Stem Cells Treatment for Extremely Complex Fistulae (HULPCIR)
2012年4月25日 更新者:Instituto de Investigación Hospital Universitario La Paz
A Phase IIa Clinical Trial to Study the Treatment of the Extremely Complex and Conventional Treatment Resistant Perianal Fistulae With Autologous Stem Cells From Lipoaspirate
The purpose of this study is to evaluate the practicability of the autologous e-ASC (Autologous Stem Cells) for the treatment of extremely complex and treatment resistant perianal fistulae.
研究概览
研究类型
介入性
注册 (预期的)
10
阶段
- 阶段2
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
学习联系方式
- 姓名:Damián García Olmo, Prof MD
- 电话号码:0034 912071022
- 邮箱:damian.garcia@uam.es
研究联系人备份
- 姓名:Mariano A García Arranz, PhD
- 电话号码:0034 912071022
- 邮箱:mgarciaa.hulp@salud.madrid.org
学习地点
-
-
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Madrid、西班牙、28046
- 招聘中
- Hospital Universitario La Paz
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接触:
- Mariano A García Arranz, PhD
- 电话号码:0034 912071022
- 邮箱:mgarciaa.hulp@salud.madrid.org
-
首席研究员:
- Damián García Olmo, Prof MD
-
副研究员:
- Héctor Guadalajara Labajo, MD
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副研究员:
- Tihomir G Hirstov, MD
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参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Signed informed consent
- Extremely Complex perianal fistulae
- Men and women over 18 years old. Good general state of health according to the findings of the clinical history and the physical examination
- Previous failure in at least one closing fistula standard treatment
Exclusion Criteria:
- Presence of severe proctitis or dominant active luminal disease requiring immediate therapy
- Patients with an abscess unless a complete toilet of the area with drainage of the collections and the absence of abscess and other collections is confirmed prior to treatment start
- Patients with a history of abuse of alcohol or other addictive substances in the 6 months prior to inclusion
- Patients with malignant tumor, except for basal cell or cutaneous squamous cell carcinoma, or patients with a prior history of malignant tumors, unless the neoplastic disease has been in remission for the previous 5 years
- Patients with cardiopulmonary disease which, in opinion of the investigator, in unstable or sufficiently serious to exclude the patient from the study.
- Patients with any type of medical or psychiatric disease which, in the opinion of the investigator, could be grounds for exclusion from study
- Patients with congenital or acquired immunodeficiencies. HIV, HBV, HCV or treponema infection, whether active or latent
- Patients who have suffering major surgery or severe trauma in the prior 6 months
- Pregnant or breastfeeding women
- Patients currently receiving, or having received within 1 month prior to enrollment into this clinical trial, any investigational drug
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:不适用
- 介入模型:单组作业
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
---|---|
实验性的:Autologous Stem Cells
|
施用将是病灶内注射细胞悬液。
它们将被放置在瘘管壁中
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Safety of treatment of extremely complex perianal fistulae. Percentage of treated extremely complex perianal fistulae and percentage of subjects with closed fistulae
大体时间:16 weeks
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Safety by control the adverse effects associated with treatment Fistula close by 3D ultrasound
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16 weeks
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
不良事件
大体时间:1、4、12、24 周
|
由 CRD 调查组控制(数据收集)
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1、4、12、24 周
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Quality of life assessment using the SF-12 Questionnaire
大体时间:1, 4, 16,24 weeks
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Test SF-12 of quality of life
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1, 4, 16,24 weeks
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员:Damián García Olmo, Prof MD、General Surgery Department (Hospital Universitario La Paz) and Cell Therapy laboratory
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Garcia-Olmo D, Garcia-Arranz M, Garcia LG, Cuellar ES, Blanco IF, Prianes LA, Montes JA, Pinto FL, Marcos DH, Garcia-Sancho L. Autologous stem cell transplantation for treatment of rectovaginal fistula in perianal Crohn's disease: a new cell-based therapy. Int J Colorectal Dis. 2003 Sep;18(5):451-4. doi: 10.1007/s00384-003-0490-3. Epub 2003 May 20.
- Garcia-Olmo D, Garcia-Arranz M, Herreros D, Pascual I, Peiro C, Rodriguez-Montes JA. A phase I clinical trial of the treatment of Crohn's fistula by adipose mesenchymal stem cell transplantation. Dis Colon Rectum. 2005 Jul;48(7):1416-23. doi: 10.1007/s10350-005-0052-6.
- Garcia-Olmo D, Herreros D, Pascual I, Pascual JA, Del-Valle E, Zorrilla J, De-La-Quintana P, Garcia-Arranz M, Pascual M. Expanded adipose-derived stem cells for the treatment of complex perianal fistula: a phase II clinical trial. Dis Colon Rectum. 2009 Jan;52(1):79-86. doi: 10.1007/DCR.0b013e3181973487.
- Aggarwal S, Pittenger MF. Human mesenchymal stem cells modulate allogeneic immune cell responses. Blood. 2005 Feb 15;105(4):1815-22. doi: 10.1182/blood-2004-04-1559. Epub 2004 Oct 19.
- Hellers G, Bergstrand O, Ewerth S, Holmstrom B. Occurrence and outcome after primary treatment of anal fistulae in Crohn's disease. Gut. 1980 Jun;21(6):525-7. doi: 10.1136/gut.21.6.525.
- García Olmo D, García-Verdugo JM, Alemany J, Gonzalez M, Gutierrez-Fuentes JA. CELL THERAPHY . Ed. Mac Graw Hill. Madrid 2007
- Bey NM. A new technique in dealing with superior rectovaginal fistulae. J. Obstrt Gynecol 1934. 41: 579-587
- Given FT Jr. Rectovaginal fistula. A review of 20 years' experience in a community hospital. Am J Obstet Gynecol. 1970 Sep 1;108(1):41-6. No abstract available.
- Daniels BT. Rectovaginal fistula: a clinical and pathological study. Doctoral dissertation. Minneapolis: University of Minnesota 1949
- LAIRD DR. Procedures used in treatment of complicated fistulas. Am J Surg. 1948 Dec;76(6):701-8. doi: 10.1016/s0002-9610(48)90211-6. No abstract available.
- Hoexter B, Labow SB, Moseson MD. Transanal rectovaginal fistula repair. Dis Colon Rectum. 1985 Aug;28(8):572-5. doi: 10.1007/BF02554145.
- Fry RD, Shemesh EI, Kodner IJ, Timmcke A. Techniques and results in the management of anal and perianal Crohn's disease. Surg Gynecol Obstet. 1989 Jan;168(1):42-8.
- Radcliffe AG, Ritchie JK, Hawley PR, Lennard-Jones JE, Northover JM. Anovaginal and rectovaginal fistulas in Crohn's disease. Dis Colon Rectum. 1988 Feb;31(2):94-9. doi: 10.1007/BF02562636.
- Tuxen PA, Castro AF. Rectovaginal fistula in Crohn's disease. Dis Colon Rectum. 1979 Jan-Feb;22(1):58-62. doi: 10.1007/BF02586761. No abstract available.
- Bandy LC, Addison A, Parker RT. Surgical management of rectovaginal fistulas in Crohn's disease. Am J Obstet Gynecol. 1983 Oct 15;147(4):359-63. doi: 10.1016/s0002-9378(16)32225-6.
- Bauer JJ, Sher ME, Jaffin H, Present D, Gelerent I. Transvaginal approach for repair of rectovaginal fistulae complicating Crohn's disease. Ann Surg. 1991 Feb;213(2):151-8. doi: 10.1097/00000658-199102000-00010.
- Tsang CB, Madoff RD, Wong WD, Rothenberger DA, Finne CO, Singer D, Lowry AC. Anal sphincter integrity and function influences outcome in rectovaginal fistula repair. Dis Colon Rectum. 1998 Sep;41(9):1141-6. doi: 10.1007/BF02239436.
- Andreani SM, Dang HH, Grondona P, Khan AZ, Edwards DP. Rectovaginal fistula in Crohn's disease. Dis Colon Rectum. 2007 Dec;50(12):2215-22. doi: 10.1007/s10350-007-9057-7. Epub 2007 Sep 11.
- Puissant B, Barreau C, Bourin P, Clavel C, Corre J, Bousquet C, Taureau C, Cousin B, Abbal M, Laharrague P, Penicaud L, Casteilla L, Blancher A. Immunomodulatory effect of human adipose tissue-derived adult stem cells: comparison with bone marrow mesenchymal stem cells. Br J Haematol. 2005 Apr;129(1):118-29. doi: 10.1111/j.1365-2141.2005.05409.x.
- Tse WT, Pendleton JD, Beyer WM, Egalka MC, Guinan EC. Suppression of allogeneic T-cell proliferation by human marrow stromal cells: implications in transplantation. Transplantation. 2003 Feb 15;75(3):389-97. doi: 10.1097/01.TP.0000045055.63901.A9.
- Chamberlain G, Fox J, Ashton B, Middleton J. Concise review: mesenchymal stem cells: their phenotype, differentiation capacity, immunological features, and potential for homing. Stem Cells. 2007 Nov;25(11):2739-49. doi: 10.1634/stemcells.2007-0197. Epub 2007 Jul 26.
- Le Blanc K, Ringden O. Immunobiology of human mesenchymal stem cells and future use in hematopoietic stem cell transplantation. Biol Blood Marrow Transplant. 2005 May;11(5):321-34. doi: 10.1016/j.bbmt.2005.01.005.
- Maccario R, Podesta M, Moretta A, Cometa A, Comoli P, Montagna D, Daudt L, Ibatici A, Piaggio G, Pozzi S, Frassoni F, Locatelli F. Interaction of human mesenchymal stem cells with cells involved in alloantigen-specific immune response favors the differentiation of CD4+ T-cell subsets expressing a regulatory/suppressive phenotype. Haematologica. 2005 Apr;90(4):516-25.
- Barrett AJ, Rezvani K, Solomon S, Dickinson AM, Wang XN, Stark G, Cullup H, Jarvis M, Middleton PG, Chao N. New developments in allotransplant immunology. Hematology Am Soc Hematol Educ Program. 2003:350-71. doi: 10.1182/asheducation-2003.1.350.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2012年3月1日
初级完成 (预期的)
2013年5月1日
研究完成 (预期的)
2013年12月1日
研究注册日期
首次提交
2012年4月23日
首先提交符合 QC 标准的
2012年4月25日
首次发布 (估计)
2012年4月27日
研究记录更新
最后更新发布 (估计)
2012年4月27日
上次提交的符合 QC 标准的更新
2012年4月25日
最后验证
2012年4月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.