Inflammatory Bowel Diseases Clinical Trial
— ADcSVF-IBDOfficial title:
Use of Autologous Adult Adipose-Derived Stem/Stromal Cells in Inflammatory Bowel Disease
Verified date | August 2022 |
Source | Healeon Medical Inc |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Inflammatory Bowel Disease (IBD) is a group of inflammatory conditions of the small bowel and colon. Main types include Ulcerative Colitis and Crohn's Disease. Symptoms are often difficult to distinguish except for location and nature of changes. IBD complex arises with interaction of environmental, genetic factors, immunological responses, and chronic and recurring inflammation. Many factor appear as contributory, but no single set of issues appear to explain the process. Microbiota, intestinal wall granulation or breach, dietary, genetic predisposition all appear to factors. Treatment is often reactive or suppressive medications, neither of which appears to reverse the disease processes. This study explores the value of a complex group of adipose-derived stem/stromal cells (AD-cSVF) in the disease process.
Status | Enrolling by invitation |
Enrollment | 100 |
Est. completion date | June 19, 2025 |
Est. primary completion date | August 14, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 85 Years |
Eligibility | Inclusion Criteria: - Patients, either sex 18 years and older with confirmed diagnosis of IBD - Patients, either sex younger than 18 years upon approval of responsible parties and agreement of investigators - Ability of patient to provide informed consent (or legal guardian) - IBD diagnosed at least 6 months earlier to therapy using usual criteria - Negative pregnancy test for women of childbearing age (menarche to menopause) Exclusion Criteria: - Mental incapacity that prevents adequate understanding of study and associate procedures and providing informed consent - Severe IBD preventing tolerance of procedures needed - Patients with impaired systemic condition, according to investigator judgment, needs immediate corticosteroid or surgical intervention - Patients that fulfill criteria of cortico-dependency and in current treatment with corticosteroids - Patients with history of colectomy - Known history of alcohol, smoking dependence or additive substance abuse - History related malignant disease - including patients participating in clinical trial with investigational drug within 6 months - Patients with known history of allergies to any substance used in this protocol - Pregnant or breastfeeding females - Presence of severe concomitant disease, in investigators opinion threatens patient's well being or safety |
Country | Name | City | State |
---|---|---|---|
United States | Regenevita LLC | Stevensville | Montana |
Lead Sponsor | Collaborator |
---|---|
Healeon Medical Inc | Terry, Glenn C., M.D. |
United States,
Aroniadis OC, Brandt LJ. Fecal microbiota transplantation: past, present and future. Curr Opin Gastroenterol. 2013 Jan;29(1):79-84. doi: 10.1097/MOG.0b013e32835a4b3e. Review. — View Citation
Axelrad JE, Lichtiger S, Yajnik V. Inflammatory bowel disease and cancer: The role of inflammation, immunosuppression, and cancer treatment. World J Gastroenterol. 2016 May 28;22(20):4794-801. doi: 10.3748/wjg.v22.i20.4794. Review. — View Citation
Baumgart DC, Carding SR. Inflammatory bowel disease: cause and immunobiology. Lancet. 2007 May 12;369(9573):1627-40. Review. — View Citation
Baumgart DC, Sandborn WJ. Inflammatory bowel disease: clinical aspects and established and evolving therapies. Lancet. 2007 May 12;369(9573):1641-57. Review. — View Citation
Bennike T, Birkelund S, Stensballe A, Andersen V. Biomarkers in inflammatory bowel diseases: current status and proteomics identification strategies. World J Gastroenterol. 2014 Mar 28;20(12):3231-44. doi: 10.3748/wjg.v20.i12.3231. Review. — View Citation
Braat H, Peppelenbosch MP, Hommes DW. Immunology of Crohn's disease. Ann N Y Acad Sci. 2006 Aug;1072:135-54. Review. — View Citation
Broomé U, Bergquist A. Primary sclerosing cholangitis, inflammatory bowel disease, and colon cancer. Semin Liver Dis. 2006 Feb;26(1):31-41. Review. — View Citation
Cario E. Toll-like receptors in inflammatory bowel diseases: a decade later. Inflamm Bowel Dis. 2010 Sep;16(9):1583-97. doi: 10.1002/ibd.21282. Review. — View Citation
Casanova JL, Abel L. Revisiting Crohn's disease as a primary immunodeficiency of macrophages. J Exp Med. 2009 Aug 31;206(9):1839-43. doi: 10.1084/jem.20091683. Epub 2009 Aug 17. Review. — View Citation
Cenac N, Andrews CN, Holzhausen M, Chapman K, Cottrell G, Andrade-Gordon P, Steinhoff M, Barbara G, Beck P, Bunnett NW, Sharkey KA, Ferraz JG, Shaffer E, Vergnolle N. Role for protease activity in visceral pain in irritable bowel syndrome. J Clin Invest. 2007 Mar;117(3):636-47. Epub 2007 Feb 15. — View Citation
Charlebois A, Rosenfeld G, Bressler B. The Impact of Dietary Interventions on the Symptoms of Inflammatory Bowel Disease: A Systematic Review. Crit Rev Food Sci Nutr. 2016 Jun 10;56(8):1370-8. doi: 10.1080/10408398.2012.760515. Review. — View Citation
Clevers H. Inflammatory bowel disease, stress, and the endoplasmic reticulum. N Engl J Med. 2009 Feb 12;360(7):726-7. doi: 10.1056/NEJMcibr0809591. — View Citation
Colman RJ, Rubin DT. Fecal microbiota transplantation as therapy for inflammatory bowel disease: a systematic review and meta-analysis. J Crohns Colitis. 2014 Dec;8(12):1569-81. doi: 10.1016/j.crohns.2014.08.006. Epub 2014 Sep 13. Review. — View Citation
Coskun M. Intestinal epithelium in inflammatory bowel disease. Front Med (Lausanne). 2014 Aug 25;1:24. doi: 10.3389/fmed.2014.00024. eCollection 2014. Review. — View Citation
Dave M, Mehta K, Luther J, Baruah A, Dietz AB, Faubion WA Jr. Mesenchymal Stem Cell Therapy for Inflammatory Bowel Disease: A Systematic Review and Meta-analysis. Inflamm Bowel Dis. 2015 Nov;21(11):2696-707. doi: 10.1097/MIB.0000000000000543. Review. — View Citation
Del Pinto R, Pietropaoli D, Chandar AK, Ferri C, Cominelli F. Association Between Inflammatory Bowel Disease and Vitamin D Deficiency: A Systematic Review and Meta-analysis. Inflamm Bowel Dis. 2015 Nov;21(11):2708-17. doi: 10.1097/MIB.0000000000000546. Review. — View Citation
Dessein R, Chamaillard M, Danese S. Innate immunity in Crohn's disease: the reverse side of the medal. J Clin Gastroenterol. 2008 Sep;42 Suppl 3 Pt 1:S144-7. doi: 10.1097/MCG.0b013e3181662c90. Review. — View Citation
Elson CO, Cong Y, Weaver CT, Schoeb TR, McClanahan TK, Fick RB, Kastelein RA. Monoclonal anti-interleukin 23 reverses active colitis in a T cell-mediated model in mice. Gastroenterology. 2007 Jun;132(7):2359-70. Epub 2007 Apr 13. — View Citation
Feller M, Huwiler K, Schoepfer A, Shang A, Furrer H, Egger M. Long-term antibiotic treatment for Crohn's disease: systematic review and meta-analysis of placebo-controlled trials. Clin Infect Dis. 2010 Feb 15;50(4):473-80. doi: 10.1086/649923. Review. — View Citation
Ghouri YA, Richards DM, Rahimi EF, Krill JT, Jelinek KA, DuPont AW. Systematic review of randomized controlled trials of probiotics, prebiotics, and synbiotics in inflammatory bowel disease. Clin Exp Gastroenterol. 2014 Dec 9;7:473-87. doi: 10.2147/CEG.S27530. eCollection 2014. Review. — View Citation
Gilardi D, Fiorino G, Genua M, Allocca M, Danese S. Complementary and alternative medicine in inflammatory bowel diseases: what is the future in the field of herbal medicine? Expert Rev Gastroenterol Hepatol. 2014 Sep;8(7):835-46. doi: 10.1586/17474124.2014.917954. Epub 2014 May 12. Review. — View Citation
Hara AK, Leighton JA, Heigh RI, Sharma VK, Silva AC, De Petris G, Hentz JG, Fleischer DE. Crohn disease of the small bowel: preliminary comparison among CT enterography, capsule endoscopy, small-bowel follow-through, and ileoscopy. Radiology. 2006 Jan;238(1):128-34. — View Citation
Henckaerts L, Figueroa C, Vermeire S, Sans M. The role of genetics in inflammatory bowel disease. Curr Drug Targets. 2008 May;9(5):361-8. Review. — View Citation
Joos S, Brinkhaus B, Maluche C, Maupai N, Kohnen R, Kraehmer N, Hahn EG, Schuppan D. Acupuncture and moxibustion in the treatment of active Crohn's disease: a randomized controlled study. Digestion. 2004;69(3):131-9. Epub 2004 Apr 26. — View Citation
Kristo I, Stift A, Bergmann M, Riss S. Surgical recurrence in Crohn's disease: Are we getting better? World J Gastroenterol. 2015 May 28;21(20):6097-100. doi: 10.3748/wjg.v21.i20.6097. Review. — View Citation
Lalande JD, Behr MA. Mycobacteria in Crohn's disease: how innate immune deficiency may result in chronic inflammation. Expert Rev Clin Immunol. 2010 Jul;6(4):633-41. doi: 10.1586/eci.10.29. Review. — View Citation
Langhorst J, Wulfert H, Lauche R, Klose P, Cramer H, Dobos GJ, Korzenik J. Systematic review of complementary and alternative medicine treatments in inflammatory bowel diseases. J Crohns Colitis. 2015 Jan;9(1):86-106. doi: 10.1093/ecco-jcc/jju007. Epub 2014 Nov 28. Review. — View Citation
Mahadeva U, Martin JP, Patel NK, Price AB. Granulomatous ulcerative colitis: a re-appraisal of the mucosal granuloma in the distinction of Crohn's disease from ulcerative colitis. Histopathology. 2002 Jul;41(1):50-5. — View Citation
Maloy KJ, Powrie F. Intestinal homeostasis and its breakdown in inflammatory bowel disease. Nature. 2011 Jun 15;474(7351):298-306. doi: 10.1038/nature10208. Review. — View Citation
Marks DJ, Harbord MW, MacAllister R, Rahman FZ, Young J, Al-Lazikani B, Lees W, Novelli M, Bloom S, Segal AW. Defective acute inflammation in Crohn's disease: a clinical investigation. Lancet. 2006 Feb 25;367(9511):668-78. Erratum in: Lancet. 2007 Jul 28;370(9584):318. — View Citation
Marks DJ, Rahman FZ, Sewell GW, Segal AW. Crohn's disease: an immune deficiency state. Clin Rev Allergy Immunol. 2010 Feb;38(1):20-31. doi: 10.1007/s12016-009-8133-2. Review. — View Citation
Molodecky NA, Soon IS, Rabi DM, Ghali WA, Ferris M, Chernoff G, Benchimol EI, Panaccione R, Ghosh S, Barkema HW, Kaplan GG. Increasing incidence and prevalence of the inflammatory bowel diseases with time, based on systematic review. Gastroenterology. 2012 Jan;142(1):46-54.e42; quiz e30. doi: 10.1053/j.gastro.2011.10.001. Epub 2011 Oct 14. Review. — View Citation
Mowat C, Cole A, Windsor A, Ahmad T, Arnott I, Driscoll R, Mitton S, Orchard T, Rutter M, Younge L, Lees C, Ho GT, Satsangi J, Bloom S; IBD Section of the British Society of Gastroenterology. Guidelines for the management of inflammatory bowel disease in adults. Gut. 2011 May;60(5):571-607. doi: 10.1136/gut.2010.224154. Review. — View Citation
Naser SA, Sagramsingh SR, Naser AS, Thanigachalam S. Mycobacterium avium subspecies paratuberculosis causes Crohn's disease in some inflammatory bowel disease patients. World J Gastroenterol. 2014 Jun 21;20(23):7403-15. doi: 10.3748/wjg.v20.i23.7403. Review. — View Citation
Smart HL, Mayberry JF, Atkinson M. Alternative medicine consultations and remedies in patients with the irritable bowel syndrome. Gut. 1986 Jul;27(7):826-8. — View Citation
Thomas S, Baumgart DC. Targeting leukocyte migration and adhesion in Crohn's disease and ulcerative colitis. Inflammopharmacology. 2012 Feb;20(1):1-18. doi: 10.1007/s10787-011-0104-6. Epub 2011 Dec 20. Review. — View Citation
Trikudanathan G, Venkatesh PG, Navaneethan U. Diagnosis and therapeutic management of extra-intestinal manifestations of inflammatory bowel disease. Drugs. 2012 Dec 24;72(18):2333-49. doi: 10.2165/11638120-000000000-00000. Review. — View Citation
Walker MM, Murray JA. An update in the diagnosis of coeliac disease. Histopathology. 2011 Aug;59(2):166-79. doi: 10.1111/j.1365-2559.2010.03680.x. Epub 2010 Nov 3. Review. — View Citation
Wang GF, Ren JA, Liu S, Chen J, Gu GS, Wang XB, Fan CG, Li JS. Clinical characteristics of non-perianal fistulating Crohn's disease in China: a single-center experience of 184 cases. Chin Med J (Engl). 2012 Jul;125(14):2405-10. — View Citation
Yamamoto-Furusho JK, Korzenik JR. Crohn's disease: innate immunodeficiency? World J Gastroenterol. 2006 Nov 14;12(42):6751-5. Review. — View Citation
* Note: There are 40 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Safety: Inflammatory Bowel Disease | Inflammatory Bowel Disease to be addressed as occurrence or frequency of adverse event during study. Includes vital signs, complete blood count, and disease progression | 12 months Evaluate Function and Adverse Events | |
Secondary | Efficacy: Quality of life index , Inflammatory Bowel Disease Questionnaire(IBD-QoL) | Comparison of response if it improves at least 30% | 1 month, 6 month, 1 year | |
Secondary | Change from Baseline in C Reactive Protein (CRP) | Blood draw and laboratory measure of CRP as reflection of inflammatory baseline change | 0, 2 weeks, 8 weeks, 12 weeks | |
Secondary | Efficacy: Change in Baseline of Modified Truelove-Witts Score (MTW) | Remission is considered if below 11, and response if it diminishes at least 30% | 0, 4 weeks, 12 weeks | |
Secondary | Efficacy: Change in Baseline in Lichtiger Index | Remission considered if reaching 0 point, and response if the score diminishes from pretreatment level | 0, 12 weeks, 6 months |
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