604304.4A GB201604304D0 (en) | 2016-03-14 | 2016-03-14 | Adipose tissue-derived stromal stem cells for use in treating refractory complex perianal fistulas in crohn's disease |
EP17160932.4A EP3219321B1 (en) | 2016-03-14 | 2017-03-14 | Adipose tissue-derived stromal stem cells for use in treating refractory complex perianal fistulas in crohn's disease |
Publications (1)
Publication Number | Publication Date |
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HRP20220539T1 true HRP20220539T1 (hr) | 2022-06-10 |
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HRP20220539TT HRP20220539T1 (hr) | 2016-03-14 | 2017-03-14 | Stromalne matične stanice iz masnog tkiva za uporabu u liječenju refraktornih kompleksnih perianalnih fistula kod crohnove bolesti |
Country Status (27)
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US (3) | US10357518B2 (hr) |
EP (2) | EP3219321B1 (hr) |
JP (2) | JP6931656B2 (hr) |
KR (1) | KR102277789B1 (hr) |
CN (2) | CN115569151A (hr) |
AU (1) | AU2017232718B2 (hr) |
BE (1) | BE1024781B1 (hr) |
BR (1) | BR112018068493A8 (hr) |
CA (1) | CA3017694C (hr) |
DE (1) | DE102017002458B4 (hr) |
DK (1) | DK3219321T3 (hr) |
ES (2) | ES2681774B1 (hr) |
FR (1) | FR3048614B1 (hr) |
GB (2) | GB201604304D0 (hr) |
HR (1) | HRP20220539T1 (hr) |
HU (1) | HUE058739T2 (hr) |
IL (2) | IL298107B2 (hr) |
LT (1) | LT3219321T (hr) |
MX (1) | MX2018010699A (hr) |
NL (1) | NL2018512B1 (hr) |
NO (1) | NO345415B1 (hr) |
PL (1) | PL3219321T3 (hr) |
RS (1) | RS63163B1 (hr) |
RU (1) | RU2742308C2 (hr) |
SG (2) | SG10202008992YA (hr) |
SI (1) | SI3219321T1 (hr) |
WO (1) | WO2017158509A1 (hr) |
Families Citing this family (7)
Publication number | Priority date | Publication date | Assignee | Title |
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US20060045872A1 (en) | 2004-08-25 | 2006-03-02 | Universidad Autonoma De Madrid Ciudad Universitaria de Cantoblanco | Use of adipose tissue-derived stromal stem cells in treating fistula |
GB201604304D0 (en) * | 2016-03-14 | 2016-04-27 | Tigenix S A U | Adipose tissue-derived stromal stem cells for use in treating refractory complex perianal fistulas in crohn's disease |
JP2020515579A (ja) | 2017-03-30 | 2020-05-28 | プロジェニティ, インコーポレイテッド | 消化管疾病の生菌生物学的製剤による治療 |
CN113544261A (zh) * | 2019-02-27 | 2021-10-22 | 泰根尼克斯独资有限公司 | 用于同种异体疗法的改良的干细胞群 |
CN111481573A (zh) * | 2020-03-26 | 2020-08-04 | 卡替(上海)生物技术股份有限公司 | 牙髓间充质干细胞在制备克罗恩病治疗药物中的用途 |
KR20230113346A (ko) * | 2020-11-25 | 2023-07-28 | 플래그쉽 파이어니어링, 인크. | 지방생성 세포 조성물 및 방법 |
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