Allogeneic Adipose Tissue-derived Mesenchymal Stem Cells for the Induction of Remission in Ulcerative Colitis

NCT01914887 | Unknown Phase 1

• 2 other identifiers: HLPDIG-2010-012010-023798-20
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

The aims of our study are to evaluate the feasibility and safety of endoscopic injection of adipose tissue-derived mesenchymal stem cells in human subjects with moderate active ulcerative colitis, assessing the absence of adverse events associated to the investigational drug, and to evaluate the efficacy of the treatment to induce remission of moderate active ulcerative colitis, by improvements in disease activity index, quality of life index, and endoscopic index.

Conditions

Ulcerative Colitis

Keywords

Ulcerative Colitis; Inflammatory Bowel Disease; Mesenchymal stem cells

Outcome Measures

Primary Outcomes (1)

• Safety

  Evaluation of the presence of any event that could be considered adverse event, especially if it can be attributed to the investigational drug. Physical exam, vital signs, and laboratory tests (hemogram, biochemistry, coagulation, and cytokines) will be performed at 0, 9-10 days, and 4, 8, and 12 weeks.

  Up to 12 weeks

Secondary Outcomes (5)

• Efficacy: Change from Baseline in Modified Truelove-Witts score

  Up to 12 weeks

• Efficacy: Change from Baseline in Quality of Life index, Inflammatory Bowel Disease Questionnaire (IBDQ-32)

  Up to 12 weeks

• Efficacy: Change from baseline in Mayo endoscopic index.

  8 weeks

• Change from Baseline in C Reactive Protein

  Up to 12 weeks

• Change from Baseline in fecal calprotectin

  Up to 12 weeks

Study Arms (1)

allogeneic ASCs

EXPERIMENTAL

Treatment consists in a cell suspension (5 million cells/mL) in aseptic buffered solution containing human expanded adipose-derived stem cells (eASCs) of allogeneic origin in disposable vials with no preservative agents. The cells will be given in different sites within the affected colonic submucosa at a total dose of 60 million cells with the use of a colonoscope.

Drug: Allogeneic adipose tissue-derived mesenchymal stem cells

Interventions

Allogeneic adipose tissue-derived mesenchymal stem cells DRUG

The cells will be given in different sites within the affected colonic submucosa at a total dose of 60 million cells with the use of a colonoscope.

Also known as: Cx-601 (company code)

allogeneic ASCs

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients of either sex aged 18 years and older
• Signed informed consent
• Patients with ulcerative colitis diagnosed at least 6 months earlier in accordance with usual criteria
• Left-sided colitis with moderate activity defined by a modified Truelove-Witts score between 11 and 21, and with no response to 4 weeks of treatment with oral and/or topical 5-aminosalicylates
• Negative pregnancy test for women of childbearing potential (from menarche to menopause) using consistently and correctly highly effective (i.e. less than 1% failure rate per year) methods of birth control

You may not qualify if:

• Mental disability that impedes adequate understanding of the study and of the associated procedures
• Extensive colitis
• Patients with an impaired general state which requires, according to the investigator judgment, immediate treatment with corticosteroids and/or anti-Tumor Necrosis Factor (TNF) and/or surgery
• Patients that fulfill criteria of corticodependency and in ongoing treatment with corticosteroids
• Patients with previous colectomies
• Known history of alcohol or other addictive substances abuse
• History of malignant disease - Patients having participated in clinical trials with any investigational drug within 6 months prior to enrolment in this study
• Patients with known allergies to penicillin, gentamicin, aminoglycosides, human serum albumin (HSA), Dulbecco's modified Eagle medium (DMEM), or materials of bovine origin
• Pregnant or breastfeeding women
• Presence of severe concomitant diseases
• Patients with suspicion of Crohn?s enterocolitis, indeterminate colitis, ischaemic colitis, radiation colitis, diverticular disease associated colitis, or microscopic colitis

Sponsors & Collaborators

• Instituto de Investigación Hospital Universitario La Paz: lead
• Fundacion para la Investigacion Biomedica del Hospital Universitario la Paz: collaborator
• Ministry of Health, Spain: collaborator

Study Sites (1)

Hospital Universitario La Paz

Madrid, 28046, Spain

RECRUITING

Related Publications (3)

• Garcia-Gomez I, Elvira G, Zapata AG, Lamana ML, Ramirez M, Castro JG, Arranz MG, Vicente A, Bueren J, Garcia-Olmo D. Mesenchymal stem cells: biological properties and clinical applications. Expert Opin Biol Ther. 2010 Oct;10(10):1453-68. doi: 10.1517/14712598.2010.519333.

  PMID: 20831449 BACKGROUND

• Duijvestein M, Vos AC, Roelofs H, Wildenberg ME, Wendrich BB, Verspaget HW, Kooy-Winkelaar EM, Koning F, Zwaginga JJ, Fidder HH, Verhaar AP, Fibbe WE, van den Brink GR, Hommes DW. Autologous bone marrow-derived mesenchymal stromal cell treatment for refractory luminal Crohn's disease: results of a phase I study. Gut. 2010 Dec;59(12):1662-9. doi: 10.1136/gut.2010.215152. Epub 2010 Oct 4.

  PMID: 20921206 BACKGROUND

• van Deen WK, Oikonomopoulos A, Hommes DW. Stem cell therapy in inflammatory bowel disease: which, when and how? Curr Opin Gastroenterol. 2013 Jul;29(4):384-90. doi: 10.1097/MOG.0b013e328361f763.

  PMID: 23666365 BACKGROUND

MeSH Terms

Conditions

Colitis, Ulcerative; Inflammatory Bowel Diseases

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Colonic Diseases; Intestinal Diseases

Study Officials

• Maria Dolores Martin Arranz, MD

  Gastroenterology Department

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maria Dolores Martin Arranz, MD

CONTACT

+34 917277467; mmartinarranz@salud.madrid.org

Fernando de Miguel, PhD

CONTACT

+34 917277389; fernando.demiguel@salud.madrid.org

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 18, 2013
• First Posted: August 2, 2013
• Study Start: June 1, 2013
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: August 2, 2013

Record last verified: 2013-07

Locations

ES (1)