JP5713924B2 - 活性化白血球組成物 - Google Patents
活性化白血球組成物 Download PDFInfo
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- JP5713924B2 JP5713924B2 JP2011552537A JP2011552537A JP5713924B2 JP 5713924 B2 JP5713924 B2 JP 5713924B2 JP 2011552537 A JP2011552537 A JP 2011552537A JP 2011552537 A JP2011552537 A JP 2011552537A JP 5713924 B2 JP5713924 B2 JP 5713924B2
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- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
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Description
本出願は、2009年3月5日に出願された、活性化白血球組成物(Activated Leukocyte Composition)という題名の仮出願第61/209,298号ならびに2009年4月1日に出願された、血管不全のための活性化白血球組成物(Activated Leukocyte Composition for Vascular Insufficiencies)という題名の仮出願第61/211,587号の利益を主張するものであり、これらの開示は参照によって本明細書に組み込まれる。
実施例2−活性化白血球組成物の分析
実施例3
本発明と関連した様々な予想外の利益を強調するため、これらの実施形態をDanonの米国特許第6,146,890号(「Danon」)に開示の処理と比較した。
図1および2に関して、全血を主成分(すなわち、赤血球、血漿、および軟膜)に分離した直後、軟膜をバッグCからバッグ4に移し、室温で12時間±2時間インキュベートした。この工程後、(溶血液が産生される)低浸透圧ショック処理のために蒸留水をバッグ1からバッグ4(またはバッグ5)に移した。この処理を約45秒間行った。直後、軟膜(白血球)を等張に戻すためバッグ2に含まれる塩化ナトリウム緩衝液をバッグ4(またはバッグ5)に移した。
Danonの教示に従い、全血を処理して3つの主成分(すなわち、赤血球、血漿、および軟膜)に分離直後、軟膜に低浸透圧ショックを与えた。したがって、本発明とは際立って対照的に、Danonの処置では、主要血液成分への分離後かつ軟膜に低浸透圧ショックを与える前に軟膜のインキュベーションを必要としない。バッグPB3に含まれる間、軟膜に低浸透圧ショックを与えた。
標準血液単位から得られる白血球(white blood cell)(白血球(leukocyte))の総量(最終容量の細胞懸濁液を乗じた最終濃度として算出)を全血の各バッチにおいて測定した。本発明の方法により処理した全血の111個のバッチ、およびDanonに開示の処置により処理した4個のバッチの平均結果を表4に説明する。
J. Li, et al., Pathophysiology of Acute Wound Healing. Clinical Dermatol. 2007 Jan−Feb; 25(1) :9−18.
G. Broughton 2nd, et al., Wound Healing: An Overview. Plast Reconstr Surg. 2006 Jun; 117(7 Suppl) :le−S− 32e−S.
AK Tsirogianni, et al., Wound Healing: Immunological Aspects. Injury. 2006 Apr;37 Suppl 1:S5−12. Epub 2006
AJ Singer, et al., Cutaneous Wound Healing. New Eng. J. Med. 1999; 341 (10) : 738−46.
P. Martin, Wound Healing−Aiming For Perfect Skin Regeneration. Science 1997; 276 (5309) : 75−81.
AD Agaiby, et al., Immuno−Inflammatory Cell Dynamics During Cutaneous Wound Healing. J. Anat. 1999 Nov; 195 (Pt 4) :531−42.
DWH Riches, Macrophage Involvement In Wound Repair, Remodeling and (登録商標)brosis. In The Molecular and Cellular Biology of Wound Repair, (1996) lnd edn (ed. Clark RAF), pp. 95±141. New York, London: Plenum Press.
D. Greiling, et al., Fibronectin Provides a Conduit for Fibroblast Transmigration from Collagenous Stroma into Fibrin Clot Provisional Matrix. J. Cell. Sci. 1997 ; 110 : 861−70
MG Tonnesen, et al., Angiogenesis In Wound Healing. J. Investig. Dermatol. Symp. Proc. 2000; 5(1) :400−6.
JP Kim, et al., Mechanisms of Human Keratinocyte Migration on Fibronectin: Unique Role of RGD Site and Integrins. J. Cell. Physiol. 1992; 151:443−50.
JJ Tomasek et al., Myofibroblasts and Mechano− Regulation of Connective Tissue Remodelling. Nat. Rev. MoI. Cell. Biol. (2002) 3:349−363
S Werner, et al., Regulation of Wound Healing by Growth Factors and Cytokines. Physiol Rev. 2003 JuI; 83 (3) :835−70.
D. A. Keen, Review of Research Examining the Regulatory Role of Lymphocytes in Normal Wound Healing. J. Wound Care. 2008
J Jameson, et al., A Role for Skin − T Cells in Wound Repair. Science 296: 747−749, 1992.
WL Havran, et al., Epithelial Cells and Their Neighbors. III. Interactions Between Intraepithelial Lymphocytes and Neighboring Epithelial Cells. Am. J. Physiol. Gastrointest Liver Physiol. 2005 Oct; 289 (4) : G627−30
J Parkin, et al., An Overview of the Immune System. Lancet. 2001; 357:1777−1789
A Moretta, et al., Human NK Cells: From HLA Class I− Specific Killer Ig−like Receptors to the Therapy of Acute Leukemias. Immunol. Rev. 2008 Aug; 224:58−69.
BM Doshi, et al., Wound Healing From a Cellular Stress Response Perspective. Cell Stress Chaperones. 2008 Dec; 13 (4) :393−9.
GJ Moran, et al., Antimicrobial Prophylaxis for Wounds and Procedures in the Emergency Department. Infect. Dis. Clin. North Am. 2008
MA Fonder, et al., Treating the Chronic Wound: A Practical Approach to the Care of Nonhealing Wounds and Wound Care Dressings. J. Am. Acad. Dermatol. 2008 Feb; 58(2) :185− 206.
JA Thackham, et al., The Use of Hyperbaric Oxygen Therapy to Treat Chronic Wounds: A Review. Wound Repair Regen. 2008, 1998 May−Jun;16 (3) :321−30
DR Berlowitz, et al., Are all pressure ulcers the result of deep tissue injury? A Review of the Literature. Ostomy Wound Manage. 2007 Oct,− 53(10) :34−8.
K. Girouard, et al., The symptom of pain with pressure ulcers: a review of the literature. Ostomy Wound Manage. 2008 May; 54(5) :30−40, 32.
Claims (15)
- 活性化白血球組成物の作製方法であり、
a)ヒト白血球を、
i)12℃〜28℃の温度で90分から最大2,3,4,5,6,7,8又は12〜20時間、又は
ii)37℃までの温度で5〜24時間
インキュベートすること;
b)工程aの白血球に低浸透圧ショックを与えること;及び
c)工程bの白血球を等張に戻すために、無機イオン、有機オスモライト又はそれらの組み合わせを含む、生理的に許容可能な溶液を有効量添加すること、
を含む活性化白血球組成物の作製方法。 - 白血球と血漿を同一ドナーから採取してもよいし異なるドナーから採取してもよい別々のヒト血漿試料を凝固剤と接触させ血清を得ること;ならびに
工程cの白血球と前記血清を混合することをさらに含む、請求項1に記載の方法。 - 前記白血球がO型陰性血液型ドナーから採取され、前記血漿がAB型陽性血液型ドナーから採取される、請求項1又は2に記載の方法。
- 前記低浸透圧ショックが白血球を水と接触させることを含み、前記生理的に許容可能な塩溶液が塩化ナトリウム溶液である、請求項1〜3のいずれか一項に記載の方法。
- 請求項1記載の方法により得られる活性化白血球組成物であり、
a)40%〜90%の顆粒球;
b)5%〜20%の単球;および
c)5%〜30%のリンパ球、
を含む活性化白血球組成物。 - 請求項1記載の方法により得られる活性化白血球組成物であり、
a)活性化白血球組成物中の白血球細胞総数に基づき少なくとも95%の生存白血球;及び/又は
b)活性化白血球組成物中の総顆粒球集団に対して少なくとも75%のCD11b(+)顆粒球、
を含む活性化白血球組成物。 - 前記組成物を得るための方法が、
白血球と血漿を同一ドナーから採取してもよいし異なるドナーから採取してもよい別々のヒト血漿試料を凝固剤と接触させ血清を得ること;ならびに
工程cの白血球と前記血清を混合することをさらに含む、請求項5又は6に記載の活性化白血球組成物。 - 前記顆粒球が、
i)52%〜78%の好中球;
ii)1%〜9%の好酸球;および
iii)1%〜2%の好塩基球、
を含む請求項5〜7のいずれか一項に記載の組成物。 - 前記リンパ球が、
i)7%〜25%のB細胞(CD19+);
ii)20%〜30%のNK細胞(CD3−/CD56+);
iii)40%〜60 T細胞(CD3+);
iv)0%〜30 NKT細胞(CD3+/CD56+);
v)8%〜20%のTヘルパー細胞、(CD4+/CD3+);ならびに
vi)20%〜30%のCD8+/CD3+細胞、
を含む請求項5,7又は8に記載の組成物。 - 医薬として用いられる請求項5〜9のいずれか一項に記載の組成物。
- 創傷治療剤として用いられる請求項5〜9のいずれか一項に記載の組成物。
- 請求項5〜11のいずれか一項に記載の活性化白血球組成物の創傷治療用医薬の製造のための使用。
- 前記創傷が褥瘡性潰瘍、圧力潰瘍、糖尿病患者の下肢潰瘍、深部胸骨創傷、術後創傷、体幹領域の難治性術後創傷、大伏在静脈獲得後の大伏在静脈に対する創傷、外傷に起因する損傷、裂肛または静脈潰瘍である請求項12記載の使用。
- 請求項5〜9のいずれか一項に記載の組成物を含むドレッシング。
- 請求項5〜9のいずれか一項に記載の組成物を含む生理的不活性および/または吸収性基質または足場。
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US20929809P | 2009-03-05 | 2009-03-05 | |
US61/209,298 | 2009-03-05 | ||
US21158709P | 2009-04-01 | 2009-04-01 | |
US61/211,587 | 2009-04-01 | ||
PCT/IB2010/000882 WO2010100570A2 (en) | 2009-03-05 | 2010-03-05 | Activated leukocyte composition |
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US8574902B2 (en) | 2009-03-05 | 2013-11-05 | Macrocure Ltd. | Activated leukocyte composition and uses for wound healing |
EP2613765A2 (en) | 2010-09-09 | 2013-07-17 | Macrocure, Ltd. | Activated leukocyte conditioned supernatant and uses for wound healing |
IN2014DN08093A (ja) | 2012-03-15 | 2015-05-01 | Macrocure Ltd | |
RU2014140795A (ru) | 2012-03-15 | 2016-05-10 | Макрокьюэ, Лтд. | Активированная иммуностимулирующая клеточная композиция, используемая для лечения инфекционных заболеваний |
EP2781224A1 (en) | 2013-03-18 | 2014-09-24 | Khorionyx | Implantable preparations comrpsing globin insoluble at physiological pH and serum for regeneration of tissues and treatment of wounds. |
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US4751001A (en) * | 1984-09-24 | 1988-06-14 | Becton Dickinson And Company | Blood partitioning apparatus |
JPH02167071A (ja) * | 1988-12-19 | 1990-06-27 | Terumo Corp | 非ヒト動物由来白血球系細胞の分離材、分離器および分離方法 |
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IL110195A (en) * | 1994-07-03 | 2003-10-31 | David Danon | Method and system for cultivating macrophages |
US6146890A (en) * | 1994-07-03 | 2000-11-14 | Danon; David | Method and system for cultivating macrophages |
US5837233A (en) * | 1995-03-17 | 1998-11-17 | University Of California | Method for treating tumors |
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RU2143685C1 (ru) * | 1998-05-19 | 1999-12-27 | Коган Александр Харитонович | Способ дифференциального подсчета гранулоцитов, моноцитов и лимфоцитов |
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AU2010220132B2 (en) | 2013-10-10 |
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KR101548783B1 (ko) | 2015-08-31 |
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IL214953A0 (en) | 2011-11-30 |
JP2012519681A (ja) | 2012-08-30 |
CA2754190A1 (en) | 2010-09-10 |
ES2428102T3 (es) | 2013-11-05 |
RU2548741C2 (ru) | 2015-04-20 |
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EP2650001A1 (en) | 2013-10-16 |
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ZA201107269B (en) | 2014-03-26 |
AU2010220132A1 (en) | 2011-10-13 |
EP2650001B1 (en) | 2016-09-07 |
DK2403509T3 (da) | 2013-09-16 |
BRPI1006759A2 (pt) | 2016-03-15 |
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